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HVAC

USER REQUIREMENTS

SPECIFICATIONS (URS)

FOR HVAC

(HEATING VENTILATION AIR

CONDITIONING)

UNITED INTERNATIONAL PHARMA COMPANY

LIMITED, VIETNAM,

VSIP 11- SINH DUONG PROVINCE, VIETNAM

UNITED INTERNATIONAL PHARMA COMPANY LIMITED,

VIETNAM

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Table of Contents
1.

REVISION INDEX ......................................................................................................................... 3

2.

APPROVAL SiGNATURES .......................................................................................................... 3

3.

OVERVIEW ...................................................................................................................................4

4.

PROCESS DESCRIPTION ........................................................................................................... 5

5.

PRODUCTIVITY REQUIREMENT ................................................................................................ 5

6.

SAFETY REQUIREMENT ............................................................................................................ 6

7.

GMP REQUIREMENTS ................................................................................................................6

8.

PROCESS CONTROL AND ALARMS.........................................................................................1

9.

CLEANING REQUIREMENT ........................................................................................................7

10.

QUALIFICATION REQUIREMENTS ............................................................................................ 7

11.

MATERIAL OF CONSTRUCTION ................................................................................................7

12.

USE OF LUBRICANTS.................................................................................................................7

13.

ENVIRONMENTAL MONITORING ..............................................................................................8

14.

PIC/S ANNEX 11 COMPLIANCE ................................................................................................. 8

15.

DESIRED DOCUMENTS ..............................................................................................................8

16.
17.

TRAINING ..................................................................................................................................... 8

TECHNICAL REQUIREMENTS ................................................................................................... 9

18.

INSPECTION AND TESTING ..................................................................................................... 11

19.

TIMELINES ................................................................................................................................. 12

20.

ABBREVIATION ......................................................................................................................... 12

21.

ANNEXURE LIST ....................................................................................................................... 12

UNITED INTERNATIONAL PHARMA COMPANY liMITED,

VIETNAM

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Dl0S-AS-URS/HVAC-00l
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1. Revision Index
Revision

Date

Reason for Revision

2. Approval signatures
This document Is prepared by SeerPharma (Singapore) Pte Ltd! on behalf of Toyo Vietnam
Corporation Ltd, Ho eh! Mlnh City, Vietnam in fUlfilment of the requirements of United
International Pharma Company Limited for the Solid and Liquid

non

sterile dose facility to be

built at VSIP II- Blnh Duong Province! Vietnam. Preparation of this document is under the
authority of TOYO Project Manager and all relevant parties within TOYO Vietnam Corporation.
Before being effective this document shall be checked by TOYO Vietnam Corporation Ltd and
approved and authorized by United International Pharma company limited.

United International Pharma Company Limited Project

Management
United International Pharma Company Limited QA

UNITED INTERNATIONAL PHARMA COMPANY LIMITED,

VIETNAM

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Toyo-Vietnam Corporation Ltd. is designing a new facility in VSIP 11- Blnh Duong
Province, Vietnam for the manufacture of non~sterile pharmaceutical products, with
the intention of the facility being compliant with PICIS regulations and standards on
behalf of United International Pharma Company Limited.
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This document is to provide a user requirement of a HVAC system, based on the

United International Pharma Company limited Vietnam requirements. The URS
describes the general requirements for function, exterior features and capacity that
the HVAC system must demonstrate in order to fulfil the busIness cbjectives of the
organization, IncludIng the relevant technical specifics of the mentioned entity. The
HVAC-system Is designed with self-contained water cooled packaged MC units, air
handling units, hot water heater, humidity control, dust collector, pumps, cooling
towers, fan coil Units and packaged MC unIts.
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GNP-Regulations
PICfS Guide to Good Manufacturing Practice for Medicinal Products Part I PE
009-9(Part I)
PICIS Guide to Good Manufacturing Practice for Medicinal Products Annexes PE
009-9(Annexes) Part 11 Computerised Systems
PIC/S Aide Memoire InspectIon of Utilities PI 009-3
Guide for
GAMP 4, Good Automated ManufacturIng Practice ref. (10]
Validation of Automated Systems In Pharmaceutical Manufacture.
ISO 14644 Cleanrooms and Associated Controlled Environments

