Laf PQ

Quality Compliance
Title: Performance Qualification Protocol Page Number: 1 of 19

Unit Under Qualification: Protocol Number: QCQRP-059-08-2023
Laminar Air Flow
Performance Qualification Protocol

Customer Information
Company Name: Saudi Veterinary Pharmacy Product Factory
Location: Sudair- KSA
UUQ Information:
Equipment Name Laminar Air Flow
Equipment ID No APD-055
Make N/A
Model N/A
Serial No. N/A
Page 1 of 19
Quality Compliance Est.
7822, Rajiyah, Alyarmuk ‫اليرموك‬-‫ شارع راجيه‬7822
Unit No. 9, Office No. 9
Tel: 920011898 9 ‫ مكتب رقم‬,9 ‫رقم الوحدة‬
Sudair 13326-3164 Email: info@compliance.com.sa ‫المملكة العربية‬-3164 -13243 ‫الرياض‬
Kingdom of Saudi Arabia www.compliance.com.sa ‫السعودية‬
Quality Compliance
Laminar Air Flow
Table of Contents
Approvals: .....................................................................................................................................................3
1. Introduction: ..........................................................................................................................................4
2. Purpose:.................................................................................................................................................4
3. Scope: ...................................................................................................................................................4
4. Responsibilities: .....................................................................................................................................5
5 Unit under Qualification General Description ...........................................................................................6
6 Prerequisite requirements: .......................................................................................................................6
7 Reference:..............................................................................................................................................6
8 Definitions and abbreviations: .................................................................................................................7
9 Calibration Status of instruments .............................................................................................................8
10 Performance Qualification Tests: .............................................................................................................9
18 Deviation: ............................................................................................................................................17
19 Attachments: ........................................................................................................................................18
21 Final Conclusion ..................................................................................................................................19
22 Final Approval .....................................................................................................................................19
23 Revision History: .................................................................................................................................19
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Quality Compliance
Laminar Air Flow
Approvals:
- Quality Compliance: signature indicates that the documentation and information contained herein complies
with the applicable regulatory, corporate, divisional/departmental requirements and current Good
manufacturing practices.
- Customer: signature indicates that this document has been prepared with your knowledge, that you agree
with the purpose and scope of this document, that the document has been reviewed by the appropriate
persons and that you understand the areas of responsibility for your department during execution of this
validation plan.
- Protocol Approval
Quality Compliance
Name Signature Date
Prepared by:
Name:
Reviewed by:
Name:
Approved by:
Name:
Customer
Name Signature Date
Reviewed by:
Name:
Approved by:
Name:
Approved by:
Name:
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Quality Compliance
Laminar Air Flow
1. Introduction:
1.1 Performance Qualification protocol (PQP) for LAF unit is executed by Quality Compliance
technical Team, at the request of Saudi Veterinary Pharmacy Product Factory. Owner of LAF unit.
1.2 Present documents are used to collect information to support the Performance qualification protocol
(PQP) through quality Compliance responsibilities are limited to what pointed out in this document
and particularly for what customer requirements is concerned. Documents prepared by Quality
Compliance should be approved by Saudi Veterinary Pharmacy Product Factory.
1.3 This Performance Qualification protocol defines the responsibilities and the procedures that must
be complied with to ensure that the PQ test of this LAF unit is successfully completed.
1.4 Performance Qualification Report (PQR) summarizes the information obtained in the PQ test
including; acceptance criteria, test results, deviations from the acceptance criteria and needed
corrective action
1.5 The performance qualification protocol aims to allow the LAF unit owner to review and approve
the PQ protocol, confirm that the LAF unit continues to operate satisfactorily.
2. Purpose:
2.1 The purpose of performance qualification is to confirm through the provision of objective evidence,
that the performance requirements for the LAF unit meet its intended use
3. Scope:
3.1 The scope of protocol applies to the LAF unit.
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Quality Compliance
Laminar Air Flow
4. Responsibilities:
4.1 Quality Compliance Team Responsible:
4.1.1 Assigning an authorized person to determine the proper implementation and documentation of
this PQP and to approve tests results
4.1.2 Obtaining approval of the PQP before qualification exercise from Saudi Veterinary Pharmacy
Product Factory.
4.1.3 Creating the required report which summarizes the data along with the required diagrams and
writing the conclusion of air handling unit status.
4.1.4 Providing the calibration certificates and technical specifications of the instruments used during
the qualification implementation.
4.1.5 Providing all documents or documents number used during the qualification implementation.
4.2 Saudi Veterinary Pharmacy Product Factory Responsibility:
4.2.1 Reviewing and approving the final PQP.
4.2.2 Attending the implementation of PQP.
4.2.3 Remedying any discrepancy raised during qualification study in the ability border of the
customer.
4.2.4 Ensuring the calibration status of the instruments installed on air handling unit.
4.2.5 Operating the air handling unit under qualification
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Quality Compliance
Laminar Air Flow
5 Unit under Qualification General Description

