Urs Hvac
Urs Hvac
Urs Hvac
Hospital Name
Page: 1 of ___
Author
Title: Name: Signature: Date:
Doc. Ref.: NZHPA CNO-SIG Page: 2 of ____
Author: URS – HVAC
Date: Draft 01
INDEX
Page
1.0 Introduction 4
2.0 Required Quality 4
3.0 User Requirements 4
4.0 Validation 6
Doc. Ref.: NZHPA CNO-SIG Page: 4 of ____
Author: URS – HVAC
Date: Draft 01
1.0 INTRODUCTION
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)
This document details the User Requirements Specification (URS) for the
Heating Ventilation and Air Conditioning (HVAC) system
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;
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.
General Requirements
All design and construction elements of the HVAC system must conform to all
relevant regulatory standards and guidelines and industry best practice.
The unit should be designed with the full consideration of all current
HSE legislation, safety and environmental protection requirements.
The design of the unit must take into account all economic
energy conserving measures.
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
Doc. Ref.: NZHPA CNO-SIG Page: 7 of ____
Author: URS – HVAC
Date: Draft 01
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.
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.
3.5.2 Monitoring
3.6 Instrumentation
Doc. Ref.: NZHPA CNO-SIG Page: 9 of ____
Author: URS – HVAC
Date: Draft 01
4.0 Validation
4.1 Objectives
4.2 Activities/Responsibilities
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).
4.4 Documentation
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.