User requirement Specification

7/21/2019 User requirement Specification

http://slidepdf.com/reader/full/user-requirement-specification-56f7a5df7e2b7 1/14

; ; i } : · . ; , § · i ~ ~ ~ ; ; ~ ~ # , £ ~ f ~ · ~ f f l E ~ l j ~ / 1 , ~ ~ 1 i { : i ; t ' i , l ~ K . ~ j ; ; \ ; r

HV C

USER REQUIREMENTS

SPECIFICATIONS (URS)

FOR HVAC

(HEATING

VENTILATION AIR



See r ha r m a

UNITED INTERNATIONAL PHARMA COMPANY LIMITED,

VIETNAM

W \ ? ~ i ; ~ i ; 1 ; W o r d : : ~ r ~ ~ , ~ i ~ ~ ~ 9 ; : Y ~ · ~ ~ ' ~ t ~ : ~ l ~ . ~ ~ · f . i f l ~ i ~ Q f " ~

:

: ~ q · ~ i ~ m ~ ~ t . : * i ~ ~ $ i ~ m : ~ ; : i i ; : ; \ . i \ ~ ~

HVAC

; i j ~ f ~ h 1 : ~ r # & . Q , : ; g ; m \ t ~ ; i f : ~ ~ \ U f

Dl0S-AS-URS/

HVAC-OO

1

~ f f . ~ ~ t . i Y ~ I § ~ ~ ~ ~ ~ H ; ~ : ~ ) ; ~ ; ~ \ ) ( : ; : " ; R ~ Y ' I ~ . 1 { ) n · : ; N O · 00

-

Table

of

ontents

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



UNITED

INTERNATIONAL

PH RM COMP NY

liMITED

VIETN M

Dl0S AS URS/HVAC 00l

00

i ~ ~ ~

1.

Revision

Index

Revision Reason

for

Revision

ate

2.

pproval

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

o

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



UNITED

INTERNATIONAL

PHARMA COMPANY LIMITED,

VIETNAM

: l ~ @ t ~ ~ H ; ~ : ~ ' 0 ; : ~ M . ~ : ~ J ~ · ~ ~ 9 . H i ~ ~ , ~ ~ : ~ . \ ~ : r . ~ S ~ F ~ ~ ~ T ~ 9 . N ~

;. .

· ~ < ; X ; : . ; : ; : :

~ ; ; , ~ = : : : " ~ ~ , ~ ~ . ~ g ~ : ; P f u ' ~ ~ ~ i X : § Y ~ i ~ w : ' : ; , ; ~ ; : X ~ ; \ HVAC

Dl05"AS-URS/HVAC-OOl

.

,

.

.

.'

..

'.

. .

. .

'

. .

.'

. .

' .4 '

'.

: . , .....

. .

3.

Overview . .

.

" .

.

.

,

'

. .

. .

. . .

.

.

..

,

' . '

,

,

'.... '

...

.

......

.. ' "

. , ' - . ,':. . ::;.;";."

..

.

,

3.1

: ..

r o j e c t

I n t r : o d u ~ ~ i o n

' \

..

' ~ . '

..

Toyo-Vietnam Corporation Ltd. is designing a new facility in

VSIP

11- Blnh Duong

Province, Vietnam for the manufacture of n o n ~ s t e r i l e pharmaceutical products, with

the intention of the facility being compliant with PICIS regulations and standards on

behalf of United International Pharma Company Limited.

...

. .

. ' .

.

,.

'

..

. .

.'

,

" t,

- :,

:

.

'.

,

. .

,

,

' :scope

, ::.: ..

. .

, .

. .

.

'

.2

:

. :.

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.

. . '.;; . '. '

" ..

,......

.

.

. . . .

'.. \

' '.'.

' ' ', . .

·3.3.:;\ , R e f e r . . ~ 9 ~ .StandardIG .... i ~ ~ l i n e J : D o c u m e n t $ . J 9 . f . ~ ~ q u i p m e n t

'

" ' , .