The LAF is installed in Production Area.
6 Prerequisite requirements:
Status
Points to be Checked Procedure No.
Yes No
Measuring Air Velocity QCTE017-00
Measuring Air Particle QCTE019-00
HEPA Filter integrity test (Leak Test) –

QCTE036-00
DOP test
Measuring Differential Pressure QCTE014-00
Air Flow Direction Test QCTE033-00
7 Reference:
7.1 Saudi Food and Drug Authority (SFDA) — Guide to Good Manufacturing Practice for Medicinal
Products — Version 2.1, 2011 — Annex 15: Qualification and Validation
7.2 ISO 14644-Part 1: Classification of air cleanliness by particle concentration.
7.3 ISO 14644- Part 3: Test methods
7.4 WHO Technical Report Series 961 Annex 5 WHO guidelines on good manufacturing practices for
heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
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Laminar Air Flow
8 Definitions and abbreviations:

Terms Description
LAF Laminar Air Flow
HVAC Heating, ventilation and air-condition system
cGMP Current Good Manufacturing Practice
ACPH Air changes per hour
DP Differential Pressure
PAO Poly Alfa Olefin
NVPC Non-viable particle count
IQ Installation Qualification
Max The Maximum thermocouple reading during the study.
Min The Minimum thermocouple reading during the study.
N/A Not Applicable
OQ Operation Qualification
PQ Performance Qualification
Serial Number The serial number of the instrument
SOP Standard Operating Procedure
Start Start time of the Study
UUQ Unit Under Qualification
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Laminar Air Flow
9 Calibration Status of instruments

9.1 Purpose
9.1.1 To verify that the following measuring devices and instruments used for qualification are identified,
calibrated and suitable for the process.
Test Instrument Name & Serial Calibration Calibration

SN
Serial No. Number Date Due Date
1 Air data Multi Meter M16212 13/06/2023 13/06/2024
2 Aerosol Photometer (DOP) 30409 29/05/2023 29/05/2024
3 Air Particle Counter 161601 27/02/2023 27/02/2024
4 Tracer Particle Generator N/A Calibration Not Required
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10 Performance Qualification Tests:

The following tests are performed during the performance qualification:
Name/Title of Rationale /Reference Rationale /Reference for

Sr. No.
Test for Test Acceptance Criteria
The purpose of this test to verify the
Differential capability of Dispensing LAF to maintain the 90-250 Pa (in-house
1.
pressure test specified pressure difference before and after specification)
HEPA filter within the Acceptance limit
The obtained results must

The purpose of this test is to measure supply
2. Air velocity be between 0.36 m/s to 0.54
air Velocity in the Booth
m/s
HEPA Filter The purpose of this test is to confirm that the According to ISO – 14644-3
3. leakage Test filter system is properly installed and that series guidelines on air
leaks have not developed during use cleanliness
The purpose of this test is to provide a quick
Based on stringent EU air
reference of the overall cleanliness of the
4. Air Particle Count classification, the acceptance
environment with respect to the concentration
criteria have been fixed
of nonviable particles.
According to ISO-14644-3
Air Flow Direction Air flow direction test should be done to
5. series guidelines on air
Test (Smoke Test) confirm the air flow direction
cleanliness
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Laminar Air Flow
11 Pressure Difference Across HEPA Filter

