Prot OQ HVAC

QUALIFICATION PROTOCOL
OPERATIONAL QUALIFICATION of
HVAC SYSTEM – LVP PLANT
Doc. No. : PV/GIQ/HVAC/001

Revised No. : 00
Date of issue :
PT. OTSUKA INDONESIA

Jl. Sumber Waras No. 25
LAWANG, MALANG, JAWA TIMUR 65216
PT. Otsuka Indonesia Page :
QUALIFICATION No : PV/GOQ/HVAC/001
LAWANG PROTOCOL Date :
Revision No. i: 00.
OPERATIONAL QUALIFICATION FOR Replaced :
HVAC SYSTEM – LVP PLANT No. :-
Date :-
LIST of CONTENT
History of Revision....................................................................................................................................ii
Approval Sheet.........................................................................................................................................ii
1. OBJECTIVE.......................................................................................................................................1
2. SCOPE..............................................................................................................................................1
3. RESPONSIBILITY.............................................................................................................................1
4. PROCEDURE....................................................................................................................................1
5. QUALIFICATION DESCRIPTION......................................................................................................2
6. ITEM CHECK LIST AND QUALIFICATION.......................................................................................3
7. ACCEPTANCE CRITERIA.................................................................................................................5
List of Attachment:
Operational Qualification Form
/conversion/tmp/scratch/421418254.doc
LAWANG PROTOCOL Date : ii
Revision No. : 00.
Date :-
a. History of revision.
Rev. No. Date Revised item Reason Remark
b. Approval record.
No. Department Approval Date Name Signature
1. GMP Department Mukhlis
2. Engineering Department Mudjiono
3. Production Department Suhari Mukti
4. QA Director Bambang Sudiyanto
1
Revision No. : 00.
Date :-
I. OBJECTIVE
To demonstrate that the Qualification of the new Heating Ventilation Air Conditioning system (HVAC) installed in
Clean room of Large Volume Parenteral plant of PT Otsuka Indonesia could operate properly as the purchase
specifications, the manufacturer literatures, and meets PT Otsuka Indonesia requirement.
II. SCOPE
For operational of any equipment and component of the HVAC system in Clean room of Large Volume
Parenteral plant of PT Otsuka Indonesia
III. RESPONSIBILITY
It is the responsibility of the validation team to

a. Prepare, review, and approve this protocol prior to execution.
b. Review and approve the data collected after the protocol’s implementation.
It is the responsibility of Engineering to

a. Train maintenance mechanics in the operation and maintenance of the system.
b. Prepare SOPs on the operation, cleaning and maintenance of the system.
c. Supervising performance of the OQ
It is the responsibility of QA to
a. Approving the protocol.
b. Approving data and conclusion
IV. PROCEDURE
For each AHU, fill in the prepared checklist with the detailed mechanical and electrical specifications, drawings,
etc. (as itemized in the OQ format) for each component as listed in the OQ format.
The individual component checklist includes a space to record the information plus any deviations found during
the operational check.
Responsible person verifies that the information is complete, prepares the deviation report and the Operational
Qualification Report and, submits to QA.
2
Revision No. : 00.
Date :-
V. QUALIFICATION DESCRIPTION
Qualification of each terminal HEPA-filtered HVAC system is to be carried out and documented. The
documentation should include as-built drawing, commissioning record, operation and maintenance manual,
etc.
The HVAC system should have been qualified upon operational. Prior to validation and after major changes,
those parts of the HVAC systems affected should be re qualified.
HVAC System
Design
Comprehensive drawing, schematic diagrams , and specifications for the complete system defining the
operating ranges for each parameter. Verify that suitable provisions have been included for servicing and
testing HEPA filter systems; such as, DOP ports, monitoring ports, scanning access and filter changing.
Equipment
Comprehensive specifications for each HVAC unit defining its function should be available. Where
applicable, operating parameters should be specified. These may vary with each HVAC unit and may
include but no be limited to the use of the following component, each of which must be calibrated and / or
qualified as required.
Services / Utilities
Electrical
Air Handling Units

For each Air Handling Unit (AHU) installed, describe the units and prepares a list of the units, the rooms
and quality of air they supply is entered in an HVAC room matrix.
VI. ITEM CHECK LIST AND QUALIFICATION
1. HVAC System for Room 10,000 / Class II & Room 100,000 / class III
Item Specification Check method / Tester

equipment
Cooling capacity: Identity of capacity

Air Conditioner unit 389,790 Btu/h Compressor
1 PK = 9000 BTU/hr
Revision No. : 00.
Date :-
Capacity : 21,000 Anemometer

