URS_HVAC.doc

User LogoUser NameUSER REQUIREMENT SPECIFICATIONSHEATING, VENTILATION AND AIR CONDITIONING (HVAC) SYSTEMDocument Reference:Reference NumberRevision:Draft Number 01Date of Issue:14/03/2005Page:1 of _AuthorTitle:Name:Signature:Date:Doc. Ref.:XXXXXX CO., LTDPage:11 of _Author:URS HVACDate:Draft 01Document Revision HistoryExample:RevisionDetailsDateAuthorDraft 1 Initial Draft _/_/_Draft 2Draft Review Taranaki, TAC and CNO-SIG_/_/_Draft 3Draft Review - Medsafe_/_/_Revision 00Original issue to MoH. _/_/_Revision 01MoH comments_/_/_INDEXPage1.0Introduction42.0Required Quality43.0User Requirements44.0Validation61.0INTRODUCTIONTaranaki Base Hospital plans to construct a new Pharmaceutical Manufacturing facility.The new facility will be used for the manufacture a range of products, which will encompass aseptically filled pharmaceuticals.The ability of the various grade rooms, within the facility, to achieve their required environments depends on the performance of the HVAC system plus a number of non HVAC system factors such as room sealing for air leaks, personnel clothing and entry procedures. The HVAC system will be required to feed 7 rooms ie Aseptic Suite, AS Change, Cytotoxic Suite, CS Change, Preparation room, Non-Sterile manufacture, and PR/NS Change. The rooms requirements are covered in more depth in URS document no. .(see URS Sterile and Cytotoxic Suite and URS NS and Repacking Suite)Aseptic Suite provides a support room of GMP grade B or greater to the Laminar Flow Cabinet URS document number. Air quality exceeds AS/NZ ISO 14644 Class 5 and Class E/F BS5295. see diagram numberAseptic Suite Change Room provides an airlock changing room of GMP grade B static to the aseptic suite. Air quality exceeds AS/NZ ISO 14644 Class 5 and Class E/F BS5295 at static and exceeds AS/NZ ISO 14644 Class 5 and Class E/F BS5295 dynamic see diagram number (no dynamic counts required)The Preparation Room, Non-Sterile Compounding and the associated changing room need to be of GMP grade D or greater URS document number. Air quality exceeds AS/NZ ISO 14644 Class 8 and Class K BS5295 see diagram numberBetween each room the pressure differentials are to be as stated in section 3.5.3 of this document.This document details the User Requirements Specification (URS) for the Heating Ventilation and Air Conditioning (HVAC) system2.0REQUIRED QUALITYThe HVAC system will supply all the rooms as stated in the facilities URS document number with the required standard of air quality according to; 1. AS/NZS ISO14644.1:2002 : Cleanrooms and associated controlled environments Part 1: Classification and air cleanliness2. AS/NZS 14644.2:2002 : Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644.13. AS/NZS ISO 14644.4:2002 : Cleanrooms and associated controlled environments Part 4: Cleanrooms and associated controlled environments - Design, construction and start-up4. ISO EN 14644.5:2004, Cleanrooms and Associated Controlled Environments Part 5: Cleanroom Operations.5. PIC/S Guide to Good Manufacturing Practice for Medicinal Products, 15th Jan 026. ISPE Baseline Guide Volume 3, Sterile Manufacturing Facilities 7. AS 1386.1-1989 Cleanrooms and clean workstations. Part 1: Principles of clean space control.8. AS 1386.3-1989 Cleanrooms and clean workstations. Part 3: Non-laminar flow cleanrooms-Class 350 and cleaner.Note: The rooms are being designed with AS1386.1-1989 & AS1386.3-1989 in mind as these standards are descriptive in the design and lay-out of the facilities. However the rooms themselves will meet and exceed the requirements for classification and cleanliness as stated in GMP Guidelines and the more up to date AS/NZ ISO 14644.1:2002 standard.3.0USER REQUIREMENTS4.1.1.1.1.1.1 General Requirements3.1 Design and ConstructionAll design and construction elements of the HVAC system must conform to all relevant regulatory standards and guidelines and industry best practice.3.2Validation and Change ControlThe HVAC system must be validated according to regulatory requirements. The validation cycle of Design, Installation, Operation, Maintenance and Performance Qualification must be implemented, in compliance with relevant guidelines and documented fully.All changes from the approved design must be documented and approved using an appropriate