OPERATIONAL QUALIFICATION PROTOCOL/REPORT

LAMINAR AIR FLOW UNIT OF STERILE AREA OF CEPHALOSPORIN

BLOCK

DOCUMENT NO. :
VERSION NO. :
DATE OF ISSUE :

XX PHARMACEUTICALS LIMITED

117 Adams Street, Brooklyn, NY 11201, USA

LOGO Operational Qualification
Document Title: OQ of Laminar Air Flow Unit
Protocol Document No:
XX PHARMACEUTICALS LIMITED Location:
117 Adams Street, Brooklyn, NY 11201, USA

Approval of Document:

Prepared By:

Name: Rex Barrett

Designation: Manager, Validation
Department: Engineering
Signature & Date:

Checked By:

Name: Caleb Hines

Designation: Manager, Engineering
Department: Engineering
Signature & Date:

Agreed By:

Name: Milton Alvarado

Designation: Manager, Engineering
Department: Engineering
Signature & Date:

Approved By:

Name: Joanna Warner

Designation: Manager, Quality Assurance
Department: Quality Assurance
Signature & Date:

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LOGO Operational Qualification
Document Title: OQ of Laminar Air Flow Unit
Protocol Document No:
XX PHARMACEUTICALS LIMITED Location:
117 Adams Street, Brooklyn, NY 11201, USA

CONTENTS

Page

1 DOCUMENT DESCRIPTION 4

2 PURPOSE 4

3 SCOPE 4

4 RESPONSIBILITIES 4

5 BACKGROUND

6 SYSTEM DESCRIPTION 5

7 VERIFICATION OF SOPs 5

8 VERIFICATION OF TRAINING 5

9 OPERATIONAL TESTING 6

1 INSTRUMENT CALIBRATION 8

1 DEVIATION AND FAILURE INVESTIGATION SUMMARY 9

1 ATTACHMENTS 9

1 REPORT SUMMARY 10

1 CONCLUSION 11

1 VERIFICATION OF COMPLETION 12

5 REPORT APPROVAL 13

1
6

1 ABBREVIATIONS 14

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LOGO Operational Qualification
Document Title: OQ of Laminar Air Flow Unit
Protocol Document No:
XX PHARMACEUTICALS LIMITED Location:
117 Adams Street, Brooklyn, NY 11201, USA

1. DOCUMENT DESCRIPTION
Document No. :
Version No. :
Date :
Description :

2. PURPOSE
To authenticate and document that the Laminar Air Flow Unit of Sterile production area of Cephalosporin Block
of XX Pharmaceuticals Limited (XPL) operates as designed and intended. The operational parameters should
be consistent with the requirements for the manufacturing process.

3. SCOPE
This Operational Qualification (OQ) is to be performed against agreed acceptance criteria on the Laminar Air
Flow Unit installed above the turn table after Depyrogenation Tunnel in Room No. PCR048 of Sterile
Production floor of Cephalosporin Block. The scope will include the verification of previously calibrated
instruments and the availability of operational, maintenance and cleaning procedures.

4. RESPONSIBILITIES
4.1 Preparation of protocol
Engineering Department.
4.2 Executing the protocol
Engineering department or other suitably qualified staff allocated from the site or contracted specialists as
appropriate.
4.3 Providing documentation of the equipment
Related departments i.e. Engineering Production, Validation or other appropriate departments and
manufacturer.
4.4 Data documentation and preparation of the report
Raw data documentation is the responsibility of those conducting the validation. Preparation of the report and
incorporation of data will be the responsibility of the Engineering Department.

5. BACKGROUND
5.1 Project Description & Related issues
This Laminar Air Flow Unit has been installed in the year 20xx in the sterile production area of Cephalosporin
Block for dispensing of raw materials.
5.2 Purchasing Information

Item Brand Origin

Manufacturer GUSU
Local Agent Precisa Techno Trade
CHINA
Model Number GMP Standard
Serial No. N.A

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LOGO Operational Qualification
Document Title: OQ of Laminar Air Flow Unit
Protocol Document No:
XX PHARMACEUTICALS LIMITED Location:
117 Adams Street, Brooklyn, NY 11201, USA

6. SYSTEM DESCRIPTION
A Laminar Air Flow Unit is used to provide unidirectional air flow. Grade A is ensured under LAF using H14
HEPA filter. A blower is used to circulate the air. The air flow direction of this LAF is vertical. There is a
differential pressure gauge to see the differential pressure across the filters which indicate the blockage of
filters.

