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Hospital Name

USER REQUIREMENT SPECIFICATIONS

HEATING, VENTILATION AND AIR
CONDITIONING (HVAC) SYSTEM
Document Reference: Reference Number

Revision: Draft Number 01

Date of Issue: 14/03/2005

Page: 1 of ___

Author
Title: Name: Signature: Date:
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Author: URS – HVAC
Date: Draft 01

Document Revision History

Example:

Revision Details Date Author

Draft 1 Initial Draft __/__/__

Draft 2 Draft Review – Taranaki, TAC and CNO-SIG __/__/__

Draft 3 Draft Review - Medsafe __/__/__

Revision 00 Original issue to MoH. __/__/__

Revision 01 MoH comments __/__/__

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INDEX

Page
1.0 Introduction 4
2.0 Required Quality 4
3.0 User Requirements 4
4.0 Validation 6
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1.0 INTRODUCTION

Taranaki 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 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: 28°C db/20°C wb.

Winter: -5°C db/-5°C wb.

3.5.1 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 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 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 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.

3.5.2 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 Responsibility
Provide URS Hospital/Vendor
Provide FDS Vendor
Carry out Design Review Hospital
Carry out FAT Vendor
Provide calibration certificates Vendor
Provide draft SOPs Hospital
Provide IQ/OQ Protocol Vendor
Approve IQ/OQ Protocol Hospital
Execute IQ/OQ (Report) Vendor
Approve IQ/OQ Report Hospital
Agree handover to users Hospital /Vendor

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

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