Prot IQ HVAC

QUALIFICATION PROTOCOL
INSTALLATION 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/GIQ/HVAC/001
LAWANG PROTOCOL Date : i
Revision No. : 00.
INSTALLATION 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:
Installation Qualification Form
/conversion/tmp/scratch/421418239.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 conforms to the purchase specifications
and the manufacturer literatures, and to document the information that the equipment meets specifications.
II. SCOPE
For new installation, modification, replacement, or relocation of any component of the HVAC system.
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 IQ
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 IQ format) for each component as listed in the IQ format.
The individual component checklist includes a space to record the information plus any deviations found during
the installation check.
Responsible person verifies that the information is complete, prepares the deviation report and the Installation
Qualification Report and, submits to QA.
QUALIFICATION 2
No : PV/GIQ/HVAC/001
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 installation. 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: 389,790 Btu/h Visual/ Document check

Air Conditioner unit Model : CLC P.025
Brand :Trane
Capacity : 21,000 m3/h Visual/ Document check

Booster Fan unit Static Pressure : 3” WG
Revision No. : 00.
Date :-
Brand : Kruger
Body / Box A.H.U No Leakage Visual/ Leakage Test
Visual/ Leakage Test

Ducting Installation No Leakage
Document Check
Electric Installation Available
(P&ID)
Grounding 0.5 – 5 ohm Ear Test
Insulation Test
Insulation 500 – 1000mΩ
24” x 12” x 12”= 10 units

HEPA Filter unit
(Dimension) 24” x 48” x 5 7/8” = 7 units Measured
24” x 24” x 5 7/8” = 6 units
Medium Filter Unit

(Dimension) 24” x 24” x 12” = 6 units Measured
Pocket Filter 24 “ x 24” x 22” = 6 units Measured

24” x 12” x 22” = 3 units
Pre Filter unit 24” x 12” x 2” = 3 units Measured
(Dimension) 24” x 24” x 2” = 6 units
Filter position Conform Measured
Certificate of components Conform Document check
Air supply installation Conform Document Check/visual
Safety aspect Conform Document Check/visual

QUALIFICATION 4
No : PV/GIQ/HVAC/001
Revision No. : 00.
Date :-
2. Laminar Air Flow System (LAF)
Item Specification Check method / Tester

equipment
(2400x5400) + (1200x9600) + (2400x4800)

Laminar Air Flow 304,thickness 2 mm Visual/ Document check
16 pcs filter efficiency 99.99 %,6 no. centrifugal
fan,1 set Air Curtin glass thickness 6 mm
Capacity : 2230 m3/h Visual/ Document check
Booster Fan unit Static Pressure : 3” WG
Brand : Kruger
Body / Box A.H.U Visual/ Leakage Test
No Leakage
Ducting Installation Visual/ Leakage Test
No Leakage
Electric Installation Document Check
(P&ID) Available
Insulation Test
Insulation test 500 – 1000mΩ
24” x 12” x 12” = 10 units

HEPA Filter unit
(Dimension) 24” x 48” x 5 7/8” = 7 units Measured
24” x 24” x 5 7/8” = 6 units
24” x 12” x 2” = 3 units

Pre Filter unit Measured
Certificate of Conform Document check

components
Air supply installation Conform Document Check/visual
Revision No. : 00.
Date :-
Safety aspect Conform Document Check/visual
Static Pressure Conform Document Check/visual
VII. ACCEPTANCE CRITERIA:
The HVAC System, its components, design and installation must comply with the protocol requirement,
machine and drawing specification, and proper assembling process.
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 IQ HVAC SYSTEM:
item Specification Check Result Date Checked Approved

method / by by
Tester
equipment
Cooling capacity: 389,790 Visual/
Air Conditioner Btu/h Document
unit Model : CLC P.025 check
Brand :Trane
Capacity : 21,000 m3/h Visual/
Booster Fan Static Pressure : 3” WG Document
unit Brand : Kruger check
Body / Box No Leakage Visual/

A.H.U Leakage Test
Visual/
Ducting No Leakage Leakage Test
Installation
Document
Electric Available Check
Installation
(P&ID)
Insulation Test
Insulation 500 – 1000mΩ
24” x 12” x 12”= 10 units

