Document No.

OQRP/MAC17/008A

Revision No. 00

Effective Date

Operational Qualification Report

BIOSAFETY CABINET CLASS II A2

ID: LE17-0018-BSC0001

PT. CKD-OTTO Pharmaceuticals

Design Qualification Protocol

PASSBOX (PB-1)
ID: PE17-0001-PB0001
 OPERATIONAL QUALIFICATION PROTOCOLREPORT

Doc. No. OQR/MAC17/008A

BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
PT. CKD-OTTO Pharmaceuticals Page No. 2 of 15

Table of Content

Reference Document 3
1. Summary 4
2. Result and discussion 4
3. Conclusion 5
4. Recommendation 5
5. Deviation Form 5
6. Appendix 5
7. Approvals 6

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 OPERATIONAL QUALIFICATION PROTOCOLREPORT

Doc. No. OQR/MAC17/008A

BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
PT. CKD-OTTO Pharmaceuticals Page No. 3 of 15

Reference Document

Document Title No Document Effective Date

URS (User Requirement Specification) URS/MAC17/008 Rev. 01 23 November 2017

IQR (Installation Qualification Report) IQR/MAC17/008A 05 January 2018

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Doc. No. OQR/MAC17/008A

BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
PT. CKD-OTTO Pharmaceuticals Page No. 4 of 15

Refference Document

Document Title No Document Effective Date

URS (User Requirement

URS/MAC17/003
Specification)

1. Summary

Operational Qualification of Biosafety Cabinet Class II A2 has been done on:

Day : Wednesday – Thursday
Date : 29 - 30th November 2017

Executor : Feri Wahyu Septiono

Position : Service Engineer
Company : PT. Esco Utama

Witness : Doris Hannelore

Position : QC Supervisor
Signature : PT. CKD-OTTO Pharmaceuticals

2. Result and discussion

Result of operational qualification for all subject tested as below:

2.1. Basic cabinet operation, electrical outlet operation, sash in fully open position, sash in sash
ready or sash height position, sash in fully closed position, are meet the acceptance criteria.
2.2. Calibration range for all test apparatus still valid and the certificate are available.
2.3. Inflow velocity test done only for the Secondary inflow measurement method using ESCO’s
probe holder and gauge block, for the Direct inflow measurement did not performed
because inflow result already represented by Secondary inflow measurement.
2.4. Down flow velocity, HEPA/ULPA Filter PAO Leak Test, Airflow Smoke Patterns, Sash Alarm
Test, Noise Level Test and Lighting Intensity Test and for the airborne particle count testing
at rest condition are meet the specification.

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Doc. No. OQR/MAC17/008A

BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
PT. CKD-OTTO Pharmaceuticals Page No. 5 of 15

2.5. Through this OQ report it was confirm, there is no critical issue caused by deviation 001 at
IQ phase, it was proven by the value of inflow and down flow velocity meet the acceptance
criteria.
2.6. Vibration testing as the optional testing do not performed on OQ phase because inside this
biosafety cabinet was not installed the weighing stone and also no activities will be done
inside this cabinet which required specific vibration value and no activities will be interrupted
by vibration.

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Doc. No. OQR/MAC17/008A

BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
PT. CKD-OTTO Pharmaceuticals Page No. 6 of 15

3. Conclusion

Conclusion for this OQ are as follows :

Complies to all specification criteria and can be continued to PQ
Done with deviation (see deviation form)
Not complies to the acceptenace criteria and will requalify on ..................................

4. Recommendation

NA

5. Equipment Description

5.1 Use of equipment

Pass Box 1 of ID PE17-0001-PB0001 is installed at 1st floor area between Washing & Steril
Room (A.1.04.16) and Corridor B – Class (A.1.04.23) in the production Anticancer Injection
Plant Facility. This equipment to maintain internal condition of the pass box inner area of the
following parameters:

Particle (/m3)
Temperature
Equipment Velocity
Room Name & relative At rest
Name (m/s)
humidity
≥0.5 µm ≥5 µm

Washing & Steril Room

Data
PASS BOX 1 (A.1.04.16) and Corridor B 0.36-0.54 ≤3520 29
collection
– Class (A.1.04.23)

Table 1

Drawing 1

Passbox (PB-1) is the production equipment to transfer the production material between two rooms.