change control system.3.3Health Safety and EnvironmentalCompliance with Health, Safety and Environmental Protection must be demonstrated and documented as appropriate.The unit should be designed with the full consideration of all current HSE legislation, safety and environmental protection requirements.Particular consideration should be given to the following:3.3.1Manual Handling and AccessConsideration must be given to the requirements of the Manual Handling Regulations for maintenance and servicing. In addition, there must be good access for routine operation and maintenance.3.3.2Other Hazards to PersonnelThe unit should not cause any emergency or hazardous situation, during correct operation/maintenance 3.3.3Environmental ConsiderationsThe design of the unit must take into account all economic energy conserving measures.3.4Future ChangesConsideration must be given to any reasonable pending or anticipated changes in all the above standards, guidelines and specifications in terms of design, construction, validation, documentation and control.3.5 General Internal Design ConditionsRefer to drawing _ for details.Room TemperatureAll areas, 18 to 20C 2C. Room HumidityThere are no humidifiers within air handling units for any zones.Room Ventilation RequirementsThe loads for each room have been assessed to give a minimum airflow based upon the fresh air requirement, heat gains, minimum air change rate or extract equipment make-up which ever is the larger.Minimum air change rates vary according to the area, generally:Clean room Class D - 20 AC/hrClean room Class C - 25 AC/hrClean room Class B - 30 AC/hrAll air handling units and fans are selected with margins of 10% volume and 21% pressure.Room Noise CriteriaAll Rooms, at rest _: Ductwork Design CriteriaDuctwork sized on a maximum pressure drop of 1 Pa/m and maximum velocities of:Plant room main: 10m/sMain branch: 7m/sSub-branch: 4m/sTerminal branches to grilles and diffusers: 2.5m/s.External Design TemperaturesSummer: 28C db/20C wb.Winter: -5C db/-5C wb.3.5.1HVAC system.HVAC systems objective is to supply conditioned air to the Aseptic Suite, aseptic suite change, Cytotoxic Suite and cytotoxic suite change, Preparation Room, Non-Sterile Compounding and the associated changing room. The system also contains general and dedicated extract systems to areas stated above.Supply System.The system comprises of a fresh air intake plenum at high level within the plant deck, an intake attenuator and an air-handling unit. The unit comprises of an intake damper, mixing section, steam heated frost coil, panel filters and bag filter, cooling coil, and main fan (c/w spare motor) and HEPA filter section. Panel filter is G4 and the bag to F8. The supply fan shall be rated for F8 filter pressure drop and HEPA filter pressure drop, plus chilled water coil loss and duct losses. The fan design duty is 600l/s at 600Pa and the chilled water coil duty is 7kw.A motorised damper will be located on the outlet of the system prior to a supply side attenuator. The system is designed to re-circulate using the general extract system with fresh air make up. Fresh air required for ventilation and pressurisation shall be sourced from the main area rather than the fresh air duct. This ensures that fresh airflow will not vary (duct pressure will vary according to main plant-room filter cleanliness).The supply fan is a single unit with spare motor and is inverter controlled to deliver design conditions at both filter clean and dirty conditions. Stand-by motor to be provided within AHU.The connecting ductwork passes from the plant deck down to the clean room walk on ceiling area. The ductwork branches out at this level to serve individual rooms. The supply air plenum shall have 5 spigots, each fitted with a balancing butterfly damper. There correspond to 5 outlets (one per room). Each outlet has a HEPA filter (TM series from Total Air Care). Outlets are ceiling mounted. There is no diffuser i.e. the HEPA filter is the terminal device. Discharge is vertically downwards. Velocity is limited to a maximum of 0.6m/s at any point. However a removable stainless steel washable screen will be fitted to protect the HEPA filter. Because the same type of HEPA filter is fitted to each room, each room will receive