PERFORMANCE QUALIFICATION

PROTOCOL

FOR

HORIZONTAL/ VERTICAL/ REVERSE

LAMINAR AIR FLOW

EQUIPMENT ID No.

LOCATION Injection Block

DATE OF QUALIFICATION
SUPERSEDED PROTOCOL No.
 PROTOCOL CONTENTS

S. No. SUBJECT PAGE No.

1. PROTOCOL APPROVAL 3

2. OBJECTIVE 4

3. SCOPE 4

4. RESPONSIBILITY 4

5. EQUIPMENT DETAILS 5

6. SYSTEM DESCRIPTION 5

7. REASON FOR QUALIFICATION 5

8. SITE OF STUDY 5

9. FREQUENCY OF QUALIFICATION 5

10. PRE-QUALIFICATION REQUIREMENTS 6

11. TESTS AND CHECKS 6

12. CHECKLIST OF ALL TESTS AND CHECKS 10

13. REFERENCE 10

14. DOCUMENTS TO BE ATTACHED 10

15. NON-COMPLIANCE 11

16. DEVIATION FROM PRE-DEFINED SPECIFICATION 11

17. CHANGE CONTROL 11

18. ABBREVIATIONS 11
1.0 PROTOCOL APPROVAL:

INITIATED BY:
DESIGNATION NAME SIGNATURE DATE
OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(PRODUCTION)
HEAD
(ENGINEERING)
HEAD
(QUALITY CONTROL)

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

MANAGER
(QUALITY ASSURANCE)

APPROVED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITY ASSURANCE)

2.0 OBJECTIVE:
 The objective of this protocol is to provide a rigorous testing to demonstrate effectiveness and
reproducibility of the System, so as to verify performance of the subjected system against
predetermined acceptance criteria.
3.0 SCOPE:
The Protocol covers all aspects of Performance Qualification for Horizontal / Vertical/ Reverse
Laminar Air Flow installed in Production and Warehouse Area of, Injection Block used for
supplying Laminar Air Flow and maintains the air cleanliness as per ISO class 5 level.
4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from each of the following Departments, shall
be responsible for overall compliance of this Protocol:

DEPARTMENTS RESPONSIBILITIES

 Shall prepare & Review the performance requalification protocol as

per the Regulatory guideline and Validation Master Plan.
 Execution of the performance requalification protocol with Production,
Quality Control & Maintenance department: verification of
components calibration records of instrument. Verification of test &
Results.
Quality Assurance  Deficiency (if any) & Corrective Action shall compile the data &
Prepare summary report
 Performance requalification protocol shall be approved by the QA
prior and after the execution.
 Shall review the executed protocol to check the compliance and
corrective action for any discrepancies found. Also shall prepare the
summary and conclusion of the performance requalification study.
 Review of Performance Qualification Protocol.
Production
 To co-ordinate and support Performance Qualification Activity.
 Review of Performance Qualification Protocol.
Engineering  To co-ordinate and support Validation Activity.
 Responsible for Trouble shooting during execution (If occurs).

5.0 EQUIPMENT DETAILS:

Equipment Name Horizontal / Vertical/ Reverse Laminar Air Flow

SEA/DPI/GF/LAF-01 to SEA/DPI/GF/LAF-13, SEA/DPI/GF/MLAF-01,
Equipment ID.
SEA/DPI/GF/DGC-01, SEA/DPI/GF/RLAF-01, SEA/WH/GF/RLAF-01.
 Manufacturer’s Name M/s Suvidha Engineers

Supplier’s Name M/s Suvidha Engineers

Place of Installation Production and Warehouse Area, Injection Block.

6.0 SYSTEM DESCRIPTION:

The Horizontal / Vertical/ Reverse Laminar Air Flow is used to maintain the air cleanliness as per ISO
class 5 level. Critical processes are carried out under Horizontal / Vertical / Reverse Laminar Air
Flow where the product and product contact surface are exposed to 0.3 µ filtered air.
During processing, movement of air shall be through the pre filter (5 micron) and then passes through
HEPA filter (0.3 micron).

7.0 REASON FOR QUALIFICATION:

 Installation of New System.

 Any major modification in the existing system.