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Doc. No. OQR/MAC17/008A

BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
PT. CKD-OTTO Pharmaceuticals Page No. 7 of 15

This unit is designed for close contamination from environment around it to maintain the material
transfer quality from the other rooms.

Air condition from HVAC system will be installed to maintain the air quality in the inner pass box.
Supply air will pass through the HEPA filter which have afficiency 99,995 % (H-14) to maintain
particle viable and non viable, then go through the perforated outlet inside pass box to make a liniar
down flow. Supply air will circulate and go through to the perforated inlet inside pass box then return
to AHU.

Operational mechanisms of Pass Box 1 is as follow:

Passbox 1 (PB-1) will be operate continously refer to HVAC system turning ON. And the process
refer to door open and door close, when the front door opened so the rear door will be lock
automatically using mechanical and electrical lock, and the otherwise is the same operation.
Indicator lamp used to be sign that the green light means that door can open and the red light means
that door locked. Operation of automatic damper refer to the airflow direction inside duct. When
HVAC system is running, automatic damper will be open and when HVAC system OFF, automatic
damper will be close.

Differential pressure before and after HEPA filter will be monitored by differential pressure gauge
(DPG). When differential pressure gauge high over the set means that HEPA filter is dirty and should
be replace. We have to know the initial pressure drop of HEPA filter installed to know the condition of
HEPA filter. There are two port that should be monitored the air pressure, that’s are pressure before
HEPA filter (Hi – Press) and pressure after HEPA filter (Low – Press).

Sequence of operational Pass box 1 as below :

One side of door open  Get inside the material  Door close  wait 1 minute  The other side
door open  Get outside the door  and close the door.

When both door close, indicator lamp for both side are green means that one side of door possible to
open. When one side door open so the oherside door is locked automatically and the indicator lamp
is red. The otherwise door is the same operation.

5.2 Functional Description

These systems contain components which have function as follow:

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Doc. No. OQR/MAC17/008A

BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
PT. CKD-OTTO Pharmaceuticals Page No. 8 of 15

 Supply/Return duct
Installation Parts to flow the air condition which have connection between AHU and
passbox, duct installed should be free of leakage.
 HF-H14 Filter
Final filter with air-cleaning efficiency 99,995 % to filter the circulation air that will
supply from AHU to inner side of pass box. Test hole close to each sensor point is
provided.

 Motorized Damper
Used for adjusting supply air and return air automatically which equipped with
manual damper handle far balancing airflow and differential pressure.
 Supply air perforated
The outlet supply air which installed at the end of supply duct, perforated type use to
make the liniar flow pattern.
 Return air perforated
The inlet return air which installed at the end of return duct. Made from perforated
stainless steel.
 Differential Pressure Gauge (DPG)
to monitor the differential air pressure before and after HEPA filter to know the
condition of filter.
 Indicator Lamp.
If door open so the other side door automatically lock. Red light means that door
cannot open and the green light means that door can open.

6. List of major component, Device and Instrument:

4.3.1.a Pass Box 1

ID Number : PE17-0001-PB0001
Brand : Local (Central Filter)
Type : Standing
Airflow Rate : 1,100 m3/h
Material : SS 304
Power : 50 W
Dimension : 970 x 780 x 1440 (LWH)

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Doc. No. OQR/MAC17/008A

BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
PT. CKD-OTTO Pharmaceuticals Page No. 9 of 15

Qty : 1 unit

4.3.1.b HEPA Filter

ID Number : PE17-0001.0001-HF0001
Brand : KOWA
Model : H4BA305610290
Dimension : 20” x 20” x 3”
Efficiency : 99,99% at 0,3 µ (H14)
Initial Pressure Drop : 333 Pa or 34 mmAq
Final Pressure Drop : 500 Pa or 50,8 mmAq
Qty : 1 Pcs

