AIRY FILTRATION COMPANY LTD.
Customer
Healthcare Formulations Ltd. Document No. Equipment Celling Type Vertical LAF
Document Operational Qualification (OQ) AIRY/2023/OQ/032 Serial No.
Name
Operational Qualification (OQ)
Celling Type Vertical LAF
Page-1
AIRY FILTRATION COMPANY LTD.
Customer
Healthcare Formulations Ltd. Document No. Equipment Celling Type Vertical LAF
Document Operational Qualification (OQ) AIRY/2023/OQ/032 Serial No.
Name
TABLE OF CONTENTS
NO. TITLE PAGE NO.
1.0 Pre Approval 03
2.0 Purpose 04
3.0 Scope 04
4.0 Responsibility 04
5.0 Validation Risk assessment 04
6.0 The instrument calibration 05
7.0 All Test 06
7.1 General Test 06
7.2 HEPA Filter Integrity Test 06
7.3 Air Velocity Test 07
7.4 Particle Count Test 07
7.5 Airflow Visualization Test 09
7.6 Sound Level Test 09
7.7 Light Level Test 10
7.8 Particle Recovery Test 10
8.0 Deviation Processing 11
9.0 Revalidation Period 11
10.0 Comprehensive Evaluation of Qualification Results 11
11.0 Troubleshooting Manual 12
12.0 Final Approval 13
Page-2
AIRY FILTRATION COMPANY LTD.
Customer
Healthcare Formulations Ltd. Document No. Equipment Celling Type Vertical LAF
Document Operational Qualification (OQ) AIRY/2023/OQ/032 Serial No.
Name
1.0 Pre-Approval
For Airy Filtration Company Ltd.
Name Designation Sign & Date
Prepared By Md. Shahadat Sarker Engineer
Checked By Md. Akram Hossain Engineer
Reviewed By Md. Abdullah Ar Rakib Director
For Healthcare Formulations Ltd.
Name Designation Sign & Date
Checked By
Checked By
Reviewed By
Approved By
Page-3
AIRY FILTRATION COMPANY LTD.
Customer
Healthcare Formulations Ltd. Document No. Equipment Celling Type Vertical LAF
Document Operational Qualification (OQ) AIRY/2023/OQ/032 Serial No.
Name
2.0 Purpose:
To Authenticate & Document that the Laminar Air Flow Unit operates as designed and indented. The
operational Parameters should be consistent with the requirements for the manufacturing process.
3.0 Scope:
The Installation Qualification (IQ) is to be performed against agreed acceptance criteria on the Celling Type
Vertical LAF . The Scope will include the verification of previously calibrated instruments and the availability
of operational Qualification.
4.0 Responsibility:
4.1 Airy Filtration Company Ltd.:
To organize and edit testing program;
To leader testing program and coordinate the whole group;
To participate in countersignature of program and audit of testing report;
4.2 Qualification & Validation Department(IPL):
To responsible for monitoring during testing;
To pre-confirm all data which provided by manufacturing dept.
To participate in countersignature and audit of testing program, report and result;
5.0 Validation Risk assessment
To determine the potential consequence of risks, mainly focus on quality of product, health of patients and
integrity of data. As show in the following table:
Severity(S) Description
It directly affects the reliability, integrity or traceability of product quality factors or
processes and quality data. The risk with super high level may cause the product to be
Super high unusable;
It directly affects the GMP principle and endangers the activities of production site.
It directly affects the reliability, integrity or traceability of product quality factors or
processes and quality data. The risk with high level may cause the product to be recall or
High (3) return;
It not completely complies with GMP principle, may cause deviation during testing and
audit.
It indirectly affects the reliability, integrity or traceability of product quality factors or
processes and quality data although do not relatively affect the product or data.
Medium(2) The risk with medium level may cause wasting of resource and has side effect to corporate
image.
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AIRY FILTRATION COMPANY LTD.
Customer
Healthcare Formulations Ltd. Document No. Equipment Celling Type Vertical LAF
Document Operational Qualification (OQ) AIRY/2023/OQ/032 Serial No.