Documents
Validation Project Plan, Document No. AS-D-l05-VPPOOl
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3.4.1 SeerPharma (Singapore) Pte Ltd

To develop User Requirement Specifications (URS)
3.4.2 Toyo Vietnam Corporation Ltd
To maintain this document
To review this document for accuracy and completeness of the related
content
To check this document
To ultimately ensure full compliance with the relevant regulatory
requirements, company policy andlor Industrial standards
3.4.3 United International Pharma Company Limited
To approvel authorize this document confirming compliance to system
requirements and regulatory needs

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Page 4 of 14

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The Heating, Ventilation and air conditioning (HVAC)- used in the new facility will be either
new or transferred from the Binh Chanh Plant to the new non-sterile facility at VSIP Il
Binh Duong Province, Vietnam
The existing HVAC to be transferred includes:
4 Air handling units (AHU)
11 Water cooled split package unit (SPU)
7 Air cooled split package unit (SPU)
1 Water cooled package water chiller
2 Hot water heater (HWH)
6 Humidity controls (H)
7 Dust collector (DC)
6 Pumps (P)
3 Cooling tower (CT)
29 Fan coli units {FCU)-ACCU's
2 Packaged A/C units
The new items will Include:
HVAC ducting
Filters (AHU and terminal filtration
Chiller system for production building
A Building Management System (BMS) shall be provided to monitor and control
the HVAC-system and associated equipment. The system shall include all
hardware, software, PC front end, graphics, panels, controls wiring and

r-------------------r-.--------------------------------~~~~-------_.

UNITED INTERNATIONAL PHARMA COMPANY LIMITED,

VIETNAM

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In the event of equipment malfunction or loss of utilities, the unit must contain
necessary protection devices to ensure that the equipment remain in a safe condition.

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6.2.1 On power failure equipment shall come to rest, to protect operator, eqUlpment itself
and the product.
6.2.2 Power restart must not be automatic and human intervention must be required.
6.2.3 After regain of power the equipment should start from the step it stopped and or Safe
Mode.

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Equipment such as filtration systems and distribution systems should be subject to
validation and planned maintenance. The HVAC-system is designed to meet the Class of
100,000 (USFDA) [= Class D (PIC/S)] for clean room conditions.

7.1.1 Room Classification Details

The following table detailed the airborne particulate classificatIon of clean areas
according to grading:

3 500
3 500
350 000

None
None
2 000

3 500
350 000
3 500 000

None
2 000
20 000

7.1.2 Room Microbiological Details:

The following table detailed the limits for microbiological monitoring of clean areas
during operation

A
B
C

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10

<1
5

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5

<1
5

1~00~---+~50--------~2~5~-------+~------~

-------------~---------,

UNITED INTERNATIONAL PHARMA COMPANY LIMITED,

VIETNAM

SeerPharma
D10S-AS-URS/HVAC-001

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8.1
8.2
8.3

8.4

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The HVAC-System should essentially have the necessary provision for adjustment /
control of the rocess arameters:
Control must be through a centralised computer console with security access and
time date stamped audit capability.
Building Management System (BMS) shall serve the following functions:
Automatic control of plant start-up/shut down
Control of room conditions (Pressure, Temperature and Relative Humidity)
Remote monitoring of plant status
Remote monitoring of room conditions (pressure, Temperature and Relative
Humidity)
Historical data logging
Remote set point for room/plant
The following areas are supported by the Building Management System (BMS):
Raw Materials (Monitoring temperature and relative humidity)
Production
FG Warehouse (Monitoring temperature and relative humidity)

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9.1

All ductwork to be supplied cleaned and bagged.

9.2

All ductwork to be stored cleaned and bagged

9.3

All ductwork are to be blown through for 12 hours with pre-filtered air prior to
installation of the terminal filters.

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Reference to VPP AS-D-lOS-VPPOOl

10.1

Equipment shall be qualified for design phase (DQ), installation phase (lQ),
Operational phase (OQ) and the performance phase (PQ).

10.2

------------------------~

Vendor shall support TOYO In execution of all the qualification phases.

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11.1

Material used for ductwork shall be of standard galvanized steel or similar qualitv.

11.2 Textile Ducting shall be used in specified areas such as: raw material warehouse,
finished goods warehouse, processing material warehouse l raw material quarantine,
finished goods quarantine l processing material quarantine

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Any lubricant, if used In the equipment that has a potential of getting In contact with
the product must be of food grade and non~toxic.

