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american national standard - American Society of Safety Engineers

1. Verification Confirmation through the provision of objective evidence that specified requirements have been fulfilled Veterinary staff at ABSL 3 facilities Individuals who are appropriately trained and licensed to protect the health and safety of laboratory animals by performing animal husbandry and veterinary care Vivarium Latin literally for place of life plural vivaria or vivariums 1 Usually an enclosed area for keeping and raising animals or plants for observation or research 2 often a portion of the ecosystem for a particular species is simulated on a smaller scale with controls for monitoring and maintaining environmental conditions Volumetric air flow rate The rate of airflow expressed in terms of volume cubic feet or liters per unit of time Airflow is commonly expressed as cubic feet per minute cfm in U S customary system units USCS units or liters per second L s in International System of Units SI units 5 APPLICABILITY AND CONFORMANCE 5 1 Applicability This standard applies specifically to new or existing Biosafety Level 3 BSL 3 and Animal Biosafety Level 3 ABSL 3 laboratories and insectaries This standard also applies to the aforementioned facilities if there has been a renovation change of use or decommissioning This standard applies to verification and testing of ventilation system components of any laboratory that is designed for working with age
2. National Air Filtration NAFA Guide to Air Filtration Washington DC NAFA 1993 American National Standards Institute ANSI AIHA Z9 3 2007 Spray Finishing Operations Safety Code for Design Construction and Ventilation New York ANSI Available at http webstore ansi org default aspx UbO3AiqF_uQ Accessed June 8 2013 American National Standards Institute ANSI ASSE Z9 9 2010 Portable Ventilation Systems New York ANSI Available at http webstore ansi org default aspx UbO3AiqF_uQ Accessed June 8 2013 American National Standards Institute ANSI Z9 4 Exhaust Systems Abrasive Blasting Operations Ventilation and Safe Practice Available at http webstore ansi org default aspx UbO3AiqF_uQ Accessed June 8 2013 24 25 26 27 28 29 30 31 32 33 34 35 AMERICAN NATIONAL STANDARD 29 14 2014 American National Standards Institute ANSI ISA S7 0 01 Quality Standard for Instrument Air Available at http webstore ansi org default aspx UbO3AiqF_uQ Accessed June 8 2013 Association for Assessment and Accreditation of Laboratory Animal Care AAALAC Guide for the Care and Use of Animals Washington DC National Academies Press 2011 Available at http www aaalac org resources theguide cfm Accessed June 11 2013 Federal Register Americans With Disabilities Act Revised ADA Regulations Implementing Title II and Title III published September 15 2010 taking
3. 69 AMERICAN NATIONAL STANDARD Z29 14 2014 Canopy thimble connected Class II biosafety cabinets e Verify that air currents from door swings and the ventilation system do not interfere with air capture at the sash opening by testing with smoke or other visual indicator e Verify inward flow at the gap of the canopy thimble connection with smoke or other visual indicator No smoke should return to the room once it enters through the gap under normal operation of the ventilation system e Verify that loss of inflow air at the canopy connection generates a local audible and visual alarm as required by NSF 49 section 5 23 4 Hard ducted Class II or Ill biosafety cabinets e Test and verify that the exhaust flow is within the acceptable airflow range provided by the manufacturer of the Class Il and Class III BSCs e For Class II BSCs verify that the supply fan interlock generates audible and visual alarms at a reduced exhaust volume of 20 within 15 seconds and that the internal cabinet fan is interlocked to shut off at the same time the alarm is activated e For Class Ill BSCs if the cabinet is 70 AMERICAN NATIONAL STANDARD 29 14 2014 exhausted by a dedicated system that is separate from the room s general exhaust ensure that when the cabinet exhaust is shut off a visual and audible alarm is activated and the room ventilation system adjusts for the reduction of flow from the Class Ill BSC
4. ANSI Z9 14 provides recommendations for testing methodologies guidance on the ventilation system components that should be inspected visually and what is needed to verify that the system components operate such that the overall system s performance i e directional inward airflow response to failures minimizing leakage etc can be verified to ensure safe operation of the facility s ventilation system A verification program needs to consider and compare federal state and local regulations for future use best practices and organizational requirements This standard provides the user with e Testing standardization uniformity and consistency through the use of minimal performance based testing and verification methodologies for BSL 3 ABSL 3 ventilation systems e Technical background and information that addresses the engineering and associated systems for ventilation within a BSL 3 ABSL 3 laboratory using the many tenants of a risk assessment and performance based approach that is fully compatible with biorisk management systems and national and international health and safety management systems without duplicating or contradicting their requirements e Risk assessment guidance and methodologies to identify hazards that can be evaluated in terms of the likelihood that a problem may occur and AMERICAN NATIONAL STANDARD 29 14 2014 the damage from such an event that may occur e The collective knowledge of biosa
5. During a risk assessment hazards are evaluated in terms of the likelihood that a problem may occur and the damage and or consequences it would cause if such an event did occur The Hazard Risk Matrix can be used to record a risk rating for each hazard in the terms high medium and low To use the assessment several concepts must be understood e Hazard Any situation that has potential to cause damage or exposure to people animals or the environment e Probability Likelihood that the particular hazard will result in a possible release damage or exposure at this location e Severity An estimation of how serious the potential problem might be in terms of harm to people animals the environment or damage to property Sample Risk Matrix Example 1 This risk matrix has been designed and adapted from the Australia New Zealand Standard for Risk Management AS NZS 4360 2004 The risk priority rating on this matrix is represented by an alphabetical code as the key below outlines Consequences Likelihood Key to the risk rating E Extreme risk Immediate action required this level of risk needs detailed research and planning by senior management 117 AMERICAN NATIONAL STANDARD Z29 14 2014 High risk Action plan is required as soon as practicable by senior management Moderate risk Action plan is required by Area Department Manager Low risk Managed by routine procedur
6. suppression water supply and waste pipe penetrations sleeving seals window door frames light framing 105 AMERICAN NATIONAL STANDARD Z29 14 2014 106 seals to wall ceiling systems HVAC air devices and other penetrations Confirm components are secure to maintain integrity of penetrations Use small inspection mirrors to aid visualization of hard to reach areas Confirm visual inspections using smoke or soap bubbles as appropriate Leaks can be visualized by smoke movement or bubble formation at the failure point Room pressures negative during leak finding tests can range from normal operating pressures to higher values e g twice the normal value as appropriate based on factors such as room construction HVAC controls and the ability to shut down BSL 3 ABSL 3 operations for testing Additional test methods may be appropriate for initial commissioning of new construction and or renovations such as e Operating the room at higher differential pressure values for the smoke bubble tests e g up to 2 w g 500 Pa Testing at this pressure may be useful in conjunction with HVAC controls testing e Room porosity tests using airflow pressure testing equipment similar to that used for duct leak testing e Verify when the BSL 3 ABSL 3 space is in decontamination fumigation mode e g with the ventilation system off that AMERICAN NATIONAL STANDARD 29 14 2014 decontamination age
7. e The magnitude and duration of the event e The relative risk of activities in the adjacent spaces e Engineering and administrative controls in place during the event e Use of primary containment devices and personal protective equipment Test Purpose and Methodology Purpose of Test To verify that reversal of airflow from BSL 3 ABSL 3 laboratories during HVAC system failure conditions is minimized and in accordance with the acceptance criteria established in the risk assessment This standard addresses escape of potentially contaminated air from the containment barrier of a BSL 3 ABSL 3 facility Site specific criteria related to reversals within the containment barrier should be stipulated in the facility risk assessment For reversals within the containment barrier criteria for sequences and events that occur more frequently e g a total power outage that might typically happen a few times a year should be more stringent than for events that are likely to happen much less frequently e g the tripping of a breaker that serves multiple exhaust fans Site specific acceptance criteria for higher risk 61 AMERICAN NATIONAL STANDARD Z29 14 2014 62 laboratories should be more stringent than for lower risk laboratories In addition to empirical testing e g using smoke or tracer gases of representative failure conditions numerical simulation e g computational fluid dynamics or other numerical method
8. initially 5 Supply fan failure of system serving adjacent areas initially 6 Exhaust fan failure of system serving adjacent areas initially 7 Single supply or exhaust system controller failure serving the BSL 3 ABSL 3 initially 8 Loss of communications on the BAS control local area network LAN initially 65 AMERICAN NATIONAL STANDARD Z29 14 2014 66 9 Controller power circuit trip initially 10 Failure of UPS output breaker or batteries for power to BAS initially 11 Duct static pressure sensor failure initially 12 Failure of automated bio seal damper loss of signal or power source to it initially 13 Failure of air terminal unit controlling airflow to the BSL 3 ABSL 3 zone initially 14 Closure of local fire smoke dampers initially If no reversal desired airflow is accomplished in empirical testing a numerical testing methodology may be used to evaluate the potential risk By using a numerical testing methodology the amount of air displacement and contaminant leakage that might occur during a power outage which may result in a momentary positive pressure reversal in a BSL 3 facility can be calculated The ultimate goal in design and operation of a BSL 3 facility is to achieve sustained directional airflow such that under failure conditions the airflow will not be reversed A numerical methodology should be applied when and only when all other measures to achieve zer
9. 3 ABSL 3 facilities can be interpreted to mean that air should flow from outside the BSL 3 ABSL 3 space to the space s inside the BSL 3 ABSL 3 facility where there is the highest probability of airborne contamination This flow mitigates the risk of airborne contaminants escaping the BSL 3 ABSL 3 facility A BSL 3 ABSL 3 facility should be evaluated as a whole i e an integrated system of HVAC elements as well as doors and other architectural features and in the context of the facility specific risk assessment when being evaluated with respect to this criterion The foundation for directional airflow testing should be to demonstrate that air originating from spaces that have the highest probability of airborne contamination will not escape the BSL 3 ABSL 3 facility s containment barrier If that cannot be demonstrated then the facility s risk assessment should address the relative risk associated with such escape and include a determination of HVAC systems shall be tested and documented for directional airflow during normal operations before initial operation periodically thereafter annually or as determined by facility specific risk assessment and after any significant alterations of the ventilation system or other alterations that can affect it Other systems equipment that impact directional airflow under normal operating conditions shall be tested so that directional airflow can be demonstrated AME
10. 8 3 10 Visual Inspection Special Considerations for PB SUS oF AG IES o icar nae E E 53 8 4 Testing Ventilation and Associated Systems General Requirements 000 eee ceceeeeeeeeeeee eee ceeeeeeeeeeeeeeeeeeaaaeeeeeeesesaaaanseeeeetes 54 8 4 1 Testing for Directional Airflow During Normal Operation 56 8 4 2 Testing for Directional Airflow During System Failures 60 8 4 3 Testing for ANICOOMS veniciicscincetionicesteeiecnedontsratveneencoanens 67 8 4 4 Testing of Primary Containment Equipment 5 69 8 4 5 Testing of Heating Ventilating and Air Conditioning HVAC System and Controls cccccccceeeeeeeeeeeeeeeeees 74 8 4 6 Testing of Electrical Systems Related to Heating Ventilating and Air Conditioning HVAC 92 8 4 7 Testing of High Efficiency Particulate Air HEPA Filters 97 8 4 8 Testing of Ductwork and Room Air Leakage 0 103 8 4 9 Testing of Specialized Heating Ventilating and Air Conditioning HVAC Components of ABSL 3 Facilities 107 8 4 10 Testing of Heating Ventilating and Air Conditioning HVAC Systems of Containment Support Areas 111 Appendices eee 113 A Corrective Action Plan CAP and Template 0 cccceeeeeeseeeeeees 113 B Factors to Consider in Performing a Risk Assessment 066 115 C Hazard Risk Matix cticrssznnticroutatexnsntacncuiedbencunniiadaiasninenbdverteontsenpiaacertce 117 D How to Compile a Standard Operating P
11. BAS system subsystems and determine that UPS operates to provide power to the BAS for the intended time If emergency generators exist they should be tested on a weekly monthly basis and have results recorded and retained Documentation Test documentation should include results of each test conducted and results of weekly monthly generator tests 8 4 7 Testing of High Efficiency Particulate Air HEPA Filters Test Purpose and Methodology Purpose of Test To verify HEPA filter leakage in situ Recommended Methodology 1 Provide a list of all the HEPA filters associated with each lab and their factory tested efficiencies plus the test certificate for each This includes all necessary calibration documentation associated with test instrumentation 2 All HEPA filters should be factory tested 3 Ultra low particulate air super ULPA ULPA SULPA filters should be tested following manufacturing 97 AMERICAN NATIONAL STANDARD Z29 14 2014 98 10 recommendations and the local SOP Each HEPA ULPA SULPA filter test should be tested upon installation annually or more often based on the owner s SOP Filters should be decontaminated prior to testing based on a risk assessment Follow the site specific SOP for decontamination and test procedures If the HEPA filter is placed inside a filter housing that could not be isolated for decontamination and testing all potentially contaminated duct work
12. Check for proper quantities alignment and tension e Check maintenance records and logs Belt guards e Check for presence of belt guard Bearings e Check for abnormal noise e Check maintenance records and logs for lubrication Motor operating temperatures within equipment specifications e Check maintenance records and logs VFDs and motor controls e Check for proper installation in appropriate NEMA enclosure e Check for operation within range of nameplate full load current e Check for power and control wiring installed in raceways and protected from physical damage Dampers and Controls e Check for condition of dampers corrosion of damper components condition of actuators linkages wiring and or pneumatic tubing to actuators etc Duct supports and connections e Verify that ductwork is supported at proper intervals to prevent failure or damage to ductwork Supply HEPA filter housings and filters where provided refer to section 8 3 8 Visual Inspection of High Efficiency AMERICAN NATIONAL STANDARD 29 14 2014 Particulate Air HEPA Filters 15 Supply bio seal dampers where provided e Check for condition of dampers corrosion of damper components flanges and connections gaskets for visible damage condition of actuators linkages wiring and or pneumatic tubing to actuators etc 16 Proper access for equipment and system maintenance e Verify in field 17 Verify that the areas that house the HVAC a
13. Door closers should be of sufficient strength to overcome pressures between adjacent spaces 2 Verification of door interlock e f provided with electrically controlled door interlocks test whether each door remains locked while the other is opened Verify operation of emergency over rides of locks e If electrically controlled door 67 AMERICAN NATIONAL STANDARD Z29 14 2014 68 interlocks are not provided verify the presence of other controls e g signage SOPs the presence of more than two doors in series including windows in doors that will sufficiently mitigate the risk of an overall loss of directional airflow when two doors are opened simultaneously 3 Verification of alarms associated with non closed doors if provided e Test each door for duration of door opening and associated alarm function 4 Verification of door switches linked to air valves or bubble tight dampers if provided e Test function of switches by monitoring the valve damper operation with respective door switch position 5 Testing for directional airflow should allow visible verification of smoke whether the door is closed or partially opened Refer to section 8 4 1 for more information Documentation Results of the tests should be documented and filed appropriately Test documentation should be retained based on the document retention policy specific for each facility 8 4 4 Testing of Primary Containment Equi
14. Michael Pentella Barbara Fox Nellis Basler and Hofmann Singapore Pte Ltd Biosafety Biosecurity International Carleton University Controlled Environment Testing Association CETA Council Rock Consulting Inc World BioHazTec Corp Det Norske Veritas DNV ENV Services Inc Facilities Dynamics Engineering Facility Systems Consultants Jacobs Consultancy Jonathan Richmond and Assoc Inc Lieber Institute for Brain Development Massachusetts Institute of Technology MIT Merrick and Company National Energy Management Institute NEMI National Institutes of Health Division of Occupational Health and Safety National Institutes of Health National Cancer Institute National Institutes of Health Office of Infrastructure Programs Sanofi Aventis SCB Compose Texas A amp M University System U S Centers for Disease Control and Prevention CDC U S Department of Agriculture Agricultural Research Services USDA ARS U S Department of Health and Human Services DHHS U S Department of Homeland Security DHS University of California Irvine University of Louisville University of Pittsburgh University of Texas Health Science Center at Houston University of Texas Medical Branch UTMB Felix Gmuender Barbara Johnson Nancy Delcellier Marc DuBois Kenneth Mangis Ted Traum Stephen McAdam Cary R Binder Lon Brightbill Jason Cohen Jeffrey L Schantz Jonathan Richmond Deborah M Barnes Michael Labosky
15. airflow should be evaluated for the entire laboratory suite as a system taking into account the presence of anterooms or other double door configurations and operating conditions Recommended Methodology Directional airflow testing can be achieved by one of several methods such as 1 Smoke testing 2 Validating pressure or airflow monitors 3 Verifying tell tale visual signs such as thin lightweight materials 4 Audible testing devices 5 Tracer gases such as sulfur hexafluoride helium or carbon dioxide fragrances e g peppermint and theatrical fogs Although one method is not preferred over others the laboratories should be tested and verified for proper performance The above tests are suitable for verifying instantaneous performance of the ventilation system To verify steady state performance over a period of time the following methods or equivalent should be considered AMERICAN NATIONAL STANDARD 29 14 2014 1 Historical trend log records from BAS 2 Other forms of historical logs maintained in accordance with the facility SOP 3 Log of differential pressure across doors for a minimum of time that reflects the test period and any influence that disturbs the stabilization of the pressures with data logged at less than 5 second intervals using calibrated portable differential pressure meters 4 Visual observation of airflow direction at doorways using a visual indicator e g tell t
16. and subsequent modifications made thereafter Pre testing Preparations Testing should be coordinated with relevant stakeholders such as contractors BSO facility manager third party testing agents laboratory technicians etc following established SOPs as applicable e Verify readiness of HVAC systems to be tested Ensure sealing and AMERICAN NATIONAL STANDARD Z29 14 2014 pressure integrity of the lab is per operational intent Confirm penetrations are sealed and not degraded refer to section 8 4 8 Confirm doors are aligned as required and latch properly Confirm all door seals and sweeps are maintained and in proper order Confirm all traps are sealed or full including floor drains sink drains ice machine drains etc Example tests may include Airflow rates and air change rates Airflow offsets Room differential pressure range Directional airflow Temperature and humidity requirements Exhaust air stack discharge velocity Fire alarm and HVAC integration BAS and related control alarm functions Peak HEPA filter loads Redundancy capacity requirements Frequency of Testing Baseline performance verification testing is necessary prior to initiation of laboratory operations and periodically thereafter All operational parameters should be verified thoroughly for proper functionality during baseline testing 75 AMERICAN NATIONAL STANDARD Z29 14 2014 8 4 5 1 A test to establish the baseline paramete
17. and or any of your directors officers employees representatives agents or contractors 4 LIMITATION OF LIABILITY a You acknowledge that each of ASSE and Owner s obligations and liabilities with respect to the Product are exhaustively defined in this Agreement You are responsible for the consequences of any use of any of the Product whether or not such use was consistent with the license granted hereunder created therefrom Whether or not ASSE or Owner has been advised of their possibility neither ASSE nor Owner nor any of its representatives or agents directors officers employees agents representatives or members shall be liable whether under contract tort including negligence or otherwise for any indirect special punitive incidental or consequential loss damage cost or expense of any kind whatsoever and howsoever caused that may be suffered by you or any of your directors officers employees agents representatives or contractors or any third party b If at any time an allegation of infringement of any rights of any third party is made or in ASSE or Owner s opinion is likely to be made with respect to any of the Product ASSE may at its option and at its own expense i obtain for you the right to continue using the Product ii modify or replace the Product or any portion thereof so as to avoid any such claim of infringements or iii refund to you the License Fee ASSE shall have no liability to you if any claim of i
18. associated with the housing care and manipulation of animals with BSL 3 agents Caging systems used in ABSL 3 can have a direct impact on the in situ ventilation system performance IVC racks used in an ABSL 3 vary in design and function by manufacturer Sealed IVC systems operated under negative pressure are considered to be primary containment equipment Such systems exhaust cage air through the cage and or rack to external or internal HEPA filters Some IVC rack systems used in an ABSL 3 use cages that are operated under negative pressure but are not sealed and may afford less protection under failure conditions Specific risk assessment for each facility should include considerations of animals agents equipment caging type and conditions under both normal and failure mode scenarios ABSL 3 rooms that use IVC systems should integrate the ventilation requirements of the IVC manufacturer with the in situ ventilations systems The ABSL 3 room should consider the following testing criteria in addition to BSL 3 requirements Recommended Methodology 1 Animal room ventilation design and test criteria should meet AMERICAN NATIONAL STANDARD 29 14 2014 containment directional airflow and pressurization needs and meet Institute of Laboratory Animal Research ILAR requirements for air change rates and thermal humidity requirements 2 IVC systems that are connected to in situ ventilation systems should be tested for p