' ,



UNITED INTERNATIONAL PHARMA COMPANY LIMITED

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 l-

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 chil ler

• 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:

V I E T N A M ~ = = = - = r : ~ = ~ =

' , : j ' \ i ; { ; ' . 1 ~ : ~ ' ~ 6 : ~ ~ ~ E . F E ~ ~ ; ~ ~ ~ ~ p ' ~ ~ ' , ; · ~ : ; ~ : . : X : ; ; ~ ~ : ~ ? ~ . ~ \ .

;

Seer har rna

HV C

Dl0S AS URS/HVAC OOl



r r ~ ~ ~ ~ _

UNITED

INTERNATIONAL PH RM COMP NY LIMITED

VIETNAM

W · ~ i i \ . : : ~ / : ~ ; ; ; t ; . ' ( r : ~ ~ ~ ; ~ i ~ . ~ : g y . i . ~ ~ ~ N : f ; ~ ~ i i ~ c ~ ~ i f ~ .

h : . _ ~ _ : N _ ; ~ _ .

_

_--: ' : ' : ' ' --1

~ ~ I ~ f . : ; ~ ; : ~ ~

i ; ~ E ~ ' ~ l p ~ ~ D t y ; § r ~ r ¥ m \ W } ~ j , } i HV C

Dl05 AS URS/HVAC 001

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 ; ; : ~ 9 w . e r . } f ~ i . i i

u r . ~ : i ~ a · R e c o v e r ; y · ; : ; ; · ; ; · · i · y f ; ' : \ ( ' ' i ~ : g

i ~ ) ' i { i ) S \ ~ ; ? { ~ t ; ~ ( i ~ . 0 ; ~ : ; i ; X ; ) : ~ : ~ i f t ; ~ 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.

i ~ 1 . ; : : ; \ l : : ; ~ ~ j ~ . ~ ~ ~ f i ~ ~ t i ~ : n . : i Q : ~ ~ ~ i $ ' ; l : : ; i ; : · ; , : ; ? ; . { : S ; ~ · \ ) } ; \ ; · ; : ~ i ' · ; ? : ; : · ; : ; i } , ; ; ; , ; i : : : ; . t j . ; ~ ~ ~ : ; { \ : ; ~ i i ; ; ~ ) i ~ W . j : & i ; ) : ~ ~ C I T . H t : j ; ; : ] i ~ \ ; M ; \ ~ ' ; : ? : : ; ; ; ; : : ; , : i , : : ; l : ; ; : ; : ' ~ : ; ~ : ; : ; : i

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

http://slidepdf.com/reader/full/6:2.%E7%9C%B4;;:~9w.er.%7Df~i.ii

http://slidepdf.com/reader/full/6:2.%E7%9C%B4;;:~9w.er.%7Df~i.ii



~

UNITED INTERNATIONAL

PHARMA COMPANY

LIMITED,

VIETNAM

Seer ha r ma

D10S AS URS/HVAC 001

: ~ ~ ~ I ~ ~ r : ( 1 . ~ ~ t t \ 00

8 1 The HVAC-System should essentially have the necessary provision for adjustment /

control of the rocess arameters:

8 2

Control must be through a centralised computer console with security access and

time date stamped audit capability.

8 3

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

8 4

The following areas are supported by the Building Management System BMS):

• Raw Materials Monitoring temperature and relative humidity)

• Production

• G Warehouse Monitoring temperature and relative humidi ty)




PH RM

COMP NY LIMITED,

VIETN M

13.1 Monitoring

of

part/des,microorganisms,humidityandtemperature.

13.2 Measurestopreventcross"contaminatlonandtheireffectivenessshould be checked

periodicallyaccordingtosetprocedures. (UIP)

13.3 Mean KineticTemperature(MKT): MKT calculationswillbe /n accordancewith

cGMP

methodologiesin theWarehouse.

