Equipment performance specifications and test procedures
Contents
1. FR 19 FR 20 FR 21 R efrigeration units Provide twin packaged refrigeration units with single phase or three phase compressors sized to give 100 stand by capacity under worst case conditions There must be a timer operated electric or hot gas defrosting system and an electrically heated condensate drip tray and drain connection Provide an automatic duty sharing circuit with seven day changeover and a manual override to be used in the event of mechanical failure Position the evaporator units so that the plume of discharged air cannot be blocked by stored vaccine Provide protection against high or low voltage and against cycle fluctuations There must be an automatic cut out when conditions are outside the freezer room manufacturer s defined safe limits and an automatic cut in within six minutes of the restoration of safe conditions U nits must be wall mounted with the condenser unit discharging inside the building that houses the freezer room Or O ption 1 The evaporator units must be wall mounted with a weatherproof condenser unit mounted externally Or O ption 2 The units must be ceiling mounted with the condenser unit discharging inside the building that houses the freezer room Or O ption 3 The evaporator units must be ceiling mounted with a weatherproof condenser unit mounted externally G uidance note Strike out options that do not apply Refrigerant CFC free complying with the requirements of the M2. WHO V amp B 02 33 ORIGINAL ENGLISH Equipment performance specifications and test procedures E1 Cold rooms and freezer rooms Vaccines and Biologicals L K World Health Organization WHO V amp B 02 33 ORIGINAL ENGLISH Equipment performance specifications and test procedures E1 Cold rooms and freezer rooms Vaccines and Biologicals amp World Health Organization TheD epartment of Vaccines and Biologicals thanks the donors whose unspecified financial support has made the production of this document possible This moduleis part of the following series E 1 Equipment performance specifications for cold rooms and freezer rooms E 2 Equipment performance specifications for motorcycles E 3 Equipment performance specifications for refrigerators and freezers E4 and E11 Equipment performance specifications for insulated containers E5 Equipment performance specifications for ice packs E 6 Equipment performancespecifications for temperature monitoring devices E 7 Equipment performance specifications for cold chain accessories E 8 Equipment performance specifications for injection devices E 9 Equipment performance specifications for steam sterilizers E 10 Equipment performance specifications for injection accessories This modulecontains references to the following documents WH 0 V amp B 02 34 Guideline for establishing or improving primary and intermediate vaccine stores WH 0 V amp B 00 13 Product
3. Cold rooms and freezer rooms 2 H ow to buy and maintain cold rooms and freezer rooms U nlike other cold chain equipment cold rooms and freezer rooms are purpose made and have to be assembled and commissioned on site The buyer is responsible for selecting a space for the room and for preparing the space so as to make it suitable for the installation A building that houses a cold room should be accessible and in good condition it should have suitable finishes and adequate ventilation and it should have the correct electricity supply T hestages involved in buying and commissioning acold room aresummarized below F or further details refer to WH O V amp B 02 34 G uidelinefor establishing or improving primary and intermediate vaccine stores and other relevant sources 1 D ecide on location and capacity D ecide on the location and the required capacity of the cold room s and freezer room s Select the space s in which the equipment is to be installed 2 Short list suppliers C ontact cold room suppliers and establish which are able to provide install commission and service cold rooms and freezer rooms conforming to the present specifications Prepare a tender list of at least three companies Although WHO does not endorse any particular manufacturers a list of suppliers with relevant experience is given in document WHO EPI V amp B 00 13 Product information sheets 2000 edition 3 Prepareand invitetenders Prepare tenderi
4. Provide a course to train qualified refrigeration technicians in the maintenance and repair of the installed equipment Guidance note Strike out the option if not required See guidance note to CR 27 O ption Maintenance Provide proposals for a routine and emergency maintenance service for an assured period of not less than five years after commissioning The emergency service must guarantee the following If one refrigeration unit fails the defective unit or component must be repaired or replaced within seven days after the failure is reported If both refrigeration units fail at least one must be repaired or replaced within 24 hours after the failure is reported The second unit must be repaired or replaced within seven more days Ancillary components such as alarms and thermometers must be replaced within seven days after reported failure Equipment performance specifications and test procedures Equipment performance specifications Guidance note M anagers of immunization services MU ST ensure that the best available maintenance arrangements are in place for the cold room Either local refrigeration technicians should be trained as indicated in clause CR 26 or the cold room installer should be contracted to provide a maintenance service similar to that described in clause CR 27 In some countries it is not possible to achieve the response times given in CR 27 In such cases the clause should be modified in consultati
