Negative Pressure Isolator
Contents
1. The second pipe line must be a S S pipe of 160mm diameter and will be supplied and installed by the successful tenderer and according to the written instructions of the manufacturer of the isolator The Tenderer must verify that the offered extract fans can be located on the roof of the BOCOC without any problems Tenderers are invited to visit the areas of the Center after arrangement of a meeting so that all installation works will be according to the needs of the BOCOC To be completed by Weight Factor 30 Reference to Product Evaluation Literature Points Page amp Paragraph Statement of Conformity Tenderer Extract Fans for Negative Pressure isolators cont d Statement of Reference to Er AMET Conformity Product Specification To be completed by Literature Requirements Tenderer Page amp Paragraph The Tenderer must verify that the fan motors of the offered Extract Fan are supplied with sealed for life bearings and that no routine maintenance will be required for the bearings a The Tenderer must verify that the extract fans offered will function with a 3 Phase motor designed for range of rated voltage 380 420 V 5 50Hz IE1 Standard Efficiency Motors b The Tenderer must verify that each of the extract fans offered will function with an Inverter C The Inverter must be a high quality one with 3 phased inlet and outlet d The Inverter must be CE marked pre2. access to all potentially contaminated areas and all other equipment areas to facilitate easy cleaning sanitization and ergonomy of all operator movements For each of the three working chambers specify what the value of the air exchange rate is separately and characterize the form of air flow Weight Negative Pressure Isolator cont d Factor cont d 60 Statement of Reference to Evaluation Conformity Product Points Tenderer Page amp Paragraph Indicate if and how nursing or other personnel can continuously monitor important working parameters like a pressure b condition of HEPA filters C air flow in all three working chambers 17 1 Indicate if service engineers and users will be allowed to perform automated or semi automated QA tests like a Automated pressure decay seal leak tests b glove leak test in an easy and quick way 17 2 List and shortly describe allavailable QA tests Indicate availability of service mode password protection for use by service engineers 19 1 Verify the availability of sealed fluorescent lighting inside the isolator cabinets giving safe view at the whole work surface State the resulting luminance in SI units lux 19 2 Indicate if Lighting systems have at least IP64 degree of protection against ingress of particles Weight Negative Pressure Isolator cont d Factor cont d 60 Statement of Reference to Evaluation
3. and recording system The Tenderer must provide two sets of manuals in English one Operation and one Service Manual The Tenderers must verify that the Isolator offered will comply with the following standards BS EN ISO 14644 EU GMP Grade A equivalent to ISO Class 5 air environment quality CE BS EN 1822 HEPA filters IEC 61010 1 2001 Electric wiring Pharmaceutical Isolators pharmaceutical Press 2004 AS 4273 1999 when optional activated carbon filter is fitted Compliance to additional relevant standards to be indicated Weight Negative Pressure Isolator cont d Factor cont d 60 Statement of Reference to Evaluation Conformity Product Points To be completed by Literature Tenderer Specification Requirements The manufacturer must be established in the international market and be officially represented in Cyprus At least two service engineers trained by the factory for servicing the offered isolator and extract fan are needed If there are no factory trained engineers employed by the Tenderer then two of the engineers employed by the Tenderer must be trained within three months from the date of signing a contract with the succesful Tenderer In addition to technical problems the service engineers will also be responsible for any periodical operation and technical training needed for the staff of the Oncology Center The tenderers must provide Curriculum Vitae of the service engine
4. purchase contract is signed If the Tenderer Representative of the manufacturer in Cyprus becomes unable to continue offering maintenance for the equipment purchased by the Bank of Cyprus Oncology Center then the Manuafacturers themselves undertake to send engineers for both the annual and the quarterly maintenance of the isolator and the extract fans The manufacturer undertakes in addition if the above unavailability becomes a reality to train an in house engineer for the maintenance of the isolator and the extract fan The successful Tenderer must provide basic training on the extract fan of an in house engineer for emergencies Warranty Spare parts Maintenance Contract Weight manufacturer support and Training of Service Factor Engineers for the Negative Pressure Isolator and the cons d extract fans offered 10 Specification Requirements 1 1 Verify that the Isolator and the extract fans offered will have a two year full warranty including service and all spare parts 1 2 Verify that the Tenderer is willing to undertake and provide an eight year service contract following the two year warranty for the isolator and the extract fans offered This service contract must cover all spare parts It must also include an annual Preventive Maintenance and Quality Assurance session performed by a Service Engineer from the factory as well as quarterly maintenance service provided by the local engineers trai