7. VERIFICATION OF SOPs
The standard operating procedure for operation and cleaning procedure of Laminar Air Flow Unit must be at
least in draft format before commencement of OQ. The necessary information are recorded in the following
table:

Sl. Effective Acceptable

SOP Name SOP No. Initials Date
No. Date (Yes/ No)
Operation and
01 Cleaning of Laminar
Air Flow Unit.

Observations:

SOP completion verified by:

Name _____________________ Designation __________________ Signature__________ Date___________

8. VERIFICATION OF TRAINING
Training should have been given regarding operation, maintenance and cleaning of Laminar Air Flow Unit to all
operators and must be documented. The documentation status is to be recorded in the following tables.
The training is to be recorded in the following tables.

Trainer Name Training course/SOP Name Trainee Name Initials Date

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LOGO Operational Qualification
Document Title: OQ of Laminar Air Flow Unit
Protocol Document No:
XX PHARMACEUTICALS LIMITED Location:
117 Adams Street, Brooklyn, NY 11201, USA

Observations:

Training complete and verified by:

Name _____________________ Designation __________________ Signature__________ Date___________

9. OPERATIONAL TESTING
9.1 Verification of start-up and normal sequence of operation
Record results of checks in the following table:
Verification of Compliance with
Criterio Acceptance Criterion
Action to be taken Acceptance Criteria
n No. Compliant
Initial Date
Yes/No
The voltage will be shown on
1 Switch ON the main power.
the display.

Switch ON the blower by The blower has to be ON and

2
pressing the ON button. air will start flowing vertically.

Differential Pressure gauge The differential pressure

3 for HEPA Filter is functioning gauge should show pressure
properly. from zero to positive direction.

Observations:

Testing complete and verified by:

Name _____________________ Designation __________________ Signature__________ Date___________

9.2 Smoke Test

9.2.1 Purpose: The purpose of the smoke test is to justify the airflow direction under the HEPA Filter is
unidirectional.
9.2.2 Test Method:
The smoke test will be performed by ______________________ According to the SOP No.
_____________________________.
9.2.3 Test Equipment/Material: Dry Ice and water.
9.2.4 Acceptance Criteria: Airflow direction is unidirectional and vertical. Attach a copy of the report of Smoke
test.

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LOGO Operational Qualification
Document Title: OQ of Laminar Air Flow Unit
Protocol Document No:
XX PHARMACEUTICALS LIMITED Location:
117 Adams Street, Brooklyn, NY 11201, USA

Observations:

Testing completed by:

Name______________________Designation_____________________Signature___________Date___________

9.3 Filter Integrity Test

9.3.1 Purpose: Filter Integrity test is performed using Poly Alpha Olephin (PAO) to check any leakage of the
filter.
9.3.2 Test Method: The test is performed by ____________________ according to the SOP NO.
______________________________.
9.3.3 Test Equipment: PAO generator, Optical Photometer.
9.3.4 Acceptance Criteria: Any leakage greater than 0.01% of the upstream challenge aerosol concentration is
considered unacceptable and wants repairs and resetting.
Attach a copy of HEPA filter integrity test certificate in attachment.
Observations:

Testing completed by:

Name______________________Designation_____________________Signature___________Date___________

9.4 Air Velocity Test

9.4.1 Purpose: The purpose of this test is to ensure the air velocity for laminar flow.
9.4.2 Test Method
9.4.2.1 Measure the air velocity under each HEPA filter of the equipment at the distance of 6” below the filter grill
and record the velocity at 5 locations (Shown in following figure) and take the average reading with the
anemometer.
9.4.2.2 Measure the air velocity under each HEPA filter of the equipment at the operation level and record the
velocity at 5 locations (Shown in following figure) and take the average reading with the anemometer.

1 2

4 3

9.4.3 Test Equipment: Calibrated anemometer (ID No.: CC-000-000-MCRI-001 with probe A1)
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LOGO Operational Qualification
Document Title: OQ of Laminar Air Flow Unit
Protocol Document No:
XX PHARMACEUTICALS LIMITED Location:
117 Adams Street, Brooklyn, NY 11201, USA

9.4.4 Acceptance Criteria: Measured air velocity should be in the range of 0.36 m/sec ~ 0.54 m/sec.
9.4.5 Result:
Pressure Drop of HEPA Filter: __________Pa

9.4.5.1 No. 1 HEPA

Location Average
Compliant Checked
Test Level L1 L2 L3 L4 L5 velocity in
(Yes/No) by
(m/sec) (m/sec) (m/sec) (m/sec) (m/sec) m/sec.