UNITED INTERNATIONAL PHARMA COMPANY LIMITED,

VIETNAM

13.1 Monitoring of part/des, microorganisms, humidity and temperature.

13.2 Measures to prevent cross"contaminatlon and their effectiveness should be checked

periodically according to set procedures. (UIP)

13.3 Mean Kinetic Temperature (MKT): MKT calculations will be /n accordance with

cGMP methodologies in the Warehouse. (UIP)

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Not applicabre .

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Following documents, but not limited to these, are expected from the vendor as part of the
supply package as hard copy (two numbers) and electronic editable version In English
Ian ua e.

15.1 Standard Operating Procedures: (UIP)

Operating
Cleaning
Maintenance and Calibration
15.2 Operation and maintenance manuals.

15.3 Drawings: As-built drawing for equipment.

15.4 Spare and/or change parts list with ordering information.
15.5 Mechanical
Material Certifications
Cleaning Certifications
Pressure Test Certifications
HEPA Certifications
15.6 Calibration certificates of critical Instruments/equipment with respect to the traceable
national reference standard instrument and their calibration procedure.

15.7 Guarantee/warranty certificates of each equipment and major bought-out Items.

Training for technical staff has to be included In the offer.

PageS of14

UNITED INTERNATIONAL PHARMA COMPANY LIMITED,

VIETNAM

SeerPha
Dl0S-AS-URS/ HVAC-OOl

00

Processing Room Solid Lines

455%RH

21 2e

Processing Room liquid Lines

21 2 C

4SPa

s65%RH

Processing Room (special)

S 20C

30 Pa

S 10 Q/oRH

Processing Room Supply

21 2e

30 Pa

565%RH

Processing Corridor

2H: 2C

45 Pa

s65%RH

22:1: 2C

15 Pa

s65%RH

nla
nla

s60%RH

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Washing

R.ooml Production

RM Warehouse

S25 C

Cool Storage Room

8 - 15C
o

S 70 %RH

Stability Control Room

30 C:I: 2C

nla

75 5 %RH

Primary Packaging Corridor

21 2C

45 Pa

45:1:5%RH

Primary Packaging Room

21 2C

30 Pa

45:i:5%RH

Secondary Packaging Room

(sep. from HVAC)

21 2C

15 Pa

5;65 %RH

Secondary Packaging Corridor

21 2C

25 Pa

5;65 %RH

Micro Lab

21 2C

15 Pa

s65%RH

Qe Laboratory (Sample Prep Room)

21:i: 2C

5 Pa

s65%RH

17.1.2 The GMP~rooms shall be Installed with room temperature and humidity sensors.
Location of sensors: In order to assure uniform temperature and humidity sensing
In a given room or zone. In product storage areas sensors need to be arranged In a
minimum of three arrays. One sensor array shall be distributed at the highest
product storage level. The other shall be distributed at the lowest product storage
level. Additional sensors will be Installed in the middle array, In accordance with
the geometry of the room, to Indicate the average temperature. Each temperature
I humidity sensor shall cover a maximum area of 500m2.
17.1.3 For Grade D rooms a minimum 10 Pa between successive pressure areas are required.

J D105~AS~URS/HVAC-OOl

Page 9 of14

UNITED INTERNATIONAL PHARMA COMPANY LIMITED,

VIETNAM~2SSS&7:~TT~~~5S~~8C~7:?~TTT:M

010S-AS-URS/HVAC-OOl
00

17.1.4 All GMP rooms and corridors will be filled with pressure differential measuring devices
with a local display and with data connection to the BMS.
17.1.5 Grade D-rooms: Between 10 and 20 room air changes I hr are required.
17.1.6

Conditions for all GMP rooms:

Temperature: 21 2 "c

17.1.7

In cases where dust Is generated (e.g. during sampling, weighing, mixing and
processing operations, packaging of dry products)/ specific provisions should be
taken to avoid cross-contamination and facilitate cleaning. (UIP)

17.1.8

Grade 0 areas are t~ be fittd with room supply dlffusers tflcor-poraUng terminal
HEPA filter (H13). In the Class D processing areas air shall be extracted from low
level extraction points. In other areas, air can be extracted from high level
extraction points.