5. separately 9 1 The offered isolator must allow performance of all operations in an easy reliable and safe way 9 2 Verify that the isolator offered has adjustable height and ergonomic design for all chambers especially the Processing Chamber Wide clear openings of all doors for easy loading inside surfaces easily reachable from the glove ports etc 9 3 Indicate the Dimensions of all doors and of the two sleeve ports The offered isolator must have ergonomically positioned DOP particle counter test ports in all chambers Weight Negative Pressure Isolator cont d Factor cont d 60 Statement of Reference to Evaluation Conformity Product Points To be completed by Literature Tenderer Specification Requirements 11 1 The isolator design must allow easy maintenance 11 2 The unit offered must allow service from a lockable front panel which is preferable Indicate the overall dimensions of the unit offered The isolator approximate dimensions are given below Length 1800 2500 mm Depth 750 mm Height 2800 mm maximum 13 1 Verify that the isolator has adjustable height as required for this tender for easier and more ergonomic use by the operators and for easier cleaning of all the external surfaces of the isolator 13 2 Indicate if the base frame has a Lockable castors b Adjustable height of the footrest c At least 350mm unobstructed knee room The offered unit must have good
6. BANK OF CYPRUS ONCOLOGY CENTER BOCOC ENTYTIO 8 Technical Specifications for the Purchase of a Negative Pressure Isolator and two Extract Fans for reconstitution of Cytotoxic drugs in the Clean Room of the Bank of Cyprus Oncology Center Npoogopa yia Ayop v g KouBoukAiou AogaAgias kai 600 Gagpio Tpuv yia Avac craor KUTTAPOOTATIKWV Mapyakwyv cro Ka8ap Aupg rio Tou OykoAoyiKoU K vrpou Tpdtregac K rrpovu r1 20011 008 TECHNICAL SPECIFICATIONS AND STATEMENT OF CONFORMITY WITH SPECIFICATIONS December 2011 BANK OF CYPRUS ONCOLOGY CENTRE 32 Acropoleos Ave 2006 Strovolos Nicosia Cyprus Tel 357 22841300 Fax 357 22511870 e mail oncology bococ org cy http www bococ org cy I Negative Pressure Isolator Maintenance Inspection Tasks Frequency Quarterly every 4 months Location BOCOC Task Description Supply Installation Commitioning Inspection and Planned Maintenance of a new Negative Pressure Isolator and two new extract fans Provide the cost of the above in Entypo 11 The second new extract fan must be connected by the successful tenderer to the existing isolator supply and installation The cost of all optional items must be given in Entypo 11A Safety requirements According to the Standards EU cGMP BS EN ISO 14644 IEC 61010 1 2001 Electric wiring Pharmaceutical Isolators Pharmaceutical Press 2004 and BS EN 1822 1 1998 HEPA filters Safe working methods All works perfor
7. Conformity Product Points To be completed by Literature Tenderer Specification Requirements ALARMS 20 1 Verify that the following are available Latched audible and visible alarm for internal pressure Alarm for failure of downflow air exchange rate Alarm for transfer chamber door not closed 20 2 Verify that Alarm mute option is available 20 3 Verify that battery back up for alarms is available 20 4 Any additional visual and audible alarms available to be indicated Verify that Electrical supply is designed for 230VAC 50Hz 1PH Verify that the Isolator is supported by Programmable Logic Controller PLC technology The isolator offered must be supplied with UPS back up to support the operation of key isolator functions for at least 20 minutes Specify what operations are possible with UPS back up and indicate how this affects the safety of personnel and cytotoxics Weight Negative Pressure Isolator cont d Factor 60 Statement of Reference to Evaluation Conformity Product To be completed by Literature Tenderer Page amp Specification Requirements The Tenderer must provide a price list with all accessories and consumables of the isolator sleeves gownlets powder free gloves suitable for cytotoxics etc The following must be quoted separately as additional options in Entypo 11A i 13 amp single splash proof socket Cable gland for computer connection iii CCTV monitoring
8. el was launched to the market Weight Negative Pressure Isolator Factor 60 Statement of Reference to Evaluation Conformity Product Points To be completed by Literature Tenderer Specification Requirements Tenderers must verify that the Isolator offered is appropriate for the safe aseptic reconstitution and dispensing of cytotoxics 2 1 Verify that the Isolator offered functions with Negative Pressure and can be connected to an external Negative Pressure Extract Fan externally ducted system 2 2 Verify that all potentially contaminated airways and plenums are under negative pressure Tenderers must provide description of the function of the whole unit with emphasis on the airflow and filtration parts and components Negative Pressure Isolator cont d Specification Requirements Conformity To be completed by Tenderer a Verify that the HEPA filtered air will be exhausted to the atmosphere via a dedicated ducting system and an extract fan located on the roof of the hospital The manufacturer must provide confirmation that the Extract Fan offered is suitable for proper operation when connected with the isolator offered based on the required pipe lengths and pipe sizes Note Technical specifications of the Extract Fan must be provided separately see relevant section on the extract fans below a Verify that all HEPA filters and lighting systems can be safely removed and r
