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Reverse Laminar Air Flow (RLAF) Booths, or sampling and dispensing booths, are another name for them. The product, operator, and environment are all intended to have a mixed air flow stream within the sample and dispensing booth. Since the dust particles that are released have numerous harmful effects, it is necessary to control their outflow.

PQ Protocol for Reverse Laminar Air Flow (RLAF)

INDEX

1.0   Approval Page of RLAF Qualification Protocol

• • Signing of this protocol indicates agreement with the Performance Qualification approach for the Reverse Laminar Air Flow (RLAF) Unit installed in Sampling Booth.

• • Further if any changes in this protocol are required, protocol will be revised and duly approved.

 2.0   Objective:

• • The purpose of this protocol is to provide the documentary evidence for performance qualification of the Reverse Laminar Air Flow unit.

3.0   Scope:

• • This protocol covers all aspects of Performance Qualification of the Reverse Laminar Air Flow Unit (RLAF) installed in Sampling Booth.

4.0   Responsibility:

• • Quality Assurance:
    • Review of results and compiling of protocol
    • Preparation and approval of PQ protocol.

• • Production Department

• • • Checking of protocol.

• • Quality Control Department

• • • Performing testing
    • Preparation of Analysis Report and submission to Quality Assurance.
    • Checking of Report.

• • Engineering Department

• • • Rectification of Breakdown during qualification study.
    • Checking of Report.

• Elements of Re-Qualification:

  • Equipment Description:
    • Equipment Details:

• • Use of Equipment: To maintain/ control the class 100 (Grade-A).

• • Name of the Equipment: Reverse Laminar Air Flow (RLAF).

• • Make of the Equipment: ________________________________

• • Model No.: ___________________________________________

• • Serial No.: ___________________________________________

• • Equipment ID No.: _________________________________

• • Location of the Equipment: _____________________________

• •  Basic Design/Operation features of Equipment:

  • Unidirectional vertical down flow clean air work station with SS 304 construction and comprising as standard features: Mini pleat HEPA filters, Pre-filters 5µ, Motor Blower, alarm, White light, Ceiling suspension arrangement, Feather touch ON/OFF switches for blower and light are provided.

• • Major components

• • Pre filter:

Blower – Motor:

Single phase, 50Hz, RPM-1440 and 230V, 0.5 HP, Extra Electrical Point for Weighing Balance and Validation, Make-Green Valley to provide required airflow volume over the anticipated life of the HEPA filter, Special bearings to ensure low noise levels.

 Mini Plate HEPA filter:

Exhaust HEPA Filter:

Intermediate Filter:

• Pre-Qualification test results of RLAF:

  • Verification of Calibration of Measuring Instruments:

• • Objective

• • To verify that all measuring instruments used in the equipment are in calibrated condition prior to execute the performance test.

• Summary of PQ – RLAF

• All measuring instrument installed to the Reverse Laminar Air Flow Unit were found in calibrated state and summary of calibration verification mentioned in below table:

•  Observation and Results

  • Verified and attached all calibration certificate  with the report.

• Calibration Verification of Test Instruments:

• • Objective

• • To verify that all test instruments used in the equipment qualification activity are in calibrated condition prior to test execution.

• • Summary

• • All test instrument used for Reverse Laminar Air Flow Unit re-qualification study were  found in calibrated state and summary of calibration verification mentioned in below table:

• •  Observation and Results

• • Verified and attached calibration certificate  with the report.

• Verification of Standard Operating Procedure:

• • Objective

• • To verify that the current version of SOP shall be used during performance qualification study.

• • Summary

• • The following SOPs were verified for its current version, mentioned in  below table:

• Qualification Tests and Results:

  • Air Velocity Measurement Verification:

• • Objective:

• • To verify and establish that the air system is balanced and capable of delivering sufficient air velocity to maintain a reverse laminar air flow.