11.1.1 Specified feature to be tested:
Differential Pressure (DP)
11.1.2 Purpose:
Verify the pressure difference between upstream and downstream of [HEPA filter].
11.1.3 Tools Required:
Differential pressure measurement meter
11.1.4 Testing Steps (Procedure):
11.1.4.1 Ensure that Differential pressure measurement meter is calibrated.
11.1.4.2 Switch on the Differential pressure measurement meter and select the suitable pressure
unit.
11.1.4.3 With all HEPA Filter fixed, the pressure difference before and after filter shall be
measured.
11.1.4.4 Place the one tube (negative or positive) Before HEPA filter and one tube (negative or
positive) after HEPA Filter depending on air direction.
11.1.4.5 Record the test results.
11.1.4.6 If the test results are out of acceptable limit the test must be repeated after taking
necessary actions.
11.1.5 Acceptance criteria

11.1.5.1 The differential pressure must be between 90 to 250 Pa
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12 Measurement of Supply air velocity in the Booth

Air Velocity
12.1.2 Purpose:
The purpose of the test is to check the uniformity of the air speed at the outlet of the absolute filter
and verify that it corresponds to the expected acceptance criteria.
12.1.3 Tools Required: 1 2
Air Velocity Sensor.
5
4 3
12.1.4.1 Switch on Capture wood
12.1.4.2 Ensure that equipment is clean and has valid calibration certificate
12.1.4.3 Select the suitable air volume unit
12.1.4.4 Operate LAF unit as per the SOP
12.1.4.5 Check the velocity at the face of Supply HEPA filter by using five sampling points
method.
12.1.4.6 Velocity measurement should be taken at 4 corners & one at a center having a distance of
150 to 300mm below the face of the supply HEPA filters as shown in the figure.
12.1.4.7 Record the reading for five locations.
12.1.4.8 Allow at least 10 seconds for each measurement.
12.1.4.9 And record all the measured values, then calculate the average for the readings
12.1.5 Acceptance Criteria:
The measured values must be within 0.45 m/s ±0.025 for Inflow
0.27 to 0.36 m/s for Downflow
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13 Air flow direction test (Smoke Test)

13.1 Specified feature to be tested:
13.1.1 Air flow direction test
13.2 Purpose:
13.2.1 The purpose of Air flow direction test should be done to confirm the airflow direction.
13.3 Tools Required:
13.3.1 Smoke Generator.
13.4 Testing Steps (Procedure):
13.4.1 Airflow direction test shall be conducted after operational airflow velocity is checked.
13.4.2 Notify the engineering department to disable the fire/smoke alarm system (if applicable)
13.4.3 Clean and transfer the smoke test apparatus (Smoke generator, etc.) to respective area.
13.4.4 Plug On the smoke generator, and connect a reducer and hose pipe of adequate size of generator
to generate a thin steam of smoke and set up the video camera.
13.4.5 Care shall be taken to ensure that the generated smoke does not obscure or mask the activity
being performed.
13.4.6 Observed the flow of smoke from generation point till it reaches the working level.
13.4.7 Entire test shall be video graphed (using CD/DVD) such that it will provide video evidence of
airflow direction.
13.5 Acceptance Criteria:
13.5.1 Smooth movement from the filter face/grill towards downwards or towards the return air risers
or towards exhaust should be observed.
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Laminar Air Flow
14 HEPA Filter leakage test