9. eplaced from the upper site of the offered isolator dirty site b Verify that the service engineer can seal the primary and all other HEPA filters into a plastic bag before removing it for safe disposal a The Tenderers must verify that the isolator offered provides an EC GMP Grade A class 100 air environment in the Processing Chamber b Verify that the isolator is a three module one with a process chamber and two fully interlocked class E Transfer Chambers Left and Right Weight Factor Cont d 60 Statement of Reference to Evaluation Product Literature Weight Negative Pressure Isolator cont d Statement of Reference to Evaluation Conformity Product Points To be completed by Literature Tenderer Specification Requirements Verify that both transfer chambers operate with timed interlocks and high air change rates Indicate the air change rates available 8 1 The Tenderers must verify that the isolator is manufactured with high quality materials and indicate what these materials are More specifically they must verify that all external and internal surfaces are durable not rusting and allow easy cleaning and disinfecting 8 2 Indicate what materials are used for the surfaces mentioned below a Interior surfaces of Processing Chamber Interior surfaces of Transfer Chambers left amp right Doors Stand External panels For any coated surfaces indicate the type of coating
10. ers including experience related to the offered items The Tenderers must provide a list of other public or private institutions in Cyprus where they have installed the same or similar equipment to that offered for this tender The Tenderers must describe any additional advantages of the offered items that are not included above The successful Tenderer must provide basic training on the isolator of an in house engineer for emergencies Extract Fans for Negative Pressure isolators Specification Requirements 1 1 The Tenderer must provide a declaration from the manufacturer of the Negative Pressure Isolator that the Extract Fans offered are suitable for proper operation in connection with the offered isolator as well as the existing isolator of the Clean Room of the Oncology Center Amercare Negative Pressure isolator model A2 1 2 The Tenderer must provide a declaration that the following will be performed a The new isolator will be connected via the existing pipe system of the present clean room to one of the new extract fans installed on the roof present arrangement V connection of two isolators in the clean room and V connection of two extract fans duty amp stand by on the roof b When the new clean room is commithioned the second new extract fan must be separately connected via a new additional pipe to the existing Amercare A2 isolator so that each isolator is functioning with its own fan
11. ferable made by a known european manufacturer e The tender must provide the name of the inverters manufacturer f The tender must provide the model of the two inverters together with all technical data sheets and a copy of user and installation instructions The Tenderer must verify that the duct connection of the Extract Fan offered is made with a flexible mount in order to enable an easy visual check whenever needed Weight Factor 30 96 Evaluation Points Extract Fans for Negative Pressure isolators Weight cont d Factor 30 Statement of Reference to Specification Conformity Product Evaluation Requirements To be completed by Literature Points Tenderer The Tenderer must verify that the offered Extract Fans have the following technical characteristics Type Negative Pressure Extract Fan Housing Material Corrosion Resinstant Moulded Polypropylene in order to handle corrosive substances that may be hazardous to health Inlet Exhaust Spigot 160mm Diameter Impeller Type Forward curved Centrifugal Impeller Drive Direct Volume approx 1000 m per hour Maximum Static Pressure approx 1300 Pa Motor Type Squirrel Cage Induction Motor Speed approx 3000 r m Motor Electrical Voltage 415VAC 3PH 50Hz Motor Rated Output approx 0 75 kW Starting method Variable Frequency Drive Waterproofing Classification At least IP55 The Tenderer must verify that the of
12. fered Extract Fans have the following additional characteristics Fans to be complete with anti vibration mountings Fans to have flexible connections with Quick Release Clips connected to the S S pipe The S S pipe to have an individual Manual Damper near each Fan for manual flow regulation whenever necessary Fans appropriate for functioning without any problems under extreme high weather temperatures over 60 C The fan environmental conditions given by the fan manufacturer to be submitted with the tender Shadow rain cover protection to be provided for both extract fans The cover protection must not complicate the accessibility to the Fans for any maintenance or visual check Weight Extract Fans for Negative Pressure isolators Factor cont d cont d 30 Statement of Reference to Evaluation Conformity Product Points To be completed by Literature Tenderer Specification Requirements The Tenderer must provide with the tender a detailed technical description of the Extract Fan offered with all accessories including data sheets and diagrams showing basic dimensions of the unit that are important for the installation and for the connection with the Negative Pressure isolators The Tenderer must provide a letter from the manufacturers of the isolator and the extract Fans guaranteeing the following a The manufacturer guarantees the availability of spare parts for at least 10 years after the
