User Requirement Specification

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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

&i~~~ Dl0S-AS-URS/HVAC-00l 00

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. ... .. . '. . ,. .. . . . '. , .. .' , : , , -':,, . ':scope , ::.: .. .. .. : . '

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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

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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

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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.

6:2.·\t;;:~9w.er.}f~i.ii ur.~:i~a·Recover;y·;:;;·;;··i·yf;':\"(''i~:gi~)'i{i)S\~;?{~t;~(i~.0;~:;i;X;):~:~ift;~m(';:;i~::~;r,;)~?:.:;·<·:;i;;:;:;:::/~· i; :,; 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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7.1.1 Room Classification Details The following table detailed the airborne particulate classificatIon of clean areas according to grading:

C

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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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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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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10.1

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

10.2

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

i~;~f~i!;;)~ai~~ri-\.'· 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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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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.~;~i~~~::i)p~~i~~.·\~p~ni~~l~~;'l?D;:g(:·~:;t:;:::::.:t·;\';·;:i:;~:;;;.?~:;tt';;;~:~;~W~\~)W:)~Ui!?!ir;;;i~~;J.mr;f~~~~ii;~!\}!S:;:~:~~)/i'i:~;;\·.:}Ui·:;-~.:'i)::; 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

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Processing Room Solid Lines

45±5%RH

21± 2°e

Processing Room liquid Lines

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Processing Room (special)

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30 Pa

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Processing Room Supply

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45 Pa

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Cool Storage Room

8 - 15°C o

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30 C:I: 2°C

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75 ±5 %RH

Primary Packaging Corridor

21± 2°C

45 Pa

45:1:5%RH

Primary Packaging Room

21± 2°C

30 Pa

45:i:5%RH

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21± 2°C

15 Pa

5;65 %RH

Secondary Packaging Corridor

21± 2°C

25 Pa

5;65 %RH

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21± 2°C

15 Pa

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21:i: 2°C

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,

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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 fitt€d 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.

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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

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UPS

USFDA

WHO

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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

1

HVAC Schematic

Detail Packaging and Processing Area.

Page 12 of14

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