4.3.1.c Differential Pressure Gauge (DPG)

ID Number : PE17-0001.0001-DP0001
Brand : Dwyer (Magnehelic)
Model : 2000-500PA
Type : Analog
Range : 0 – 750 Pa
Qty : 1 Pcs

4.3.1.d Motorized Damper

ID Number 1 : PE17-0001.0001-MD0001
ID Number 2 : PE17-0001.0001-MD0002
Brand : Honeywell
Model : MS3105J3030
Power Capacity : 5 Newton
Electricity : 24 Vac/dc, 50/60 Hz, 24 Vdc
Qty : 2 Pcs

4.3.1.e TL Lamp
ID Number : PE17-0001.0001-LAM0001
Brand : Philips
Model : LED
Power Capacity : 15 Watt
Qty : 1 Pcs

4.3.1.f UV Lamp
ID Number : PE17-0001.0001-LAM0001
Brand : Sankyo Denki
Model : G10T8
Power CapacityQty : 10 Watt1 pc
:

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Doc. No. OQR/MAC17/008A

BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
PT. CKD-OTTO Pharmaceuticals Page No. 10 of 15

Operational Requirement

No Equipment Requirement
Passbox Unit (Flow In operational passbox design, airflow should be sirculated
1
Direction) air from AHU and return to AHU.
Sequence design : Open the door (Indicator lamp is green
2 Interlock door light) The other door cannot open (Indicator lamp is red
light).
Operainal design : When open the door TL lamp ON but UV
3 UV Lamp and TL Lamp lamp OFF and when close the door UV Lamp ON and TL
Lamp OFF.

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Doc. No. OQR/MAC17/008A

BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
PT. CKD-OTTO Pharmaceuticals Page No. 11 of 15

7. Abbreviation

Term Abbreviation

DQ Design Qualification
AHU Air Handling Unit
PB Pass Box
HF-H-14 Hepa Filter H-14
GMP Good Manufacturing Practice
HVAC Heating, Ventilation and Air Conditioning
Pa Pascal
W Watt
URS User Requirement Specification
NA Not Aplicable
mmAq milimeterAqua
DPG Differential Pressure Gauge
UV Ultra Violet
RH Relative Humidity
µm Micro Meter

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Doc. No. OQR/MAC17/008A

BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
PT. CKD-OTTO Pharmaceuticals Page No. 12 of 15

Comment /
Corrective Action / Accepted
Deviation Comment / Deviation
Justification (Y/N)
Ref. No.

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Doc. No. OQR/MAC17/008A

BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
PT. CKD-OTTO Pharmaceuticals Page No. 13 of 15

Appendix #1. Comparison to URS

Appendix #2. Technical specification document verification

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BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
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8. Deviation Form

Comment /
Corrective Action / Accepted
Deviation Ref. Comment / Deviation
Justification (Y/N)
No.

9. Appendix

Appendix 1. Operational Qualification Result

Appendix 2. Summary of Operational Qualification
Appendix 3. Certificate Test Apparatus and Service Engineer
Appendix 4. Ceritficate Calibration by PT. Esco Utama

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BIOSAFETY CABINET CLASS II A2
Rev. No. 00
ID: LE17-0018-BSC0001
Effective Date
PT. CKD-OTTO Pharmaceuticals Page No. 15 of 15

10. Approvals

This protocol ireports prepared by PT. CKD-OTTO Pharmaceutical for new unit installation of
Biosafety Cabinet Class II A2 at PT. CKD-OTTO PHARMACEUTICALS located at Delta Silicon –
Cikarang, Indonesia.

Name Position Signature Date

Prepare by Doris Hannelore QC Supervisor

Elizabeth Ratna S QC Asst. Manager

Reviewed by
Suharyono Engineering Manager

Irawati Raharjo QA Asst. Manager

Approved by
Dian Cahyaningtyas QA/QC Senior Manager

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