HEPA Filter
unit 24” x 48” x 5 7/8” = 7 units Measured
(Dimension)
24” x 24” x 5 7/8” = 6 units
Medium Filter
Unit 24” x 24” x 12” = 6 units Measured
(Dimension)
Revision No. : 00.
Date :-
Pocket Filter 24 “ x 24” x 22” = 6 units Measured

24” x 12” x 22” = 3 units
Pre Filter unit 24” x 12” x 2” = 3 units Measured
Certificate of Conform Document

components check
Air supply Conform Document

installation Check/visual
Safety aspect Conform Document

Check/visual
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)
Merk:
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 Result Date Checked Approved

method / by by
Tester
equipment
(2400x5400) + (1200x9600)
Laminar Air + (2400x4800) Visual/
Flow 304,thickness 2 mm Document
16 pcs filter efficiency 99.99 check
%,6 no. centrifugal fan,1 set
Air Curtin glass thickness 6
mm
Capacity : 2230 m3/h Visual/
Booster Fan Static Pressure : 3” WG Document
unit Brand : Kruger check
Body / Box Visual/

A.H.U No Leakage Leakage Test
Ducting Visual/
Installation No Leakage Leakage Test
Electric Document
Installation Available Check
(P&ID)
Insulation Test
Insulation test 500 – 1000mΩ
Revision No. : 00.
Date :-
24” x 12” x 12” = 10 units

HEPA Filter
unit 24” x 48” x 5 7/8” = 7 units Measured
(Dimension)
24” x 24” x 5 7/8” = 6 units
24” x 12” x 2” = 3 units

Pre Filter unit Measured
Certificate of Document
components Conform check
Air supply Document

installation Conform Check/visual
Document
Safety aspect Conform Check/visual
Document
Static Pressure Conform Check/visual
CONCLUSION :
SUGGESTION:
Approved by : Reported by :
Mudjiono T. Joko Purnomo

Date : Date :

Prot IQ HVAC

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QUALIFICATION PROTOCOL

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

PT. OTSUKA INDONESIA

Revision No. : 00.

1. GMP Department Mukhlis

2. Engineering Department Mudjiono

3. Production Department Suhari Mukti

4. QA Director Bambang Sudiyanto

Revision No. : 00.

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: 389,790 Btu/h Visual/ Document check

Capacity : 21,000 m3/h Visual/ Document check

Body / Box A.H.U No Leakage Visual/ Leakage Test

Visual/ Leakage Test

Grounding 0.5 – 5 ohm Ear Test

24” x 12” x 12”= 10 units

24” x 24” x 5 7/8” = 6 units

Medium Filter Unit

Pocket Filter 24 “ x 24” x 22” = 6 units Measured

Filter position Conform Measured

Certificate of components Conform Document check

Air supply installation Conform Document Check/visual

Safety aspect Conform Document Check/visual

2. Laminar Air Flow System (LAF)

Item Specification Check method / Tester

(2400x5400) + (1200x9600) + (2400x4800)

24” x 12” x 12” = 10 units

24” x 24” x 5 7/8” = 6 units

24” x 12” x 2” = 3 units

Filter position Conform Measured

Certificate of Conform Document check

Air supply installation Conform Document Check/visual

Safety aspect Conform Document Check/visual

Static Pressure Conform Document Check/visual

VII. ACCEPTANCE CRITERIA:

Customer / Company ordering PT Otsuka Indonesia

FORM IQ HVAC SYSTEM:

item Specification Check Result Date Checked Approved

Body / Box No Leakage Visual/

Grounding 0.5 – 5 ohm Ear Test

24” x 12” x 12”= 10 units

Pocket Filter 24 “ x 24” x 22” = 6 units Measured

Filter position Conform Measured

Certificate of Conform Document

Air supply Conform Document

Safety aspect Conform Document

Mudjiono T. Joko Purnomo

2. Laminar Air Flow System (LAF)

CHECK LIST QUALIFICATION:

Item Specification Check Result Date Checked Approved

Body / Box Visual/

24” x 12” x 12” = 10 units

24” x 12” x 2” = 3 units

Filter position Conform Measured

Air supply Document

Mudjiono T. Joko Purnomo

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