5. and test procedures Equipment performance specifications Sketch plan of site Draw a sketch plan of each cold room site giving room dimensions positions and sizes of doorways positions and sizes of windows height of room at lowest point position of fixed equipment radiators air conditioners etc Provide supporting photographs if possible WHO V amp B 02 33 25 The Department of Vaccines and Biologicals was established by the World Health Organization in 1998 to operate within the Cluster of Health Technologies and Pharmaceuticals The Department s major goal is the achievement of a world in which all people at risk are protected against vaccine preventable diseases Five groups implement its strategy which starts with the establishment and maintenance of norms and standards focusing on major vaccine and tech nology issues and ends with implementation and guidance for immunization services The work of the groups is outlined below The Quality Assurance and Safety of Biologicals team team ensures the quality and safety of vaccines and other biological medicines through the devel opment and establishment of global norms and standards The Initiative for Vaccine Research and its three teams involved in viral bacterial and parasitic diseases coordinate and facilitate research and development of new vaccine
6. is empty and when the temperature is the same inside and outside the room During the test the freezer room door must be kept closed The time needed for the internal temperature to drop below 15 C is recorded The test period is at least 48 hours Running test The number of hours the compressor runs should be recorded with the door closed and the room empty The internal and external temperatures the evaporator and condenser temperatures and the pressures of the system are monitored The maximum temperature difference in the freezer room is measured and the locations of any warm or cold spots are recorded Temperature rise test The electricity supply to the room is cut off and the period for the internal temperature to rise from the normal operating temperature by 5 C is measured Control and monitoring equipment tests The operation of automatic duty sharing temperature control and temperature monitoring and alarm equipment is tested If computerized temperature monitoring is used the software is loaded configured and tested Stand by generator operation test The power output of the stand by generator is checked together with the operation of the automatic mains failure control system The generator is run continuously for 48 hours Training Provide an operator s training course that lasts at least four hours covering all aspects of safe operation and routine non specialist maintenance of the freezer room O p
7. rooms Annex 1 CFC free symbol 20 Equipment performance specifications and test procedures Equipment performance specifications Annex 2 Location details for cold room or freezer room N ote C omplete one worksheet for each cold room or freezer room location Unit reference T Locationofcold room J stated tedn indie a a a a Describe location e g n medicalstoreattached tos hi ARRAS Eaa EE SA EE TE central hospital Insert tick or number where appropriate 2 Number of storeys in building including basement s eae 3 Location of space Basement ae Note cold rooms are heavy Ground floor lowest floor in building an Floor loading should be checked by a structural engineer Ground floor above a basement or crawl space f n Upper floor an 4 Floor structure Solid concrete laid directly on the ground eae Note floors must be Raised concrete floor spanning between supports f mn damp proofand strong enough to support weight of cold room Timber joists beams spanning between supports sttesees Other describe eee WHO V amp B 02 33 21 E1 Cold rooms and freezer rooms 5 Floor finish Cementconcrete eae Note a level dust free Timber boards ca washable surface in good POSEER Ceramic or terrazzo tiles oaa Plastic tiles n Other describ
8. stored volume litres Capacity and location The cold room s and shelving layout s must be sized to accommodate the volume s of vaccine set out in the table below Cross refer to clause CR 16 CR 7 CR 8 CR 9 CR 10 Guidance note Calculate and insert the required net storage volume for each cold room Make sure you know the type of packaging in which the vaccine is to be stored eg intermediate packaging or insulated shipping containers C hoosing the latter will greatly increase the required size of the cold room Include the volume of any other items that are to be stored in the cold room M akea generous allowance for future needs e g new vaccines in smaller presentations integrated services Location details nstall cold room s in the locations s indicated on the worksheet s and drawing s attached to this specification Details of the location s are shown on the drawing s G uidance note For each location complete the worksheet at the end of this document and provide a dimensioned drawing Control by thermostat C old room temperature must be controlled by a thermostat within the tolerances specified in clause CR 4 The thermostat must be calibrated to I1TS 90 and accurate to 0 5 C or better H oldover time In the event of power failure the cold room temperature must remain above 0 C at the specified minimum ambient operating temperature or below 10 C at the specified maximum ambi
9. cluding panel construction shelving refrigeration units refrigerant alarm system including dB rating of sounder temperature recorder and proposed consumables and spare parts D etails of the voltage stabilizer if required CR 21 Evaporator area D etails of the oil separator if condenser located outside Power consumption data CR 10 Electrical safety certifications for all components CR 11 Equipment performance specifications and test procedures Equipment performance specifications CR 4 CRS D etails of the proposed spare parts and consumables inventory C R 22 andC R 23 D etails of the proposed training programme s C R 26 D etails of the proposed maintenance service and the local maintenance agent together with specific proposals for routine and emergency maintenance CR 27 Anticipated empty weight of the complete installation s in kilograms Tender details Specify delivery time Specify warranty terms Specify shipping details including packed weight and volume Price for supplying the specified components to the site s including payment terms and currency Price for installing and commissioning the components including payment terms and currency Price for supplying the spare parts including payment terms and currency Price for training users including payment terms and currency Price for training repair technician s i