Booster Fan unit m3/h
Static Pressure : 3” Differential pressure
WG measurement (Magnehelic)
Body / Box A.H.U Visual/ Leakage Test

No Leakage
Ducting Installation Visual/ Leakage Test
No Leakage
Installation
Electric system specification Avometer / Ampere meter
Grounding 0.5 – 5 ohm Ear Test
Insulation 500 – 1000mΩ Insulation Test
HEPA Filter unit

24”x12”x12”= 10 units 99.99%
24”x 48” x 5 7/8” = 7 units 99.99% Integrity Test / particle counter
24” x 24” x 5 7/8”= 6 units 99.99%
Medium Filter Unit 90 – 95% Particle counter

24” x 24” x 12” = 6 units
Pocket Filter
24 “ x 24” x 22” = 6 units 90 – 95% Particle counter
24” x 12” x 22” = 3 units
Pre Filter unit

24” x 12” x 2” = 3 units 60% Particle counter
2. Laminar Air Flow System (LAF)
Item Specification Check method /

Tester equipment
Centrifugal fan As specification Anemometer
Revision No. : 00.
Date :-
Capacity : 2230 Anemometer

Static Pressure: 3” Differential pressure

WG measurement
(Magnehelic)
Body / Box A.H.U
No Leakage Visual/ Leakage Test
Ducting Installation
No Leakage Visual/ Leakage Test
Insulation Test
Insulation test 500 – 1000mΩ
HEPA Filter unit

24” x 12” x 12” = 10 units
24” x 48” x 5 7/8” = 7 units 99.99% Integrity test / particle

counter
24” x 24” x 5 7/8” = 6 units
Pre Filter unit

24” x 12” x 2” = 3 units
Differential pressure
Static Pressure 3” WG measurement
(Magnehelic)
VII. ACCEPTANCE CRITERIA:
The HVAC System and its components can meet operational specification and PT. Otsuka Indonesia
standard.
Revision No. : 00.
Date :-
DESCRIPTION:
1. HVAC System for Room 10,000 / Class II & Room 100,000 / class III
Equipment name HVAC system
Function Temperature, Relative Humidity , Particle, Microbial and
Differential Pressure controller
Location LVP BS LINE
Group LVP
Date February, 2006
Customer / Company ordering PT Otsuka Indonesia

Machine designation Temperature, Relative Humidity , Particle,
Microbial and Differential Pressure controller for
LVP BS clean room area
Year of construction 2005
Machine number -
Order number -
Description Quantity
Supply and install Air Conditioning split duel 1 unit
Cooling capacity : 389,790 BTU/h
Model : CLC P.025
Merk : Trane
Supply and install Booster Fan 1 unit
Capacity : 21,000 m3/h
Static Pressure : 3” WG
Merk : Kruger
Supply and install Ducting 1 lot
Supply and install Pre filter efficiency : 25 – 30 %
Supply and install Medium filter (bag filter90%) 1 unit
Supply and install Pre filter and Medium filter housing galvanized plat 1 unit
(customizing)
Supply and install HEPA filter 23 units
Supply and install HEPA filter housing galvanized plat (customizing) 23 units
Supply and install panel and cabling 1 lot
Dismantling existing equipment and ducting
Note : Air change 25 x / jam
Cable brand : Supreme
Panel brand : PT. SPLN
Filter brand : A.A.F
AC brand : Trane
Fan brand : Kruger
Revision No. : 00.
Date :-
FORM OQ HVAC SYSTEM – LPV PLANT
Item Specification Check method / Result Date Checked Approved

Tester equipment by by
Cooling capacity: Identity of capacity

Air Conditioner unit 389,790 Btu/h Compressor
1 PK = 9000 BTU/hr
Capacity : Anemometer
Booster Fan unit 21,000 m3/h
Static Pressure : Differential pressure
3” WG measurement
(Magnehelic)
Body / Box A.H.U Visual/ Leakage Test
No Leakage
Ducting Installation Visual/ Leakage Test
No Leakage
Installation Avometer / Ampere
Electric system specification meter
Insulation 500 – 1000mΩ Insulation Test
HEPA Filter unit

24”x12”x12”= 10 units 99.99%
24”x 48” x 5 7/8” = 7 units 99.99% Integrity Test /

particle counter
24” x 24” x 5 7/8”= 6 units 99.99%
Medium Filter Unit 90 – 95% Particle counter

24” x 24” x 12” = 6 units
Pocket Filter
24 “ x 24” x 22” = 6 units 90 – 95% Particle counter
24” x 12” x 22” = 3 units
Pre Filter unit