19. control approaches pressurized fire shafts etc Each facility must therefore have a dedicated fire testing plan to ensure that the function and response of ventilation systems during fire alarm conditions are known to management and incorporated into the SOP and risk assessment Testing entity should in collaboration with the responsible authorities test fire alarm procedures and potential impact on containment operations List all adverse fire protection and containment implications and ensure SOPs address the containment implications Testing entity should review project design documents and in particular the control sequence of operations and if necessary consult with facility 81 AMERICAN NATIONAL STANDARD Z29 14 2014 82 management and the local AHJ to determine what pertinent guidelines and standards have been adopted as code or waivers For example National Fire Protection NFPA standards 45 NFPA 90A and NFPA 105 have implications that can directly affect required ventilation operation and fire protection response Inspect and test to ensure fire protection approaches will not pose unacceptable risks to containment e g ensure no smoke dampers have been installed in the exhaust system The following testing should be considered 1 Initiate fire alarm outside of containment initially and as otherwise required e Confirm that in case of a fire alarm initiated outside the
20. effect on March 15 2011 updated November 15 2010 2010 ADA Standards for Accessible Design Available at http www ada gov index html Accessed June 9 2013 American National Standards Institute ANSI ASHRAE 110 1995 Method of Testing Performance of Laboratory Fume Hoods Available at http webstore ansi org RecordDetail aspx sku ANSI 2FASHRAE 110 1995 UVYBBBw3uQw Accessed June 9 2013 National Environmental Balancing Bureau NEBB Procedural Standards for Testing Adjusting and Balancing of Environmental Systems 7th ed Gaithersburg MD NEBB 2005 Available at http www nebb org assets 1 7 PST_TAB_2005 pdf Accessed June 9 2013 Associated Air Balance Council AABC Home page Available at http www aabc com Accessed June 9 2013 National Fire Protection Association NFPA NFPA 45 2009 Standard on Fire Protection for Laboratories Using Chemicals Available at http www nfpa org categoryList asp categoryID 24andURL Codes 20and 20Standardsandc ookie_test 1 Accessed June 9 2013 National Fire Protection Association NFPA NFPA 90A Standard for the Installation of Air Conditioning and Ventilating Systems Available at http www nfpa org categoryList asp categoryID 24andURL Codes 20and 20Standardsandc ookie_test 1 Accessed June 9 2013 National Fire Protection Association NFPA NFPA 105 Standard for Smoke Door Assemblies and Other Opening Protective Testing Available at http www
21. focuses on performance verification of ventilation system engineering controls and related systems within a BSL 3 ABSL 3 laboratory Testing and verification of ventilation systems in BSL 3 ABSL 3 labs include e Supply e Exhaust e Directional airflow e Biosafety cabinets e Air filtration e Exhaust stacks e Fan failure scenarios e Redundancy e Canopy hoods autoclaves e Specific ABSL 3 requirements Testing and verification of related systems within BSL 3 ABSL 3 labs include e Optimizing maintenance of pressure gradients and maintaining temperature and humidity e Physical integrity e Sealing and leakage factors e Interlocking systems e Airlocks e Doors windows e Emergency and backup power systems e Alarms e Operating sequences 4 DEFINITIONS Acceptance criteria The indicators and agreed upon requirements established by project stakeholders standard setting authorities the institution occupants etc to determine when a space or component of a facility e g a laboratory ventilation system is adequate or meets design criteria and intent Animal biosafety level 3 ABSL 3 A level of laboratory containment that is suitable for work with laboratory animals infected with indigenous or exotic agents agents that present a potential for aerosol transmission and agents causing serious or potentially lethal disease ABSL 3 containment builds on the standard practices procedures containment equip
22. given facility should be made based on site specific conditions and risk assessment T 10 11 12 13 14 15 Identify the personnel needed to test the facility Provide a written test procedure for each test to be conducted State the acceptance criteria for each test to be conducted and the basis for those criteria Provide a drawing of the laboratory showing where directional airflow pressure differential meters are to be located Provide a simplified schematic of directional airflows across doors into and within the containment zone Provide a simplified schematic of the ventilation system Provide a simplified schematic of the normal and emergency power systems State safety precautions to be taken pertaining to the testing to include a safety briefing requirement Address security issues and notifications Address verifications of alarms generated by the failures scenarios Provide a list of test equipment Provide documentation of the most recent calibration certificates of the test equipment used Address building occupant notifications Provide a testing script to be used with the requirement that the testing be conducted from start to finish without interruption Provide a sign in sheet requiring all testing participants to sign as witnesses 15 AMERICAN NATIONAL STANDARD Z29 14 2014 16 to the tests The testing regimen should include the verification of the ventilation sy
23. may receive current information on all standards by calling or writing the American National Standards Institute Published February 2014 by American Society of Safety Engineers 1800 East Oakton Street Des Plaines Illinois 60018 2187 847 699 2929 www asse org Copyright 2014 by American Society of Safety Engineers All Rights Reserved No part of this publication may be reproduced in any form in an electronic retrieval system or otherwise without the prior written permission of the publisher Printed in the United States of America FOREWORD This Foreword is not part of the American National Standard ANSI ASSE Z9 14 2014 The Z9 14 Subcommittee was chartered to develop the American National Standard Testing and Performance Verification Methodologies for Ventilation Systems for Biosafety Level 3 BSL 3 and Animal Biosafety Level 3 ABSL 3 Facilities Over 1 000 BSL 3 ABSL 3 laboratories and animal facilities have been constructed in the United States The design for their ventilation systems has been largely guided by the criteria defined in successive versions of Biosafety in Microbiological and Biomedical Laboratories BMBL from the Department of Health and Human Services DHHS the Centers for Disease Control and Prevention CDC and the National Institutes of Health NIH Biosafety in Microbiological and Biomedical Laboratories BMBL n d the American Society of Heating Refrigerating and Air Condition
24. of the ventilation system The ANSI Z9 14 standard focuses specifically on the ventilation system features of BSL 3 ABSL 3 facilities Because the ventilation system is affected by and has an effect on other systems and equipment in a laboratory those systems and equipment may be included in the standard to some extent as an associated system ANSI Z9 14 provides testing standardization uniformity and consistency through the use of minimal performance based testing and verification methodologies for BSL 3 ABSL 3 ventilation systems in facilities How to Read This Standard ANSI Z9 14 is presented in a two column format Beginning with section 5 0 Applicability and Conformance the left column presents the requirements of the standard the right column provides clarification and explanation of the requirements and information on how to comply to the standard The standard contains appendices that are informative and are not considered a mandatory part of the standard The standard is not meant to be all encompassing Rather it establishes minimum acceptable criteria for completing the verification process and documenting the necessary information for regulatory and historical purposes It is somewhat general in nature so that it can be applied to any BSL 3 ABSL 3 laboratory We hope however that future versions will continue to expand and amplify these concepts as additional experience is gained Suggestions for improvement of this sta
25. provisions if applicable Procedures for use of bags cinching straps rubber bands etc should be strictly enforced when new and replacement filters are installed During the annual efficiency test of the HEPA filters straps and bag seals to the rings should be verified to be properly installed and that records exist of the proper installation before opening the access door of a potentially contaminated housing Otherwise decontamination procedures should be taken following local risk assessments and SOPs 7 Testing in place Verify in field that test sections are provided as a means for testing HEPA filters in place prior AMERICAN NATIONAL STANDARD 29 14 2014 to being placed into service 8 Pressure gauges and connecting tubing e Verify in field that pressure gauge tubing joints and connections are tight and leak free Verify pressure gauges for operation of filters within specified range 9 HEPA filter performance verification reports e Review prior performance verification and maintenance reports to evaluate the initial conditions of the filters when they were placed into service and any repairs performed since then 8 3 9 Control Systems Fail Safe Operation The verification process shall include review of Refer to section 8 3 for failure scenarios documentation for each failure test performed and related documentation 8 3 10 Visual Inspection Special Considerations for ABSL 3 Facil
26. requirements may not have been promulgated In which case the final status comparison should be made to industry standards or best practices In addition to a comparison to regulations industry standards and best practices the heating ventilating and air conditioning HVAC testing and performance results must be viewed in light of organizational requirements These may be more restrictive to protect future liability As with all process steps the verification of conformance to standards is not complete without retention of appropriate records as required by the original plan and relevant standards Also testing and verification of related systems within a BSL 3 ABSL 3 lab should include e Optimized maintenance of pressure gradients and maintenance of temperature and humidity e Physical integrity e Sealing and leakage factors e Interlocking systems e Anterooms e Doors windows 13 AMERICAN NATIONAL STANDARD Z29 14 2014 the ventilation system e Building automation system BAS set point where supply and exhaust track each other e Air filtration e Exhaust stacks e Redundancy e Canopy hoods autoclaves e Specific ABSL 3 requirements Those aspects of primary containment devices that directly affect the ventilation system performance e g for a Class II B2 biosafety cabinet the interlock between the biosafety cabinet and the heating ventilating and air conditioning HVAC controls but not the pe
27. should be decontaminated based on a risk assessment if aerosol sampling is required for determining the upstream concentration Each HEPA filter should be tested in situ by particle or aerosol challenge testing If it is not possible to do a surface scan test then gross probe testing should be performed Test HEPA filters by using the scanning method according to the Institutes of Environmental Sciences and Testing IEST RP 034 1 and NSF 49 standards Test HEPA filters using airflow rates at rated operational designs and or 20 rated flow Upstream challenge concentration should be verified by actual measurement If using a Laskin nozzle generator it is allowable to AMERICAN NATIONAL STANDARD 29 14 2014 11 12 13 14 calculate the upstream challenge There are several materials available for creating aerosol challenge When utilizing an oil aerosol PAO poly alpha olefin is the most widely used in the United States PAO replaced DOP diocytl phthalate because DOP is considered a carcinogen There are other oils available for use the testing entity owner should agree on the material to be used When scan testing using a particle counter PSL polystyrene latex spheres should be used For surface scan testing a 0 01 leak or higher is considered significant and the filter gasket should be repaired or replaced For gross probe testing a 0 005 leak or higher is considered significant a
28. strategies the failure scenarios should include testing to confirm that switching operating the units does not impact the electrical failure test scenarios Refer to section 8 4 2 Testing for Directional Airflow during System AMERICAN NATIONAL STANDARD 29 14 2014 Failures as the verification of the HVAC system under electrical failures is covered in that section The following tests elaborate more specifically on the testing of the electrical systems themselves Test various power failure scenarios Electrical power failures and restorations should perform in accordance with the documented sequence of operations 1 Test normal to from emergency power closed transition This test should not interrupt power to critical systems serving the containment area for facilities where emergency power can be operated concurrently with normal power e Switch to emergency power under a closed transition sequence e Record and document no electrical power dips surges or outages that impact the critical systems and subsystems e After determining all systems are stably operating switch to normal power from emergency power and document no impacts to critical systems and or subsystems 2 Test normal to from emergency power source interruption interruption e Systems and equipment should transition to from emergency mode in a controlled manner For 95 AMERICAN NATIONAL STANDARD Z29 14 2014 96 facilities where em
29. that should be maintained include If applicable and available to BSL 3 ABSL 3 ventilation Architectural drawings Containment boundaries BSL 3 room air leakage report if applicable 4 Mechanical plumbing fire safety and electrical drawings 5 Air balance drawings 6 Airflow diagrams 7 Control diagrams and sequences of operation 8 Program of requirements POR basis of design BOD and HVAC relevant project specifications e Facilities may not always have current or comprehensive BOD documents In some cases documents may not have been updated to reflect final requirements Project BOD and construction documents should not solely be relied upon as complete or current but must be tempered with the knowledge and experience of the facility biosafety officer facility SOPs and the verification team Questions or concerns should be discussed with facility management to the extent such items impact completion of verification activities 9 Commissioning documentation and performance verifications for HVAC 25 AMERICAN NATIONAL STANDARD Z29 14 2014 26 systems and related components e If commissioning and other testing documentation are not available the facility should provide any documentation available to facilitate the testing and performance verification of the ventilation systems 10 Testing adjusting and balance TAB reports 11 Description of operational changes modifications or adjustme
30. trend logs via calibrated BAS sensors or independent temperature and humidity loggers placed at representative locations in the space 6 Log conditions over 2 hours to confirm requirements are met Documentation Test documentation should include records of all sensor calibrations and tests and logs of space temperature and relative humidity for each space 79 AMERICAN NATIONAL STANDARD 29 14 2014 80 8 4 5 4 Measurement of BSL 3 ABSL 3 exhaust stack velocity to atmosphere shall be performed as indicated by facility risk assessments 8 4 5 5 Each laboratory ventilation system shall be tested for response to fire smoke alarms in accordance with requirements as Purpose of Test To verify that the exhaust discharge velocity is per the design requirement The velocity should be equal to or greater than that noted in the most recent version of project documentation listed in section 8 2 This velocity may be modified based on a combination of risk assessment facility use and SOPs BSL 3 ABSL 3 exhaust air system may or may not have HEPA filtration The need to ensure that the exhaust plume is directed into the atmosphere and does not re entrain into air intakes is important Normally survival of infectious material is limited outside of the natural hosts Ensuring that exhaust plumes are high enough into the atmosphere allows for temperature fluctuations dilution and ultraviolet to avoid risks of infection an
31. 13 European Committee for Standardization CEN CEN Workshop Agreement CWA 15793 Laboratory Biorisk Management Standard Brussels CEN 2008 Available at ftp ftp cenorm be PUBLIC CWAs wokrshop31 CWA15793 pdf Accessed June 11 2013 U S Department of Health and Human Services S3 Science Safety and Security Finding the Balance Together Biosafety Biosecurity Biocontainment and Biorisk Management Available at http www phe gov s3 Pages default aspx Accessed June 11 2013 National Institutes of Health NIH Office of Biotechnology Activities NIH Guidelines for Research Involving Recombinant DNA Molecules Bethesda MD NIH Available at http oba od nih gov rdna nih_guidelines_oba html Accessed June 8 2013 American National Standards Institute ANSI Z9 8 IAQ and HVAC Standard New York ANSI Available at http webstore ansi org default aspx UbO3AiqF_uQ Accessed June 5 2013 123 AMERICAN NATIONAL STANDARD Z29 14 2014 12 13 14 15 16 17 18 19 20 21 22 23 124 Encarta Dictionary Empirical Available at http www bing com Dictionary search q define empirical Accessed June 12 2013 American Society of Heating Refrigerating and Air Conditioning Engineers AHRAE ANSI AIHA Z9 5 The American National Standard for Laboratory Ventilation Method of Testing Performance of Laboratory Fume Hoods Atlanta GA ASHRAE 2003 American National Standards Insti
32. A 2001 American Society of Heating Refrigerating and Air Conditioning Engineers ASHRAE American National Standard ANSI ASHRAE Standard 62 1 2010 Ventilation for Acceptable Indoor Air Quality Atlanta GA ASHRAE 2010 1 54 2010 American Society of Heating Refrigerating and Air Conditioning Engineers ANSI ASHRAE Standard 62 1 2010 User s Manual Atlanta GA ASHRAE 2010 1 178 2010 CFR 21 Part 11 Food and Drugs as required Subpart C Buildings and Facilities Sec 211 42 Design and construction features Available at http www accessdata fda gov scripts cdrh cfdocs cfcfr CFRSearch cfm CFRPart 211 amp showFR 1 amp subpartNode 21 4 0 1 1 11 3 Accessed June 11 2013 Assistant Secretary for Environment Safety and Health Health Hazard Alert Washington DC U S Department of Energy Issue 93 1 1993 Memarzadeh F Health and safety risk assessment methodology to calculate reverse airflow tolerance in a Biosafety Level 3 BSL 3 ABSL 3 or airborne infection isolation room All environment International Journal of Risk Assessment and Management 14 1 2 157 175 2010 National Institutes of Health NIH Biosafety Level 3 Laboratory Certification Requirements and Checklist Bethesda MD NIH 2006 Available at http www ors od nih gov sr dohs Documents bsl3_certguide pdf Accessed June 8 2013 Australian Government Department of Health and Ageing Australian Guidelines and Forms for Certification of Physical C
33. ANSVASSE 29 14 2014 et american Nation St lt 0 S K ANSI ASSE Z9 14 2014 Testing and Performance Verification Methodologies for Ventilation Systems for Biosafety Level 3 BSL 3 and Animal Biosafety Level 3 ABSL 3 Facilities ANSI ASSE Z9 14 2014 AMERICAN SOCIETY OF SAFETY ENGINEERS The information and materials contained in this publication have been developed from sources believed to be reliable However the American Society of Safety Engineers ASSE as secretariat of the ANSI accredited Z9 Committee or individual committee members accept no legal responsibility for the correctness or completeness of this material or its application to specific factual situations By publication of this standard ASSE or the Z9 Committee does not ensure that adherence to these recommendations will protect the safety or health of any persons or preserve property ANSI ANSI ASSE 29 14 2014 American National Standard Testing and Performance Verification Methodologies for Ventilation Systems for Biosafety Level 3 BSL 3 and Animal Biosafety Level 3 ABSL 3 Facilities Secretariat American Society of Safety Engineers 1800 East Oakton Street Des Plaines Illinois 60018 2187 Approved January 24 2014 American National Standards Institute Inc American National Standard Approval of an American National Standard requires verification by ANSI that the requirements for due process consensus and other crite
34. Paul Langevin Davor Novosel Deborah Wilson Jean Khoshbin Esmail Torkashvan Dale Martin Sheri Bernstein Bruce Whitney William Howard Richard Henkel Joseph Kozlovac Theresa Lawrence Kevin Anderson Gary Landucci Colleen Jonsson Daniel Fisher Bradford S Goodwin Jr Miguel A Grimaldo Contents SECTION citanacenresmsdiaracnratarcanneinreanrciaraaandaardimettadinatenastnicanntinstennsigisaniasa PAGE Exec tive SummMaTY seeriad areta aa d aeaa aE senichendeadcunelee dance 1 PUMOS Ercan apnea e Eaa aa EERENS 2 11010 91S P E E E E E 2 Definitions sgsnccviectscemsactacimettacsmibssadininthadamibsantownettntamnalsadeiaeoictadensecteasasl 3 Applicability and Conformance cccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 11 S Applicably eeen a era es eae eee ere ree 11 5 2 COMOMMANCE vinci sivieanlicicaistianiaiatacdiicaaisnlniaaaainees 12 5 3 Verification of Conformance to Regulations ccceeeee 13 MDB siesta ic i ae ig ai 0 a ae ci a ala ig aa in atone 13 6 1 Ventilation Testing Performance Categories cceee 13 6 2 Generic Typical Sequence of Testing and Performance VSRMCAMOM aiicrnicissccancnniccancdieesiasasasniaseiusctdnaietiensatenptiraraeannsaneentans 14 6 3 Roles Responsibilities and Qualifications cccccceseeceeeeees 17 6 3 1 Role Responsibility as It Relates to a BSL 3 ABSL 3 Facility sistscsgrcicetensdasranpsagadnsiunaitugaduehaaaioancadtungidenes 19 RISKASSoSS
35. RICAN NATIONAL STANDARD 29 14 2014 PURPOSE This plan describes audit findings documents and responsibility for addressing the findings It also describes progress towards addressing the findings INSTRUCTIONS Provide enough information to enable the reader to understand the nature of the finding the impacts and the planned remedy DIRECTIONS Create plan by area or by audit Allow for the plan to be separate for the area or the auditor Date Action f Risk Level A y a Facility P Sa ENS Owner Planned gequate 1 g Audit Di nes Action Priority E Current i Proceed with Agree Finding Description Responsible Completion Comments by 4 Required Red Yellow Status Performance Disagree Person s Date eis Item Green Verification Yes No 114 AMERICAN NATIONAL STANDARD 29 14 2014 Appendix B Factors to Consider in Performing a Risk Assessment 1 Facility layout Containment boundaries e Primary containment biosafety cabinet BSC caging systems etc e Secondary containment rooms hoods etc e Tertiary containment anteroom shower locker room etc Site specific risks e g natural hazards such as seismic high winds floods etc proximity to public proximity to other facilities or hazards that can introduce risk to the facility or its operational response Specialized laboratory equipment and use particularly aerosol generating Ac
36. RICAN NATIONAL STANDARD 29 14 2014 specific measures taken to mitigate that risk Although this standard only applies to the escape of air at the containment barrier testing of directional airflow should be performed at the transitions i e doorways and boundaries between areas of higher and lower risk between all spaces within the BSL 3 ABSL 3 facility as determined by the facility risk assessment If directional airflow cannot be demonstrated under normal operating conditions at a transition point then other mitigating factors such as the presence of two doors in series personal protective equipment use and the relative risk of the agents in use should be considered in determining the acceptance criteria for the test for that point Test Purpose and Methodology Purpose of Test To verify that under normal operating conditions the HVAC system provides directional airflow by drawing air into the containment space from clean areas toward potentially contaminated areas except as determined by specific site conditions such as clean room containment spaces The testing should evaluate directional airflow both at individual doorways and for the entire laboratory suite Note The testing should account for normal operating conditions such as door 57 AMERICAN NATIONAL STANDARD Z29 14 2014 58 opening closing which may affect the sustained directional airflow requirement at an individual doorway Directional
37. TER ANYFILE S CONTAINED HEREWITH THE STANDARD S AND OTHER INFORMATION PROVIDED HEREWITH ARE COPYRIGHTED BY DOWNLOADING ANY FILE PROVIDED HEREWITH TO YOUR COMPUTER YOU ARE ACCEPTING AND AGREEING TO THE TERMS OF THIS LICENSE AGREEMENT IF YOU ARE NOT WILLING TO BE BOUND BY THE TERMS OF THIS LICENSE AGREEMENT PRIOR TO DOWNLOADING OR COPYING TO YOUR COMPUTER ANY FILES S YOU MUST DECLINE ACCESS TO SUCH MATERIALS 1 GRANT OF LICENSE Subject to the provisions contained herein and to the payment of all applicable fees the American Society of Safety Engineers ASSE grants you a nonexclusive non transferable license to the materials contained herewith the Product Your licensed rights to the Product are limited to the following a This License Agreement does not convey to you an interest in or to the Product but only a limited right of use revocable in accordance with the terms of this License Agreement b You may install one copy of the Product on and permit access to it by a single computer owned leased or otherwise controlled by you In the event that computer becomes dysfunctional such that you are unable to access the Product you may transfer the Product to another computer provided that the Product is removed from the computer from which it is transferred and the use of the Product on the replacement computer otherwise complies with the terms of this Agreement Neither concurrent use on two or more computers nor use in a local