10. corporated components and equipment including panel construction shelving refrigeration units and refrigerant alarm system including dB rating of sounder temperature recorder and proposed consumables and spare parts D etails of the voltage stabilizer if required FR 23 Evaporator area D etails of the oil separator if condenser located outside Power consumption data FR 10 Electrical safety certifications for all components FR 11 D etails of the proposed training programme s C R 26 Equipment performance specifications and test procedures Equipment performance specifications D etails of the proposed spare parts and consumables inventory FR 24 and FR 25 D etails of the proposed training programme s FR 28 Details of the proposed maintenance service and of the local maintenance agent together with specific proposals for routine and emergency maintenance and details of the proposed spares inventory FR 29 Anticipated empty weight of the complete installation in kilograms Tender details Specify delivery time Specify warranty terms Specify shipping details including packed weight and volume Price for supplying the specified components to the site s including payment terms and currency Price for installing and commissioning the components including payment terms and currency Price for supplying the spare parts including payment term
11. e chlorofluorocarbon decibels Expanded Programme on Immunization WH O hours herz International Chamber of Commerce commercial delivery terms International Standards O rganisation Kelvin kilograms kilovolt ampere kilowatts kilowatt hours metres square metres cubic metres millimetres personal computer WHO UNICEF product information sheets International Temperature Scale of 1990 U nited N ations Children s Fund watts World H ealth Organization Equipment performance specifications 1 Introduction 1 1 Coldroomsand freezer rooms Cold rooms and freezer rooms are normally used to store vaccines at the national or subnational level for periods of several months If a cold room or freezer room fails the immunization services of an entire country may be placed at risk Consequently equipment must be specified installed and maintained to the highest available standards This document outlines specifications for step in and walk in units with a capacity of up to about 40m3 It should be modified to suit individual cases Cold rooms and freezer rooms that are significantly larger should only be specified in consultation with a refrigeration specialist 1 2 Equipment descriptions The performance specifications given in this document apply to the following types of rooms suitable for storing vaccines E1 CR Cold rooms 2 C to 8 C E1 FR Freezer rooms 15 C to 25 C WHO V amp B 02 33 1 E1
12. e ee 6 External wall construction Masonry brick block or stone eee Steel frame with cladding anen Timber frame with cladding aenn Other describe eee 7 External wall insulation Nome Fibreglass or mineral fibre eee Plastic foam eae Other describe cee 8 External wall insulation thickness Approximate thickness mm eaten 9 Internal finish to walls Exposed masonry eee Note a dust free non Plaster or render cee combustible surface is required Plasterboard drywall eae Timberboarding eae Other describe eee 22 Equipment performance specifications and test procedures Equipment performance specifications 10 Roof construction Concrete Note a sound roof free of leaks is required Timber or steel framed pitched roof Timber or steel framed flat roof Other describe 1 Ceiling finish None room open to roof space Note a dust free non combustible surface is required Concrete Fibreboard lining Plasterboard drywall lining Other describe 12 Roof insulation None Fibreglass or mineral fibre Plastic foam Other describe 13 Roof insulation thickness Approximate thickness mm 14 Heating air conditioning Permanent heating system installed Mechanical air extraction system installed Air conditioning system installed 15 Electricity supply volts Note consult the elect
13. e only if the power supply is sufficiently reliable f the supply is not reliable provide tenderers with the information listed in Annex 2 clause 15 Consumables Provide consumables sufficient for two years of normal operation at the specified location s Spare parts Providespare parts sufficient for two years of normal operation at the specified location s G uidance note Spare parts may not be necessary if there isa service contract with a local agent Consider purchasing spare refrigeration unit s so as to ensure the maintenance of the integrity of the system in the event of a unit failure Try to standardize room sizes so that the spares inventory has universal application Refer to CR 27 Instructions For each cold room provide a user s manual a workshop manual and an installation guide in theo language G uidance note Specify the international language most used in the country WHO V amp B 02 33 9 E1 Cold rooms and freezer rooms CR 25 CR 26 CR 27 Installation and commissioning Installation and commissioning must be carried out by the manufacturer the supplier or the supplier s appointed agent D etails of the commissioning tests must be recorded and a copy of the test report must be handed over with the instruction manuals G uidance note T he following protocol is an indication of the tests that may be carried out Cool down time The refrigeration unit is started when the room is emp