6” BELOW
HEPA Filter

9.4.5.2 No. 2 HEPA

Location Average
Compliant Checked
Test Level L1 L2 L3 L4 L5 velocity in
(Yes/No) by
(m/sec) (m/sec) (m/sec) (m/sec) (m/sec) m/sec.

6” BELOW
HEPA Filter

Observations:

Testing completed and verified by:

Name_____________________Designation__________________Signature______________ Date____________

10. INSTRUMENT CALIBRATION

Instrument calibration to be recorded in the following tables:
10.1 Reference instruments

Within Current Calibration

Sl.
Instrument Name ID No. Calibration Record Sheet Initial& Date
No.
(Yes/No) Reference No.

01 Vane Measuring Probe Yes

Differential Pressure
02 Yes
probe

Observations:

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LOGO Operational Qualification
Document Title: OQ of Laminar Air Flow Unit
Protocol Document No:
XX PHARMACEUTICALS LIMITED Location:
117 Adams Street, Brooklyn, NY 11201, USA

Testing completed and verified by:

Name_____________________Designation__________________Signature______________ Date____________

11. DEVIATION AND FAILURE INVESTIGATION SUMMARY

Record in the column below any deviations or failures that occurred during the OQ exercise.

Deviation/
Description and assessment of impact on validation Initial Date
Failure No.

12. ATTACHMENTS
Attached data are listed in the table below:
Attachmen
Description of Attachment Initial Date
t
No.

Attached document verified by:

Name _____________________ Designation __________________ Signature______________ Date____________

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LOGO Operational Qualification
Document Title: OQ of Laminar Air Flow Unit
Protocol Document No:
XX PHARMACEUTICALS LIMITED Location:
117 Adams Street, Brooklyn, NY 11201, USA

13. REPORT SUMMARY

The report summary of Operational Qualification of Laminar Air Flow Unit of Cephalosporin Block is as follows:

Sl. Acceptance Criteria Met Deviation found

Checking parameter
No. Yes No Yes No

1 Verification of SOPs

2 Verification of Training

3 Verification of start up and normal sequence of

operation

4 Smoke test

5 Filter integrity test

6 Air velocity test

7 Calibration of Instruments

Comments:

Performed by:

Name …………………………. Designation …………………… Signature ……………………... Date ……………..

Verified by:

Name …………………………. Designation …………………… Signature ……………………... Date ……………..

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LOGO Operational Qualification
Document Title: OQ of Laminar Air Flow Unit
Protocol Document No:
XX PHARMACEUTICALS LIMITED Location:
117 Adams Street, Brooklyn, NY 11201, USA

14. CONCLUSION

The Operational Qualification of Laminar Air Flow Unit of Cephalosporin Block Complies / Does Not Comply

with the acceptance criteria taken above and the results obtained have been filled up in the respective table of

each test.

The Laminar Air Flow Unit of Cephalosporin Block is / is not qualifying the Operational Qualification test as per

this Protocol. Hence, the system can be / cannot be used for Performance Qualification.

Performed by:

Name …………………………. Designation …………………… Signature ……………………... Date ……………..

Verified by:

Name …………………………. Designation …………………… Signature ……………………... Date ……………..

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LOGO Operational Qualification
Document Title: OQ of Laminar Air Flow Unit
Protocol Document No:
XX PHARMACEUTICALS LIMITED Location:
117 Adams Street, Brooklyn, NY 11201, USA

15. VERIFICATION OF COMPLETION

Department Name Designation Signature Date

Comments:

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LOGO Operational Qualification
Document Title: OQ of Laminar Air Flow Unit
Protocol Document No:
XX PHARMACEUTICALS LIMITED Location:
117 Adams Street, Brooklyn, NY 11201, USA

16. REPORT APPROVAL

Name Designation Signature & Date

Milton Alvarado Manager, Engineering

Laurie Ramirez Manager, Plant

Joanna Warner Manager, Quality Assurance

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LOGO Operational Qualification
Document Title: OQ of Laminar Air Flow Unit
Protocol Document No:
XX PHARMACEUTICALS LIMITED Location:
117 Adams Street, Brooklyn, NY 11201, USA

17. ABBREVIATIONS

Short Form Full meaning

N.A Not Available

N/A Not Applicable

LAF Laminar Air Flow

HEPA High Efficiency Particulate Air

SOP Standard Operating Procedure.

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