38. TIONAL STANDARD Z29 14 2014 8 2 2 Evidence of Documentation Basic background supporting information of the containment facility shall be provided for development of the Testing Plan 24 verification and cessation of operations if required 2 Project scope 3 Roles responsibilities and qualifications see section 6 3 of individuals performing the tests 4 Test protocols and acceptance criteria for testing and performance verification 5 When documentation will be collected 6 Document retention requirements 7 Location and contact information for record repository 8 Relevant SOPs 9 Documentation of risk assessments 10 Final report that should include e Documentation of test results e Mitigation requirements and timeline for remediation e Certificates of calibration of test equipment e Recommendations Supporting documentation and relevant information are important to ensure an accurate testing and performance verification of the ventilation system Documentation should be maintained current to reflect architectural and or engineering system changes Documentation should be verified as current complete and representative of the intended operating arrangements of each system as approved by the facility management design engineers AMERICAN NATIONAL STANDARD 29 14 2014 requirements of reviewing approval authorities and in accordance with the current risk assessment Examples of documents
39. TO THE PRODUCT AND ASSE AND THE OWNER MAKE NO OTHER REPRESENTATION OR WARRANTY OR CONDITION OF ANY KIND WHETHER EXPRESS OR IMPLIED EITHER IN FACT OR BY OPERATION OF LAW WITH RESPECT TO ANY OF THE PRODUCT INCLUDING WITHOUT LIMITATION WITH RESPECT TO THE SUFFICIENCY ACCURACY OR UTILIZATION OF OR ANY INFORMATION OR OPINION CONTAINED OR REFLECTED IN ANY OF THE PRODUCT ASSE AND THE OWNER EXPRESSLY DISCLAIMS ALL WARRANTIES OR CONDITIONS OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE NO OFFICER DIRECTOR EMPLOYEE MEMBER AGENT CONSULTANT CONTRACTOR REPRESENTATIVE OR PUBLISHER OF THE COPYRIGHT HOLDER IS AUTHORIZED TO MAKE ANY MODIFICATION EXTENSION OR ADDITION TO THIS LIMITED WARRANTY 3 INDEMNIFICATION The Owner ASSE any agent representative publisher or distributor of the Product or any of their respective directors officers employees agents representatives or members the ASSE and Owner Indemnified Parties shall have no liability for and you shall defend indemnify and hold each of the ASSE and Owner Indemnified Parties harmless from and against any claim loss demand liability obligation and expenses including reasonable attorneys fees based upon or arising out of any injury or damage or any product liability claim including but not limited to any personal or bodily injury or property damage arising out of pertaining to or resulting in any way from the use or possession of any of the Product by you
40. VAC system could include 1 Replacement of exhaust or supply fans that serve the BSL 3 ABSL 3 containment areas 2 Replacement of ductwork valves or dampers that serve these areas 3 BAS logic programming changes 4 Structural changes to the BSL 3 ABSL 3 rooms 5 Addition or removal of hard ducted BSCs or fume hoods that cause changes in the air balance of the room with respect to the entire laboratory Instruments and testing devices should have cyclical calibration for validating 55 AMERICAN NATIONAL STANDARD Z29 14 2014 shall have been calibrated and or certified using standards traceable to the National Institute of Standards and Technology NIST or equivalent standards If devices that are components of the building e g pressure sensors and airflow indicators are used for testing purposes they shall be calibrated annually using a calibrated external device performance and verifying that they have sufficient accuracy and range required for testing 1 Obtain and include all recent certificates of calibration in test documentation 2 Calibrations of instruments should be done at least annually 8 4 1 Testing for Directional Airflow during Normal Operation HVAC systems shall be tested for directional airflow to demonstrate that air in the BSL 3 ABSL 3 flows from areas of lower risk to areas of higher risk during normal operation 56 Generally the directional airflow criterion for BSL
41. Verification may be accomplished via review of current certified TAB report Directional airflow Inspect and compare to design e Verification may be accomplished by inspection of pressure indicating devices at doors or via smoke tests at doors and comparing to as built AMERICAN NATIONAL STANDARD 29 14 2014 LO drawings Pressurization controls e Verification may be accomplished by review of as built drawings Filtration Verify and compare to requirements e Verification may be accomplished by visual inspection in field and review of testing verification Equipment redundancy where applicable e Verification may be accomplished by inspection in field and review of recent testing and commissioning documentation noting available system capacity and redundancy Standby power Verify and compare to design e Verification may be accomplished by inspection in field and review of recent generator testing and commissioning documents noting performance of mechanical systems with standby power Power failure results from unplanned outages and impact on BSL 3 ABSL 3 ventilation e Verify BAS trend logs alarms and controls for the outage period and power restoration on pressure and directional airflow measurements Instrumentation accuracy and calibration for critical devices Interlocks 31 AMERICAN NATIONAL STANDARD Z29 14 2014 e Verify appropriate operation of sequences and software interlocks and hardware interlo
42. al details are initialized and verified The final record of system operation Site specific risks Specific risks that are associated with the facility due to its unique AMERICAN NATIONAL STANDARD 29 14 2014 geographic location use of specific hazardous agents and the proposed work processes and equipment involving hazardous agents used at that facility Standard A document established by consensus and approved by a recognized body that provides for common and repeated use rules guidelines or characteristics for activities or their results aimed at achievement of the optimum degree of order in a given context Standard operating procedure SOP A set of written instructions that document a routine or repetitive activity followed by an organization SULPA Super ULPA filters have an efficiency of 99 9999 on the same basis as ULPA filters The low penetration expected from ULPA and SULPA filters is such that they must be totally free of even the smallest leak The standardization of testing methods in both the United States and Europe for ULPA and SULPA filters is now in the process of being finalized Until it is the individual user requiring filters at this efficiency level must be certain that the tests performed on filters demonstrate their ability to meet the user defined needs Supply air The total amount of air delivered to a space used for ventilation heating cooling humidifica
43. ale smoke etc Steady state pressure differentials should remain between the minimum level needed for detection by the pressure sensor and the level at which door operation is adversely affected The differential pressure must not exceed the level that causes the force required to operate the door to exceed applicable codes e g fire code or Americans With Disabilities Act ADA requirements Smoke testing of the full door perimeter 360 should be performed with the door in a closed and open position using a smoke generating device that is moved slowly around the perimeter of the door The test method should be based ona site specific risk assessment including factors such as the presence of two doors in series gaskets or other seals and transfer grills or other air bypass devices 59 AMERICAN NATIONAL STANDARD Z29 14 2014 When determining the extent of the door opening for the test facility personnel should take into consideration the airflow offset at the doorway the presence of other doors in series and the relative risk of activities in the adjacent spaces Smoke testing of air transfer devices should be done at different points along the face of the air transfer grille Documentation Test documentation should include specific doors devices and locations where test was conducted chosen test method for each location and results of test for each location The performance of the entire laborato
44. amage to housing to note if welds are damaged or performance is compromised during further verification e Check access doors latches and gaskets for proper operation e Check for proper support of filter housing Check for seismic bracing where required by local codes and project BOD 2 Visual inspection of filter media e Verify performance filter function integrity will be verified through the methodology in section 8 4 7 at initial filter installation or replacement e Verify in field the integrity of the filter media filter frame filter gasket elastomeric or gel and the seal between the media and frame e Look for filter damages percentage of patching of the filter media damages to the gasket tears or sagging etc 3 Ductwork in and out of housings e Verify in field that ductwork in and out of filter housings is of the specified material and construction type e Verify ductwork is properly supported 4 Bubble tight isolation dampers 51 AMERICAN NATIONAL STANDARD Z29 14 2014 52 Check for condition of dampers corrosion of damper components flanges and connections gaskets for visible damage condition of actuators linkages wiring and or pneumatic tubing to actuators etc Filter decontamination provisions Verify in field that filter housing is equipped with decontamination provisions if in place Decontamination is required by a SOP prior to removal Bag in bag out
45. andards research technology standards guidelines numeric index Accessed June 8 2013 U S Department of Agriculture Animal Research Service USDA ARS 242 1 Manual USDA ARS Facilities Design Standards Number 242 1 ARS Washington DC USDA ARS July 2002 Available at http www afm ars usda gov ppweb pdf 242 01m pdf Accessed June 11 2013 World Health Organization Laboratory Biosafety Manual 3rd ed Geneva WHO 2004 Available at http www who int csr resources publications biosafety en Biosafety7 pdf Accessed June 11 2013 National Institutes of Health NIH Design Requirements Manual Bethesda MD NIH Division of Technical Resources 2008 Available at http orf od nih gov PoliciesAndGuidelines BiomedicalandAnimalResearchFacilitiesDesignPolici esandGuidelines Pages DesignRequirementsManualPDF aspx Accessed June 11 2013 National Fire Protection Association NFPA Standards and Glossary Standards available at http www nfpa org catalog category asp category 5Fname Codes and Standards amp Page 1 amp src catalog Glossary available at http www nfpa org assets files pdf glossarya2004 pdf Accessed June 11 2013 National Science Foundation NSF International Standard American National Standard for Biosafety Cabinetry Biosafety Cabinetry Design Construction Performance and Field Certification Annex E 2011 available at http www nsf org business newsroom pdf nsf_49 11_annex e pdf Accessed June 11 20
46. area network or other network is permitted You shall not merge adapt translate modify rent lease sell sublicense assign loan or give to or otherwise transfer any of the Product or copies thereof or remove any proprietary notice or label appearing on any of the Product to any individual or entity for any reason or purpose You may copy the Product only for backup purposes c You acknowledge and agree that the Product is proprietary to the Copyright holder the Owner identified on the front page of the Product and is protected under U S copyright law and international copyright treaties You further acknowledge and agree that all right title and interest in and to the Product including all intellectual property rights are and shall remain entirely with the Owner d You shall provide ASSE or any designee of ASSE with all information necessary to assure compliance with the terms of this Agreement In the event you are not in compliance with the terms of this Agreement through the actions of unrelated third parties you shall use your best efforts to cooperate with ASSE and any of its designees to assure compliance 2 LIMITED WARRANTY a ASSE warrants for your benefit alone that unless disclosed in the Product to the contrary ASSE and the Owner can license the Product and all copyright and trademarks related thereto or therein b THE EXPRESS WARRANTIES SET FORTH IN THIS SECTION 2 CONSTITUTE THE ONLY WARRANTIES WITH RESPECT
47. arium room temperature pressure control system Animal cage racks Building automation systems BAS control sequences graphics and alarm reporting Ductwork and isolation dampers Fumigant injection systems and ports if available Heat recovery systems Control air compressors for ventilation control Variable frequency drives VFDs Emergency power systems Evidence that component testing functional performance testing and integrated system testing have been completed after construction and after each time systems are modified To ensure that the ventilation system for the laboratory facility is properly documented and available for verification by authorities and to serve as a baseline for future test comparisons the following 27 AMERICAN NATIONAL STANDARD Z29 14 2014 28 documents should be verified if applicable and available 1 Normal and reduced air change rates to emergency or energy saving per containment room or zone as confirmed from TAB reports and building automation airflow reports 2 Directional airflows produced on design documents across all doorways supporting containment zones 3 Pressure differential values for normal and failure modes across each containment perimeter door 4 Test results of smoke testing for normal operation of all containment perimeter doors and large containment transfer devices such as autoclaves and pass through cabinets 5 Test results of pressure dif
48. as the voltage on an electropneumatic transducer also remove the motive power to the actuator 7 Failure of air terminal unit controlling airflow to the BSL 3 ABSL 3 zone e Remove the control signal to the actuator such as the voltage on an I P transducer Also remove the motive power to the actuator Documentation Test documentation should indicate results of tests and data showing the responses of the control and HVAC systems Characterize the responses to the events tested Document by listing all devices that were tested and verified and their respective results Purpose of Test To confirm the facility has been performing per requirements over time Recommended Methodology The following tests are recommended 1 Perform trend and event log analysis AMERICAN NATIONAL STANDARD 29 14 2014 91 AMERICAN NATIONAL STANDARD Z29 14 2014 Analyze the trends of the relevant biocontainment parameters and review the alarm and activity log for those parameters e Containment zone differential pressure e Zone air changes or component airflows e Zone temperature e Zone humidity where it is controlled Documentation Testing entity should produce summary report of findings to the owner At a minimum trends and alarm history should be reviewed 8 4 6 Testing of Electrical Systems Related to Heating Ventilating and Air Conditioning HVAC 92 Record and document electrical power dip occurrence Tes
49. breeding or observing living insects In a BSL 3 insectary the insects are the vectors for infectious diseases assuming the insects have been infected with the specific agent under study Special precautions must be taken to prevent escape into the environment as the insects may not be indigenous to the locale Inspection audit Conformity evaluation by observation and judgment Laboratory Room within a facility designated for work with biological agents and or toxins Mitigation The steps taken to alleviate current risk or prevent or reduce future risk AMERICAN NATIONAL STANDARD 29 14 2014 Material Safety Data Sheet MSDS A document designed to provide both workers and emergency personnel with the proper procedures for handling or working with a particular substance An MSDS includes information such as physical data melting point boiling point flash point etc toxicity health effects first aid reactivity storage disposal personal protective equipment and spill leak procedures An MSDS is of particular use if a spill or other accident occurs Particle leakage estimation A calculation of the quantity of air particles leaked under failure conditions that must be provided by the laboratory being verified if zero tolerance reverse airflow cannot be achieved Personal protective equipment PPE Material including clothing e g gown gloves respirators safety glasses u
50. cess control Waste management Current security threat risk local national and international threats that could compromise the safety of the general public the environment the security of the personnel the research and the facility Building utilities Work flow routing internal and external 10 Dependency upon outside sources for utilities i e steam electricity gas etc 11 Building systems e Ventilation systems including HEPA filtration isolation valves exhaust versus supply duct locations e Building automation system e Existing system redundancies e Non containment building systems that could adversely impact containment including fire suppression systems 12 Agents used including e Quantity infectious dose e Concentration 115 AMERICAN NATIONAL STANDARD Z29 14 2014 e Route of transmission e Availability of treatment 13 History of spills or accidental releases 14 Area and surface decontamination methodology 1 Vaporized hydrogen peroxide 2 Paraformaldehyde 3 Chlorine dioxide 4 Other 15 Regulations standards guidelines 16 New or existing equipment related to ventilation systems including but not limited to BSCs Class III cabinet fume hoods HEPA filters etc 17 Systems replacement part availability 18 Facilities current maintenance and preventative maintenance program 19 Catastrophic event 116 AMERICAN NATIONAL STANDARD Z29 14 2014 Appendix C Hazard Risk Matrix
51. cility organization and or management shall be responsible for coordinating the selection and involvement of appropriate personnel for the risk assessment and performance verification of HVAC systems There are numerous factors to consider in performing a risk assessment see Appendix B A Hazard Risk Matrix can be used to record a risk rating for each hazard see Appendix C The team could include the BSO as defined in this document responsible facility manager or director veterinary staff ABSL 3 building engineer HVAC engineer or other subject specialists as appropriate and maintenance staff and security personnel as required 8 GUIDELINES FOR IMPLEMENTING TESTING AND PERFORMANCE VERIFICATION 8 1 Verification Verification shall be done according to a pre approved written plan that follows an acceptable model and it shall be fully documented 22 The major elements of verification are e Verification of documentation e Verification of visual inspection e Verification of conformance to relevant standards e Verification of presence that systems are maintained and proper operation of systems and associated critical components e Verification of testing The steps in verification are e Visual inspection document review e Testing of assumptions e Comparison to relevant standards e Identification of deviations from 8 2 Documentation Documentation shall be maintained throughout the testing a
52. cks for critical functions 8 3 2 Visual Inspection and Evaluation of Architectural Features The verification process shall include an inspection of space configuration and adjacencies as they relate to ventilation strategies for containment and directional airflow and compare to design specifications Visually inspect the location of accessible critical ventilation components to confirm no apparent condition which would likely pose risk of damage or malfunction e g chemical storage hazards probability of mechanical damage security concern or improperly protected fire environmental or water damage risk 32 The verification process should verify zones of containment risk levels and basic ventilation strategies Assess location of BSL 3 ABSL 3 labs in relation to other zones such as BSL 2 support labs offices and break rooms elevators loading docks etc for effects on laboratory pressurization and airflow Access to the laboratory should be through a series of two self closing interlocked doors Assess the location of biosafety cabinets BSCs fume hoods and doors in relation to air flow and capture velocities from supply diffusers and exhaust grilles Assess personnel traffic patterns to minimize influence of face velocity disturbance in relation to fume hoods and BSCs The integrity of all surfaces penetrations and seals on the containment perimeter shall be visually inspected Penetration seals s
53. closed spaces Suggested verification and visual inspection methods are provided here Alternately for assessed by visual inspection AMERICAN NATIONAL STANDARD 29 14 2014 each piece of equipment in the system the manufacturer s preventive maintenance checklist may be used to complete the visual inspection requirements Visual inspection should include observation that the following components are present and in good operating condition 1 Outside air intake louver e Verify for re entrainment cleanliness and security as noted above 2 Filters e Check filters for cleanliness and pressure drop and review maintenance logs 3 Coils and controls e Check condition of coils for corrosion leaks and cleanliness e Check condition of control valve actuators linkages wiring and or pneumatic tubing to actuators etc 4 Humidifiers and controls e Check condition of humidifiers for corrosion leaks and cleanliness e Check for visible condensation on surfaces lack of absorption e Check condition of control valve actuators linkages wiring and or pneumatic tubing to actuators etc 5 Supply fans e Verify in field fan condition corrosion supports abnormal vibrations condition of flexible duct connections etc 6 Motor e Verify in field for condition 41 AMERICAN NATIONAL STANDARD Z29 14 2014 42 10 11 12 13 14 corrosion supports abnormal vibrations etc Belts e
54. containment area the fire alarm system does not shut down or adversely affect the laboratory ventilation systems e Confirm any smoke control reactions do not cause sustained reversal of airflow from the containment area 2 Initiate a fire alarm inside of containment initially and as otherwise required e Confirm that in case of a fire alarm initiated inside the containment area the ventilation system reacts according to 8 4 5 6 The BAS control systems shall be tested during abnormal operation and to verify performance as indicated by facility risk assessments Tests shall be performed before initial operation and periodically thereafter as determined by the facility risk assessment and SOP and after any significant alterations that can adversely impact the ventilation system AMERICAN NATIONAL STANDARD 29 14 2014 requirements established by the design and risk assessment e Confirm the reaction does not cause a sustained positive pressure compared to the adjacent non containment areas 3 Initiate a smoke duct detector activation initially and as otherwise required e Confirm that in case of a smoke duct detector activation the ventilation system reacts according to requirements established by the design and risk assessment e Confirm that smoke control reaction does not cause a sustained positive pressure compared to the adjacent non containment areas Acceptance criteria should be defined in the ri
55. d by the individual institution The date of conformance shall be determined by the institution choosing to use it The institution should establish a transitional period to meet the expectations of the standard 12 Minimal acceptable conditions for ventilation system performance in BSL 3 ABSL 3 facilities include 1 During normal facility operations the maintenance of air movement from areas that are not contaminated by any biological hazards towards areas that may be progressively more contaminated inside the laboratory Depending on the specific risk assessment biological hazards that may exist inside the containment barriers of BSL 3 ABSL 3 must be controlled through the use of engineering controls adequate administrative controls practices and procedures and proper use of personal protective equipment The directional movement of air inside the laboratory between spaces with similar hazard profiles should be determined by operational needs 2 Ventilation systems in BSL 3 ABSL 3 should be designed to minimize any outward flow of potentially contaminated air from inside to outside the containment zone during failures and recovery from failures of the ventilation systems This is a fundamental requirement necessary to protect persons animals and the environment in areas outside of the containment zone Findings that individual test results do not meet the ideal conditions such as transient airflow reversal within contain
