Laminar Air Flow Operational Qualification, Purpose
Laminar Air Flow Operational Qualification, 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.
Laminar Air Flow Operational Qualification, 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 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.
Responsibility
- Preparation of protocol
-Engineering Department. - Executing the protocol
-Engineering department or other suitably qualified staff allocated from the site or contracted specialists as appropriate. - Providing documentation of the equipment
-Related departments i.e. Engineering Production, Validation or other appropriate departments and manufacturer. - 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.
Background
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.
Purchasing Information
[][]Manufacturer: GUSU
[][]Local Agent: LS Techno Trade
[][]Model Number: GMP Standard
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.
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. No. | SOP Name | Effective Date | Acceptable (Yes/ No) | Initials with date |
|---|---|---|---|---|
| 01 | Operation and Cleaning of Laminar Air Flow Unit. | |||
| 02 |
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 |
|---|---|---|---|---|
Operational testing
- Verification of start-up and normal sequence of operation
- Record results of checks in the following table:
| Criterion No. | Action to be taken | Acceptance Criteria | Compliant Yes/No | Initial/Date |
|---|---|---|---|---|
| 01 | Switch ON the main power. | The voltage will be shown on the display. | ||
| 02 | Switch ON the blower by pressing the ON button. | The blower has to be ON and air will start flowing vertically. | ||
| 03 | Differential Pressure gauge for HEPA Filter is functioning properly. | The differential pressure gauge should show pressure from zero to positive direction. |
Smoke Test
- Purpose: The purpose of the smoke test is to justify the airflow direction under the HEPA Filter is unidirectional.
- Test Method:
- The smoke test will be performed by ______________________ According to the SOP No. _____________________________.
Test Equipment/Material: Dry Ice and water. - Acceptance Criteria: Airflow direction is unidirectional and vertical. Attach a copy of the report of Smoke test.
Filter Integrity Test
- Purpose: Filter Integrity test is performed using Poly Alpha Olephin (PAO) to check any leakage of the filter.
- Test Method: The test is performed by ____________________ according to the SOP NO. ______________________________.
- Test Equipment: PAO generator, Optical Photometer.
- 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.
Air Velocity Test
- Purpose: The purpose of this test is to ensure the air velocity for laminar flow.
Test Method:
- 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.
- 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.
- Test Equipment: Calibrated anemometer.
- Acceptance Criteria: Measured air velocity should be in the range of 0.36 m/sec ~ 0.54 m/sec.
Result:
No. 1 HEPA
No. 2 HEPA result shall be plotted.
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.
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Laminar Air Flow Operational Qualification