14.1.1 Specified the feature to be tested:
14.1.1.1 HEPA Filter leakage test
14.1.2 Purpose:
14.1.2.1 The purpose of this test is to confirm that the filter system is properly installed and that
leaks/blocks have not developed during usage.
14.1.3.1 Aerosol generator
14.1.3.2 Aerosol photometer (DOP Photometer)
14.1.4.1 HEPA Filter leak test should be conducted after operational air volume is checked
14.1.4.2 The concentration of aerosol upstream of the filter should be between (1to 100) mg/m3.
14.1.4.3 The test is performed by introducing the PAO (Poly Alfa Olfein) aerosol challenge upstream
of the filter and scanning the downstream side of HEPA filter media, frame, gasket and grid
or mounting frame system with the photometer probe to find the leakage
14.1.4.4 To have a homogenous mixing of an aerosol added, align the aerosol generator at the return
air duct or supply plenum duct of that HVAC system/ clean room.
14.1.4.5 Remove the filter grill of the Terminal HEPA filter, if the grills are available.
14.1.4.6 Check the upstream concentration and set as 100%.
14.1.4.7 Find the penetration of the aerosol in percentage at the downstream by scanning the filter
face by moving the sensor probe with slightly overlapping strokes. The probe should be held
in a distance of approximately 2 cm from the downstream filter face or the frame structure.
14.1.4.8 Ensure that the sensor probe of the photometer travels specifically through the grey areas like
the bond between the filter frame and the media, installation joints, the gasket joints etc. so
that the aerosol does not pass through the filter medium.
Acceptance Criteria:
The overall penetration / designated leak should be less than 0.01% of the upstream
challenged aerosol concentration.
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15 Measuring Air particle

Air particle count check
15.1.2 Purpose:
15.1.2.1 The purpose of this test is to provide a quick reference of overall cleanliness of the
environment with respect to the concentration of nonviable particles and thus providing an
indication of airborne particle level.
15.1.3.1 Calibrated Non-viable airborne particle counter
15.1.4.1 Ensure that the instrument is clean and has valid calibration certificate.
15.1.4.2 The no of locations monitored shall be selected based on following table
15.1.4.3 The single sample volume, Vs, per sampling location is determined by using Formula
15.1.4.3.1 𝑆𝑎𝑚𝑝𝑙𝑒 𝑣𝑜𝑙𝑢𝑚𝑒 (𝑉𝑠) = × 1000

15.2 Where Vs is the minimum single sample volume per location, expressed in liters
15.2.1.1 Cn,m is the class limit (number of particles per cubic meter) for the largest considered
particle size specified for the relevant class;
15.2.1.2 20 is the number of particles that could be counted if the particle concentration were at the
class limit.
15.2.1.3 Sample volume required for grade A is as per given formula
15.3 𝑆𝑎𝑚𝑝𝑙𝑒 𝑣𝑜𝑙𝑢𝑚𝑒 (𝑉𝑠) = × 1000
15.4 𝑆𝑎𝑚𝑝𝑙𝑒 𝑣𝑜𝑙𝑢𝑚𝑒 (𝑉𝑠) = 1 × 1000
15.5 𝑆𝑎𝑚𝑝𝑙𝑒 𝑣𝑜𝑙𝑢𝑚𝑒 (𝑉𝑠) = 1000 𝑙𝑡𝑟𝑠
15.5.1.1 A room layout shall be prepared to identify locations.
15.5.1.2 Operate the non-viable particle counter as per the standard operating
procedure/operating manual.
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Laminar Air Flow
15.5.1.3 Set the minimum sampling time as 1 minute.

15.5.1.4 The no. of locations per room shall be followed as per below table
15.5.1.5 At each location, position the particle counter probe in the plane of the work activity or
another specified point.
15.5.2 Acceptance Criteria:

15.5.2.1 The maximum concentration limits for particles equal to or larger than the considered
sizes are given below
Clean room Static condition /At rest

classification  0.5 particles/m3  5 particles/m3
ISO 5 35 20 20
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Laminar Air Flow
16 Final Qualification Report:

Sr. Test Result Done By Checked by
Name/Title of Test
No. (Pass/ Failed) Sign. / date Sign. / date
1. Differential pressure test
2. Air velocity test
3. HEPA Filter leakage Test
4. Air Particle Count test
5. Air Flow Direction Test
17 Re-Validation and Management of Changes / Modifications:

Any changes/modifications made to the equipment after its qualification shall be recorded in “Change
Control” as per Saudi Veterinary Pharmacy Product Factory site procedure, and its impact on the qualification
status of the equipment should be evaluated.
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Laminar Air Flow
18 Deviation:
Any deviations from acceptance criteria encountered while running the qualification shall be recorded as per
Saudi Veterinary Pharmacy Product Factory site procedure, summary of the event to be described as
below:
18.1 Event Description
18.2 Root cause:
18.3 Corrective Action:
18.4 Preventive Action:
Filled By: Signature: Date:

Checked By: Signature: Date:
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Laminar Air Flow
19 Attachments:
SN Name Attachment No
1 Calibration certificates of the instruments used during qualification 01
2 Air Velocity Report 02
3 HEPA Filter integrity Test Report 03
4 NVPC Report 04
5 Air Flow Direction Report 05
6 Differential Pressure Test Report 06
20 Personnel Identification
Identify all personnel involved in the execution of the present protocol.
Quality Compliance Team Saudi Veterinary Pharmacy Product

Factory Team
Name: Abdel Halim Thekrallah Name
Department: Technical Department:
Position: C&Q Employee Position:
Signature: Signature:
Date: ______/_______/__________ Date: ______/_______/__________

Name: Peter Name
Department: Technical Department:
Position: C&Q Employee Position:
Signature: Signature:
Date: ______/_______/__________ Date: ______/_______/__________
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Laminar Air Flow
21 Final Conclusion
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
22 Final Approval
Quality Compliance
Name Signature Date
Prepared by:
Reviewed by:
Approved by:
Customer
Name Signature Date
Reviewed by:
Approved by:
Approved by:
23 Revision History:
Revision No. Date Description
Page 19 of 19

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Quality Compliance

Title: Performance Qualification Protocol Page Number: 1 of 19

Performance Qualification Protocol

Equipment Name Laminar Air Flow

5 Unit under Qualification General Description

Measuring Air Velocity QCTE017-00

Measuring Air Particle QCTE019-00

HEPA Filter integrity test (Leak Test) –

Measuring Differential Pressure QCTE014-00

Air Flow Direction Test QCTE033-00

8 Definitions and abbreviations:

9 Calibration Status of instruments

Test Instrument Name & Serial Calibration Calibration

1 Air data Multi Meter M16212 13/06/2023 13/06/2024

2 Aerosol Photometer (DOP) 30409 29/05/2023 29/05/2024

3 Air Particle Counter 161601 27/02/2023 27/02/2024

4 Tracer Particle Generator N/A Calibration Not Required

10 Performance Qualification Tests:

Name/Title of Rationale /Reference Rationale /Reference for

The obtained results must

11 Pressure Difference Across HEPA Filter

11.1.5 Acceptance criteria

12 Measurement of Supply air velocity in the Booth

13 Air flow direction test (Smoke Test)

14 HEPA Filter leakage test

15 Measuring Air particle

15.1.4.3.1 𝑆𝑎𝑚𝑝𝑙𝑒 𝑣𝑜𝑙𝑢𝑚𝑒 (𝑉𝑠) = × 1000

15.5.1.3 Set the minimum sampling time as 1 minute.

15.5.2 Acceptance Criteria:

Clean room Static condition /At rest

16 Final Qualification Report:

1. Differential pressure test

2. Air velocity test

3. HEPA Filter leakage Test

4. Air Particle Count test

5. Air Flow Direction Test

17 Re-Validation and Management of Changes / Modifications:

18.1 Event Description

18.2 Root cause:

18.3 Corrective Action:

18.4 Preventive Action:

Filled By: Signature: Date:

Quality Compliance Team Saudi Veterinary Pharmacy Product

Date: ______/_______/__________ Date: ______/_______/__________

Date: ______/_______/__________ Date: ______/_______/__________

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