56. d cross contaminations Recommended Methodology Test airflow and velocity at all exhaust stacks for normal minimum airflow conditions Test velocity under reduced airflow modes for failure scenarios or for reduced ventilation scenarios Documentation Test documentation should include velocity measurements for each test condition for each stack Purpose of Test To verify containment directional airflow and system operations when building fire protection systems AMERICAN NATIONAL STANDARD 29 14 2014 established in project documents including are activated Fire protection and the facility risk assessment and requirements associated life safety requirements for of the AHJ Tests shall be performed before containment spaces are sometimes initial operation and periodically thereafter as opposing regarding the required determined by the facility risk assessment and responses of the ventilation systems The AHJ including after any significant alterations design intent and risk assessment should that can adversely impact the ventilation or have specifically defined the responses associated control systems to a fire or smoke condition These parameters must be verified to ensure no sustained reversal of airflow occurs when fire protection systems are activated Recommended Methodology Solutions will vary for individual facilities based upon a number of variables such as facility design system zoning and fire separations smoke
57. d exhaust ducts associated with containment zones should be tested to procedures defined by the Sheet Metal and Air Conditioning Contractors National Association 103 AMERICAN NATIONAL STANDARD Z29 14 2014 104 SMACNA standard Leakage Class A This test should be conducted only if the ductwork is not protected by HEPA filters Tightness tests for leakage should be based on a risk assessment and whether the air systems are potentially contaminated or subjected to decontamination gases The risk of ductwork contamination on the supply air side is minimized by the pressure of air and normal operations Ductwork systems on the exhaust side between the containment zone and HEPA filter should be tested in accordance with ASME N510 Testing of Nuclear Air Treatment Systems Acceptance criteria should be in accordance with design intent with a leakage rate not exceeding 0 1 of volume at 1000 Pa 4 w g Ductwork should also be structurally tested to endure normal and maximum operating pressures especially during fan failure testing Tests could exceed 2500 Pa 10 w g under certain failures The testing entity individual should assess ductwork design prior to fan failure testing and verify structural capacity When fan failure tests occur the ductwork should be observed for structural deformation and displacement from hangers and support AMERICAN NATIONAL STANDARD 29 14 2014 Documentation Test docum
58. d on arisk assessment Use of Differential Pressure Monitors Calibrated differential pressure monitors along with data loggers portable units or instruments associated with BASs may be utilized to measure and record steady state and transient differential pressures during system failures Use of Smoke or Tracer Gases Visualization with smoke or tracer gas is a direct method of assessing whether air originating in the laboratory or vivarium escapes outside of the containment barrier Methods could include the use of a smoke generator in the laboratory and photometer outside of the containment barrier or a tracer gas and associated sensor outside the barrier to assess the 63 AMERICAN NATIONAL STANDARD Z29 14 2014 64 changes in airflow patterns The detectors should be placed at locations determined by risks assessment Examples of acceptance criteria to be established in the risk assessment 1 The differential pressure at any one of the barriers between any contaminated space and the clean space outside the containment barrier never reverses direction 2 The differential pressure at any barrier between any contaminated space and the clean space outside the containment barrier remains in the proper direction while or at any time after the differential pressure of the next barrier towards containment reverses 3 Smoke or tracer gases generated inside the laboratory or vivarium are not observed or detected
59. ditionally the space between interlocked doors should be verified for the ability to move large pieces of equipment 4 Checking the emergency over rides release of door interlock in emergency egress situations If mechanical interlocks are present open and close doors in all possible sequences Ensure that delay set points are tight enough to preclude inadvertent over ride of interlock systems Suggested verification and visual inspection methods are provided here Alternately for each piece of equipment in the system manufacturer s preventive maintenance checklist may be used to complete the visual inspection requirements Inspection should include the following 1 Exhaust air discharge stack location and velocities should be such that exhaust air is dispersed away from occupied areas and building air intakes or verified by risk assessment and wind 35 AMERICAN NATIONAL STANDARD Z29 14 2014 36 wake analysis Velocity should be equal to or greater than that noted in the most recent version of project documentation listed in section 8 2 e Verification of stack discharge velocity may be performed by review of stack airflow from current TAB report and diameter of stack outlet stack velocity sensors or fan airflow sensors in combination with stack discharge outlet diameter Code mandated minimum distance between exhaust air discharge and outside air intake operable windows doors and other build
60. duct construction is provided by fully welded construction All un welded components such as air valves in these duct sections should be fully accessible for bagging prior to decontamination 3 Exhaust air valves actuators and control wiring tubing e Check for condition of air valve 39 AMERICAN NATIONAL STANDARD Z29 14 2014 8 3 5 Visual Inspection of Supply Air System Major features of the supply air system arrangement and installation shall be 40 assembly corrosion of housing condition of actuators linkages wiring and or pneumatic tubing to actuators etc Exhaust bio seal dampers where provided e Check for condition of dampers corrosion of damper components flanges and connections gaskets for visible damage condition of actuators linkages wiring and or pneumatic tubing to actuators etc Continuous seal between ductwork and the room exhaust grille e Verify during initial installation and maintain written photo documentation for records Insulation requirements for ductwork that is exposed to inclement weather where thermal differences can cause condensation e Verification should be conducted in field and should include inspection of wetted surfaces and insulation Make sure any section of pressurized exhaust ductwork is not installed in enclosed areas near air handling unit AHU intakes Periodically inspect flexible duct connections in positive pressure exhaust ducts located in en
61. ducted in field and should include inspection of wetted surfaces and insulation and surfaces Visual inspection should include Hi Supply ductwork construction materials and general condition joining methods gaskets seals etc e Verify that the installation meets the project BOD and specification requirements Segments of supply ductwork intended for gaseous decontamination where provided between supply bio seal damper and room diffuser should be of gas tight construction or SOPs should require appropriate procedures to avoid leakage of decontamination gases to surrounding spaces Typically gas tight duct construction is provided by fully welded construction All un welded components in these duct sections should be fully accessible for bagging prior to decontamination Supply air valves actuators and control wiring tubing AMERICAN NATIONAL STANDARD 29 14 2014 e Check for condition of air valve assembly corrosion of housing condition of actuators linkages wiring and or pneumatic tubing to actuators etc e Check re heat coils for cleanliness and leaks Where terminal humidifiers are provided check for leaks and cleanliness e Check condition of reheat coil and humidifier control valve actuators linkages wiring and or pneumatic tubing to actuators 4 Supply bio seal dampers where provided e Check for condition of dampers corrosion of damper components flanges and connections gasket
62. e of not less than instrument air quality in conformance with ANSI ISA 7 0 01 Alarms should be verified operational at the BAS to indicate failure of compressed air source or system pressure loss 47 AMERICAN NATIONAL STANDARD Z29 14 2014 8 3 7 Primary Containment Equipment Biosafety cabinets and other primary containment equipment connected to the ventilation system shall be assessed by visual inspection All biosafety cabinets shall be certified before use at least annually and whenever relocated in accordance with National Science Foundation NSF Standard 49 or an equivalent method 48 Visual inspection of control power system should include 1 Control power for all heating ventilating and air conditioning HVAC controls should be served by standby power system e Verify in field or by review of as built control drawings e Control power for controllers and critical control components should be provided with battery backup or UPS and appropriate memory e Verify in field Control wiring to sensing and control devices should be protected to avoid damage and accidental failures at terminations e Verify in field that control wiring is routed in conduits and conduits are appropriately supported and routed away from maintenance traffic areas Inspection for BSCs and other primary containment equipment when present should include the following 1 Review primary containm
63. e the pressure alarm point on the BAS Confirm all occurrences of alarms are annunciated in the alarm module and tracked in the event log Note that alarm annunciation can typically be done in concert with failure mode testing Documentation Document by listing all alarm devices verified and the conditions in which they were annunciated 85 AMERICAN NATIONAL STANDARD Z29 14 2014 BAS input and output I O device and or control device shall be verified 86 Purpose of Test To verify I O devices sensors safeties valves dampers etc are calibrated and operating properly The responsibility for configuring calibrating adjusting etc BAS devices will lie with entities other than the testing entity such as the installing contractor or maintenance staff The testing entity should perform quality assurance checks based on a sampling strategy to assess confidence in the BAS devices Recommended Methodology Review documentation of input calibration and output verification Maintenance frequency recommended by manufacturer should be clearly indicated on documentation and documents should show adherence to recommended intervals 1 Confirm I O calibration and verification via spot check e Select a mix of the I O and confirm calibration stroke and range actuation etc as applicable e Check calibration of all differential pressure indicators monitoring containment barriers initially e Check calibra
64. ed first and considered in the design and testing plan prior to testing Pressure relief devices are available to mitigate this problem with excessive pressures Performance testing should include tests conducted initially to establish baseline parameters and after any alterations of the BAS or other system component that may adversely impact the BAS function and periodically thereafter as indicated by facility risk assessments Purpose of Test Alarms are necessary to provide notice to occupants and first responders in an emergency situation out of range operating conditions and failed operating conditions Typical conditions include 1 Laboratory or containment barrier pressure reversal 2 Door standing open AMERICAN NATIONAL STANDARD 29 14 2014 3 Simultaneous interlocked door opening Failure of fans Low exhaust duct static Failure of HVAC control devices e g variable air volumes Recommended Methodology The following tests are recommended 1 Verify that visual and audible notification devices annunciate upon abnormal operating conditions inside the containment zone by causing each alarm condition For instance cause pressure alarm by over riding controls to change flows to the point they will result in an alarm condition 2 Verify that visual and audible notification devices annunciate upon abnormal operating conditions inside the containment zone by over riding alarm mode trigger For instance over rid
65. eeting environmental conditions and directional airflow Refer to facility operating and maintenance records Historical data on airflow available from control or monitoring systems should be reviewed during periodic testing It is the responsibility of the facility s staff to calibrate airflow sensors in accordance with manufacturer s recommendations Re testing will typically not involve AMERICAN NATIONAL STANDARD Z29 14 2014 checking airflow sensor calibration Recommended Methodology Determine and document laboratory ventilation performance requirements Test methods utilized by TAB agents vary However the basic principles and methods should follow National Environmental Balancing Bureau NEBB or Associated Air Balance Council AABC test methods 1 Measure actual airflows at all outlets and inlets 2 Measure face velocity at primary containment fume hoods capture hoods etc 3 Confirm calibration of the airflow measuring devices 4 Ensure air distribution patterns within the room do not compromise primary containment or cause localized airflow reversals at barrier 5 Calculate air change rates and compare to design and current requirements 6 Determine calculate transfer airflows 7 Assess indicated or measured airflow rates relative to design current requirements During this testing consider the effects of filter loading During initial testing airflows should be confirmed at the ex
66. ent Containment perimeter The boundary between the laboratory animal facility or post mortem room and the area outside of containment An anteroom if present is considered to be within the containment perimeter Corrective action plan CAP A step by step plan of action and schedule to remedy a deficiency or non performance A CAP assigns responsibility and a timeline and specifications for documenting the corrective actions taken The essential elements of a CAP include 1 Assigning responsibilities to ensure that a responsible individual is assigned for the identified deficiency or action item 2 Creating an implementation schedule with set milestones 3 Ensuring that corrective actions are taken for identified deficiencies 4 Identifying a completion date and providing periodic updates against that completion date and 5 Documentation indicating that all actions have been taken to correct the deficiencies includes sign off when corrective actions are completed Critical control air The complete system that provides a required compressed air supply deemed necessary for the operation or fail safe condition of critical BSL 3 ABSL 3 HVAC controls or containment equipment e g pneumatic dampers air powered sterilizer door gaskets HVAC controls Decontamination A procedure or set of procedures that eliminates or reduces biological agents and toxins to a safe level with respect to t
67. ent equipment BSC or other performance verification document including serial number verification Verify that the testing agent verifier has been supervised by an NSF AMERICAN NATIONAL STANDARD 29 14 2014 approved testing agent verifier and that their equipment meets current performance verification requirements 3 Verify that installation of BSC is correct for cabinet type 4 Verify correct placement of primary containment equipment BSC fume hood etc with respect to air devices doors and traffic patterns 5 Class II Type A BSCs can recirculate HEPA filtered cabinet air into the room All thimble capture devices should be verified for operation and integration with the room exhaust 6 Class Il Type B1 biosafety cabinets are required by NSF 49 to be hard ducted to ventilation system e Verify appropriate duct connection and integrity 7 Class Il Type B2 BSCs are required by NSF 49 to be hard ducted to ventilation system e Verify appropriate duct connection and integrity 8 Verify Class Ill BSCs are provided with HEPA filtered supply air and double HEPA filtered exhaust air connections 9 Verify that the exhaust of a Class III BSC is connected up through the second exhaust HEPA filter of the cabinet and that the supply air is provided in such a manner that it prevents positive pressurization of the cabinet 49 AMERICAN NATIONAL STANDARD Z29 14 2014 10 11 Fume hoods t
68. entation should include specific sections of ductwork where the test was conducted and results of the test for each duct section Provide the calibration certificates for the equipment used for the verification should be valid on the date of test 8 4 8 2 When required by the facility risk Purpose of Test To verify and minimize assessment room tightness room air leakage unplanned uncontrolled room air test shall be performed before initial leakage to ensure proper HVAC control operation periodically thereafter as for directional airflow and to ensure determined by the facility risk assessment and HVAC systems react to room the SOP and after any alterations of the decontamination systems to avoid ventilation system or other alterations that can leakage of hazardous gases When BSL affect the room containment 3 ABSL 3 laboratories are to be decontaminated by fumigation penetrations in the barrier envelope should be sealed or capable of being sealed to prevent excessive migration of fumigants out of the space Recommended Methodology 1 All room sealing should be done prior to performing final TAB and final setup of airflow control devices 2 Visually verify that all architectural finishes are sealed smooth and void of chips and abnormal wear 3 Visually verify all penetrations are sealed smooth and are capable of withstanding fumigation The verification should include all service electrical gas fire detection
69. entry of the BSL 3 ABSL 3 suite e g before entering the anteroom and at interior doors based on the facility risk assessment e g at interior lab doors or major containment boundaries The monitors should be mounted so they are visible when entering the rooms These are typically installed on the cleaner side prior to entering the containment space Alarm indication should be located inside the laboratory space s at the entrance of the laboratory suite and at the remote notification location The presence of at least two self closing doors in series is a fundamental mechanism to achieve overall directional airflow ina BSL 3 ABSL 3 lab or suite The operation of the doors should be verified to confirm that both or all the doors in series are not opened simultaneously If mechanical interlocks are not present facility SOPs should require that multiple doors are not opened simultaneously 8 3 4 Visual Inspection of Exhaust Air System Visual inspection of the exhaust air system shall include an assessment of the major features of the exhaust air system arrangement and installation AMERICAN NATIONAL STANDARD 29 14 2014 Inspection should include 1 Ensuring that doors automatically close and latch 2 Checking function of door interlock systems or facility SOPs as appropriate 3 Checking the distance between entrance doors from the anteroom making sure the distance is adequate for door operation Ad
70. ergency power operates only when normal power is out disconnect the normal power source e Record and document that emergency power is supplied to all critical and subsystems intended e After all systems have stabilized restore normal power and document that there are no impacts to critical systems and or subsystems Test that operation of general UPS where installed into and out of source interruption and equipment should transition to from UPS mode in a controlled manner Based on the facility risk assessment there should be documentation on the sequence of operations for the UPS and the minimum time the UPS will maintain service e Disconnect power to UPS and determine that UPS operates to provide power to all connected loads for the intended time Test operation of BAS UPS where installed into and out of service interruption BAS controls should remain powered and active The BAS controls should be locally backed up and controls programming maintained during a power outage There should be written documentation for the minimum time the UPS batteries will maintain operation 8 4 7 1 HEPA filters shall be tested upon installation 12 18 months from the last test or at a frequency to be determined by the site specific risk assessment Each HEPA filter or bank of HEPA filters shall be tested in situ by particle or aerosol challenge testing AMERICAN NATIONAL STANDARD 29 14 2014 e Disconnect power to
71. es and employees under supervision Trivial risk Unlikely to need specific application of resources ar_2er The numbers and letters associated with the criteria for likelihood and consequences reflect accuracy in the rating For example a risk rating may be H but does that represent possible and severe or likely and severe or likely or major etc It is a way of explaining the reasoning behind the risk priority rating It also recognizes that there are a few versions of the same rating just with different criteria being assessed Sample Risk Matrix Example 2 This risk matrix has a risk priority rating represented by a numerical code as the key below outlines How likely is it to be that bad How severely could it hurt someone or how ill could it make someone Key to the risk rating 1 and 2 The hazard has a high risk of creating an incident It requires immediate executive management attention to rectify the hazard Control action must be immediately implemented before working in the area or carrying out the work process 3 and 4 The hazard has a moderate risk of creating an incident It requires management attention in a reasonable timeframe to prevent or reduce the likelihood and 118 AMERICAN NATIONAL STANDARD 29 14 2014 severity of an incident Control action of a short term nature would need to be taken immediately so that work could still be carried out w
72. ferential trending logs if available of normal and failure mode testing including electrical systems failure tests 6 Test results of BAS control alarms during testing of ventilation system verifying that in room containment perimeter access points and remote alarms are working 7 High efficiency particulate air HEPA filter housing test reports of efficiency tightness and structural integrity 8 Ductwork that is considered part of the secondary barrier tightness test reports 9 BSL 3 ABSL 3 room air leakage report if applicable AMERICAN NATIONAL STANDARD 29 14 2014 10 Biosafety cabinets and other primary containment devices that directly interact with the ventilation systems such as test results and certificates 11 Capture velocities for bench sweeps canopies and snorkels inside containment 12 Test results of devices such as downdraft tables and ventilation pass through devices 13 Test results of room decontamination systems that integrate with the ventilation systems if applicable 14 Technical support area ventilation tests for directional airflow and HEPA filtration efficiency if applicable 15 Control instrumentation calibration records 8 3 Visual Inspection of Ventilation and Related Systems The visual inspection methods and results shall be performed and documented as part of the performance verification process for the ventilation system Visual inspection is conducted to con
73. fety and design professionals and owners operators who recognize the need to establish uniformity in the requirements and methodologies for the testing and performance verification of the ventilation system of BSL 3 ABSL 3 laboratories The criteria contained herein should be supplemented expanded or consolidated as required to adapt to the specific testing and verification effort the organization and the specific regulatory and policy requirements that may apply in each case Suggested acceptance criteria where available are provided in the standard Establishment of acceptance criteria is the responsibility of facility management Acceptance criteria should be based on site specific risk assessment and performance objectives 2 PURPOSE The purpose of ANSI Z9 14 is to provide a one stop resource for guidance to inspect and test the performance of a BSL 3 ABSL 3 laboratory ventilation system 3 SCOPE Methodologies are provided to perform visual inspection and evaluation of 1 Directional airflow 2 Anterooms 3 Primary containment systems Building ventilation system 5 Heating ventilation and air conditioning HVAC testing 6 Filtration ABSL 3 and integration of individually ventilated caging static caging systems other elements and downdraft tables 8 Document validation 9 Pressure reversal 10 Failure testing 11 Leakage issues related to HVAC 12 Qualifications of testers ANSI Z9 14