 Change of Location.
 Periodic requalification
 Any other (Specify the reason in Qualification Report)

8.0 SITE OF STUDY:

Production Area, Injection Block,
FREQUENCY OF QUALIFICATION :

S. No. Test parameter Frequency

1 Air Velocity Once in every 6 months + 1 month.
2 HEPA Filter Integrity Test (PAO Test) Once in every 6 months + 1 month.
3 Non Viable Particle Count Test Once in every 6 months + 1 month.
4 Air Flow Pattern Test (Smoke Test). Once in 2 years + 1 month.
5 Differential Pressure Monitoring Test Once in every 6 months + 1 month.
6 Environment Monitoring Daily

9.0 PRE-QUALIFICATION REQUIREMENTS :

9.1 TEST EQUIPMENT:
All instruments used for revalidation must be calibrated.
9.2 TRAINING OF EXECUTION TEAM:
 Provide the training to a team for the execution of protocol before execution of the same. Record of
training shall be recorded in Performance Qualification Report No. PQR/CEQ/014-01.
10.0 TESTS & CHECKS:
10.1 AIR VELOCITY:
A) OBJECTIVE:
This test shall be performed to check the air flow velocity in the Horizontal/ Vertical/ Reverse
Laminar Air Flow.
B) EQUIPMENT / INSTRUMENT USED:
Vane Type Anemometer
C) PROCEDURE:
 All Horizontal/ Vertical/ Reverse Laminar Air Flow shall be in continuous operation.
 Switch “ON” the anemometer and allow it for some time for stabilization.
 Keep the anemometer in FPM mode.
 Take the velocity reading of air at five locations (one at center and four in corners as shown
in the Figure-1) of each filter, 150 mm (Approximately 6 inches) below the filter face.
Figure-1
1 2

HEPA Filter Sampling location

Reading shall be taken placing anemometer 5 for about 10 seconds at each location.
4 3
Calculate average velocity for each filter using following formula
V = v/I
Where;
V =Average velocity in ft. /min; v = individual velocity reading; I =No. of locations
D) ACCEPTANCE CRITERIA:
Air velocity should be 90±20% ft. /min.

E) RESULT RECORDING:
Record the results in Performance Qualification Report No.
10.2 HEPA FILTER INTEGRITY TEST (PAO TEST):
A) OBJECTIVE:
This test is performed to ensure that the HEPA filter installed are maintaining their porosity
and fixed properly in the appropriate place, such that there is no leakage from the filter media
and other joint gaskets, frames etc.
B) EQUIPMENT / INSTRUMENT USED:
 PAO Generator
  Photometer
C) PROCEDURE:
 All Horizontal / Vertical/ Reverse Laminar Air Flow shall be in continuous operation.
 Connect the Upstream port of HEPA filter to the Upstream Port of aerosol Photometer.
 Connect the Scanning Probe to downstream port of Photometer.
 Switch “ON” the Horizontal / Vertical/ Reverse Laminar Air Flow and open dry compressed
air line to aerosol generator so that generated aerosol vapor (concentration of 20 to 80
mg/m3) sucked by the blower.
 Adjust the dry compressed air Pressure in the range of 1-2 kg/cm² to aerosol generator.
 Switch “ON” the aerosol Photometer and set the upstream concentration to 100%. Once the
100 % setting is established at the upstream side, turned the instrument knob to downstream.
 Keep the scanning probe approximately 1 inches/ 3cm below the HEPA filter face and started
scanning the entire HEPA filter face area and frame area of filter and ensured that scanning
rate is not exceeding 15cm /sec.
D) ACCEPTANCE CRITERIA:
The filter leakage should not be more than 0.01

E) RESULT RECORDING:
Record the results in Performance Qualification Report No. PQR/CEQ/014-01.
10.3 DIFFERENTIAL PRESSURE MONITORING:
A) OBJECTIVE:
This test is performed to ensure that the differential pressure of Horizontal / Vertical/ Reverse
Laminar Air Flow is maintained as per specified limit.
B) EQUIPMENT / INSTRUMENT USED:
Magnehelic Gauges.
C) PROCEDURE:
 All Horizontal / Vertical/ Reverse Laminar Air Flow shall be in continuous operation.
 Monitor the Differential pressure of Horizontal / Vertical/ Reverse Laminar Air Flow at
interval of 1 hour (9 am to 5:30 pm) for consecutive 3 days as per limit defined in SOP No.
SEA/QAD/043 “Recording of temperature, Relative humidity and differential pressure.”
D) ACCEPTANCE CRITERIA:
Differential pressure of the LAF in between 8-16 mm of WC.