Name
It has a little affect to the reliability, integrity or traceability of product quality factors or
Low(1) processes and quality data although do not affect the product or data.
6.0 The instrument calibration
To verify that The Instrument and measuring equipment have calibration certificates and the certificates are up-to-date
Check the calibration certificates of the measuring equipment provided with the technical documentation. Check that
the instruments have proper traceability and up to date calibration.
Write the name of the Instrument and measuring equipment with calibration certificate no., calibration date and due
date of calibration in the verification matrix.
Instrument Name Manufacturer Model Calibration Date Calibration Due Date
Page-5
AIRY FILTRATION COMPANY LTD.
Customer
Healthcare Formulations Ltd. Document No. Equipment Celling Type Vertical LAF
Document Operational Qualification (OQ) AIRY/2023/OQ/032 Serial No.
Name
7.0 All Test
7.1 General Test
Observation Confirm results
Test method Requirement (Pass√ / Fail ×)
Check power switch and motor whether Motor starts, works and closes normally
operates normal
Click/Touch the Fan on/off in HMI to turn The Laminar Air Flow fan works accordingly
on/off the Fan
Switch the button The equipment can be stopped immediately
Performed By: Date: Checked By: Date:
7.2 HEPA Filter Integrity Test
To check the integrity of the Celling Type Vertical LAF .The methodology described is according to ISO 14644-3-2019 and
equipment used to perform this test is:
- Aerosol generator.
- Aerosol Photometer detector.
- PAO Oil
Acceptance Criteria:
The aerosol concentration after the filter must be lower than 0.01% the concentration before the filter.
HEPA Filter Integrity Test
Equipment Name & Id Filter Reference Maximum Remarks Conformity
Penetration
Media
Yes/No
Side
Performed By: Date: Checked By: Date:
7.3 Air Velocity Test
Page-6
AIRY FILTRATION COMPANY LTD.
Customer
Healthcare Formulations Ltd. Document No. Equipment Celling Type Vertical LAF
Document Operational Qualification (OQ) AIRY/2023/OQ/032 Serial No.
Name
To determine the average airflow velocity of CELLING TYPE VERTICAL LAF and Equipment used for the test is
Anemometer.
The minimum number of measuring points should be determined by formula
N = √10×A
Where
N is the number of measuring points;
A is the measuring area in m²
Acceptance Criteria:
Average Air Velocity is 0.45 m/s ± 20%
Air Velocity Test
Equipment Id Point Conformity
1 2 3 4 5 Average
Yes/No
Performed By: Date: Checked By: Date:
7.4 Airborne particle count Test
Determinate particulate cleanliness classification in ‘at rest conditions’ is in accordance with specifications.
Sample Location Table:
Area of Zone (m²) below or No of Location Area of Zone (m²) below or No of Location
equal equal
2 1 76 15
4 2 104 16
6 3 108 17
8 4 116 18
10 5 148 19
24 6 156 20
28 7 192 21
32 8 232 22
Page-7
AIRY FILTRATION COMPANY LTD.
Customer
Healthcare Formulations Ltd. Document No. Equipment Celling Type Vertical LAF
Document Operational Qualification (OQ) AIRY/2023/OQ/032 Serial No.
Name
36 9 276 23
52 10 352 24
56 11 436 25
64 12 636 26
68 13 1000 27
72 14 >1000 27 x [Room area(m²) /
1000]
Note: If a room area is above an area defined table 2 for the minimum number of sample points consider the minimum
number for above room area. For example, for a clean room with an area of 25m², the minimum of sample points should
be “7” related to room area of 28m².
Acceptable Criteria:
ISO 14644-1:2015 Classification (At Rest)
EU GMP Class Maximum Allowable Concentration (Particles/m3) for particles equal to and greater than
Number the considered sizes, shown below
0.5 µm 5.0 µm
A 3520 20
B 3520 29
Airborne particle Count Test
Sampling Points Particle Size Measured Particle Remarks Conformity
S1 Yes/No
S2
Performed By: Date: Checked By: Date:
7.5 Airflow Visualization Test
To confirm that the airflow direction and uniformity comply with design and performance specifications CELLING TYPE
VERTICAL LAF and, if required, spatial and temporal characteristics of airflow in the installation
Page-8
AIRY FILTRATION COMPANY LTD.