• • Summary:

• • Air Velocity Measurement was performed as per procedure defined in the respective protocol and results meets the acceptance criteria defined in the protocol and results are as below:

• Acceptance Criteria

• The velocity as all locations shall be 90 FPM ± 20% (0.45 m/s ± 20%) when measured at 6 inches downstream from the filter face.
• Results 
• Observations and results were recorded and also attached with report.

• Integrity Testing of HEPA Filters (By External Agency)

  • Objective:

• • To establish that the integrity of the HEPA Filters installed in the Reverse Laminar Air flow is meeting the desired requirement.

• • Summary:

• • Integrity Testing of HEPA Filters was performed as per procedure and results meet the acceptance criteria and test results are as below:

• Acceptance Criteria:

• • The Aerosol penetration/leak through HEPA filters shall not be more than 0.01% of the upstream concentration.

• Results 
  • Observations and results were recorded and also attached with report.

• Differential Pressure Monitoring:

• Objective

• • The objective of this test is to show that the differential pressures across the HEPA filter of Reverse Laminar Air flow are within designed accepted values.

• • Summary:

• • Differential Pressure Monitoring was performed for three consecutive days in morning, afternoon and evening time and its results were meets the acceptance criteria.

• Acceptance Criteria

• • The ∆P across the HEPA filter should be between 08-18 mm of water.

• • The ∆P across the Intermediate filter should be between 02 – 06 mm of water.

• • The Negative Pressure should be between 0.5 – 2.5 mm of water.

• Results

• • Observations and results recorded in annexure no.: I and also attached with report.

• Non Viable Particle Monitoring:

• • Objective

• • To establish that Reverse Laminar Air flow unit is capable to achieve the requirement of Grade A conditions for Non-Viable Particulates under RLAF.

• • Summary:

• • Non Viable Particle Monitoring was performed for both conditions viz. at rest as well as in operation and its results was meets the acceptance criteria and details test results is as below table:

• Acceptance Criteria

• The measured particle count should meet the acceptance criteria defined in Table

• • Results

• • Observations and results are recorded and also attached with report.

• Microbiological Environmental Monitoring:

  • Objective:

• • The objective of this test is to verify that the Reverse Laminar Air flow can maintain the required cleanliness with respect to microbiological contamination as defined in international Standards:

• • Summary:

• • Test was performed as per procedure mentioned in the respective SOP for Environmental Monitoring and results comply the acceptance criteria.

• • Acceptance Criteria:

•  Observations and Results:

  • Observations and results recorded in the formats given with the protocol and also attached with report.

• • Flow Pattern Studies:

  • Objective:

• • To verify and demonstrate the laminarity and unidirectional parallel airflow throughout the Reverse Laminar Air flow so as to maintain Grade “A” environmental conditions.

• • Summary:

• • As per protocol this test is to be carried once in year. This test was carried out during last performance qualification i.e..

• • Acceptance Criteria

• • The Smoke Flow Pattern should move from top to bottom towards the working surface without any visually significant turbulence.

• Recovery:

  • Objective:
  • This test is to be performed for determining performance and efficiency of Reverse Laminar Air flow system to achieve desired level.

• • Summary:

• • As per protocol this test is to be carried once in year. This test was carried out during last performance qualification i.e.

• • Acceptance Criteria

• • For informatory purpose only.

• Re-Qualification Criteria and Action to be taken In Case of Failure

  • Performance re-qualification of Reverse Laminar Air Flow will be performed twice in year as per the test matrix mentioned in the protocol.

• • The qualification should also be performed additionally in case of following:

• • Any major modification in equipment after the last performance qualification. This must be properly documented through a change control system.

• • Any change in operational parameters with respect to that specified.

• Summary and Conclusion:

• • Based on qualification test results and available data it is concluded that:

• • The tests i.e. Air Velocity Measurement Verification, Integrity Testing of HEPA Filters, Differential Pressure Monitoring, Non Viable Particle Monitoring, Active Air Sampling, Passive Air Sampling are complying the acceptance criteria mentioned in the approved protocol , Hence the Reverse Laminar Air Flow Unit  is qualified for its intended use.

• Attachment: