urs_hvac

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USER REQUIREMENT SPECIFICATIONS HEATING, VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM Document Reference:

Reference Number

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Draft Number 01

Date of Issue:

14/03/2005

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NZHPA CNO-SIG

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URS – HVAC

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Document Revision History Example: Revision

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Date

Draft 1

Initial Draft

__/__/__

Draft 2

Draft Review – Taranaki, TAC and CNO-SIG

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Draft 3

Draft Review - Medsafe

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Revision 00

Original issue to MoH.

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Revision 01

MoH comments

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Author

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NZHPA CNO-SIG

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URS – HVAC Draft 01

INDEX Page 1.0

Introduction

4

2.0

Required Quality

4

3.0

User Requirements

4

4.0

Validation

6

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INTRODUCTION Taranaki Base Hospital Manufacturing facility.

plans

to

construct

a

new

Pharmaceutical

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 number] Aseptic 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 number] Between 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) system

2.0

REQUIRED QUALITY

The 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 cleanliness 2. AS/NZS 14644.2:2002 : Cleanrooms and associated controlled environments – Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644.1 3. AS/NZS ISO 14644.4:2002 : Cleanrooms and associated controlled environments – Part 4: Cleanrooms and associated controlled environments -

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Design, construction and start-up 4. 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 02 6. ISPE Baseline Guide Volume 3, Sterile Manufacturing Facilities 1. 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.

3.0

USER REQUIREMENTS

General Requirements 3.1

Design and Construction

All design and construction elements of the HVAC system must conform to all relevant regulatory standards and guidelines and industry best practice. 3.2

Validation and Change Control The 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.

3.3

Health Safety and Environmental Compliance 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:

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3.3.1

Manual Handling and Access Consideration 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.

3.3.2

Other Hazards to Personnel The unit should not cause any emergency or hazardous situation, during correct operation/maintenance

3.3.3

Environmental Considerations The design of the unit must take into account all economic energy conserving measures.

3.4

Future Changes Consideration 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 Conditions Refer to drawing _________ for details. Room Temperature All areas, 18 to 20°C ±2°C. Room Humidity There are no humidifiers within air handling units for any zones. Room Ventilation Requirements The 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/hr Clean room Class C - 25 AC/hr Clean room Class B - 30 AC/hr All air handling units and fans are selected with margins of 10% volume and 21% pressure. Room Noise Criteria All Rooms, at rest ______________: Ductwork Design Criteria Ductwork sized on a maximum pressure drop of 1 Pa/m and maximum velocities of: Plant room main: 10m/s Main branch: 7m/s Sub-branch: 4m/s Terminal branches to grilles and diffusers: 2.5m/s. External Design Temperatures

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Summer: Winter: 3.5.1

28°C db/20°C wb. -5°C db/-5°C wb.

HVAC 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 airhandling 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 recirculate 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 control The following minimum pressures shall be maintained.

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Sterile Suite 60Pa Sterile Suite Change 45Pa Cytotoxic Suite 60Pa Cytotoxic Suite Change 45Pa Clean Room 30Pa Non Sterile Room 30Pa Clean Room/NS Change 15Pa GMP standards state minimum 12.5Pa differentials between rooms No 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 nonreturn 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. 3.5.2

Monitoring Sterile 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

Instrumentation

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All instruments shall be supplied with calibration certificates traceable to NAMAS/NPL standards. 3.7

Maintenance arrangements The 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.

4.0

Validation 4.1

Objectives The 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 aspects Compliance shall be demonstrated by comparing test results against specific acceptance criteria.

4.2

Activities/Responsibilities The vendor shall be responsible for validation activities and provide validation documentation as indicated in Table 1 below.

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Table 1 Activity Provide URS Provide FDS Carry out Design Review Carry out FAT Provide calibration certificates Provide draft SOPs Provide IQ/OQ Protocol Approve IQ/OQ Protocol Execute IQ/OQ (Report) Approve IQ/OQ Report Agree handover to users 4.3

Responsibility Hospital/Vendor Vendor Hospital Vendor Vendor Hospital Vendor Hospital Vendor Hospital Hospital /Vendor

Rationale Details 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 being to complete testing as soon as possible, simplify IQ inspections and reduce the amount of site testing to a minimum. The vendor may use their standard FAT/SAT and/or IQ/OQ documents providing these are pre-approved by the Validation team (as stated in the VMP). Where the vendor is unable to provide some or all of the validation capability, then an alternative solution shall be agreed with the Hospital Pharmacy Manufacturing Unit.

4.4

Documentation The vendor shall provide documentation as specified below and in the validation documentation schedule The documentation shall provide adequate information for operation, maintenance, health & safety, environmental, statutory and validation requirements. The vendor shall provide evidence, at tender stage, of understanding of and ability to provide the documentation. The documentation shall include, but is not limited to: • Detailed operation and maintenance manual and recommended maintenance schedule • Complete parts list with detailed listing of all manufactured and purchased components with manufacturer and part number • Recommended spare parts list • As built drawings including exploded view, electrical schematic and

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•

4.5

P & ID. Control system documentation including detailed hardware descriptions and functional specificationI/O list, programme listings, instrument list and calibration certificates.

Training The vendor shall provide suitable training for the users as appropriate.