13. med on the Negative Pressure Isolator must comply with the method and risk assessments described in relevant international standards for safe and proper working in a Clean Room A written report detailing the tasks performed must be provided by the contracting company on completion of any Planned Preventive Maintenance PPM or any other Service visit or when any work is undertaken in the Clean Room Planned Preventive Maintenance PPM The tenderers must submit a table with detailed check lists which will include all Maintenance Tasks they are proposing to perform during PPM according to the instructions of the manufacturer The tenderers must also submit a list of at least two Service Engineers who will be the responsible persons to perform this PPM Certificates regarding their qualifications must also be submitted as indicated in Entypo 6 of this tender II Outline Specifications All installation works acceptance testing commissioning and quality control tests of all installed systems must be performed according to the Standards EU cGMP BS EN ISO 14644 IEC 61010 1 2001 Electric wiring Pharmaceutical Isolators Pharmaceutical Press 2004 and BS EN 1822 1 1998 HEPA filters 1 The successful tenderer must submit the following a The names of at least two institutions in Cyprus where the tenderer has done similar installations b Provide documentation to verify the above e g either copies of the contrac
14. ned at the factory The cost of this service contract must be indicated in Entypo 11 The Tenderers must provide a list of the most important electronic mechanic pneumatic and other spare parts that the manufacturer suggests having in stock and be available at the premises of their representative in Cyprus Additionally the Tenderers must provide with their tender an estimated delivery time for the other spare parts that may be needed one day but are not available in the stock kept in Cyprus The Tenderers must indicate the ability of the system to accept upgrades of the system s software All upgrades and hardware releases during the warranty and service contract periods to be included and installed without any additional costs for the BOCOC for at least ten years Statement of Reference to Evaluation Conformity Product Points To be completed by Literature Tenderer Page amp Paragraph
15. ng both the new isolator and the pre existing isolator with their new extract fans in the new Clean Room In case that the new isolator of the successful tenderer will not be made by the same manufacturer as the existing one Amercare then the successful tender will be responsible for the installation and commitioning of the isolator of its manufacturer only In this case Amercare s representative has to declare separately the costs just to re install and commition the present Amercare A2 isolator in the new Clean Room after connecting it to the new extract fan In any case each isolator in the new Clean Room will be connected to one exctract fan installed on the roof of the building via a ductpipe The time period to arrange above will be defined to the tenderer by BOCOC and must not in any way affect the scheduled program of other works in process of the BOCOC extension All tenderers are invited to arrange a meeting either with Dr Chris Constantinou Head of Medical Physic Departmetn or Mr Nestoras Georgiou Biomedical Engineer to clarify any questions regarding the above 3 All Items offered i e the Negative Pressure Isolator the Extract Fans and all related accessories controls etc must be of the latest state of the Art and compatible with each other They must satisfy the needs of a modern medical oncology department III Negative Pressure Isolator Essential Information To be completed by Tenderer Model Year on which mod
16. ts for relevant installations or Service Contracts for Maintenance or reference persons with telephone numbers from the relevant departments of the hospitals and or the consulting engineers of the hospitals 2 Installation and Commissioning of the Negative Pressure Isolator After completion of installation including connection of both new negative pressure exract fans to the new isolator and the existing A2 Amercare isolator the systems will be subjected to inspection and Quality Control under supervision of a manufacturer engineer specialized in such installations A file containing all measurements and results must be submitted to the Medical Physics Department of the BOCOC The new isolator will be initially installed in the existing Clean Room of the Center At some point during the planned construction of the new Clean Room the existing clean room will have to be remodeled and the successful tenderer will be responsible for de installing all the isolators new and already existing storing the already existing one Amercare A2 isolator and re installing only the new isolator with its extract fan in a temporary room which will be used for the intermiddent period until the new clean room is completed The timetable to start the above works may last from one to three years from the date of the tender submission When the new clean room is commitioned the successful tender will be responsible for de installing and re installing and commitioni
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