17.1.9

Room conditions such as pressure, temperature and humidity/ are monitored by

Building Management System (BMS). This applies for RM, PM and FG warehouses
and the centralized control system of the chiller In production area (all warehouse
areas are monitored for temperature and relative humidity on

17.1.10 HVAC ducting & filters will be new Installed.

17.1.11 Warehouse & administration building will be Installed with the eXisting/relocated
AHU system.
17.1.12 New chiller system will be installed for production building.
17.1.13 Plant director, general director, group head room, meeting room, training room and
board room will be used stand alone air conditioning system.
17.1.14 The control panel of the HVAC shall be of lockable type.
17.1.15 Control circuit of BMS work station is connected to UPS.
17.1.16

Starting and stopping sequence of the HVAC-system shall be of an orderly

sequence to prevent any contamination to the rooms. (UIP)
~~~
17.2.1

Ductwork must be flushed for 12 hours with pre-filtered air on all supplies and
returns before Installation of HEPA or final filters.

17.2.2

Duct sections should be supplied cleaned and covered until time of assembly. The
entire system should be cleaned and tested for leakage before start up.

17.2.3

Minimum duct leakage should be tested to limits established by the fabrication

specification.

.....

~---------,-----.

UNITED INTERNATIONAL PHARMA COMPANY LIMITED,

VIETNAM

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18.1

HVAC

Installation Testing (Vendor)

Equipment shall be Inspected and tested upon Installation at site (SAT/Commissioning).
All testing will be performed by the vendor and witnessed by the client or client
representative.

Re uired Testin

ISO 14644-2

Test Parameter.
.Test Procedure
Particle Count Test
ISO 14644-1 Annex A
Air Pressure Difference
ISO 14644-1 Annex 85
Airflow
ISO 14644-1 Annex 64
Installed Filter Leaka e
ISO 14644-3 Annex 66
Recover
ISO 14644-3 Annex 613
Airflow Visualization
ISO 14644-3 Annex 67
Air Chan e R a t e s _
Tem erature and Humidit
Calibration of Instruments

18.2 Ongoing COmpliance Testing (UIP)

Re uired Testin

ISO 14644-2

Schedule of Tests to Demonstrate Contlnuin Com lIance

Test Parameter
Class
Maximum Time Test Procedure
Interval
ISO 14644-1 Annex A
6 Months
ISO 14644-1 Annex B5
12 Months
ISO 14644-1 Annex 64
12 Months

Test Parameter
Installed Filter leakage
Containment
leaka e
Recover
Airflow
Visuallzatlo n

Maximum Time
Interval
All Classes 24 Months

Test Procedure

All Classes 24 Months

ISO 14644-3 Annex B4

All Classes 24 Months

All Classes 24 Months

ISO 14644-3 Annex B13

ISO 14644-3 Annex B7

ISO 14644-3 Annex 66

UNITED INTERNATIONAL PHARMA COMPANY LIMITED,

VIETNAM

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19.1

Submission of detailed Functional Design Specifications (FDS) and schematic

drawings four (4) weeks before SAT.

19.2

Submission of FAT/SAT specifications four (4) weeks before SAT

19.3

Mechanical and electrIcal drawings with equipment delivery.

20.

Abbreviation
Terms
cGMP
DQ
EU-GMP
FAT
GAMP
GMP
IQ
ISO
m
MOC
OQ
P&ID
PlC

,-~-

",~

QA
SAT
SOP

SS

UPS

USFDA

WHO

21.

Abbreviation
Current Good ManufactlJrlna Practice
Design Qualification
European -Good Manufacturing Practice
Factorv Acceptance Test
Good Automated Manufacturing Practices
Good Manufacturing Practices
Installation Qualification
International Standards Organization
Meter
Material Of Construction
Operational Qualification
Process and Instrumentation Diagram
ProQrammable Loalc Controller
Performance Qualification
Quality Assurance
Site AccEWtance Test
Standard Qperatlng Procedures
Stainless steel
Uninterrupted Power supply
United States Food and Drug Administration
World Health Organisation

Annexure List

Annex
No

Drawing I Document No

HVAC Schematic

Detail
Packaging and Processing Area.

Page 12 of14

UNITED INTERNAnONAL PHARMA COMPANY LIMITED, VIETNAM

SeerPhsrma~
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