24” x 24” x 2” = 6 units
Revision No. : 00.
Date :-
CONCLUSION :
SUGGESTION:
Approved by : Reported by :
Mudjiono T. Joko Purnomo

Date : Date :
Revision No. : 00.
Date :-
2. Laminar Air Flow System (LAF)
Description Quantity
Supply and install local Laminar Flow 1 unit
Size (2400x5400)+(1200x9600)+(2400x4800)
Brand:
Fan filter module : 50 pcs
Stainless Steel 304, thickness 2 mm
C/w - 16 pcs filter efficiency 99.99 %
- 6 no. centrifugal fan
- 1 set Air Curtin glass thickness 6 mm
CHECK LIST QUALIFICATION:
Item Specification Check method / Result Date Checked Approved

Tester equipment by by
Centrifugal fan As specification Anemometer
Capacity : 2230 Anemometer

Static Pressure: 3” Differential pressure

WG measurement
(Magnehelic)
Body / Box
A.H.U No Leakage Visual/ Leakage Test
Ducting
Installation No Leakage Visual/ Leakage Test
Insulation Test
Insulation test 500 – 1000mΩ
HEPA Filter unit

24” x 12” x 12” =
10 units
24” x 48” x 5 7/8” 99.99% Integrity test /
= 7 units particle counter
Revision No. : 00.
Date :-
24” x 24” x 5 7/8”

= 6 units
Pre Filter unit

24” x 12” x 2” = 3
units
60% Particle counter
24” x 24” x 2” = 6
units
Differential pressure
Static Pressure 3” WG measurement
(Magnehelic)
CONCLUSION :
SUGGESTION:
Approved by : Reported by :
Mudjiono T. Joko Purnomo

Date : Date :

Prot OQ HVAC

Загружено:

Сведения о документе

Исходное описание:

Оригинальное название

Авторское право

Доступные форматы

Поделиться этим документом

Поделиться или встроить документ

Параметры публикации

Этот документ был вам полезен?

Это неприемлемый материал?

Авторское право:

Доступные форматы

Prot OQ HVAC

Загружено:

Авторское право:

Доступные форматы

QUALIFICATION PROTOCOL

Doc. No. : PV/GIQ/HVAC/001

PT. OTSUKA INDONESIA

1. GMP Department Mukhlis

2. Engineering Department Mudjiono

3. Production Department Suhari Mukti

4. QA Director Bambang Sudiyanto

It is the responsibility of the validation team to

It is the responsibility of Engineering to

Air Handling Units

VI. ITEM CHECK LIST AND QUALIFICATION

Item Specification Check method / Tester

Cooling capacity: Identity of capacity

Capacity : 21,000 Anemometer

Body / Box A.H.U Visual/ Leakage Test

Grounding 0.5 – 5 ohm Ear Test

Insulation 500 – 1000mΩ Insulation Test

HEPA Filter unit

24”x 48” x 5 7/8” = 7 units 99.99% Integrity Test / particle counter

24” x 24” x 5 7/8”= 6 units 99.99%

Medium Filter Unit 90 – 95% Particle counter

Pre Filter unit

2. Laminar Air Flow System (LAF)

Item Specification Check method /

Centrifugal fan As specification Anemometer

Capacity : 2230 Anemometer

Static Pressure: 3” Differential pressure

HEPA Filter unit

24” x 48” x 5 7/8” = 7 units 99.99% Integrity test / particle

Pre Filter unit

24” x 24” x 2” = 6 units 60% Particle counter

VII. ACCEPTANCE CRITERIA:

Customer / Company ordering PT Otsuka Indonesia

FORM OQ HVAC SYSTEM – LPV PLANT

Item Specification Check method / Result Date Checked Approved

Cooling capacity: Identity of capacity

Grounding 0.5 – 5 ohm Ear Test

Insulation 500 – 1000mΩ Insulation Test

HEPA Filter unit

24”x 48” x 5 7/8” = 7 units 99.99% Integrity Test /

Medium Filter Unit 90 – 95% Particle counter

Pre Filter unit

Mudjiono T. Joko Purnomo

2. Laminar Air Flow System (LAF)

CHECK LIST QUALIFICATION:

Item Specification Check method / Result Date Checked Approved

Centrifugal fan As specification Anemometer

Capacity : 2230 Anemometer

Static Pressure: 3” Differential pressure

Grounding 0.5 – 5 ohm Ear Test

HEPA Filter unit

24” x 24” x 5 7/8”

Pre Filter unit

Mudjiono T. Joko Purnomo

Вам также может понравиться