74. firm annual testing requirements and to prepare the facility for formal inspections by regulatory authorities or the authorities having jurisdiction AHJ Visual inspection is conducted as part of the performance verification process The inspection process and the frequency and method of inspection are determined by local risk assessments or regulatory e g Federal Select Agent Program requirements 29 AMERICAN NATIONAL STANDARD Z29 14 2014 8 3 1 Visual Inspection and Evaluation of Engineering Controls The verification process shall include review and visual inspection of ventilation system installation including conformance with the requirements of applicable standards the risk assessment and any additional requirements necessary for proper operation and maintenance of the ventilation system 30 In general verification can be completed by Inspection in field Review of as built drawings and BOD Review of documentation of most recent tests Review of equipment certifications Review of daily charts graphs or review of BAS Review of documents only should not be considered as a substitute for visual inspection of apparent conformance in the field At a minimum verify the following Verify no recirculation of room or equipment air to areas outside the containment area e Verification may be accomplished via review of current as built drawings Air change rates Measure and calculate e
75. format such as that used by International Organization for Standardization ISO the ISO has templates for purchase They include templates for CAPS risk assessment SOPs etc Go to http www iso org iso home standards htm search for Templates then by template type i e risk assessment 120 Summary of SOP content Issue date Date of approval Title and authors author may be the organization or lab ID number version number page numbers Introduction Purpose objective Applicability Responsibility Materials Step by step procedure Review revision and distribution process Approvals Relevant documents references regulations Management controls Training requirement AMERICAN NATIONAL STANDARD 29 14 2014 Appendix E Index of Acronyms AABC Associated Air Balance Council ABSL 3 Animal Biosafety Level 3 ADA Americans with Disabilities Act AHJ authority having jurisdiction AHU air handling unit ASSE American Society of Safety Engineers ANSI American National Standards Institute ARS Animal Research Service ASHRAE American Society of Heating Refrigerating and Air Conditioning Engineers ATS automatic transfer switch BAS building automation system BMBL Biosafety in Microbiological and Biomedical Laboratories BSC biological safety cabinet BSL 3 Biosafety Level 3 BSO biological safety officer CAP corrective action plan DOP diocytl phthalate HEPA high efficiency particulate air HVAC heati
76. g air into the containment space from clean areas toward potentially contaminated areas except as determined by specific site conditions such as clean room containment spaces Directional airflow is dependent on the 33 AMERICAN NATIONAL STANDARD Z9 14 2014 Devices used to verify airflow direction shall be inspected for function visibility and clarity of communication for the BSL 3 ABSL 3 users Where the devices are integrated into the HVAC control system communication of alarm information to the control system shall be demonstrated Time delays associated with containment space alarms shall be verified In the event of loss of directional airflow personnel in the containment space shall be notified of such condition via audible and or visual alarms Directional airflow for the entire laboratory suite as a system must be evaluated for both normal operations and system failures taking into account the presence of anterooms or other double door configurations Door operations shall be inspected for ability to maintain directional airflow 34 operational integrity of the laboratory s HVAC system and associated controls HVAC systems should be carefully monitored and have periodic maintenance performed to sustain operational integrity Loss of directional airflow compromises safe laboratory operation A means for users to verify airflow direction should be present Monitors should be provided both at the outer
77. gement plans 1 Ensuring the formation of a ventilation and to maintain biosafety biocontainment verification team with appropriate and biosecurity authority to implement a facility testing and verification program 2 Identifying a clear reporting structure to an entity or institutional official 3 Ensuring that the team is appropriately constituted and staffed with adequate resources 4 Ensuring that an appropriate risk assessment is conducted and documented to form the basis of the testing and verification program for the laboratory BSL 3 ABSL 3 facility 5 Ensuring testing and verification are done at an appropriate frequency 6 Ensuring that entity assignments are made and documented 7 Ensuring safe operation of the BSL 3 ABSL 3 laboratory This is typically performed by top management such as the president CEO Providing resources for implementing this standard This is typically performed by top or senior management 8 Collecting pre inspection documentation 19 AMERICAN NATIONAL STANDARD Z29 14 2014 Member Responsibilities Testing and Verification Team Responsibilities Team leader shall have ultimate responsibility for team activities including assignment of team roles and responsibilities and interactions with entity s leadership e Development of site specific testing and performance verification SOP e Testing and performance verification documentation 20 9 Ensuring that the facility
78. graph A Supplement to NIH Guidelines for Recombinant DNA Research 1979 Available at http ors uchc edu bio resources pdf 3 3 2 D 2_NIH_Lab 20Safety 20Monograph 1979 pdf Accessed June 11 2013 American Conference of Governmental Industrial Hygienists ACGIH Industrial Ventilation A Manual of Recommended Practice 25th Edition Cincinnati OH ACGIH 2004 127 D ASSE Sets the Standard We have a variety of standards for purchase that will improve productivity increase efficiency reduce cost and minimize risk ANSI Secretariat for e A10 Construction amp Demolition Operations e A1264 Protection of Floor amp Wall Openings e Z9 Ventilation Systems e Z10 Safety amp Health Management e Z15 Motor Vehicle Safety e Z88 Respiratory Protection e Z117 Confined Spaces e Z244 Control of Hazardous Energy Lockout Tagout amp Alternative Methods e Z359 Fall Protection e Z390 Hydrogen Sulfide H2S Training Programs e Z490 Safety Health amp Environmental Training e Z590 Competence amp Certification in the Safety Profession and Prevention Through Design U S Technical Advisory Group Administrator for e Fall Protection e Safety amp Health Management Systems e Risk Management Assessment For more information visit www asse org standards or contact customer service at 1 847 699 2929 END USER LICENSE AGREEMENT IMPORTANT READ CAREFULLY BEFORE DOWNLOADING OR COPYING TO YOUR COMPU
79. h NIOSH O Brien Dennis Paulson Kathleen Pomer Ellen Price John Robson Forensic Inc Rollins Mark Sheehy John Non Voting Members Lindsay Cook CIH CSP Lee Hathon John H Llibre Don R Scarbrough The Z9 14 Subcommittee Neil McManus CIH ROH Kyle Hankinson Kenneth Hankinson Farhad Memarzadeh Ph D P E Michael Elliott Dennis O Brien Ph D P E CIH Kathleen Paulson P E Ellen Pomer John Price CIH CSP Ronald D Schaible CSP CIH Mark Rollins CIH CSP John Sheehy Ph D CIH The Z9 14 Subcommittee on Testing and Performance Verification Methodologies for Ventilation Systems for Biosafety Level 3 BSL 3 and Animal Biosafety Level 3 ABSL 3 Facilities that developed this standard was comprised of the following members Farhad Memarzadeh Ph D P E Chair National Institutes of Health NIH Director Division of Technical Resources Louis DiBerardinis CIH CSP MIT Vice Chair Massachusetts Institute of Technology MIT Director Environment Health and Safety Office Organization Represented Affiliated Engineers Metro DC Inc American Biological Safety Association ABSA American Society for Microbiology ASM Association for Assessment and Accreditation of Laboratory Animal Care International AAALAC Association of Public Health Laboratories APHL Barb Nellis Consulting Name of Representative Krishnan Ramesh Paul Jennette Claudia Mickelson Bradford S Goodwin
80. hall be readily visible when applicable for inspection cleaning and maintenance Penetrating components shall be sufficiently rigid in construction to maintain the integrity of the penetration seal 8 3 3 Visual Inspection of Directional Airflow In the event that multiple containment zones exist in series within a laboratory or laboratory suite the air shall flow from one space to the next towards the space with the highest potential for contamination This will create sequentially more negative room pressures AMERICAN NATIONAL STANDARD 29 14 2014 Properly sealed laboratory surfaces walls floors and ceilings are essential to maintain controlled directional airflow and ventilation system performance Room leakage or tightness is also critical when gaseous fumigants are used for decontamination Examples of elements to inspect include 1 Operational condition of doors door gaskets and thresholds 2 Windows on containment perimeter wall are non operable and sealed in place type construction 3 Pass through equipment for leak tightness bio seal etc Double door autoclave flange bio seal 5 Piping and electrical wall or ceiling penetrations including fire sprinklers 6 Seals around light fixtures receptacles diffusers and grilles 7 Sealing of electrical and communication data wires within conduit 8 Components mounted to walls and ceilings Inward directional airflow is established by drawin
81. hat are placed inside BSL 3 ABSL 3 facilities should be inspected for airflow alarms if present filtration needs carbon and HEPA and recirculating options An SOP should be in place for use of a fume hood which is not the same as a BSC including its integration to the rooms negative pressure If fume hoods are used inside BSL 3 ABSL 3 spaces filtration requirements HEPA and or carbon use of chemicals chemical compatibility decontamination and efficiency testing need to be documented in SOPs and reviewed by verifying testing agents Other primary containment devices should be inspected per a SOP 8 3 8 Visual Inspection of High Efficiency Particulate Air HEPA Filters HEPA filter installations shall be assessed by visual inspection HEPA filters shall be tested at least annually 50 Note When the visual inspection of the HEPA filter housing requires accessing the potentially contaminated section of the housing proper decontamination procedures should be taken following local risk assessments and SOPs Inspection should include the following 1 Integrity of filter housing e Verify in field for general condition of filter housing specified construction material and pressure class This can be reviewed together with filter shop drawings and factory testing Filter media shall be inspected before and after installation AMERICAN NATIONAL STANDARD 29 14 2014 e Check for dents or d
82. he transmission of infection or other adverse effects Directional airflow Air flow that moves from a low hazard to a higher hazard area Downdraft table Specially constructed autopsy necropsy tables that are ventilated to partially control particulates odors and volatile chemicals This type of engineering control typically requires a connection to building mechanical systems plumbing exhaust ventilation There are available self contained portable downdraft tables that provide particulate protection through a HEPA filtration system which returns filtered air These pieces of equipment must be tested and must comply with the design of the building and the manufacturers recommendations Empirical testing Testing based on observation and experiment derived solely from experience Environmental health and safety plan An institution s organization s policy document containing information and methods of working as part of the process for minimizing risks to employees visitors and the environment Exhaust to supply interlock A means of control BAS electrical to shut off supply airflow to a BSL 3 suite in the event of exhaust system failure that could cause a reversal of pressurization in the containment zone Facility An operational unit and associated buildings and equipment used to manage biological agents and toxins A facility includes the laboratory together with the supp
83. i e the room s ventilation system prevents positive pressurization and or an airflow direction reversal Hard ducted Class biosafety cabinets and chemical fume hoods Test and verify that the exhaust flow and face velocity is within the acceptable ranges provided by the manufacturer of the BSC or fume hood or as required by applicable standards e g ANSI ASHRAE 110 Verify that air currents from door swings and the ventilation system do not interfere with air capture at the sash opening by testing with smoke or other visual indicator Ventilated animal caging equipment connected to the building exhaust system The ventilated animal caging equipment should meet the requirements for air change rates and thermal or humidity requirements from The Guide 71 AMERICAN NATIONAL STANDARD Z29 14 2014 72 Ventilated animal caging equipment that is connected to in situ ventilation systems should be tested for proper operation to ensure directional airflow negative pressure and controls alarming Ventilated animal caging equipment that is integrated using single airflow control valves from several cage racks should be tested with multiple racks connected and disconnected valve performance needs to be validated whether it is installed with a 1 to 1 ratio or 1 to greater than 1 ratio Ventilated animal caging equipment that is connected to in situ ventilation systems should include tests to validate ro
84. ing Engineers ASHRAE standards U S Department of Agriculture Animal Research Service USDA ARS 242 1 Manual World Health Organization WHO Biosafety Guidelines Biosafety Manual and the National Institutes of Health Design Requirements Manual DRM Many of these guidelines offer design requirements but lack the testing and performance verification methodology to ensure the safe operation of the ventilation system for these laboratories Using a risk assessment and performance based approach this standard provides the technical specifications and background information needed to address the technical engineering and associated systems for ventilation within a BSL 3 ABSL 3 laboratory As such it is fully compatible with biorisk management systems and national and international health and safety management systems without duplicating or contradicting their requirements The purpose of the ventilation system is to provide the necessary environment for biocontainment occupational health and animal health in accordance with standards and containment guidelines It specifically is designed to prevent unintended release of aerosolized infectious biological agents The ANSI Z9 14 standard provides the combined knowledge acquired over the years by biosafety professionals design professionals and owners operators of BSL 3 ABSL 3 laboratories which establishes the requirements and methodologies for the testing and performance verification
85. ing openings or occupied areas for re entrainment or airstream exposure potential e Verification may be conducted in field and assisted by review of as built drawings Laboratory exhaust stack termination height should be verified to conform to applicable standards e Verification may be conducted in field and assisted by review of as built drawings Verify presence and operation if possible of interlock between supply and exhaust air systems e Verification may be conducted by review of control sequences in BAS and review of commissioning report Verify that rainwater cannot accumulate in exhaust fan housing e Verification may be conducted in field or by review of as built drawings indicating fans offset from stack or via fan housings are provided with drains Primary exhaust air equipment condition and operation shall be assessed by visual inspection AMERICAN NATIONAL STANDARD 29 14 2014 6 Terminal exhaust filters if present e Verify integrity of filters and seals Visual inspection should include 1 Exhaust discharge stack e Verify in field for stack condition stability supports etc 2 Exhaust fan and fan housing e Verify in field fan condition corrosion supports abnormal vibrations condition of flexible duct connections etc 3 Motor e Verify in field for condition corrosion supports abnormal vibrations etc 4 Belts e Check for proper quantities alignment and tension check main
86. ing to actuators etc 13 Exhaust HEPA filter housings and filters where provided refer to section 8 3 8 Visual Inspection of High Efficiency Particulate Air HEPA Filters 14 Exhaust bio seal dampers e Check for condition of dampers including integrity of seals corrosion of damper components flanges and connections gaskets Accessible portions of exhaust air ductwork distribution components and room connections shall be assessed for integrity by visual inspection AMERICAN NATIONAL STANDARD 29 14 2014 for visible damage condition of actuators linkages wiring and or pneumatic tubing to actuators etc 15 Proper access for equipment and system maintenance e Verify in field e Verify that the areas that house the HVAC and electrical equipment are ventilated for proper operation of the equipment Visual inspection should include 1 Exhaust ductwork construction materials joining methods gaskets seals etc e Verify that the installation meets the project BOD and specification requirements Inspect accessible elements of ductwork for evidence of corrosion damage or impending leakage 2 Segments of exhaust ductwork intended for gaseous decontamination should be of gas tight construction If an air valve is installed in these duct segments SOPs should require bagging and taping or other appropriate procedures to avoid leakage of decontamination gases to surrounding spaces Typically gas tight
87. ion of critical electrical equipment to BAS 8 Monitoring of critical UPS where installed and standby power by BAS Recommended Methodology Containment systems should respond in such ways as to avoid operating conditions that present risks to workers and the environment Electrical systems including backup generators for normal power outages provide effective AMERICAN NATIONAL STANDARD Z29 14 2014 94 strategies to maintain containment including minimization of flow reversals Emergency generators can normally respond within 10 15 seconds to restore power whereas UPS systems where installed provide continuity of power between transitions of normal to emergency power systems Based on the risk assessment for the facility each supporting system should have a documented sequence of operation strategy for power failure and restoration This will include the criteria for time limitations for power restoration This section covers only the electrical power to the main electrical systems As appropriate to address the risk assessment similar testing scenarios should be considered for multiple levels of electrical failure down to the individual systems As electrical power will be critical to all the containment systems testing should be performed when all the containment systems are tested If the facility primary electrical system includes load shedding multiple generating standby units or other electrical demand
88. is safe to perform verification This is typically performed by BSO or facility management 10 Ensuring that BSL 3 ABSL 3 lab entry requirements have been met This is typically performed by a BSO or facility management and includes safety and security training and occupational health requirements 11 Ensuring that required corrective actions to address identified deficiencies have been developed and completed 12 Ensuring that appropriate re verification is completed to address deficiencies such as ascertaining intended results for the item of concern issues that may have been impacted by the concern or elements of the corrective action plan CAP once completed Each role responsibility should be assigned to an individual the individual may have more than one role responsibility Team leader should ensure that team assignments are made and documented See section 8 Guidelines for Implementing Testing and Performance Verification 7 Risk ASSESSMENT AMERICAN NATIONAL STANDARD 29 14 2014 7 1 Risk Assessment Overview for Work with Hazardous Agents Materials A comprehensive risk assessment is an integral part of planning design construction maintenance and safe operation of any biocontainment facility and shall be done prior to opening a new or after modifications to an existing facility and whenever agents procedures and personnel change The risk assessment and subsequent corrective action plan CAP see A
89. ith further long term action taken to ensure that the hazard was fully controlled 5 and6 The hazard has a low risk of creating an incident It requires supervisor and employee attention in a reasonable timeframe to prevent or reduce the likelihood and severity of an incident Sample Risk Matrix Example 3 This matrix is used by the U S Department of Defense and Department of Homeland Security for risk assessments Risk Assessment Matrix Probability of the Event Occurring Outcome Catastrophic Critical Low Marginal Low Negligible Low Definition of Terms Severity Probability e Catastrophic Exposure or event results in e Frequent Occurs very often expected to death or permanent disability occur continuously e Critical Exposure or event results in severe e Likely Expected to occur several times injury or illness during an employee s tenure e Marginal Exposure or event results in mild e Occasional Expected to occur over a period injury or illness of time will occur at some point e Negligible Exposure or event results in e Seldom Occurs as an isolated incident not need for first aid or minor medical expected to occur treatment e Unlikely Occurs rarely cannot be considered impossible 119 AMERICAN NATIONAL STANDARD Z9 14 2014 Appendix D How to Compile a Standard Operating Procedure SOP Every SOP should contain the following information using a comprehensive
90. ities Visual inspection of ABSL 3 facilities shall Inspection should include include all applicable BSL 3 criteria i Based ona wecassesement aamal caging systems should comply with Ventilation system shall meet the f primary containment requirements requirements of Guide for the Care and Use of for BSL 3 operation and the facility Laboratory Animals The Guide SOPs 2 Review connections between rack blowers and HVAC system if provided and ensure room balance and directional airflow is maintained 3 Review fan blowers assigned to cage racks for operability noise effects 53 AMERICAN NATIONAL STANDARD Z29 14 2014 and connectivity 4 Verify cages and their connecting ports are properly mounted to the internal rack HVAC connections 5 Review whether individually ventilated caging HEPA filter if provided testing tags are up to date and provided 6 Verify if static loading on filter exceeds manufacturer recommendations or local set points based on risk analysis 7 Verify operability of local adjustable air valves attached to individually ventilated caging 8 Verify that positive negative P N control valves if provided are properly set 9 Review recirculating racks influence on room s air distribution and odor control devices 8 4 Testing Ventilation and Associated Systems General Requirements HVAC systems shall be tested and documented before initial operation periodica
91. k testing or when filter loading causes elevated static pressures resulting in the inability to maintain proper airflow In some cases filters may be changed based on a facility requirement or practice HEPA filters installed in series should be tested individually In line HEPA filters may require the use of a portable fan to introduce AMERICAN NATIONAL STANDARD 29 14 2014 8 4 7 2 HEPA filter housings that are exposed to elevated pressures or incur gas decontaminations shall be tested for structural integrity and leakage at the factory after initial installation and at a frequency to be determined by the site specific risk assessment airflow for HEPA testing 21 Where parallel redundant HEPA filters are installed ensure that facility operations are not interrupted while testing filters and housings except as determined by the facility risk assessment Documentation Test documentation should include test results for each filter Purpose of Test To ensure that the integrity of the housing can be sealed for gaseous testing and withstand normal and maximum operating pressures experienced during fan failures Recommended Methodology 1 Filter housings should be decontaminated prior to testing based on a risk assessment Follow the site specific SOP for decontamination 2 The design engineer should provide the test pressure to be used which is the system s maximum operating pressure in accordance with
92. lding automation system BAS Automated systems used to alarm monitor and control building functions such as smoke management heating ventilating and air conditioning HVAC and lighting Certification A systematic documented process to ensure systems perform in accordance with available certification standards or applicable verification guidance Class IIl biological safety cabinet Class III BSC A gas tight biological safety cabinet with a non opening completely sealed viewing window that is accessed using long heavy duty rubber gloves attached to ports in the cabinet Both supply and exhaust air are HEPA filtered allowing for maximum protection of the environment and the worker Operations in the cabinet are conducted through attached rubber gloves The cabinet is maintained under negative air pressure of at least 0 50 in water gauge w g 120 Pascal Pa Down flow air is drawn into the cabinet through HEPA and ultra low penetration air ULPA filters The exhaust air is treated by double HEPA ULPA filtration or by HEPA ULPA filtration and incineration Commissioning 1 A systematic process through documented verification that all building systems perform interactively AMERICAN NATIONAL STANDARD Z29 14 2014 according to the documented design intent and owner s operational needs 2 The process of ensuring that systems are capable of being operated and maintained according to design int