14. e restoration of safe conditions U nits must be wall mounted with the condenser unit discharging inside the building that houses the cold room Or WHO V amp B 02 33 7 E1 Cold rooms and freezer rooms CR 17 CR 18 CR 19 O ption 1 The evaporator units must be wall mounted with a weatherproof condenser unit mounted externally Or O ption 2 The units must be ceiling mounted with a condenser unit discharging inside the building that houses the cold room Or O ption 3 The evaporator units must be ceiling mounted with a weatherproof condenser unit mounted externally Guidance note Strike out options that do not apply Some vaccines are damaged by exposure to a temperature of 0 5 C Size the evaporator units so that the plume of discharged air at a temperature below 0 C is clear of shelving units If necessary provide a removable mesh cage around the evaporator so as to maintain a safe storage zone O ption Provide a low temperature protection system to prevent the temperature of the cold room dropping below 2 C under worst case winter conditions Guidance note Strike out this option only if thereisNO risk of the ambient temperature outside the cold room falling below the 2 C internal minimum specified in CR 4 for periods of more than a few hours For example even a hot zone location COULD require low temperature protection during the winter months Refrigerant CFC free to comply with the requirem
15. ent operating temperature for at least 8 hours Power consumption C onfirm the following for each cold room at thetime of tendering the maximum starting current per phase the maximum running current per phase the estimated annual energy consumption in kW hrs Low power consumption is a factor in the selection of equipment Equipment performance specifications and test procedures Equipment performance specifications CR 11 Electrical safety rating At the time of tendering confirm the national or international electrical safety standards to which each incorporated electrical and electronic component is manufactured and installed CR 12 Panel insulation The thermal transmittance U value of the roof wall and floor panels must be 0 25 W m K or better Foam insulation must be CFC free G uidance note T here may be a case for increasing the thickness to 125 mm U 0 2 or 150 mm U 0 17 in very hot climates CR 13 Panel construction Panels must be of hot dip galvanized steel sheet fully insulated and without internal structural members or stiffeners between the skins Tongued and grooved joints between panels must be designed so as to minimize cold bridging Gaskets must be resistant to damage from oil fats water and detergents Floor panels must have a hard wearing non slip finish Wall and roof panels must have a white plastic coating CR 14 Door construction Doors must be insulated to the same standa
16. ent per phase the maximum running current per phase the estimated annual energy consumption in kW hrs Low power consumption is a factor in the selection of equipment Equipment performance specifications and test procedures Equipment performance specifications FR 11 FR 12 FR 13 FR 14 FR 15 FR 16 FR 17 Electrical safety rating At the time of tendering confirm the national or international electrical safety standards to which each incorporated electrical and electronic component is manufactured and installed Provide written evidence of compliance Panel insulation The thermal transmittance U value of the roof wall and floor panels must be 0 25 W m K or better Foam insulation must be CFC free Panel construction Panels must be made from hot dip galvanized steel sheet fully insulated without internal structural members or stiffeners between the skins Tongued and grooved joints between panels must be designed to minimize cold bridging Gaskets must be resistant to damage from oil fats water and detergents Floor panels must have a hard wearing non slip finish Wall and roof panels must have a white plastic coating Pressure relief valve Provide a pressure relief valve in the roof Door construction D oors must be insulated to same standard as in clause FR 12 They must be lockable with 100 fail safe provision for opening from inside The clear opening width of the door must be at least 600
17. ents of the M ontreal Protocol Flammable refrigerants are not acceptable The casing of each refrigeration unit must carry a permanent label clearly identifying the refrigerant used in letters not less than 10 mm high The casing of each refrigeration unit must be permanently marked with the WH O EPI CFC free symbol as shown in Annex 1 The symbol must be not less than 100 mm in diameter Lighting Providean internal ceiling mounted tungsten filament light fitting with an external switch and pilot light The external light and light switch must be fixed to the wall of the cold room enclosure near the entrance door N ote Fluorescent lighting damages certain vaccines and must not be used Alarm system Providea mains operated audible alarm with battery backup and automatic recharge which is triggered in the event of mains failure or when cold room temperatures are outside the set limits O ption Alarm sounder repeater located in G uidance note The alarm sounder must be located where it can be heard This may not be in the building where the cold room is housed Equipment performance specifications and test procedures Equipment performance specifications CR 20 CR 21 CR 22 CR 23 CR 24 Temperature recording Provide PC based temperature and event logging equipment including temperature sensor s adoor open sensor and program diskettes Provide a dial thermometer or digital thermometer mounted on the wall of t
