The Laminar Air Flow LAF PQ Protocol and Report demonstrate that the system consistently performs within predefined specifications. This step by step guide explains all the details regarding the qualification of the LAF that is used in pharmaceutical industries for maintaining the area.
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Protocol Approval
PROTOCOL PREPARED BY:
| Department | Name | Signature | Date |
| Quality Control |
PROTOCOL REVIEWED BY:
| Department | Name | Signature | Date |
| Quality Assurance (Executive/ Manager) | |||
| Head QC (Manager) | |||
| Engineering (Officer/ Executive) |
PROTOCOL APPROVED BY:
| Department | Name | Signature | Date |
| Quality Assurance (Head QA) |
Objective of the LAF PQ Protocol
The objective of this Performance Qualification report is to:
- To provide evidence that the equipment performance is in accordance with the predefined standard.
- To demonstrate that the system is performing reproducibly and consistently within its Pre defined operating range.
Scope of Performance Qualification
The document includes the Performance Qualification report of the following system:
| In-house name of the equipment | Laminar Air Flow System |
| Equipment identification number | |
| Supplier Name and address |
Reference Documents and Applicable Guidelines
Following documents are referred during preparation of the report:
| Document Name | Document Number |
| PQ protocol of LAF |
Performance Qualification Test Plan
The qualification of the LAF was done by verifying / testing the parameters as listed in the following table –
| S. No. | Tests | Start Date of Study |
| Differential pressure measurement | ||
| Air Velocity | ||
| HEPA filter Integrity Test | ||
| Non-Viable Particulate count Monitoring | ||
| Air Borne Viable Particulate Monitoring | ||
| Smoke Test (Flow pattern study) |
The above-mentioned tests provided a documented verification of the performance of the area throughout the representative / anticipated range & ensure that the area is maintaining satisfactorily.
Step-by-Step LAF PQ Protocol Procedure
The methodology used to execute each test along with the observations and results is given below:
Differential pressure measurement:
The differential pressure of the LAF was well maintained as per the pressure zoning concept so that the pressure cascade and the required cleanliness as per the hygiene zone was achieved and maintained.
This test was performed in the following conditions / situations during the validation study:-
- 03 consecutive days under “at rest” condition.
- 03 consecutive days under “dynamic” condition.
The Differential Pressure was monitored through the Calibrated Magnehelic Gauges installed on LAF. The validation port was sealed with silicone sealant so that steam leakage does not occur.
The LAF was started 20 minutes prior to the start of test.
The above procedure was repeated for 3 consecutive days in rest condition and 3 consecutive days in operation condition.
Air Velocity Test:
This test was performed to demonstrate that the LAF is balanced and capable of delivering sufficient air volumes to maintain a minimum cross-sectional velocity as per design.
Test was executed in each LAF and across HEPA filter as applicable.
Anemometer was kept below the face of HEPA filter and velocity was recorded.
Measurement was taken for minimum of 30 seconds at each location.
Velocity (in FPM) was determined on 5 locations i.e. centre + four corners, for the filter using Anemometer in
| V1 V2 V3 V4 V5 |
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Average velocity in FPM (Feet per minute) = V1+V2+V3+V4+V5/5
HEPA filter Integrity Test:
This test was performed to ensure that the HEPA filter installed in LAF were not damaged during operation so that there was no leakage from the filter media and the other joint gaskets, frames etc. or check the filter integrity.
Test was performed when LAF was in operation mode.
PAO cloud/aerosol was introduced as a challenge agent into the upstream side of the HEPA filter system with the range of 20- 80 mg/m3 concentration and concentration in the photometer was detected.
Photometer upstream concentration was set to 100%.
Once the 100% setting were established at the upstream side, the instrument knob was turned to downstream. Scanning probe was kept one inch below the HEPA filter and scanning was started of the HEPA filter face and fitment of HEPA filter with frame.
All the HEPA filters listed in the were tested and were within the accepted limits
The complete data generated during the qualification test was compiled for complete evaluation of the system. The collected data was examined to identify-
The upstream concentration was within the range of 20- 80 mg/m3
The downstream penetration was less than 0.01% for 100% set up stream concentration.
Aerosol at the downstream of the HEPA filter surface and joints were less than 0.01% of the upstream concentration.
Non-Viable Particulate count Monitoring:
This test was performed to ensure that the LAF is capable of achieving and maintaining the desired cleanliness as per standard within the control limits and for desired time period. The test also ensured that the LAF is also capable of maintaining the same during one year irrespective of the seasonal variation.
Sampling Procedure followed during execution is mentioned below.
Particle counter was setup in accordance with the manufacturer’s instructions.
The volume of air sampled was as per EUGMP standard.
The sampling probe was positioned pointing into the airflow.
Sampling volume for grade A was minimum 1 m3 air volume at each location
Result of each sample measurement was recorded as the concentration of each of the considered particle size i.e. 0.5µ and 5.0µ diameter.
Where only one sampling location was used, the average value of the sample data for each considered particle size was calculated and recorded.
The clean zone were meeting the specified air cleanliness classification mentioned below:
| Grade | Particles / M3 | |||
| 0.5µm | 5.0µm | |||
| At rest | In operation | At rest | In operation | |
| Class A | 3520 | 20 | 3520 | 20 |
Viable Particulate count Monitoring: LAF PQ Protocol
This test was performed to ensure that the LAF is capable of achieving and maintaining the desired cleanliness as per the EUGMP within the control limits and for desired time period.
The particle count test was performed by trained personnel only.
Measuring and testing instruments being used were calibrated with reference to the NPL traceable reference standard.
While performing particle counts in static conditions, test was performed with men in material absent.
While performing particle counts in dynamic conditions, test was performed with maximum allowable material presence.
Viable particle count monitoring at rest condition & in dynamic condition for grade A was performed successfully.
The viable count was done by using the following methods:
1. Active air sampling (Volumetric Air Sampling)
2. Passive air sampling (Settle Plate)
3. Surface sampling
The clean zone was meeting the specified limit of air cleanliness for as per EUGMP standards
Smoke Test (Air Flow Pattern Study):
This Test was performed to establish that the airflow pattern in the critical activity points (e.g. processing equipment where product is exposed and needs protection) was appropriate to ensure protection of product and safe guard against any possible contamination and cross contamination.
The air flow pattern was evaluated at the points where probability of air stagnation was high to rule out any dead pockets.
Smoke was generated near the supply HEPA and video graph was carried out to record the air flow pattern over and around critical process equipment/ activity area, return riser and doors.
The air flow was adequately flushed and covered the equipment and was vertical.
There were no eddy currents and dead pockets found.
The airflow was observed from area of high pressure to area of low pressure.
Acceptance Criteria for LAF Qualification Tests under LAF PQ Protocol
| Test | Description |
| Differential Pressure | The differential pressure should be within the desired specification. |
| Air Velocity Test | The air velocities at each point on a filter should be within (FPM) 90±20% of the average air velocity of that filter. |
| HEPA Filter Integrity Test | The upstream concentration shall be within the range of 20- 80 mg/m3The downstream penetration should be less than 0.01% for 100% set up stream concentration. The scanning speed should not exceed 5 cm/sec. Aerosol at the downstream of the HEPA filter surface and joints should be less than 0.01% of the upstream concentration. In case if the sealed area is more than 1% and/or any individual sealed area is more than 1 m2 then the filter should be rejected and replace with the new one |
| Non- Viable Particle Count | The clean zone is deemed to have met the specified air cleanliness classification if the averages of the particle concentrations measured at each of the locations do not exceed the concentration limits |
| Air Borne Viable Particulate Monitoring | The clean zone is deemed to have met the specified limit of air cleanliness. |
| Smoke Test (Air Flow pattern study) | The air flow should adequately flush and cover the equipment and should be vertical.There should not be any eddy currents and dead pocketsThe airflow should be observed form area of high pressure to area of low pressure through doors and openings |
Summary and Final Conclusion
Summary Report :
The following conclusion can be made after execution of PQ and reviewing the annexure.
Air Borne Viable Particulate Monitoring:
The Clean rooms met the specified limit of air cleanliness as per standards. All the counts observed were within the limit and meets the acceptance criteria of the protocol. No count was observed over limit.
Below mentioned are the limits below which counts were observed.
| Grade | A |
| Settle Plate (90mm) | <1 CFU per meter cube |
| Surface Monitoring (55 mm) | <1 CFU per plate |
Conclusion:
On the basis of results observed it is concluded that the LAF is consistentlycapable for obtaining and maintaining the required working conditions asestablished in Performance Qualification Protocol.
No Deviation was observed during the qualification of LAF protocol
The air flow adequately flushed and covered the activity area and was vertical. There were no eddy currents and dead pockets found. The airflow was observed from area of high pressure to area of low pressure.
It is thus concluded that the systems, are meeting the acceptance criteria specified in the performance qualification.
Therefore, on the basis of this qualification study the LAF are qualified for microbiology area on the set parameters at which the validation was successfully executed.
Note: As this report is for initial qualification so, new protocol shall be made for periodic qualification with numbering character as mentioned in for Performance Qualification document.