PT CS2 Pola Sehat

Quality Assurance Section

Spesifikasi Biosafety Cabinet

N
Parameter Spesifikasi
o
1. Down Flow Velocity 0.25 – 0.45 m/s
2. In Flow Velocity 0.35 – 0.55 m/s
1. Upstream aerosol concentration must be
greater than 10 µg/L
2. The scanning rate shall be maintained at a
Filter Integrity Testing
3. speed approximately 5 cm/s, and at 1 inch
(Tes Integritas Filter)
below the filter area
3. The percentage of penetration shall not
exceed 0.01%
1. Average of light intensity when the lamp on ≥
Lighting Intensity 450 Lux
4.
(Intensitas Cahaya) 2. Average of background light intensity ≤ 150
Lux
Maximum permitted number of particles at rest
Particle Count condition are:
5.
(Bilangan Partikel) 1. ≥0.5 µ = NMT 3,500,000 particles/m3
2. ≥5 µ = NMT 20,000 particles/m3
Noise Level
6. The noise level should be ≤ 85 dB
(Tingkat Kebisingan)
Airflow Pattern by
7.
Smoke Test
Microbial contamination - Air Sampling: ≤100 CFU/m3
8. by air sampling and - Sedimentation Plate: ≤50 CFU/4h
sedimentation plate - Rodac Plate: ≤300 CFU/25m2
PT Aventis Pharma
Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard

Testing 1
Procedure Appropriate
Test Objective
Equipment operates successfully as per the instruction in the SOP written for
operation
Test Description
1. Read thoroughly the SOP for operation of the equipment
2. Operate the equipment as per the instruction in the SOP for operation
3. Verify that the operation procedure is correct and match as routine
procedure
4. Examine the system based on the procedure and mark-up the procedure as
follows:
Yellow highlight : to confirm the appropriated procedure
Blue overwrite : to indicate the additional procedure/comments
Red strikethrough : to indicate the procedure is not appropriate with actual
procedure
5. Record the SOP name with number and effective date

Sign and date the SOP as “Verified in Qualification”, attach the marked up
document to this test sheet
Acceptance Criteria
The procedure is appropriate with actual procedure
Result

Comment / Deviation (if any)

Performed by: __________________________________________ Date:_____________

Verified by :____________________________________________ Date:_____________

Testing 2
Preventive Maintenance System and Calibration
Test Objective
To ensure that the preventive maintance measures and calibration are entered in
e-MMS
Test Description
Check whether preventive maintance measures and calibration are entered in e-
MMS
Acceptance Criteria
The preventive maintance measures are entered in e-MMS
Result

Page 2 of 6
PT Aventis Pharma
Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard

Comment / Deviation (if any)

Performed by: __________________________________________ Date:_____________

Verified by :____________________________________________ Date:_____________

Testing 3
Downflow Velocity
Test Objective
To ensure the downflow velocity is met with the requirements
Test Equipment
Calibrated Anemometer
Test Description
1. Operate the BioSafety Cabinet as per SOP
2. Downflow is measured at 6 different locations (100 mm from the perimeter
wall) front, middle and back
3. Measure and record the downflow velocity using calibrated anemometer at the
location as per Appendix 1
Acceptance Criteria
The downflow velocity is met with the requirements (0.25 – 0.45 m/s)
Result

Comment / Deviation (if any)

Performed by: __________________________________________

Date:_____________

Verified by :____________________________________________ Date:_____________

Testing 4
Inflow Velocity
Test Objective
To ensure the inflow velocity is met with the requirements
Test Equipment
Calibrated Anemometer
Test Description

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Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard
1. Operate the BioSafety Cabinet as per SOP
2. Inflow velocity measurement is done by lowering the BSC windshield to open
only 75%
3. Measure and record the inflow velocity using calibrated air flow meter at the
location as per Appendix 2 (11 point)
Acceptance Criteria
The inflow velocity is met with the requirements (0.35 – 0.55 m/s)
Result

Comment / Deviation (if any)

Performed by: __________________________________________

Date:_____________

Verified by :____________________________________________ Date:_____________

Testing 5
Filter Integrity Test
Test Objective
To verify the absence of bypass leakage (between filter frame and ceiling grid
system) in the installation of the filters and verify that the installed filters are
free of defects and small leaks
Test Equipment

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PT Aventis Pharma
Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard
Calibrated Photometer, Aerosol Generator, and Aerosol Challenge Agent
Test Description
1. Connect power cable and turn on the photometer
2. Flush the photometer for 15 minutes
3. Prepare the aerosol generator along with the aeorosol challenge agent
4. Connect tuinf rom compressed air to aerosol generator
5. Turn On the compressed air
6. Turn On the BSC
7. Set the air velocity after Hepa Filter 0.45 m/s ± 20%
8. Open the compressed air regulator
9. Open the aerosol generator nozzle for the aeorosol challenge test to be
generated and introduced in upstream of the filter. The concentration is
controlled not more than 10 µg/L with the photometer and record the value.
10.Perform the scanning of the HEPA Filter at 1 inch below the filter area with
scan rate 5 cm/s as per the following diagram:

11. The first scanning is at the edge of the heap filter then to the side of the
HEPA filter
12.Identify the suspected leaks and record. Retest is conducted after remedial
action has been taken and recorded. When filter area beyond repair and
replacement are made, a record will also be made to reflect the
replacement
Acceptance Criteria
1. Upstream aerosol concentration must be greater than 10 µg/L
2. The scanning rate shall be maintained at a speed approximately 5 cm/s, and
at 1 inch below the filter area
3. The percentage of penetration shall not exceed 0.01%
Result

Page 5 of 6
PT Aventis Pharma
Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard

Comment / Deviation (if any)

Performed by: __________________________________________

Date:_____________

Verified by :____________________________________________ Date:_____________

Page 6 of 6
PT Aventis Pharma
Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard
Testing 6
Airflow Pattern by Smoke Test
Test Objective
To verify airflow pattern in order to ensure containment and cleanliness of the
cabinet
Test Equipment
Smoke Generator
Test Description
Part A
1. Check that the air intake and exhaust portasls of the cabinet are not
obstructed
2. Setup and start the video camera to provide a visual record of the
procedure
3. Turn the unit off and allow sufficient time to stagnate air inside the biosafety
cabinet
4. Using a some generator, introduce smoke into the enclosure in continuous
streams near the filter(s) at the start of the work zone, in a grid pattern,
payin attention to the perimeter and corners
5. Fill the enclosure with smoke with the smoke generator
6. Turn the unit ON and verify the direction and flow-charateristics of the air
within the cabinet
7. Ensure that all the smoke has been evacuated from the cabinet before
proceeding
8. Stop filming and Document observation in result section.
Part B
1. Ensure that the access opening of the cabinet is fully open
2. Start the camera
3. Down flow test: using a smoke generator, pass smoke from one end of the
cabinet to the other, along the centerline of the work surface at a heigh of
10 cm above the top of the access opening
4. Filter and work zone test: Pass smoke approximately 5 cm away from the
filters and at the start of the work zone
5. Work opening edge retention test: pass smoke aloge the perimeter of the
work opening edfes, approximately 3-8 cm outside the cabinet; pay
attention to the corners and vertical edges
6. Sash/Window seal test: pass smoke up the inside of the window 5 cm from
the sides and along the top of the work area
7. Stop filming and Document observation in the result section
Acceptance Criteria

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Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00 Name of Equipment : Biosafety Cabinet
Labgard
1. Recording media captured all the video of the smoke test
2. Ariflow within the work area is downward ith no dead spots or refluxing
(upward flow)
3. Airflow is through the front plenum into the unit
4. Ambient air does not pass over the work surface
5. There is no escape of smoke from the cabinet
6. No smoke refluxes out of the cabinet once drawn in nor does smoke billow
over the work surface or penetrate onto it
Result
Step Expected Results Actual Results Pass/ Fail
Recording media captured
All all images of the smoke
test
Smoke flows downward
with no dead spots,
Part A, 6 refluxing or drift.
Smoke does not escape
from the cabinet
The smoke demonstrates
smooth downward flow
Part B, 3
with no dead spots or
reflux
The smoke demonstrates
smooth downward flow
Part B, 4 with no dead spots or
refluex. No smoke escapes
from the cabinet
No smoke is refluxed out
of the cabinet once drawn
in nor does the smoke
billow over the work
Part B, 5 surface or penetrate onto
it.
Airflow along the entire
perimeter of the work
access opening is inward
Smoke does not escape
Part B, 6
from the cabinet

Comment / Deviation (if any)

Page 8 of 6
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Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard

Performed by: __________________________________________

Date:_____________

Verified by :____________________________________________ Date:_____________

Testing 7
Light Intensity
Test Objective
To ensure the lighting intensity is met with the requirements
Test Equipment
Calibrated light intensity meter (Lux meter)
Test Description
1. Press Light ON/OFF button
2. Measure and record the lighting intensity on background and light on using
calibrated light intensity meter at the location as per Appendix 3 (6 point)
Acceptance Criteria
3. Average of light intensity when the lamp on ≥ 450 Lux
4. Average of background light intensity ≤ 150 Lux
Result

Page 9 of 6
PT Aventis Pharma
Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard
Comment / Deviation (if any)

Performed by: __________________________________________

Date:_____________

Verified by :____________________________________________ Date:_____________

Testing 8
Noise Level
Test Objective
To ensure the Noise Level is met with the requirements
Test Equipment
Calibrated Sound Level Meter
Test Description
1. Operate biosafety cabinet as per SOP
2. Measure and record the noise using calibrated Sound Level Meter at left, right
and and center of the working desk area at the location as per appendix 4 (3
point)
Acceptance Criteria
The noise level should be ≤ 85 dBA
Result

Comment / Deviation (if any)

Page 10 of 6
PT Aventis Pharma
Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard

Performed by: __________________________________________ Date:_____________

Verified by :____________________________________________ Date:_____________

Testing 9
Particle Count for 0.5 µ and 5 µ at Rest Condition
Test Objective
To Ensure the particle count for 0.5 µ and 5 µ are meet with specification at
Rest Condition
Test Equipment
Calibrated Air Borne Particle Counter
Test Description

1. Put the probe at working under the filters

2. Start the particle caounter
3. Take readings by moving the probe at speed around 20 cm/s
4. Attach the reading and record the result

Acceptance Criteria
Maximum permitted number of particles at rest condition are:
3. ≥0.5 µ = NMT 3,500,000 particles/m3
4. ≥5 µ = NMT 20,000 particles/m3
Result

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PT Aventis Pharma
Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard

Comment

Deviation (if any)

Perform by: ____________________________________________ Date:_____________

Verified by :____________________________________________ Date:_____________

Page 12 of 6
PT Aventis Pharma
Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard
Testing 10

Microbial Contamination by Air Sampling, Sedimentation Plate and Rodac Plate

Test Objective

To ensure the microbial contamination is meet with specification

Test Equipment

Tryptic Soya Agar (TSA) setting plate, and Calibrated MAS 100 Air Sampler

Test Description
A. By Air Sampling
1. Petridish containing TSA put in the MAS 100 Air Sampler
2. Run the MAS 100 Air Sampler for 10 minutes (1 m3)
3. Take out the petridish from MAS 100 Air Sampler
4. Incubate the petridish in incubator at 30-35°C for 3-5 days
5. Calculate the colonies
6. Record and attach the result
B. By Sedimentation Plate
1. Open Petridish containing TSA for 3 hours
2. Close the petridish
3. Incubate the petridish in incubator at 30-35°C for 3-5 days
4. Calculate the colonies
5. Record and attach the result
C. By Rodac Plate
1. Open Petridish containing TSA and Polysorbate 80%
2. Placed the petridish on the surface and slightly press for approximately 2
days
3. Remove the plate and shut immediately
4. Clean the examined surface carefully and disinfect
5. Incubate the petridish in incubator at 30-35°C for 3-5 days and then 2 days at
20-25°C
6. Calculate the colonies
7. Record and attach the result
Acceptance Criteria

1. Air Sampling: ≤100 CFU/m3

2. Sedimentation Plate: ≤50 CFU/4h
3. Rodac Plate: ≤300 CFU/25m2

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Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard
Result

Comment

Deviation (if any)

Perform by: ___________________________________________ _

Date:_____________

Verified by :____________________________________________

Page 14 of 6
PT CS2 Pola Sehat
Quality Assurance Section

Appendix 1
Downflow Velocity

Acceptance Criteria:
 Downflow Velocity : 0.25 – 0.45 m/s

Measurement in respective Location

5 6
Back

3 4
Middle

1 2
Front

Point Result (m/s)

1
2
3
4
5
6
Max
Min
Average
Meet Specification / Not Meet
Conclusion
Specification

Performed by: __________________________________________

Date:_____________

Verified by :____________________________________________
Appendix 2
Inflow Velocity

Acceptance Criteria:

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Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard
 Inflow Velocity : 0.35 – 0.55 m/s

Measurement in respective Location

2 5 8
1 11
1 1
3 6 9
1 1 1

1 4 10
7
1 1 1

Point Result (m/s)

1
2
3
4
5
6
7
8
9
10
11
Max
Min
Average
Meet Specification / Not Meet
Conclusion
Specification

Performed by: __________________________________________

Date:_____________

Verified by :____________________________________________
Appendix 3
HEPA Integrity

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Quality Operations Department

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Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard

3.1 Layout of The Hepa Filter

3.2 Test Result

Upstream Downstream
HEPA
Concentration Penetration
Exhaust
Supply

Performed by: __________________________________________

Date:_____________

Verified by :____________________________________________ Date:_____________

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Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard
Appendix 3
Light Intensity

Acceptance Criteria:
 Average of light intensity when the lamp on ≥ 450 Lux
 Average of background light intensity ≤ 150 Lux

Measurement in respective Location

Light Intensity Result

Point
Background (LUX) Light On (LUX)
1
2
3
4
5
6
Max
Min
Average
Conclusio Meet Specification / Not Meet Specification / Not
n Meet Specification Meet Specification

Performed by: __________________________________________

Date:_____________

Verified by :____________________________________________

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Quality Operations Department

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Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard

Appendix 4
Noise Level

Acceptance Criteria:
 The noise level should be ≤ 85 dBA

Measurement in respective Location

Point Result (dBA)

1
2
3
Max
Min
Average
Meet Specification / Not Meet
Conclusion
Specification

Page 5 of 6
PT Aventis Pharma
Quality Operations Department

PERFORMANCE QUALIFICATION PROTOCOL

Document No. : EQ/Q/PQP/014/18-00
Name of Equipment : Biosafety Cabinet
Labgard

Performed by: __________________________________________

Date:_____________

Verified by :____________________________________________

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