18. f vaccine set out in the table below Cross refer to clause FR 17 FR 7 FR 8 FR 9 FR 10 Guidance note Calculate and insert the required net storage volume for each freezer room M ake sure you Know the type of packaging in which the vaccine is to be stored eg intermediate packaging or insulated shipping containers C hoosing the latter will greatly increase the required size of the freezer room nclude the volume of any other items that are to be stored in the freezer room M ake a generous allowance for future needs e g new vaccines in smaller presentations integrated services Location details nstall freezer room s in the locations s indicated on the worksheet s and drawing s attached to this specification Details of the location s are shown on the drawing s G uidance note For each location complete the worksheet at the end of this document and provide a dimensioned drawing Control by thermostat Freezer room temperature must be controlled by a thermostat within the tolerances specified in clause FR 4 The thermostat must be calibrated to 1TS 90 and accurate to 0 5 C or better H oldover time n the event of power failure the freezer room temperature must remain below 10 C for a minimum period of 8 hours at the specified maximum ambient operating temperature Power consumption C onfirm the following for each freezer room at the time of tendering the maximum starting curr
19. he cold room in an accessible position Temperature loggers and thermometers must be calibrated to IT S 90 and accurate to 0 5 C or better Or O ption 1 Provide a digital electronic recorder with continuous digital temperature read out mounted on the wall of the cold room in an accessible position The recorder must have a memory of at least 7 days temperature sensor s adoor open sensor and a printing device allowing a hard copy of the temperature records to be retained The device must be calibrated to 1TS 90 and accurate to 0 5 C or better Or O ption 2 Provide a 7 day wall mounted pen recording thermometer with a temperature sensor and a door open sensor T he device must be calibrated to ITS 90 and accurate to 0 5 C or better G uidance note PC based system is now considered essential for national stores and is preferred for all cold rooms H owever a digital recorder with a print out facility or a pen recorder may be acceptable for small subnational stores If no suitablePC isavailableto run the temperature logging software ensure that one is obtained as part of the installation contract D oor open sensors are desirable but not essential Voltage stabilizer Provide protection against high or low voltage and against cycle fluctuations The cold room manufacturer must offer a voltage stabilizer appropriate to the electricity supply conditions where the store is to be constructed Guidance note Strike out this claus
20. if the power supply is sufficiently reliable f the supply is not reliable provide tenderers with the information listed in Annex 2 clause 15 Consumables Provide consumables sufficient for two years of normal operation at the specified location s Spare parts Providespare parts sufficient for two years of normal operation at the specified location s G uidance note Spare parts may not be necessary if a service contract is taken out with a local agent C onsider purchasing spare refrigeration unit s so as to ensure the maintenance of the integrity of the system in the event of a unit failure Try to standardize room sizes so that the spares inventory has universal application Refer to FR 29 Instructions For each freezer room provide a user s manual a workshop manual and an installation guide in the oo eee language Guidance note Specify the international language most used in the country WHO V amp B 02 33 17 E1 Cold rooms and freezer rooms FR 27 FR 28 FR 29 Installation and commissioning Installation and commissioning must be carried out by the manufacturer the supplier or the supplier s appointed agent D etails of the commissioning tests must be recorded and a copy of the test report must be handed over with the instruction manuals G uidance note T he following protocol is an indication of the tests that may be carried out Cool down time The refrigeration unit is started when the room
21. information sheets 2000 edition Thisdocument was produced by the Access to Technologies of theD epartment of V accines and Biologicals Ordering code WH O V amp B 02 33 Printed D ecember 2002 Thisdocument isavailable on the nternet at www who int vaccines documents C opies may berequested from World H ealth O rganization D epartment of V accines and Biologicals CH 1211 G eneva 27 Switzerland e Fax 41 22 791 4227 Email vaccines who int World H ealth O rganization 2002 All rights reserved Publications of the World H ealth O rganization can be obtained from M arketing and Dissemination World H ealth Organization 20 Avenue A ppia 1211 Geneva 27 Switzerland tel 41 22 791 2476 fax 41 22 791 4857 email bookorders who int Requests for permission to reproduceor translate WH O publications whether for saleor for noncommercial distribution should be addressed to Publications at the above address fax 41 22 791 4806 email permissions who int The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World H ealth O rganization concerning the legal status of any country territory city or area or of its authorities or concerning the delimitation of its frontiers or boundaries D otted lines on maps represent approximate border lines for which there may not yet be full agreement The mention of s
22. mm for rooms of up to 10 cubic metres and at least 800 mm for larger rooms Provide an internal clear plastic strip curtain Provide a door frame heating element Guidance note A door frame heating element is essential for freezer rooms H eater mat Provide an electric resistance heater mat below the floor of the freezer room with thermostatic control Guidance note U nder certain circumstances a freezer room can freeze the soil under the room floor Freezing causes the ground to expand and this can crack a concrete floor slab Laying an electric heater mat under the freezer room floor panels eliminates this risk A heater mat is also necessary if a freezer room is located on an upper floor in order to prevent excessive cooling of the structural floor slab and consequent damage from moisture condensation on the ceiling below Whether a heater mat is required ultimately depends on the location of the store the climatic regime and the size of the freezer room seek the manufacturer s advice Shelving Provide wall mounted or free standing stove enamelled steel galvanized steel stainless steel or aluminium slatted adjustable shelving units to carry vaccine in packages Slatted shelves are preferred Shelves must be not less than 450 mm and not more than 600 mm deep at approximately 450 mm vertical centres The lowest shelf must be mounted 200 mm above the floor WHO V amp B 02 33 15 E1 Cold rooms and freezer rooms FR 18