air at the same filtration standard. However only the Sterile Room and clean side of second airlock are particle count tested to grade B criteria. A grade D criterion applies to other areas. Pressure differential between rooms, lobbies and circulation areas is maintained by pressure control dampers at room interfaces.Room pressure controlThe following minimum pressures shall be maintained.Sterile Suite60PaSterile Suite Change45PaCytotoxic Suite60PaCytotoxic Suite Change45PaClean Room30PaNon Sterile Room30PaClean Room/NS Change15PaGMP standards state minimum 12.5Pa differentials between roomsNo door grilles will be fitted. Leakage of air from higher to lower pressure space will be via door surround gap/sealing. Desired room pressures will be obtained by adjustment of return air dampers. For example in the sterile room, return air volume will be slightly less than supply air volume with the balance being door leakage.Extract System.The return air plenum shall have 5 spigots, each fitted with a balancing butterfly damper. There correspond to 5 outlets (one per room). Each outlet consists of an egg-crate grille. The grilles are sized for a minimum velocity of 2m/sec (to keep the grille clean). Grilles are ceiling mounted except in the Sterile Room. In the Sterile Room there is a triangular builders work duct enclosing a diameter 250mm duct dropper to a low level egg-crate grille. A return air fan is not required. The supply fan shall be rated for F8 filter pressure drop and HEPA filter pressure drop, plus chilled water coil loss and duct losses. The fan design duty is 600l/s at 600Pa and the chilled water coil duty is 7kw.The low-level extracts from each room are fitted with non-return dampers to prevent back-flow of contaminated air in the event of failure of the main extract fan.For further detail please refer to drawings and to the specification section of the HVAC System history files. 3.5.2MonitoringSterile room temperature, and chilled water valve position will be monitored by the BMS system. See URS _Room pressures shall be locally monitored using Magnehelic gauges. Room pressure shall be measured relative to adjacent lower pressure space. The gauge panel will be mounted outside in the main area. The pressure across the prefilter and the fan shall also be monitored. Therefore there will be 7 gauges in total.In addition there shall be an alarm if airflow is low. This alarm is transmitted to the BMS.3.6 InstrumentationAll instruments shall be supplied with calibration certificates traceable to NAMAS/NPL standards.3.7Maintenance arrangementsThe HVAC system is to be designed for long maintenance free periods.The vendor shall propose an efficient service organisation to provide support when it is required. Spare parts must available when required. 4.0Validation4.2 ObjectivesThe cGMP compliant facility, will be subject to a validation exercise. An Impact Assessment will be completed to define the extent of validation. The completed validation qualification reports shall demonstrate compliance with the URS, the requirements of cGMP and product licensing authorities. The activities shall encompass construction, installation and operational aspectsCompliance shall be demonstrated by comparing test results against specific acceptance criteria. 4.2 Activities/ResponsibilitiesThe vendor shall be responsible for validation activities and provide validation documentation as indicated in Table 1 below.Table 1ActivityResponsibilityProvide URSUser/VendorProvide FDSVendorCarry out Design Review UserCarry out FATVendorProvide calibration certificatesVendorProvide draft SOPsUserProvide IQ/OQ ProtocolVendorApprove IQ/OQ ProtocolUserExecute IQ/OQ (Report)VendorApprove IQ/OQ ReportUserAgree handover to usersUser/Vendor4.3RationaleDetails of overall validation methodology are given in the VMP for the project, reference number _. As the horizontal laminar cabinet is a self-contained, stand-alone item of equipment, it is recommended that a comprehensive FAT is carried out, using simulated loading to be specified by the Hospital Pharmacy Manufacturing Unit. Provided the instrumentation is calibrated beforehand, and results of this testing are documented and witnessed, they may then be referenced in a IQ and OQ document. The objectives b