Customer
Healthcare Formulations Ltd. Document No. Equipment Celling Type Vertical LAF
Document Operational Qualification (OQ) AIRY/2023/OQ/032 Serial No.
Name
With the laminar flow stopped, generate smoke into the working area. Switch on the equipment and recorded all the
process with the video camera. The equipment used in this test is a fume generator and a video recorder. Prepare CD for
Document purpose.
Acceptance Criteria:
Smoke should flow downward smoothly, no dead spots, reflux, or escape
Airflow Visualization Test
Observation Acceptance Criteria Remarks
Met(Yes/No)
Performed By: Date: Checked By: Date:
7.6 Sound Level Test
To verify the noise produced inside the CELLING TYPE VERTICAL LAF
The methodology described is according to NEBB: 2009. The equipment used in this test is a noise level meter. Divide
the measuring plane into grid cells of equal area and carry out measures of the noise level in the middle of the grid cells
inside the equipment (1.5 m from the floor) and check several points outside the equipment (1 m from the equipment).
Acceptance Criteria:
Average Noise level must be ≤70 dB
Noise Level Test
Expected Result Inner Point Average Conformity
1 2 3
Yes/No
≤70 dB
Performed By: Checked By:
Page-9
AIRY FILTRATION COMPANY LTD.
Customer
Healthcare Formulations Ltd. Document No. Equipment Celling Type Vertical LAF
Document Operational Qualification (OQ) AIRY/2023/OQ/032 Serial No.
Name
7.7 Light Level Test
To verify the light intensity level inside the CELLING TYPE VERTICAL LAF.
The methodology described is according to NEBB: 2009. The equipment used in this test is a LUX meter and
take measures of the light level in each of these parts by placing the LUX meter on the working area (80 – 120
cm above the floor).
Acceptance Criteria:
Light level inside the LAMINAR AIR FLOW must be Not Less than 600 lux
Light Level Test
Expected Result Inner Point Average Conformity
1 2 3 Yes/No
> 600 lux
Performed By: Checked By:
8.0 Deviation Processing
In case of deviation in the Qualification process, the Qualification team shall analyze and take
corrective measures.
9.0 Revalidation Period
The validation team shall determine the re-validation period according to the confirmation data and
report to the quality supervisor for approval
10.0 Comprehensive Evaluation of Qualification Results
Based on the validation data, the validation team evaluates the whole Qualification process and draws
a conclusion.
Page-10
AIRY FILTRATION COMPANY LTD.
Customer
Healthcare Formulations Ltd. Document No. Equipment Celling Type Vertical LAF
Document Operational Qualification (OQ) AIRY/2023/OQ/032 Serial No.
Name
11.0 Troubleshooting Manual
Items Problem Condition Probable Cause Problem-Solving
1.0 No Power Without Connecting 1.0 Please check the circuit and make sure if there’s
any short circuit.
2.0 Check power supply if power is connected
2.0 No Air Blow Motor fan is not in 1.0 Please check the circuit and make sure if there’s
operation any short circuit.
2.0 Double check with the motor
3.0 No Lighting The circuit is not connected 1.0 Please check the circuit and make sure if there’s
or lamp tube, starter runs any short circuit.
out off. 2.0 Check with the lamp tube.
3.0 Check with the starter.
Report if result is failed.
Content
Handling
Method
Page-11
AIRY FILTRATION COMPANY LTD.
Customer
Healthcare Formulations Ltd. Document No. Equipment Celling Type Vertical LAF
Document Operational Qualification (OQ) AIRY/2023/OQ/032 Serial No.
Name
12.0 Final Approval
For Airy Filtration Company Ltd.
Name Designation Sign & Date
Prepared By Shahadat Sarker Engineer
Checked By Akram Hossain Engineer
Reviewed By Abdullah Ar Rakib Director
For Healthcare Formulations Ltd.
Name Designation Sign & Date
Checked By
Checked By
Reviewed By
Approved By
Page-12