23. n an accessible position Temperature loggers and thermometers must be calibrated to IT S 90 and accurate to 0 5 C or better Or O ption 1 Provide a digital electronic recorder with continuous digital temperature read out mounted on the wall of the freezer room in an accessible position The recorder must have a memory of at least 7 days temperature sensor s a door open sensor and a printing device so that a hard copy of temperature records can be retained The device must be calibrated to IT S 90 and accurate to 0 5 C or better Or O ption 2 Provide a 7 day wall mounted pen recording thermometer with a temperature sensor and a door open sensor T he device must be calibrated to ITS 90 and accurate to 0 5 C or better Guidance note A PC based system is now considered essential for national stores and is preferred in all cold rooms H owever a digital recorder with a print out facility or a pen recorder may be acceptable for small subnational stores If no suitablePC isavailableto run the temperature logging software ensure that one is obtained as part of the installation contract D oor open sensors are desirable but not essential FR 23 Voltage stabilizer Provide protection against high or low voltage and against cycle fluctuations The cold room manufacturer must offer a voltage stabilizer appropriate to the electricity supply conditions where the store is to be constructed G uidance note Strike out this clause only
24. ncluding payment terms and currency Estimated annual cost of consumables Cost of five year maintenance agreement including payment terms and currency Temperature control The temperature of the cold room must remain between 2 C and 8 C when measured in any part of the room under any loading condition between empty and full and over the full ambient temperature range specified in CR 5 Climatic conditions The temperature control set out in CR 4 is to be achieved under the following climatic conditions H ot zone maximum continuous ambient summer temperature 43 C minimum continuous ambient winter temperature 0 C Or Temperate zone maximum continuous ambient summer temperature 32 C minimum continuous ambient winter temperature 0 C Or Cold zone maximum continuous ambient summer temperature 32 C minimum continuous ambient winter temperature 5 C G uidance note Select one climate regime only and strike out the descriptions that do not apply Alternatively specify the actual temperature regime derived from national climate data n cold climates pay particular attention to the selection of the worst case minimum winter temperature For example isthe room in which the cold room isto be located permanently heated and will this heating be 100 reliable If not low temperature protection is essential WHO V amp B 02 33 5 E1 Cold rooms and freezer rooms CR 6 Unit ref Location Maximum
25. ng documentation with reference to the model specifications contained in the present document and invite tenders At the same time tenders may be invited for stand by generators if these are needed Guidance on specifying and buying generators is given in document WH O EPI V amp B 00 13 Product information sheets 2000 edition 4 Placeorder R eceive and evaluate tenders reach agreement on an installation programme and place an order with the winning supplier 5 Prepare the site Prepare the space for the cold room in accordance with the supplier s requirements and the guidance set out in document WH O V amp B 02 34 Guideline for establishing or improving primary and intermediate vaccine stores 6 Supervise Supervise the installation procedure and oversee commissioning and user training 7 Monitor M onitor the performance of the equipment in use and monitor the effectiveness of the maintenance agreement 8 Renew Ensure that the maintenance agreement is renewed after the expiry of the initial contract 2 Equipment performance specifications and test procedures Equipment performance specifications 3 H ow to use this document There are numerous cross references between the standard clauses of the two specifications below In order to avoid confusion users should strike through any inapplicable clauses or options but should not change the clause numbers WHO V amp B 02 33 3 E1 Cold rooms and freezer room
26. on with the installer WHO V amp B 02 33 11 E1 Cold rooms and freezer rooms 5 Freezer rooms operating at FR 1 FR 2 FR 3 15 C to 25 C Type of equipment Freezer room s for storing bulk vaccine Location of installation As in clause FR 6 and in accordance with the further details referred to in clause FR 7 D divery terms lt Term gt Incoterms 2000 lt destination or port of entry gt G uidance note Specify the required ncoterms and point of delivery Quality control standards Component manufacture and all installation and commissioning processes must be in accordance with ISO 9001 Guidance note The current version is ISO 9001 2000 but certification to ISO 9001 1994 should be acceptable Details to be submitted with tender Submit the following supporting information with the tendering documents ignore any clauses that have been deleted Technical details Plans elevations and sections at 1 50 scale showing each freezer room including its equipment and the shelving layout proposed M ethod statement describing proposed shipment and assembly procedures FR 27 Programme for manufacture delivery and erection D etails of any building work to be carried out by the purchaser including any requirements for permanent ventilation heating or cooling in the space s housing the freezer room s e Evidence of ISO 9001 certification FR 2 Full technical details of all in