93. libration certificate on the date of test if the equipment requires it AMERICAN NATIONAL STANDARD 29 14 2014 8 Small in line filters e g installed in magnehelic photohelic gauge lines should be factory leak tested Installation of the small in line filters protecting magnehelic photohelic gauges in the filter housing should be tested as part of the leak testing of the housing Documentation Test documentation should include test results for each filter housing 8 4 8 Testing of Ductwork and Room Air Leakage Test Purpose and Methodology 8 4 8 1 Ductwork that is a considered Purpose of Test To ensure that contaminated b transports air containing ductwork serving containment spaces hazardous substances or c if used for gaseous and transporting potentially decontamination shall be tested for its degree contaminated air are sufficiently tight of structural resistance tightness and leakage and structurally stable under normal and maximum operating pressures Such ductwork shall be tested upon installation before initial operation as determined by the Prior to testing the testing facility risk assessment and after any entity individual should assess the alterations of the ventilation system or other performance requirements of the ducts alterations that can affect the ductwork such as maximum operating pressure design pressure duct pressure and classification etc Recommended Methodology 1 Supply an
94. lly thereafter annually or as determined by facility specific risk assessment and after any significant alterations of the ventilation system or other alterations that can affect it Except where specifically indicated in the following subsections test acceptance criteria shall be established by the facility risk assessment 54 Given the high degree of variability in BSL 3 ABSL 3 facility layout and system configurations this standard cannot define precise periodic testing frequencies or acceptance criteria for all conditions Therefore to accommodate this variability and to ensure that the testing reflects the actual work performed at each location testing frequencies and acceptance criteria should be determined by facility specific risk assessments All external instruments i e portable or not a component of the building used for testing AMERICAN NATIONAL STANDARD 29 14 2014 When performing a risk assessment to determine the frequency of periodic testing of HVAC systems as well as acceptance criteria facility owners should address factors including but not limited to e The relative risk of the BSL 3 ABSL 3 work performed in the facility other activities in the facility and the facility s surroundings e Accessibility of HVAC components e g ductwork installed in chases e Relative risk i e both probability and consequence of a component s failure Examples of major changes to the H
95. ls to top management AMERICAN NATIONAL STANDARD 29 14 2014 7 Failure of multiple AHUs or supply fans as expected in worst case scenarios 8 Normal power failure and transfer to emergency source power uninterruptible power supply UPS or emergency generator 9 Transfer from emergency power to normal power 10 Failure of BAS and controls system failure Circumstances may be such that because of the normal and emergency power distribution testing may not be easily accomplished In which case a simulated power test is sometimes possible where just the automatic transfer switch ATS can be manipulated If not then the suggested procedure is to verify that there is a maintenance program that annually tests the emergency generator under load conditions and there is annual maintenance of the ATS If a test is simulated for the BSL 3 zone under test test procedures should assess impact of adjacent areas that may be still running and may influence pressures tests could also simulate concurrent failures in adjacent zones Two groups of individuals should perform the activities described in this standard 1 Entity Management Those individuals with facility specific roles and responsibilities such as upper management owner s representative senior management biological safety officer biorisk management advisor 17 AMERICAN NATIONAL STANDARD Z29 14 2014 18 2 Testing and Verification Team Those i
96. mMeENie aeee ie edadeae alae 21 7 1 Risk Assessment Overview for Work with Hazardous Agents Materials cccceeceeeeeeeeeeeeeeeeeeeeeeseseesaaaeaeeeeeeeeeeee 21 Guidelines for Implementing Testing and Performance Verification 22 81 Verifications E T 22 8 2 DOCUMENTATION ss sroka rnidan anaE A 23 8 2 1 Required and Recommended Documentation 23 8 2 2 Evidence of Documentation 0 sssseeeeeeeeeeeeeeees 24 8 2 3 Ventilation Testing Documentation Verification 27 8 3 Visual Inspection of Ventilation and Related Systems 29 8 3 1 Visual Inspection and Evaluation of Engineering CONntrolS osne a E EENE 30 8 3 2 Visual Inspection and Evaluation of Architectural Features 20 cece cccceeeeeeeeeeee ce eeeeeeeeeeeeeeaaeeaeeeeeeeeeeeaaaenneeeeeeees 32 8 3 3 Visual Inspection of Directional Airflow cccccceeeeees 33 8 3 4 Visual Inspection of Exhaust Air System ccceeee 35 8 3 5 Visual Inspection of Supply Air System eeeeeees 40 8 3 6 Visual Inspection of Critical Control System Air and POWED cccece cece ee eeeeeeeeeeeeeeeeeeeeeeeeeeeeeaaeeneeeeeeeeeeesaas 46 8 3 7 Primary Containment Equipment cceeeeeseeeeeees 48 8 3 8 Visual Inspection of High Efficiency Particulate Air AMEPRANLFIOTS eee eee eee eee eee 50 8 3 9 Control Systems Fail Safe Operation ccceeeees 53
97. main with the acceptable range in accordance with the risk 87 AMERICAN NATIONAL STANDARD Z9 14 2014 88 assessment typical acceptable range is above 0 03 and below 0 15 water gauge w g across the barrier with directional airflow from clean to dirty areas The following tests should be considered 1 Impose a minor set point change to the airflow and static pressure loops and observe response and return to normal operational set point e Confirm containment barrier pressures remain within tolerance 2 Enter and exit the space in accordance with SOPs e Confirm the control system reacts in a stable fashion so as to maintain airflow and differential pressures within acceptable ranges 3 Operate sashes of primary containment across ranges applicable during normal use 4 Configure the rooms and systems into all modes of operation per the design intent e Confirm proper operation during those modes 5 Confirm airflow and pressure control on normal use of scientific equipment Monitor the barrier differential pressure and airflow control during normal use of laboratory equipment Examples include e Partial blockage of downdraft and necropsy tables percentage of blockage should be as stipulated in SOPs The BAS control systems shall be tested during abnormal operation AMERICAN NATIONAL STANDARD 29 14 2014 e Sash movement on biosafety cabinets and fume hoods e Repositioning of snorkel exhausts 6 Isola
98. ment and facility requirements of ABSL 2 Anteroom For the purpose of this standard anteroom refers to the zone between the two self closing doors in a facility designed to minimize air escaping from the containment space e g laboratory animal room or central AMERICAN NATIONAL STANDARD 29 14 2014 containment corridor into non containment spaces Authority having jurisdiction AHJ An organization office or individual responsible for enforcing the requirements of a code or standard or for approving equipment materials an installation or a procedure Automatic transfer switch ATS An automatic device for transferring one or more load conductor connections from one power source to another Biocontainment The practices techniques equipment and facilities needed to contain biohazardous materials such as pathogenic microorganisms or toxins and preventing their release into the environment thus minimizing worker exposure Biocontainment includes the physical containment barriers in a facility such as contained dressing and shower rooms sealed service penetrations specialized doors entry and exit avenues to prevent cross contamination specialized air handling systems for contamination control personal protective equipment biosafety cabinets and other primary containment devices etc Biohazard biological hazard hazardous biological agent 1 An infectious or otherwise harmf
99. ment spaces during some failure mode testing will not necessarily mean that a facility is deemed non conformant Rather such findings documented and incorporated into the risk assessment process will enable the entity s administration to determine if corrective action is required Corrective actions may be in the form of physical and or administrative controls Proper documentation of this process can be considered demonstration of conformance 5 3 Verification of Conformance to Regulations Identify the relevant regulations and standards through which the conformance verification process is made Experts in the field shall be consulted This systematic review against previously identified relevant standards may result in the identification of deviations from these standards The verification process shall not end until disposition for these deviations are identified and the results are verified to be as expected 6 OVERVIEW 6 1 Ventilation Testing Performance Categories Testing and verification of ventilation systems in BSL 3 ABSL 3 labs shall include e Supply e Exhaust e Directional airflow e Engineering controls such as biological safety cabinets BSCs micro isolators downdraft tables fume hoods and other primary containment devices connected to AMERICAN NATIONAL STANDARD 29 14 2014 Perhaps the most essential comparison is that of the current status to local state and federal laws In some cases legal
100. nd electrical equipment are ventilated for proper operation of the equipment 18 Outside air intakes for re entrainment potential e Verify in field that required minimum distances are provided between outside air intake and lab exhaust boiler exhaust cooling towers generators loading docks plumbing vents vacuum pump discharge etc 19 Outside air intake e Verify in field for cleanliness snow build up standing water in vicinity blockage of screens and louvers etc 20 Outside air intake security measures e Verify that security measures based on risk assessment are in place where the air intake louvers are protected from potential incursions of unauthorized personnel e g secured grilles 21 Verify presence and operation if 43 AMERICAN NATIONAL STANDARD Z29 14 2014 Primary supply air equipment condition and operation shall be assessed by visual inspection Accessible portions of supply air ductwork distribution components and room connections shall be assessed and verified to be in good operating condition by visual inspection 44 22 possible of interlock between supply and exhaust air system e Verification may be conducted by review of control sequences in BAS and review of commissioning report Verify insulation requirements for ductwork including ductwork externally located that is exposed to inclement weather where thermal differences can cause condensation e Verification should be con
101. nd the filter s gasket s should be repaired or replaced If the HEPA filter housing is not equipped with the aerosol challenge injection distribution ports injection ports should be provided in the ductwork upstream of the HEPA filter s so that the aerosol challenge can be introduced Adequate distance approximately 8 duct diameters should be given to provide a more even distribution of challenge to the filter s If the HEPA filter housing is not equipped with an upstream 99 AMERICAN NATIONAL STANDARD Z29 14 2014 100 15 16 17 18 19 20 challenge sampling port an upstream challenge sampling port should be installed for measuring the upstream challenge This should be just upstream of the HEPA filter s If the HEPA filter housing is not equipped with a scanning section a downstream sampling port should be installed for gross probing the duct This port should be placed where adequate air mixing can occur approximately 8 duct diameters Filter leaks or gasket leaks can be repaired using room temperature vulcanizing sealant RTV 100 silicone or by making a patch using filter media Filter leaks or gasket leaks can be repaired using RTV 100 silicone or by making a patch using filter media Per IEST 0 34 no patch should exceed 5 of the filter s face area Suitable cure time should be allowed before re testing HEPA filters should be changed when the filter fails the lea
102. nd verification process Regulatory and legal documentation shall be kept as a minimum requirement The institution will determine the documentation confidentiality security and retention duration requirements for all records and findings AMERICAN NATIONAL STANDARD 29 14 2014 standards and pre defined acceptance criteria e Identifying further need for conformance with relevant standards Testing and verification may be done with internal or external resources The resources must exhibit the requisite skills and knowledge to verify the work being evaluated Documentation for testing and performance verification of ventilation systems is a multi level endeavor Documentation occurs to some degree at all points in the process Decisions should be made about when documentation will begin the sources of the documentation specific documentation that is needed the responsible parties for collecting and maintaining the documentation and identification of a documentation coordinator 8 2 1 Required and Recommended Documentation A plan shall be developed for the testing and performance verification methodologies for the ventilation system of the facility The plan for the testing and performance verification methodologies for the ventilation system of the facility should include 1 Summary statement regarding the facility location ownership nature of operations extent of testing and 23 AMERICAN NA
103. ndard are welcome They should be sent to American Society of Safety Engineers 1800 East Oakton Street Des Plaines IL 60018 2187 This standard was processed and approved for submittal to ANSI by the American National Standards Committee on Ventilation Systems Approval of the standard does not necessarily imply nor is it required that all Committee members voted for its approval At the time ANSI approved this standard the Z9 Committee had the following members Theodore Knutson MS P E Chair Geoffrey Raifsnider P E Vice Chair Timothy R Fisher CSP CHMM ARM CPEA Secretary Jennie Dalesandro Administrative Technical Support Organization Represented Name of Representative American Foundry Society Robert Scholz American Industrial Hygiene Association Lou DeBerardinis CIH CSP MIT American Society of Heating Refrigerating amp A C Thomas C Smith ASHRAE American Society of Safety Engineers ASSE Paul Osley P E CSP CIH CHMM Jeffrey Nesbitt CSP CIH Burton D Jeff D Jeff Burton MS P E Crooks Steven Steven Crooks CIH CSP Figureroa Crescente Crescente Figueroa Ph D CIH Global Finishing Solutions Geoffrey Raifsnider P E Brian Schadrie P E Gunsel Steven Steven Gunsel P E Knutson Ventilation Inc Theodore Knutson MS P E Gerhard Knutson Ph D CIH McManus Neil National Association of Metal Finishers National Institutes of Health NIH National Institute for Occupational Safety amp Healt
104. ndividuals who will be actually performing the testing and performance verification methodologies The testing and verification team may be completely made up of individuals who are not associated with the entity i e outside contractors or they may be made up in whole or part by entity staff Team experience should include Working knowledge of current codes and standards applicable to the facility type and geographic location aspects of design construction and commissioning risk management developing and implementing an integrated program of conformance specific knowledge of facility operations history including preventative maintenance performed prior equipment failure and detailed nature of work performed inside the operational facility Team and team leader should be designated by the BSL 3 ABSL 3 facility owner and consist of personnel deemed qualified to perform testing and performance verification procedures The following are some typical team members Biosafety professional BSO Facility manager HVAC specialist Testing engineer AMERICAN NATIONAL STANDARD 29 14 2014 e Occupational health and safety specialist e Operations and maintenance personnel e Owners e Principal investigator or lab director e Controls specialist s 6 3 1 Role Responsibility as It Relates to a BSL 3 ABSL 3 Facility Entity Responsibilities Management plans should include Entities must establish mana
105. nfpa org categoryList asp categoryID 24andURL Codes 20and 20Standardsandc ookie_test 1 Accessed June 9 2013 Institutes of Environmental Sciences and Testing Technologies USA IEST RP 034 11993 IEST RP CC 001 3 HEPA and ULPA Filter Available at http www iest org RecommendedPractices IESTRPCC001 tabid 9637 Default aspx American Society of Mechanical Engineers ASME ASME N509 2002 Nuclear Power Plant Air Cleaning Units and Components New York ASME 2002 Sheet Metal and Air Conditioning Contractors National Association SMACNA HVAC Air Duct Leakage Test Manual 2nd ed New York ASME 2012 Available at 125 AMERICAN NATIONAL STANDARD Z29 14 2014 36 37 38 http www smacna org bookstore index cfm fuseaction search_resultsandcfid 822 7505andcf token 53053003 Accessed June 9 2013 American Society of Mechanical Engineers ASME N510 Testing of Nuclear Air Treatment Systems New York ASME 2007 Available at http www asme org kb standards des Accessed June 2012 McGurk G B A Study of Air tightness in Australian High level Bio containment Facilities Applied Biosafety 14 2 72 80 2009 Standards New Zealand AS NZS 4360 2004 Australia New Zealand Standard for Risk Management Wellington Standards New Zealand 2004 Other Resources 126 American Institute of Architects AIA Guidelines for Design and Construction of Hospital and Healthcare Facilities Washington DC AI
106. nfringement would have been avoided except for your refusal to use any modified or replacement Product supplied or offered to be supplied pursuant to this Section 4 b or to otherwise cease using the Product Notwithstanding anything contained in this Agreement and except as set forth in Section 4 b hereof ASSE and or Owner s liability to you for damages pursuant to this Section 4 b if any shall not exceed the amounts of the License Fee paid by you for the Product subject to any such claim c Section 4 b state the entire liability of ASSE and Owner with respect to the infringement or alleged infringement of any third party rights of any kind whatsoever by any of the Product 5 TERMINATION This Agreement may be terminated immediately by Owner or ASSE upon breach of any provision of this Agreement by you Upon any termination of this Agreement you shall immediately discontinue the use of the Product and shall within ten 10 days either return files s on diskette s if any to ASSE or certify in writing to ASSE that the Product has been deleted from your computer and is eliminated from your premises 6 GOVERNING LAW This Agreement shall be governed by the laws of the State of Illinois without reference to its conflict of laws provisions and you further consent to jurisdiction by the state and federal courts sitting in the State of Illinois 7 MISCELLANEOUS This Agreement constitutes the complete and exclusive agreement between ASSE and y
107. ng ventilating and air conditioning I O input output 121 AMERICAN NATIONAL STANDARD Z29 14 2014 I P ISO IVC LAN NEBB NEMA NFPA NIST NSF Pa PAO P N RTV SMACNA SOP SULPA TAB ULPA UPS w g WHO 122 current to pressure International Organization for Standardization individually ventilated cage local area network National Environmental Balancing Bureau National Electrical Manufacturers Association National Fire Protection Association National Institute of Standards and Technology National Science Foundation Pascal poly alpha olefin positive negative room temperature vulcanizing Sheet Metal and Air Conditioning Contractors National Association standard operating procedure super ULPA testing adjusting and balance ultra low penetration aerosol uninterruptable power supply water gauge World Health Organization AMERICAN NATIONAL STANDARD 29 14 2014 Appendix F References 1 10 11 Department of Health and Human Services DHHS The Centers for Disease Control and Prevention CDC and the National Institutes of Health NIH Biosafety in Microbiological and Biomedical Laboratories BMBL 5th ed Washington DC NIH CDC DHHS 2009 Available at http www cdc gov biosafety publications BMBL_5th_Edition pdf Accessed June 11 2013 American Society of Heating Refrigerating and Air Conditioning Engineers ASHRAE Standards Available at http www ashrae org st
108. nt or an odorous surrogate is not drawn into the adjacent or nearby non containment spaces by relatively negative pressures in those spaces Verify structural capability of wall and ceiling systems prior to determining leak test pressures 1 Undesirable leaks should be recorded and repaired Additional testing may be used to verify efficacy of repairs There are various testing methods and criteria that have been used by other countries to verify leak rates of containment facilities A study that verified and tested 18 facilities in Australia proved that leak rates can be varied and greater than what is necessary to contain a gas and that additional measures may be necessary during a gas decontamination process Documentation Test documentation should include specific rooms where the test was conducted and results of the test for each room 8 4 9 Testing of Specialized Heating Ventilating and Air Conditioning HVAC Components of ABSL 3 Facilities Test Purpose and Methodology Ventilation systems serving ABSL 3 rooms shall Purpose of Test To ensure that 107 AMERICAN NATIONAL STANDARD Z29 14 2014 be tested Individually ventilated cage IVC rack systems connected to house exhaust shall also be tested in normal and failure mode conditions 108 ventilation requirements meet design performance requirements and serve to maintain containment ABSL 3 facilities can present increased biosafety risks
109. nts at the BSL 3 ABSL 3 level as defined by the Biosafety in Microbiological and Biomedical Laboratories BMBL AMERICAN NATIONAL STANDARD 29 14 2014 ANSI Z9 14 is a voluntary standard This standard could apply to any BSL 3 ABSL 3 laboratory including small animal and insectary facilities The standard should be incorporated into the design of any BSL 3 ABSL 3 laboratory facility that is designed for working with agents at the BSL 3 ABSL 3 level as defined by the BMBL It is designed to provide guidance for collecting preparing and retaining documentation performing visual inspection and testing and verification methodologies for the performance of ventilation system components that have been previously identified in other manuals and documents that address high containment laboratories or animal facilities ANSI Z9 14 may be used as an adjunct standard operating procedure SOP or along with other methodologies that may be available to ensure that the ventilation system in a high containment facility can provide a safe environment for building occupants and the external environment ANSI Z9 14 may be useful for 1 Facilities that have similar functions and risks but do NOT follow the same testing methods for ventilation 2 Users who require assistance to perform the tests 11 AMERICAN NATIONAL STANDARD Z29 14 2014 5 2 Conformance Conformance with this standard in whole or in part shall be determine
110. nts in practice that may differ from those published in record design documents 12 Maintenance schedules and records including HVAC systems control systems and instrumentation electrical and stand by power systems 13 Documentation of abnormal conditions and recorded system faults 14 Performance verification reports if available 5 Facility SOPs Commissioning and other testing documentation should be provided for the verification process If these documents are not available the facility should provide any documentation available to facilitate the testing and performance verification of the ventilation systems In addition to the previously noted commissioning and testing documentation the following documentation if available should be provided for systems including if applicable and available to BSL 3 ABSL 3 ventilation 8 2 3 Ventilation Testing Documentation Verification Confirm that documentation resulting from the testing and performance verification of the ventilation system has provided the appropriate information AMERICAN NATIONAL STANDARD 29 14 2014 Om eae S 10 11 12 13 14 15 16 17 18 19 Supply air systems Exhaust air systems HEPA filter systems Fume hood if applicable Biosafety cabinets and other primary containment devices Humidifiers Chilled water heating hot water systems Steam and condensate systems Supply and exhaust air valves Lab viv