(UIP)

~ : ~ 2 ; : R : ; i ; : ~ i c z ~ < A " " ~ i . C ; ' , ~ . ~ ; ~ Q m p . i i p . n ~ ~ · \ i ; ~ : ~ ~ X N ~ : : ~ : ; § g M ~ I i ; o ; ~ ; ~ ; j i , ~ ' [ ~ ( : ; ( ~ ~ ' ~ ~ ~ ' i N ; ' ~ ~ j j , A · g j { i : · ~ · : ; i D ; . ' i > / ~ : . ; ~ : ' : ; S ' \ : : : : : ; : \ · ; : \ : · ; : , · ·

Notapplicabre.

; ~ i ~ ~ ~ : : i ) p ~ ~ i ~ ~ . · \ ~ p ~ n i ~ ~ l ~ ~ ; l ? D ; : g : · ~ : ; t : ; : : : : : .

: t · ; \ ' ; · ; : i : ; ~ : ; ; ; . ? ~ : ; t t ' ; ; ; ~ : ~ ; ~ W ~ \ ~ ) W : ) ~ U i ? i r ; ; ; i ~ ~ ; J . m r ; f ~ ~ ~ ~ i i ; ~ \ } S : ; : ~ : ~ ~ ) / i ' i : ~ ; ; \ · . : } U i · : ; - ~ . : ' i ) : : ;

Followingdocuments,butnotlimitedto these,areexpectedfromthevendor s partof the

supplypackageashardcopy(twonumbers)andelectroniceditableversion In

nglish

Ian

ua e

15.1

StandardOperatingProcedures: (UIP)

• Operating



UNITED INTERNATIONAL PHARMA COMPANY LIMITED

VIETNAM

o

Seer ha

Dl0S AS URS/

HVAC-OOl

00

Processing Room Solid Lines

21±

2°e

45±5%RH

Processing Room liquid Lines

21±

2

Q

C 4SPa

s65%RH

Processing Room (special)

S 20°C

30 Pa

S 10

Q oRH

~ .

Processing Room Supply 21± 2°e

30

Pa

565%RH

Processing Corridor 2H: 2°C 45 Pa

s65%RH

Washing R ooml Production

22:1:

2°C

15 Pa

s65%RH



UNITED INTERNATIONAL PHARMA

COMPANY

LIMITED

V I E T N A M ~ 2 S S S 7 : ~ T T ~ ~ ~ 5 S ~ ~ 8 C ~ 7 : ? ~ T T T : 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 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 areas are 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



~ - - - - - - - - - - - - - - .

UNITED INTERNATIONAL PHARMA COMPANY LIMITED,

VIETNAM

,,;,.':?;

: : : i : l ~ ~ ; ~ · ; \ · ~ ~ ~ ~ ; ; ~ ~ E ~ U i · ~ ~ ~ ~ J ~ i ~ : ~ , ~ ~ § ~ , F ; ~ ; € ~ I i e ~ ~ , : : ; i ~ ~ i . N ; ~ i ~ : W ~ ~ ; , ; r i ; f

Seer ha r ma

HVAC

18 1

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

ilter

Leaka e ISO

14644-3

Annex

66

Recover ISO 14644-3 Annex 613

Airflow Visualization ISO 14644-3 Annex 67

Air

Chan e ates·· · · · · · · · ·_·· · · ·




PHARMA

COMPANY

LIMITED,

VIETNAM

~ ; · l f ' : } ~ ' w ~ m ' ~ ; ' ; ; , ~ ; ~ , ~ ~ ~ : i ~ ~ q ~ ~ ' ~ ~ ~ ~ ~ . i / ~ , ~ ~ ~ ~ i i ;

~ A i I , q N t ; ; , : : :

-;

~ : . ~ : ~ : : ; , ~ : : ~ ~ , ; ~ q 4 ) p . m ~ , ~ ~ : Z 1 ~ \ ¥ ' ~ f , ~ H ~ , ; ; . ; J ; , { \ i ~ N

HVAC

t R g f , y [ { ~ I } ~ ' . N ; 9 : : U g ~ ~ ~ ( . ; W } M ' ~ L ; ~ \ D105-AS-URS/HVAC-OOl

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 Abbreviation

I

GMP

Current Good ManufactlJrlna Practice

Design Qualification

Q

EU-GMP

European -Good Manufacturing Practice

FAT Factorv Acceptance Test

GAMP Good Automated Manufacturing Practices

GMP

IQ

Good Manufacturing Practices

Installation Qualification



--

_

_\oW"__

I ~

..... I I J • t

LC'ro

UNITED INTERNA nONAL PHARMA COMPANY LIMITED VIETNAM

S e e r P h s r m a ~

COI4r-:rQ:;NCC::: II'"

:t ' )r... iP ..IANc;a

Dl0S AS URS/HVAC OOl

00

HVAC

Schemat ic

Packaging Area

A11l.