27. ontreal Protocol Flammable refrigerants are not acceptable The casing of each refrigeration unit must carry a permanent label clearly identifying the refrigerant used in letters not less than 10 mm high The casing of each refrigeration unit must be permanently marked with the WH O EPI CFC free symbol see Annex 1 The symbol must be not less than 100 mm in diameter Lighting Providean internal ceiling mounted tungsten filament light fitting with an external switch and a pilot light An external light and light switch must be fixed to the wall of the freezer room enclosure near the entrance door N ote Fluorescent lighting damages certain vaccines and must not be used Alarm system Provide a mains operated audible alarm with battery backup and automatic recharge which is triggered in the event of mains failure or when freezer room temperatures are outside the set limits O ption Alarm sounder repeater located in wu G uidance note The alarm sounder must be located where it can be heard This may not be in the building where the freezer room is housed Equipment performance specifications and test procedures Equipment performance specifications FR 22 FR 24 FR 25 FR 26 Temperature recording Provide PC based temperature and event logging equipment including temperature sensor s adoor open sensor and program diskettes Provide a dial thermometer or digital thermometer mounted on the wall of the freezer room i
28. pecific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World H ealth O rganization in preference to others of asimilar nature that are not mentioned Errors and omissions excepted thenames of proprietary products are distinguished by initial capital letters The World H ealth O rganization does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use C ontents Abbreviation Sariman eae oes re lan A ee ine tena eats vV Ie _ ntroduction sassiivcnsctiaatscniin senses ceandatacnniatdtdansdvantitia adaba yaana darabi adnada aara 1 1 1 Cold rooms and freezer FOOIMS esenee 1 1 2 Equipment descriptionS ssssssssesrsreresisrsrsrsrrssesestnrnrsttntnnrnrenrnrnnnnnrnrenenenent 1 2 How to buy and maintain cold rooms and freezer rooMS sssussssusnnnunnennnunnas 2 3 How to use this document sssssssssssssssnnnnnnnnnnnnnnnnnnnnnnnannnnnannnnnnnannnnnannnnnannnnnannnnn ana 3 4 Cold rooms operating at 2 C to 48 C wees 4 5 Freezer rooms operating at 15 C to 25 C ween 12 Annex L CFC free symbol sisii sernsscnisavassnantuavsancaviseteannsanttaniseriuananias 20 Annex 2 Location details for cold room or freezer room Qs 21 C CFC dB EPI hrs Hz Incoterms 2000 ISO K kg kVA kW kWh m m2 m3 mm PC PIS 1TS 90 UNICEF W WHO A bbreviations degrees centigrad
29. rd as in clause CR 12 Doors must be lockable with 100 fail safe provision for opening from inside The clear opening width of door must be at least 600 mm for rooms of up to 10 cubic metres and at least 800 mm for larger rooms Provide an internal clear plastic strip curtain O ption Provide a door frame heating element Guidance note A door frame heating element is recommended in humid climates CR 15 Shelving Provide wall mounted or free standing stove enamelled steel galvanized steel stainless steel or aluminium slatted adjustable shelving units to carry vaccine in packages Slatted shelves are preferred Shelves must be not less than 450 mm deep and not more than 600 mm deep at approximately 450 mm vertical centres The lowest shelf must be mounted 200 mm above the floor CR 16 Refrigeration units Provide twin packaged refrigeration units with single phase or three phase compressors sized to give 100 stand by capacity under worst case conditions There must be a timer operated electric or hot gas defrosting system and a condensate drip tray and drain connection Provide an automatic duty sharing circuit with seven day changeover and manual override to be used in the event of mechanical failure Provide protection against high or low voltage and against cycle fluctuations There must be an automatic cut out when conditions are outside the cold room manufacturer s defined safe limits and an automatic cut in within 6 minutes of th
30. ricity supply company and or ask an electrical engineer to check the amps cycles Hz supply 0 B O Is three phase supply possible Yes no aan Voltage range sses LO r Roe Ra att V Cycle range nesre Oina Hz WHO V amp B 02 33 23 E1 Cold rooms and freezer rooms 16 Expected hours of supply 24 hours perday eae See clauses CR 9 and FR 9 18 24 hours perday eae Increase holdover time for supply of less than 16 hrs 12 18hoursperday eee 8 12 hrs perday nae 17 Unexpected loss of supply Once or morea month fanns Failure frequency during Once or moreaweek sss expected supply hrs Once or morea day aeea 18 Stand by generator installed NO L Note to calculate adjusted kVA reduce the rated kVA by 1 for each 100 m the site is above sea level and by 1 for e Manufacturer and model each 5 5 C that the maximum ambient temperature is above 20 C Thus for a site at 500m altitude and 32 C de rate kVA by 5 for altitude and by 2 seeresrsrrssessrrrssserrerssrrrnsnrrnnsnrnnnennnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnrnnnnrrnnnnrreenneeeet Yes give details below eaten for temperature i e by 7 e Petrol eae e Diesel eee e Rated output KVA n e Adjusted for altitude and temperature KVA e Handstart n e Automatic start on mains failure eae 24 Equipment performance specifications