111. o tolerance have been ruled out Only after determining that zero tolerance cannot be achieved for the BSL 3 facility in question should a numerical model be employed to perform a health and safety risk assessment to determine the reverse airflow tolerance 8 4 3 Testing of Anterooms Anterooms shall be tested for directional airflow in conjunction with associated HVAC and door controls refer to section 8 4 1 for specific information on testing for directional airflow The containment function provided by anterooms shall be tested and documented before initial operation periodically thereafter annually or as determined by facility specific risk assessment and after any significant alterations of the anterooms or associated ventilation system elements or other alterations that can affect that function AMERICAN NATIONAL STANDARD 29 14 2014 Documentation Results of the failure tests should be documented and filed appropriately Test documentation should be retained based on the document retention policy specific for each facility Test Purpose and Methodology Purpose of Test To verify performance of ventilation systems serving the anteroom during routine entry and exit from the containment space Recommended Methodology Anterooms should be tested to verify functionality The following tests should be done when applicable 1 Test of self closing devices on each door to latch the door in closed position e
112. ologies can be used to supplement the risk assessment Refer to the following sections for more specific information on the related systems and components that may be failed 8 4 5 Testing of Heating Ventilating and Air Conditioning HVAC System and Controls 8 4 6 Testing Electrical Systems Related to Heating Ventilating and Air Conditioning HVAC Recommended Methodology HVAC verification should be performed and documented by personnel having experience with the HVAC system in the facility and or expertise with HVAC systems in BSL 3 ABSL 3 laboratories Test failure scenarios as applicable and determined plausible should be based upon the complexity of the facility The types of tests described below and their frequency are provided as a comprehensive resource of methodologies that should be considered in developing a site specific HVAC performance verification plan AMERICAN NATIONAL STANDARD 29 14 2014 Directional airflow testing during system failures can be performed using 1 The measurement of differential pressures across a containment barrier and all doors between the laboratory or vivarium and the containment barrier 2 Visualization or measurement of smoke tracer gases at doors between the laboratory or vivarium and the containment barrier 3 Visual observation of airflow indicators at doors between the laboratory or vivarium and the containment barrier 4 Anumerical testing methodology base
113. om pressurization with the individually ventilated cages disconnected Test impact of in situ and facility system failures on ventilated animal caging equipment performance ventilated animal caging equipment should maintain negative pressure Verify procedures for total fan failure including power failure and include electrical normal and standby power and UPS failure tests if equipped Test for fan interlocks between ventilated animal caging equipment and exhaust fans if AMERICAN NATIONAL STANDARD 29 14 2014 supplied if main exhaust fails hard connected ventilated animal caging blowers should also fail e Where ventilated animal caging equipment is used and the local risk assessment determines that reduced airflow rates are allowable these rates should be tested to ensure containment pressure relationships and directional airflows are maintained Equipment isolators connected to the building exhaust system Due to the wide variety of equipment isolators in use e g rigid vs flexible walls open vs glove access and self exhausted vs exhausted by the facility s ventilation system the test methodologies described for other primary containment equipment should be applied as appropriate on a case specific basis For example self exhausted isolators with open access that discharge to the room should be tested using the same methodologies as Class and II BSCs that discharge to the room Documenta
114. onents 9 If units include automatic door operation confirm proper operation and sealing 10 Test the impact of in situ and facility system failures on IVC performance IVC racks used in ABSL 3 rooms should maintain negative pressure e Verify procedures for total fan failure including power failure and include electrical normal and standby power and UPS failure tests if equipped e Test for fan interlocks between IVC and exhaust fans if supplied if main exhaust fails hard connected IVC blowers should also fail e Where IVC are thimble connected to in situ exhaust AMERICAN NATIONAL STANDARD 29 14 2014 test that the IVC can maintain performance by discharging exhaust air through a thimble connection when the main exhaust fails e Where IVC are used and the local risk assessment determines that reduced airflow rates are allowable these rates should be tested to ensure containment pressure relationships and directional airflows are maintained Documentation Test documentation should include specific rooms where the test was conducted and the results of the test for each room 8 4 10 Testing of Heating Ventilating and Air Conditioning HVAC Systems of Containment Support Areas Appropriate directional airflow between containment support spaces and adjacent areas shall be maintained and verified in accordance with the risk assessment Test Purpose and Methodology Purpose of Test To verify appro
115. ontainment Facilities Canberra Australian Department of Health and Ageing 2001 Available at http www ogtr gov au internet ogtr publishing nsf content certifications 1 Accessed June 11 2013 AMERICAN NATIONAL STANDARD 29 14 2014 Mani P Langevin P International Veterinary Biosafety Working Group Veterinary Containment Facilities Design and Construction Handbook Ottawa Ontario International Federation of Biosafety Association 2006 Available at http www tecrisk com projekte projekt1 Handbook_070323 pdf requires a user name and password Accessed June 11 2013 American Glovebox Society AGS Guideline for Gloveboxes 3rd ed AGS G001 Santa Rosa CA AGS 2007 Available at http www gloveboxsociety org 2007_Guidelines_Table_of_Contents pdf Accessed June 9 2013 British Standards Institution BSI British European Standard BE EN 12469 2000 Biotechnology Performance Criteria for Microbiological Safety Cabinets London BSI 2000 Available at http shop bsigroup com en ProductDetail pid 000000000030014516 Accessed June 11 2013 U S Department of Agriculture USDA Animal and Plant Health Inspection Service APHIS and Centers for Disease Control and Prevention CDC National Select Agent Registry Available at http www selectagents gov index html Accessed June 11 2013 U S Department of Health Education and Welfare Public Health Service National Institutes of Health Laboratory Safety Mono
116. orting infrastructure equipment and services including ancillary rooms such as anteroom changing rooms sterilizing rooms and storage rooms In the context of this standard additional kinds of facilities include vivaria aquaria and greenhouses Facility manager An individual who is responsible for the overall operation and maintenance of a facility Failure testing A method of simulating a failure event to determine whether backup systems function as designed Filters See HEPA ULPA SULPA Fume hood An engineering control with one open side for personnel access that is intended to contain and exhaust hazardous gases and vapors The open side is equipped with at least one sash moving vertically or horizontally to modulate the AMERICAN NATIONAL STANDARD 29 14 2014 size of the opening Various baffles and airfoils are incorporated to provide linear airflow across the face of the opening in accordance with ANSI Z9 5 High efficiency particulate air HEPA filter An air filter consisting of ultra fine fibers that is effective for trapping microscopic particles and infectious agents in the air A throw away extended or pleated medium dry type filter with the following components 1 rigid casing enclosing the full depth of the pleats 2 minimum particulate removal of 99 97 of a 0 3 micron nominal particle size for HEPA or Type A filters Insectary A specially designed facility for keeping
117. ou with respect to the subject matter hereof and supercedes all prior oral or written understandings communications or agreements not specifically incorporated herein This Agreement may not be modified except in writing duly signed by an authorized representative of ASSE and you If any provision of this Agreement is held to be unenforceable for any reason such provision shall be reformed only to the extent necessary to make it enforceable and such decision shall not affect the enforceability i of such provision under other circumstances or ii of the remaining provisions hereof under all circumstances Headings shall not be considered in interpreting the Agreement 8 EXPORT You may not load or export or re export any of the Product or any underlying information or technology except in full compliance with all United States and other applicable laws and regulations BY ACCESSING THE PRODUCT YOU ACKNOWLEDGE THAT YOU HAVE READ THE TERMS OF THIS LICENSE AGREEMENT AND AGREE TO BE BOUND BY ITS TERMS Printed in U S A
118. outside the containment barrier Note The program requirements and site specific facility risk assessment may dictate more stringent or different acceptance criteria for areas inside the containment envelope However internal requirements are not addressed by this standard Failure tests Failure conditions with recommended frequencies in italics that should be tested when applicable 1 Mechanical or electrical failure of a single BSL 3 ABSL 3 exhaust fan or fan AMERICAN NATIONAL STANDARD 29 14 2014 component s initially and every 12 18 months 2 Failure of the normal preferred source power supporting supply and exhaust fan components and transition to the emergency or alternate source If a backup system emergency or alternate source of power supply is available for the laboratory HVAC system the ability to transition from normal power to the backup system should be verified If no backup system is available the ability of the HVAC system to transition to a static condition i e no outward airflow should be verified initially and every 12 18 months 3 Return from power outage or emergency or alternate power source to normal or preferred power source initially and every 12 18 months 4 Electrical failure of multiple including redundant BSL 3 ABSL 3 supply fans or fan component s Plausible multiple fan failures are those fans fed from a common distribution element such as a single breaker
119. persons and the environment Biosafety level BSL The combination of laboratory practices and techniques safety equipment and laboratory facilities appropriate for the operations performed and the hazards posed by the infectious agents and the laboratory function or activity Biosafety levels are described in the BMBL Biosafety level 3 BSL 3 A level of laboratory containment applicable to clinical diagnostic teaching research or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure Laboratory personnel must receive specific training in handling pathogenic and potentially lethal agents and must be supervised by scientists competent in handling infectious agents and associated procedures Biosafety professional Biological safety officer BSO An individual who identifies assesses and controls occupational health risks adverse effects on the environment including agriculture risks to the community and public health associated with exposure to biohazardous agents and materials and develops programs to manage these risks This professional is a key resource in the design and construction of containment facilities AMERICAN NATIONAL STANDARD 29 14 2014 BSL 3 ABSL 3 facility A laboratory designed and operated at biosafety level 3 BSL 3 or animal biosafety level 3 ABSL 3 Bui
120. pment Primary containment equipment that is connected to or affected by air currents from the HVAC system shall be tested and documented before initial operation periodically thereafter annually or as determined by facility specific risk assessment and after any significant alterations of the equipment or associated HVAC system elements or other alterations that can affect the equipment performance AMERICAN NATIONAL STANDARD 29 14 2014 Test Purpose and Methodology Purpose of Test To verify that the ventilation system operations do not negatively affect the performance of the primary containment equipment that is connected to or can be affected by the ventilation system Examples of primary containment equipment that should be tested include but are not limited to e Class and II BSCs that discharge to the room placement in the room with respect to air currents e Canopy thimble connected Class Il BSCs e Hard ducted Class II or III BSCs e Hard ducted Class BSCs and chemical fume hoods e Ventilated animal caging equipment connected to the building exhaust system see section 8 4 9 e Equipment isolators connected to the building exhaust system Recommended Methodology Class and II biosafety cabinets that discharge to the room e Verify that air currents from door swings and the ventilation system do not interfere with air capture at the sash opening by testing with smoke or other visual indicator
121. ppendix A will ensure that testing and verification procedures can be performed in a safe and secure manner for all personnel involved Since each facility is unique the risk assessment should be designed to factor in the specific features of each facility Examples include but are not limited to the containment boundaries hazardous materials biological agents used including specific related SOPs current decontamination SOPs existing building engineering systems existing system redundancies if any and the facility s current maintenance program It should also include review of anticipated manipulations of the agents as that might affect the mechanical needs of the laboratory The results of the risk assessment should be documented and maintained as part of the permanent record of the facility The deficiencies that are identified in the risk assessment should be captured in the CAP see Appendix A that should be used in tracking remedial actions Successive risk assessments should be performed until remedial actions are resolved During a risk assessment hazards are evaluated in terms of the likelihood that a problem may occur and the damage and or consequences it would cause if such an event did occur 21 AMERICAN NATIONAL STANDARD Z29 14 2014 Risk assessment as it relates to testing and performance verification methodologies for ventilation systems shall be performed by a team of qualified individuals The fa
122. priate pressure relationships for containment support areas such as rooms housing liquid waste and carcass treatments or containment exhaust ductwork are in conformance with the risk assessment The goal is to minimize potential for cross contamination in the event of a failure Recommended Methodology 1 Identify applicable support spaces 2 Perform directional airflow testing as outlined in sections 8 4 1 and 8 4 2 111 AMERICAN NATIONAL STANDARD Z29 14 2014 112 Assess the risk of potential migration of contaminants from support spaces under failure conditions and implement physical and or operational measures to mitigate the risk Documentation Test documentation should include specific support areas where the test was conducted and the results of the test for each space AMERICAN NATIONAL STANDARD 29 14 2014 APPENDICES Appendix A Corrective Action Plan CAP and Template The International Organization for Standardization ISO has templates for purchase They include templates for CAPS risk assessment SOPs etc Go to http www iso org iso home standards htm search for Templates then by template type i e risk assessment Corrective Action Plan Institution Name Address Facility Area Audited Auditor Audit Date Name Audit Agency Follow up Action Performance Signature of Verification Testing Date Seal Agent Verifier 113 No of Finding AME
123. rformance of the internal supply filter micro isolators aerosolization chambers glovebox All other equipment that impacts the HVAC system such as freezers incubators centrifuges Although this is not intended to be a test standard for primary containment devices devices connected to the ventilation system must be confirmed to be properly operational and or maintained and or certified in accordance with their requirements e Emergency and backup power systems e Alarms e Operating sequences e Ventilation system integration with BAS normal and backup power and related critical systems e g fire control systems 6 2 Generic Typical Sequence of Testing and Performance Verification The following testing sequence is generic and needs to be adapted specifically to the facility being tested A standard operating procedure 14 The following list includes typical elements of SOPs for performing performance verifications of BSL 3 ventilation systems SOP shall be developed by qualified individuals for testing a facility to verify high containment facilities The verification shall only proceed when there is consensus with the SOP by all parties involved A risk assessment shall be included when developing the SOP for testing a facility to identify cases where the testing cannot be performed due to site specific conditions AMERICAN NATIONAL STANDARD 29 14 2014 Inclusion of individual elements for a
124. ria for approval have been met by the standards developer Consensus is established when in the judgment of the ANSI Board of Standards Review substantial agreement has been reached by directly and materially affected interests Substantial agreement means much more than a simple majority but not necessarily unanimity Consensus requires that all views and objections be considered and that a concerted effort be made toward their resolution The use of American National Standards is completely voluntary their existence does not in any respect preclude anyone whether he she has approved the standards or not from manufacturing marketing purchasing or using products processes or procedures not conforming to the standards The American National Standards Institute does not develop standards and will in no circumstance give an interpretation of any American National Standard Moreover no person shall have the right or authority to issue an interpretation of an American National Standard in the name of the American National Standards Institute Requests for interpretation should be addressed to the secretariat or sponsor whose name appears on the title page of this standard Caution Notice This American National Standard may be revised or withdrawn at any time The procedures of the American National Standards Institute require that action be taken periodically to reaffirm revise or withdraw this standard Purchasers of American National Standards
125. rocedure SOP 120 E Index of AC ONYINS cictcngsdesnmgrcunmnaacunniay Duanncqudadatonangatapanaheaciicngactaniiss 121 F Referentes citi cg nee dale ena inate aR lalate 123 AMERICAN NATIONAL STANDARD ANSI ASSE Z9 14 2014 American National Standard for Testing and Performance Verification Methodologies for Ventilation Systems for Biosafety Level 3 BSL 3 and Animal Biosafety Level 3 ABSL 3 Facilities 1 EXECUTIVE SUMMARY Testing and verification of the ventilation system of laboratories that operate at Biosafety Level 3 BSL 3 Animal Biosafety Level 3 ABSL 3 are necessary processes for ensuring that the performance and operation of the systems consistently maintain a safe environment for human occupants research animals and the internal and external environment Because each facility is unique testing and verification acceptance criteria will differ among facilities Therefore a risk based approach to testing and verification of the ventilation system is recommended It is highly encouraged that each facility develops and maintains standard operating procedures SOPs that address testing and verification of the ventilation system and associated components Additionally there should be SOPs for performing a risk assessment and for the sequence of testing and performance verification Risk assessments should be performed initially and at regular periods throughout the life cycle of the facility
126. roper operation to ensure directional airflow negative pressure and controls alarming 3 IVC systems that are integrated using single airflow control valves from several cage racks should be tested with multiple racks connected and disconnected valve performance needs to be verified whether it is installed with a 1 to 1 ratio or 1 to several ratio 4 IVC systems that are connected to in situ ventilation systems should include tests to verify room pressurization with the IVCs disconnected 5 IVC systems that have internal HEPA filtration should confirm HEPA filter verification procedures Ongoing verification should be determined based on local risk assessment 6 Confirm proper airflow of IVC connections to in house systems 7 Test individually ventilated cage cage change station and BSC HEPA filters for efficiency and confirm primary containment devices have been certified annually 8 Test influence of increased heating 109 AMERICAN NATIONAL STANDARD Z29 14 2014 110 impact of wash downs and cleaning e Ensure that temperature gains are offset with cooling requirements and air change rates e Ensure that additional temperature gains do not influence room pressure differentials e Confirm required pressure differentials are not contravened as a result of operating procedures e Verify and test ventilation systems used for decontaminating the IVC rack including the rack internal manifold and comp
127. rs of the HVAC system shall be performed for all containment spaces These tests shall include actual measurements of supply exhaust return and transfer airflow rates calibration of airflow monitoring devices and air change rates changes per hour Review airflow parameters currently indicated on control and monitoring systems and compare them to current requirements during each re test Tests shall be performed before initial operation and periodically thereafter as determined by the facility risk assessment and SOP and after any significant alterations that can adversely impact the ventilation system 76 Planning for subsequent tests of the HVAC system should be made based on the facility risk assessments and periodically re examined to ensure adequacy of the plan The types of tests described below are provided as a comprehensive resource of methodologies for consideration in development of a site specific HVAC performance verification plan that should be developed for every high containment laboratory Refer to section 8 4 2 for recommended intervals between re testings Purpose of Test Design airflows are established to maintain space temperature relative humidity and minimum ventilation requirements Airflow offsets are established to maintain directional airflows for containment This test normally entitled TAB should confirm that the actual flow rates meet the performance expectations for m
128. ry suite as a system should also be documented 8 4 2 Testing for Directional Airflow during System Failures HVAC systems shall be tested for directional airflow during system failures During system failures momentary changes in airflow patterns can be acceptable based on the facility risk assessment 60 In general air in the BSL 3 ABSL 3 should flow from areas of lower risk to areas of higher risk during normal operating conditions but during system failures momentary static conditions or transient flow reversals can happen Although the testing and acceptance criteria for directional airflow during normal operations see section 8 4 1 should be applied to the evaluation of performance during system failures the momentary static conditions or transient flow reversals that could happen during system failures should be evaluated in the context of the facility risk assessment To ensure that the HVAC systems in BSL 3 ABSL 3 laboratories meet the basic functional containment requirement during failure events the HVAC systems shall be tested and documented for directional airflow during system failures before initial operation periodically thereafter annually or as determined by facility specific risk assessment and after any significant alterations of the ventilation system or other alterations that can affect it AMERICAN NATIONAL STANDARD 29 14 2014 When performing the risk assessment consider factors such as
129. s for visible damage condition of actuators linkages wiring and or pneumatic tubing to actuators etc 5 Continuous seal between ductwork and the room supply diffuser e Verify during initial installation and maintain written photo documentation for records 6 Supply diffusers should be located and installed so they do not interfere with BSC operation and provide best location for achieving effective room air change rate h e Verify in field for proper air distribution 45 AMERICAN NATIONAL STANDARD Z29 14 2014 8 3 6 Visual Inspection of Critical Control System Air and Power Pneumatic control air system and control power system shall be assessed and verified to be in good operating condition by visual inspection so as to maintain any required critical control or secondary containment features during normal operation and in the event of loss of power failure of a generator or failure of primary compressors and equipment 46 Visual inspection of pneumatic control equipment should include 1 Primary and redundant equipment is adequately arranged and in proper operation e Verify in field 2 Compressed air system should be served by standby power system e Verify in field 3 Where a separate receiver and distribution piping is the selected means of system backup a check valve or other fail safe valve should be provided in the piping system to prevent loss diversion of air from the critical system