O

-

AIR

miiAl EXCHANISeR

~ ~ A : t . ? ' . . . . . i ~ . Y J : : m

AIR "'A.NQ ,.tNG VNI1

_.........

I l ~ . ~ · ~ . . , m l l n "

~ L

D U s r c ~

[

_ .

. - : : ~ ~ J £ : : ' ~ ~ -

, - -

1

f

I i

~ . . v ..,. ..... .......... I

i . . . . . . . p ~ , . . , 1 - p ~ ' . I C91i1<I1:.1OR

q O C , , ~ ~ . Q . . J I I : I I l ~ ~ 1 1 X . =

L

I

' U ' l D t N ' A C . ~ W I i I I I I " . ~ = ~ ~ 2 ' 2 . ~ ~ Q = ~ ' % < J ~ C '

~ : t _ c : : -

_ , , . . ,

..... .. _

~ . . . . . .

:iiIr_

l i t

.....

C Q : 1 . . ~

R 7 . f t D - . ; z : r a D S ' ~

---J

I

- - I f - '""' . il'l'---

< : - - l . ~ r

1'UBt

..... D <ZIIY

Page

3 of 4

~ ] ~ ~ ~ f . ~ J i ; . i ~ f ~ g ] ; i ~ J i , : 1

DI05-AS-URS/HVAC-OOl

http://slidepdf.com/reader/full/t')r...iP

http://slidepdf.com/reader/full/t')r...iP



G

SeerPhsrms

COt ; rQSN a

;:..

e o r , ; f f ' L I A ' < ~ 1 £

UNITED INTERNAllONAL PHARMA COMPANY LIMITED VIETNAM

{ ; : ~ ~ ~ ~ ~ ; ~ : ; ~ t s ; ~ ~ l U ; @ ; : ; f ( ; : ~ ~ : t ~ : ; ~ ~ i j ' f ) : ~ \ : ; l ~ ~ ~ ~ : . ~ ~ ~ ~ ~ ~ , ~ I 2 ~ ; e ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ : 0 W : { : , 0 ~ s T : e , . : ) ; : : ' : £ r ; i f . : ~ ~ ; } : ; ; , ) ; ; ~ : · : : Y ~ ; ~ i ; : '

~ ~ 9 V ~ € m ; ~ ~ ~ ~ ; ~ ¥ ~ t ~ t i t : ; ~ { I g 1 i m ; i ~ ~ { ~ r j i 0 ~ \ f ; ~ @ . m HV C

D l 0 S ~ A S - U R S / H V A C - O O l

: 5 ~ x l ~ J 9 : ~ } N , d ? { \ : : ; ; ) ; : ~ ; : \ : 1

HV C Schemat ic

Processing

rea

A l B t I A N O U ~ . U N r r

NR TO·

AlB

HEAT EXCHANGER

AIR

h \ ~ _ U . N l t

~ U f ' N A

~ .

t ~ M

I \8j

~ W \ \ ' A : a ~ c : ; ; x .

SU?Pt V

Nt

I

O U S T c o u . e ~

PRI':lCESStN' G

ROOM

~ l c : x > J : l I l O

zI Zda=c

4 ~ : J , ~

010

- r - ~ ~ , l . . < M

1

T

lCl. V1.

i o ' 1 l : ~

c Q A A t ' , Q ~

a.A8S

Q C l . ~

~ : . : . : ~ e

a

...

~

---1-1

Page

140f14

D10S AS URS/HVAC OOl

Documents

User requirement Specification