31. s CR 1 CR 2 CR 3 4 Cold rooms operating at 2 C to 8 C Type of equipment C old room s for storing bulk vaccine Location of installation As in clause CR 6 and in accordance with the further details referred to in clause CR 7 Number and size of units As in clause CR 6 D divery terms lt Term gt Incoterms 2000 lt destination or port of entry gt G uidance note Specify the required ncoterms and point of delivery Quality control standards Component manufacture and all installation and commissioning processes are to be in accordance with ISO 9001 Guidance note The current version is ISO 9001 2000 but certification to ISO 9001 1994 should be acceptable Information to besubmitted with tender Submit the following supporting information with the tendering documents ignore any clauses that have been deleted Technical details Plans elevations and sections at 1 50 scale showing each cold room its refrigeration equipment and the shelving layout proposed M ethod statement describing proposed shipment and assembly Procedures CR 25 D etails of any building work to be carried out by the purchaser including any requirements for permanent ventilation heating or cooling in the space s housing the cold room s Programme for manufacture delivery and erection Evidence of ISO 9001 certification CR 2 Full technical details of all incorporated components and equipment in
32. s and currency Price for training users including payment terms and currency Price for training repair technician s including payment terms and currency Estimated annual cost of consumables Cost of five year maintenance agreement including payment terms and currency FR 4 Temperature control Freezer room temperature must remain between 25 C and 15 C when measured in any part of the room under any loading condition between empty and full and over the full ambient temperature range specified in FR 5 FR 5 Climatic conditions The temperature control set out in FR 3 must be achieved under the following climatic conditions H ot zone maximum continuous ambient summer temperature 43 C and minimum continuous ambient winter temperature 0 C Or Temperate zone maximum continuous ambient summer temperature 32 C and minimum continuous ambient winter temperature 0 C Or Cold zone maximum continuous ambient summer temperature 32 C and minimum continuous ambient winter temperature 5 C G uidance note Select one climate regime only and strike out the descriptions that do not apply Alternatively specify the actual temperature regime derived from national climate data WHO V amp B 02 33 13 E1 Cold rooms and freezer rooms FR 6 Unit ref Location Maximum stored volume litres Capacity and location The freezer room s and shelving layout s must be sized to accommodate the volume s o
33. s and immunization related technologies The Vaccine Assessment and Monitoring team assesses strategies and activities for reducing morbidity and mortality caused by vaccine preventable diseases The Access to Technologies team endeavours to reduce financial and technical barriers to the intro duction of new and established vaccines and immunization related technologies The Expanded Programme on Immunization develops policies and strategies for maximizing the use of vaccines of public health importance and their delivery It supports the WHO regions and countries in acquiring the skills competence and infrastructure needed for implementing these policies and strategies and for achieving disease control and or elimination and eradication objectives Department of Vaccines and Biologicals Health Technology and Pharmaceuticals World Health Organization CH 1211 Geneva 27 Switzerland Fax 41 22 791 4227 Email vaccines who int or visit our web site at http www who int vaccines documents
34. tion Provide a course for qualified refrigeration technicians in the maintenance and repair of the installed equipment O ption Maintenance Provide proposals for a routine and emergency maintenance service for an assured period of not less than five years after commissioning The emergency service must guarantee the following If one refrigeration unit fails the defective unit or component must be repaired or replaced within seven days after the failure is reported If both refrigeration units fail at least one must be repaired or replaced within 24 hours after the failure is reported The second unit must be repaired or replaced within seven more days Ancillary components such as alarms and thermometers must be replaced within seven days after reported failure Equipment performance specifications and test procedures Equipment performance specifications Guidance note M anagers of immunization services M U ST ensure that the best available maintenance arrangements are in place for the freezer room Either local refrigeration technicians should be trained as indicated in clause FR 28 or the freezer room installer should be contracted to provide a maintenance service similar to that described in clause FR 29 In some countries it is not possible to achieve the response times given in FR 29 In such cases the clause should be modified in consultation with the installer WHO V amp B 02 33 19 E1 Cold rooms and freezer
35. ty and when the temperature is the same inside and outside the room D uring the test the cold room door must be kept closed The time needed for the internal temperature to drop below 8 C is recorded The test period is at least 48 hours Running test The number of hours for which the compressor runs is recorded with the door closed and the room empty The internal and external temperatures the evaporator and condenser temperatures and the pressures of the system are monitored The maximum temperature difference in the cold room is measured and the location of any warm or cold spots is recorded Temperature rise test The electricity supply to the room is cut off and the period required for the internal temperature to rise by 5 C from the normal operating temperature is measured Control and monitoring equipment tests The operation of automatic duty sharing temperature control temperature monitoring and alarm equipment is tested If computerized temperature monitoring is used the software is loaded configured and tested Stand by generator operation test The power output of the stand by generator is checked together with the operation of the automatic mains failure control system The generator is run continuously for 48 hours Training Provide an operator s training course lasting not less than four hours and covering all aspects of safe operation and routine non specialist maintenance of the cold room O ption
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