130. s or other materials Risk assessment is the exercise of identifying analyzing evaluating probability versus consequence and finally mitigating any potential hazard Risk assessment is a common first step in an overall risk management process See section 7 Risk Assessment Room air balance A general term relating to mass air balance that describes the proper relationship of air within a laboratory with respect to the total exhaust airflow from the lab and the supply makeup airflow into the lab The relationship of these airflows also establishes the pressure differential between the laboratory room and adjacent rooms and spaces Room pressure differential monitor Any device used to measure differences in pressure between two physically separated areas or rooms Select agents Select agents and toxins are a subset of biological agents and toxins that the Department of Health and Human Services HHS and the Department of Agriculture USDA have determined to have the potential to pose a severe threat to public health and safety to animal or plant health or to animal or plant products The current list of select agents and toxins can be found within 7 CFR 331 3 9 CFR 121 3 121 4 and 42 CFR 73 3 73 4 7 Sequence of operations A fully descriptive detailed account of system operation that is developed during the design process and finalized upon commissioning when the operation
131. sed to prevent exposure to or contamination of a person by chemical or biological matter Primary containment The primary safety barrier for control of biohazardous materials to protect personnel and the environment from exposure to those materials Primary containment requires using proper storage containers good microbiological technique and the use of appropriate primary containment devices Secondary containment The laboratory room or enclosure where the procedures are performed or the animals are housed Secondary barriers include controlled access to the space and ventilation systems that minimize the release of infectious aerosols from the laboratory Tertiary containment The building envelope and physical operation with items such as shower locker room etc Primary containment device Device providing primary containment of biohazardous material Primary containment devices can include biological safety cabinets centrifuges with sealed rotors or safety cups equipment isolators animal caging or other equipment that protects personnel and environment from exposure to biohazards Risk Combination of the probability of occurrence of harm and the severity of that harm Risk assessment The qualitative and quantitative evaluation of risk posed to human health animal health and or the environment by the actual or potential presence and or use of specific hazardous biological agent
132. sk assessment Documentation Test documentation should include containment performance directional airflow for various fire alarm conditions tested The following tests will ensure that the BAS and or control systems properly control the HVAC systems within a containment laboratory and protect related primary secondary and tertiary containments These tests should confirm the design and operating performances to maintain containment The extent of building automation and 83 AMERICAN NATIONAL STANDARD Z29 14 2014 84 BAS systems shall be continuously monitored to facilitate an immediate notification and response by qualified personnel as appropriate to the alarm condition In the event that the facility does not have an automated system there must be a means for and verification of appropriate alarming and reporting Verify alarms are functioning properly control systems vary greatly among BSL 3 ABSL 3 laboratories The intent of this section is to address typical HVAC and associated control elements ina BSL 3 ABSL 3 laboratory Not all of these elements will apply to all laboratories Apply the requirements below to applicable elements serving the facility Structures and ductwork should be capable of withstanding both normal and abnormal pressures caused by fan failures wind pressures and other environmental influences Excessive high pressures positive or negative caused by testing should be evaluat
133. stem s normal operation prior to testing failure of ventilation system components System set points should be recorded for the exhaust and supply systems from the BAS if applicable These set points are necessary to determine when the ventilation system has returned to its normal operation after a failure test Calibrated differential pressure meters can be used and placed across each pressure differential test location as per the SOP drawing of the laboratory Each of these locations should be smoke tested to verify the meter is measuring directional airflow as confirmed by the direction of the smoke A baseline of data should be logged for a minimum period e g 4 minutes with data of pressure recordings logged at a minimum of 5 second intervals Likely failure scenarios that should be tested at a minimum are Failure of a single exhaust fan If the laboratory has redundant exhaust fan s then each redundant exhaust fan is failed as a single exhaust fan failure 3 Failure of multiple exhaust fans as expected in worst case scenarios Normal start up of ventilation system Failure of a single air handling unit AHU If the laboratory has redundant AHUs or supply fans then each redundant AHU or supply fan is failed as a single fan failure 6 3 Roles Responsibilities and Qualifications The ultimate responsibility for the safe operation of a BSL 3 ABSL 3 laboratory facility rests with the institution specifically this fal
134. t Purpose and Methodology Purpose of Test To ensure that ventilation systems are properly serviced with normal power emergency standby power and UPS power where installed as determined by local risk assessment and that they all work in accordance with design performance objectives Electrical systems provide the power normal emergency standby and UPS where installed for the operation of systems and equipment that support primary containment devices secondary barriers HVAC systems treatment systems and security The electrical design engineer should verify the AMERICAN NATIONAL STANDARD 29 14 2014 desired performance expectations of the systems and operations during normal and emergency power conditions and verify which systems require additional protection with UPS where installed The electrical systems that control HVAC systems should be thoroughly tested verifying 1 Adequacy of power supply to serve fans pumps valves etc 2 Power to fans and variable frequency drives VFDs 3 Power to airflow control devices Power to BAS and other control systems for monitoring controlling and alarming HVAC normal and failure modes 5 Power to security and door systems that interface with HVAC such as door switches and magnetic locks that control airflow valves 6 Power to hydronic pumps that serve air handling systems and energy recovery systems inside HVAC systems 7 Appropriate monitoring and operat
135. te primary containment devices as would be required for decontamination per the SOP Documentation Test documentation should indicate results of tests and data showing the responses of the control and HVAC systems Characterize the response to the events tested Document by listing all devices that were tested and verified and their respective results Purpose of Test To confirm the BAS or control system reacts properly to plausible failures of HVAC and control system components Refer to section 8 4 2 Testing for Directional Airflow during System Failures as the verification of the HVAC system under control system failures is covered in that section The following tests elaborate more specifically on the testing of the control systems themselves Tests should be performed to confirm the proper response of the BAS control systems to ensure the containment barrier can withstand the forces imposed and to ensure safe egress Recommended Methodology Establish real time monitoring of space pressure differentials either via the BAS or local instrumentation Observe performance of the BAS and control system through the failure events or abnormal operation 89 AMERICAN NATIONAL STANDARD Z29 14 2014 90 Confirm the systems react effectively to minimize any directional airflow reversals while not causing extreme forces on the doors and the containment envelope Generally initial reactions may result in more negative press
136. tenance records and logs 5 Belt guard e Check for presence of belt guard 6 Bearings e Check for abnormal noise check maintenance records and logs for lubrication 7 Motor operating temperatures within equipment specifications e Check maintenance records and logs 8 Dampers and control e Check for condition of dampers corrosion of damper components condition of actuators linkages wiring and or pneumatic tubing to actuators etc 9 Heat recovery coils filters and controls e Check condition of coils for 37 AMERICAN NATIONAL STANDARD Z29 14 2014 38 corrosion leaks and cleanliness e Check filters for cleanliness and pressure drop and review maintenance logs e Check for condition of dampers corrosion of damper components condition of actuators linkages wiring and or pneumatic tubing to actuators etc 10 VFDs and motor controls e Check for proper installation in appropriate National Electrical Manufacturers Association NEMA enclosure e Check for operation within range of nameplate full load current e Check for power and control wiring installed in raceways and protected from physical damage 11 Duct supports and connections e Verify that ductwork is supported at proper intervals to prevent failure or damage to ductwork 12 Dilution air dampers if applicable e Check for condition of dampers corrosion of damper components condition of actuators linkages wiring and or pneumatic tub
137. the American Society of Mechanical Engineers ASME standard N509 2002 Nuclear Power Plant Air Cleaning Units and Components 2002 a minimum test pressure of 1000 Pa 4 w g 3 Where parallel redundant HEPA filters are installed ensure that 101 AMERICAN NATIONAL STANDARD Z29 14 2014 102 facility operations are not interrupted while testing filters and housings except as determined by the facility risk assessment Follow decontamination procedures when using bypass filters or ducts Housing leakage rate should be tested in situ by pressure decay using devices such as dampers or shut off plates Acceptance criteria rate of leakage should not exceed 0 1 of volume min at a minimum test pressure of 1000 Pa 4 w g Structural integrity should be tested to verify housing stability during normal and maximum operating pressures Using a minimum of 1000 Pa 4 w g minimum test pressure or whatever maximum pressure can be induced from associated fans under failure conditions i e sometimes this test pressure can exceed 2500 Pa 10 w g or greater During the structural integrity test visually verify that e The housing shape is retained e No deformations are visible e Dampers remain in position and are sealable to bubble tight gas tight standards e Structural supports are per design and approved construction The equipment used for the verification should have a valid ca
138. tion Test documentation should be retained based on the document retention policy specific for each facility 73 AMERICAN NATIONAL STANDARD Z9 14 2014 8 4 5 Testing of Heating Ventilating and Air Conditioning HVAC System and Controls 74 HVAC systems shall be tested to verify the necessary air changes and directional airflow during normal operation and directional airflow during system failures Tests shall be performed before initial operation and periodically thereafter as determined by the facility risk assessment and the SOP and after any significant alterations that can adversely impact the ventilation system Test Purpose and Methodology HVAC systems for BSL 3 ABSL 3 laboratories should be designed to provide directional airflow without airflow reversals unless airflow reversal s are documented to be acceptable by a written risk assessment These HVAC systems should also minimize any reversal of airflow out of the containment spaces during system failures Purpose of Test To verify the capability of BSL 3 ABSL 3 HVAC systems to provide a safe and reliable containment airflow during normal operating conditions and system failure conditions General Methods A structured plan should be prepared for testing HVAC systems and controls that defines all performance verification activities to be performed during this process This plan should also identify all deviations that occur from the original design
139. tion and dehumidification 2 7 AMERICAN NATIONAL STANDARD Z9 14 2014 Testing and performance verification The systematic review of all features and processes associated with the laboratory ventilation system to ensure that the entire system and all its individual components are operating as designed Transducer a device that converts an electrical signal into a pneumatic signal i e I P transducer means current to pressure Transport velocity The air velocity required to prevent dry air contaminants from settling out in the duct ULPA Ultra low penetration air filters have a minimum efficiency of 99 999 for particles in the most penetrating particle size at the specified media velocity The most penetrating particle size is defined as that particle diameter for which penetration through the medium is a maximum Ventilation system 1 A system consisting of a supply system and associated devices and ductwork for delivering conditioned air to a space point source exhaust and building exhaust systems and associated devices and ductwork for removing potentially contaminated air from a space 2 the dilution ventilation system HVAC system building ventilation system and their components 3 a system for removing contaminated air from a space consisting typically of the following elements a exhaust hood b ductwork c air cleaning 10 equipment d exhauster and e discharge stack
140. tion of minimum of a percentage of the differential pressure indicators monitoring the containment barriers 2 Confirm status indication on all exhaust fans under a belt loss BAS control system functionality during normal operation shall be verified AMERICAN NATIONAL STANDARD Z29 14 2014 scenario Belts should be removed and motor should be run at full speed Confirm control system identifies the loss of status in this scenario initially Refer to section 8 4 2 Documentation Document by listing all devices that were tested and verified and their respective results Confirm volatile programming of controllers is backed up and can be uploaded to the controller The facility manager should identify the control program backup location and demonstrate that it is current Purpose of Test To confirm the BAS or control system operates properly over time during normal use Refer to section 8 4 1 Testing for Directional Airflow during Normal Operation above as well as for testing of HVAC and controls systems as any applicable control system will be tested in the course of that testing The following is specific to the BAS control systems Recommended Methodology Establish real time monitoring of space pressure differentials either via the BAS or local instrumentation Observe normal airflow control and static pressure and ensure airflows stay above minimum airflow rate as indicated by design intent and pressures re
141. tional Airflow during System Failures Refer to facility operating and maintenance records for review of historical documentation Purpose of Test Design space temperatures and relative humidity are established to maintain occupant comfort scientific equipment and process requirements animal holding requirements etc This test should confirm that the HVAC system meets the performance expectations to meet the required environmental conditions The risk assessment should identify critical rooms in which temperature and humidity maintenance are critical to containment Refer to facility operating and maintenance records Historical records should be reviewed to confirm the ability of the system to maintain conditions AMERICAN NATIONAL STANDARD 29 14 2014 over any applicable assessment period Recommended Methodology To verify steady state performance of space temperature and relative humidity the following methods or equivalent should be considered 1 Confirm calibration of the temperature and humidity sensors or stats 2 Confirm sensors are representative of required conditions 3 Initiate set point and load changes to confirm response of control systems 4 Operate spaces across ranges of set points load conditions and modes of operation and confirm system s ability to meet requirements 5 Log conditions over at least one week and analyze data to confirm requirements are met such as via historical
142. to the non critical system Alternative arrangements such as uninterruptable power supply UPS systems and backup air sources should be confirmed operational e Verify in field 4 Acheck valve or other fail safe arrangement should be present in the compressor discharge piping or inlet connection to each air receiver to prevent loss of system air when the supply source is disabled 5 Control air piping to sensing and control devices should be protected to avoid damage to piping and accidental failures at joints and device AMERICAN NATIONAL STANDARD 29 14 2014 terminations e Verify in field that control air piping and tubing is appropriately supported and adequately protected or not susceptible to damage 6 Verify in field pressure levels of control air reservoirs to ensure available pressure is provided in event of compressor failure 7 Alarms should be provided at monitored BAS to indicate failure of compressed air source equipment or system pressure loss e Verify in field at BAS 8 Air dew point should be low enough to prevent freezing or condensation of control air lines e Verify in field that desiccant dryers or equivalent to achieve required dryness are used in the air supply system and properly adjusted to at least 5 F 2 8 C below the lowest temperature to which any portion of the system could be exposed 9 Verify air quality and visual inspect for adequate pressure Critical air should b
143. tremes of filter loading Documentation Test documentation should include TAB documents listing 77 AMERICAN NATIONAL STANDARD Z29 14 2014 78 8 4 5 2 Test each room for directional airflow prior to initial operation and periodically thereafter as determined by the facility risk assessment and SOP and after any significant alterations that can adversely impact the ventilation system This requirement is to physically test the differential pressure and directional airflow 8 4 5 3 Measurement of temperature and relative humidity for all rooms inside the containment barrier and in rooms that support operations that are critical for the maintenance of the containment barrier shall be performed as indicated by facility risk assessments Baseline testing shall include calibration of sensors and confirmation of system s ability to maintain required conditions Tests shall be performed before initial operation and periodically thereafter as determined by the facility risk assessment and SOP and after any significant alterations that can adversely impact the ventilation system airflow rates and as applicable comparison to the airflow rates indicated by monitoring and control systems calculated air change rates and airflow offsets for each space Test documents should also include trend logs of the airflow performance over time Refer to sections 8 4 1 Directional Airflow during Normal Operation and 8 4 2 Direc
144. tute ANSI AIHA Z9 11 2008 Laboratory Decommissioning New York ANSI Available at Available at http webstore ansi org default aspx UbO3AiqF_uQ Accessed June 5 2013 CFR 7 part 331 TITLE 7 Agriculture Subtitle B Regulations of the Department of Agriculture Chapter III Animal and Plant Health Inspection Service Department of Agriculture Part 331 Possession Use and Transfer of Select Agents and Toxins Washington DC U S Government Printing Agency CFR 9 TITLE 9 Animals and Animal Products Chapter Animal and Plant Health Inspection Service Department of Agriculture Part 121 Possession Use and Transfer of Select Agents and Toxins Washington DC U S Government Printing Agency Available at http www selectagents gov resources 9 20CFR 20121 pdf Accessed June 8 2013 CFR TITLE 42 Public Health C Chapter Public Health Service Department of Health and Human Services Subchapter F Quarantine Inspection Licensing Part 73 Select Agents and Toxins Washington DC U S Government Printing Agency PCS Engineering Solutions Writing Sequences of Operation Using the Description of Controls Tool Suite Available at http www pcs engineering com files Sequence_of_Operation_Instructions pdf Accessed June 15 2012 International Standards Organization ISO ISO IEC Guide 2 2004 definition 3 2 Available at http www iec ch members_experts refdocs iec isoiec dir2 7Bed6 0 7Den pdf Accessed June 11 2013
145. ul biological agent or part thereof presenting a real or potential risk to humans animals plants or the AMERICAN NATIONAL STANDARD Z29 14 2014 environment 2 A potential source of harm caused by biological agents or toxins Biological safety cabinet BSC An enclosed cabinet designed to serve as the primary means of containment for working safely with infectious microorganisms A biosafety cabinet provides personnel environmental and product protection when appropriate practices and procedures are followed Three kinds of biological safety cabinets designated as Class Il and Ill have been developed to meet varying research and clinical needs Most biosafety cabinets use high efficiency particulate air HEPA filters in the exhaust and supply systems The exception is a Class biosafety cabinet which does not have HEPA filtered supply air Different kinds of Class II biosafety cabinets are used for different containment needs They include Class II Type A1 cabinets formerly designated Type A Class Il Type A2 cabinets when exhausted to the environment were formerly designated Type B3 and Class II Type B1 and B2 cabinets Biological safety manual A collection of standard operating procedures SOPs training documents responsibilities etc that is specific to a facility Biorisk biological risk A combination of the probability of occurrence of harm and the severity of that harm where the so
146. urce of harm is a biological agent or toxin The source of harm may be accidental or deliberate Biorisk assessment See also Risk assessment The process of evaluating the biological risk s arising from a biohazard s taking into account the adequacy of any existing controls and deciding whether or not the biorisk s is acceptable Biorisk management biological risk management The systematic analysis of strategies and methods that is performed in order to minimize the likelihood of a biosecurity or biosafety incident The process places responsibility on the facility and its manager to demonstrate that appropriate and valid biorisk reduction procedures have been established and implemented Biosafety biological safety The application of combinations of laboratory practices and procedures laboratory function and design safety equipment and appropriate occupational health programs when working with potentially infectious microorganisms and other biohazards Biosafety practices and procedures are designed to reduce the exposure of laboratory personnel the public agriculture and the environment to potentially infectious agents and other biological hazards The key principles of biosafety are risk assessment and containment Biosafety also refers to the development and implementation of administrative policies to prevent the transmission of potentially harmful biologic agents to workers other
147. ures than considered acceptable during normal operation however differential pressures should come back into the normally acceptable ranges within 30 seconds Door forces caused by the ventilation system should not exceed manufacturer s recommendation for the application used and may vary per facility use and the SOP Consider testing the following failures 1 Single supply or exhaust system controller failure serving the BSL 3 ABSL 3 e Remove power from the controller and confirm the I O positions per design intent and that the reaction of the systems does not violate the directional airflow criteria or cause extreme forces on the building envelope and or extreme door forces 2 Loss of communications on the BAS controls LAN e Defeat communications with individual controllers for instance by removing the LAN cable from the controller as well as power down switches or routers on the control LAN Confirm the stand alone control of the controllers and the ability to re establish Analyze historical trends and data available from BAS communications when restored 3 Controller power circuit trip e Fail power supplies to controllers 4 Failure of UPS output breaker or batteries for power to BAS 5 Duct static pressure sensor failure e Remove signal wire to the controller Confirm the controller response to the failed sensor 6 Failure of automated bio seal damper e Remove the control signal to the actuator such

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