E) RESULT RECORDING:
Record the results in Performance Qualification Report No. PQR/CEQ/014-01.
10.4 AIR FLOW PATTERN TEST (SMOKE TEST):
A) OBJECTIVE:
 This test shall be performed to verify unidirectional air flow in front of Horizontal / Vertical/
Reverse Laminar Air Flow.
B) EQUIPMENT / INSTRUMENT USED:
 Smoke Generator.
 Video Recording Camera.
C) PROCEDURE:
 All Horizontal / Vertical/ Reverse Laminar Air Flow shall be in continuous operation.
 Before performing the Air flow pattern test, identified the Horizontal / Vertical/ Reverse
Laminar Air Flow name & ID and video recording to be carried out of smoke visualization.
 Airflow test shall be performed in the following events,
 At rest conditions
 Dynamic conditions.
D) ACCEPTANCE CRITERIA:
 The air flow from the laminar air flow units shall be uniform, unidirectional without any
turbulence at the critical points of product exposure.
 The air flow shall demonstrate air after hitting the surface should not bounce back to the
same surface and carried away from the surface to return risers.
E) RESULT RECORDING:
Record the results in Performance Qualification Report No. PQR/CEQ/014-01.
10.5 NON-VIABLE PARTICLE COUNT TEST:
A) OBJECTIVE:
This test shall be performed to demonstrate that the clean room complies with ISO standards.
B) EQUIPMENT / INSTRUMENT USED:
Non-viable particle counter.
C) PROCEDURE:
All Horizontal / Vertical/ Reverse Laminar Air Flow shall be in continuous operation.
 Operate the counter as per respective SOP.
Connect the probe to the sampling port.
Count the particle at locations marked on the diagram at work level and run the particle counter
for 10 minute at the flow rate of 100 Ltr air / minute.
Before carrying out this test, ensured that the area is flushed for 1 hour with no person and
material movement inside the room. The areas got cleaned after the test.
The cumulative readings of 0.5µm and 5.0 m shall be used for the area classification
Paste the printouts generated by the particle counter on A4 page and shall be photocopied.
Verify the printouts for all calculations and acceptance criteria mentioned below.
D) ACCEPTANCE CRITERIA:
 Maximum permitted no of particles / cubic meter of air
ISO
At Rest In operation
Class
≥ 0.5µm ≥ 5.0 µm ≥ 0.5 µm ≥ 5.0 µm

5 3,520 00 3,520 00

E) RESULT RECORDING:
Record the results in Performance Qualification Report No. PQR/CEQ/014-01.
10.6 MICROBIOLOGICAL MONITORING:
A) OBJECTIVE:
This test is performed to ensure that the Horizontal / Vertical/ Reverse Laminar Air Flow is
free from microbial contamination or under specified limit.
B) EQUIPMENT / INSTRUMENT USED:
 Calibrated Air sampler
 Media plates.
C) PROCEDURE:
a) Active Air Sampling:
 Sampling shall be done for three consecutive 03days at pre determined locations.
Operate the air sampler as per the SOP No. SEA/QCD/114 and sample the air at least
1000 liters at each pre determined locations.
 Microbiological monitoring data of Active Air Sampling shall be attached with periodic
qualification report.
b) Passive Air Sampling:
 Sampling shall be done for three consecutive days at pre determined locations. Plate
exposure shall be followed as per the SOP No. SEA/QCD/114 at each pre determined
locations.
 Microbiological monitoring data shall be attached with periodic qualification report.
D) ACCEPTANCE CRITERIA:
Active air sampling Settle plate monitoring
ISO Class
(CFU/m3) (CFU/plate/4 Hrs)
5 <1 <1

E) RESULT RECORDING:
Record the results in Performance Qualification Report No. PQR/CEQ/014-01.
11.0 CHECKLIST OF ALL TESTS AND CHECKS:
This checklist is provided to ensure that all tests or checks required for this protocol to be executed and
consisting of following tests.
 S. No. TESTS OR CHECKS
01 Air Velocity
02 Filter Integrity Test (PAO Test)
03 Differential Pressure Monitoring
04 Air Flow Pattern Test (Smoke Test)
05 Non-Viable Particle Count Test
06 Microbiological Monitoring
12.0 REFERENCES:
 Operation Manual of LAF’s.
 SOP No. SEA/IND/033 “Operation and Cleaning of Laminar Air Flow”.
 Validation of Pharmaceutical Process, Frederick J. Carleton & James P. Agalloco.
 ISO 14644:2015 part 1, 2 & 3.
13.0 DOCUMENTS TO BE ATTACHED:
 External Agency Instruments Traceability
 Certificates from External Agency.
 Microbiological Test Report.
 Temperature and Relative Humidity Monitoring.

14.0 NON COMPLIANCE:

All non-compliance, during the execution of protocol shall be handled as per current version of SOP
“Handling of General Non-Compliance” and same shall be a part of Validation Report.
15.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY:
All protocol deviation, non conformances and out of specification results obtained shall be
investigated as per current version of SOP “Handling of Deviation” and same shall be a part of
Validation Report.
16.0 CHANGE CONTROL, IF ANY:
All change control, during the execution of protocol shall be handled as per current version of SOP
“Change Control” and same shall be a part of Validation Report.
17.0 ABBREVIATIONS:
No. : Number
Ltd. : Limited
ID No. : Identification Number
QA : Quality Assurance
SOP : Standard Operating Procedure