Validation of Laminar Air Flow and Its SOP

Validation of Laminar Air Flow; Purpose

To validate Laminar Air Flow in order to support of processing area and Microbiology Test.

Validation of Laminar Air Flow; Scope

This SOP applies for validation of Laminar Air Flow used in Processing area and Microbiology Section XX Pharmaceuticals Ltd.

Definitions/Abbreviation :

Validation: Validation is the established documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications & quality attributes.

DOP Test: Dioctyl Pthalate is a combustible non-toxic colorless oily liquid with slight odor. This chemical is used in HEPA filter integrity test at vaporized condition by DOP Test Meter.

[] HEPA : High Efficiency Particulate Air

[] CSDA : Casein Soyabean Digest Agar

[] SDA    : Sabouraud Dextrose Agar

[] LAF    : Laminar Air Flow

 Responsibilities

The roles and responsibility is as follows

Executive/ Senior Executive, Microbiology

Perform Microbiology Air monitoring of Laminar Air Flow & report preparation.

Executive/ Senior Executive, Engineering

Perform Air Velocity Test, DOP test and report preparation.

Microbiology/ Assistant Manager, Engineering

Ensure Laminar Air Flow Validation, documentation and application of sound technical information.

Head of Quality Assurance

Take initiative to Approval of SOP

Procedure:

Instructions

• Wear protective items such as sterile latex free gloves, laboratory coat and eye protection (if required).
• Disinfect whole surface of all apparatus with the help of 70% IPA or any others disinfectants before transferring into Laminar Air Flow.
• Make sure that all personal ornaments, cell phone are left to prevent unauthorized contamination, before working under Laminar Air Flow.

Microbiological Monitoring

• Start Laminar Air flow at least before 30 minutes of validation.
• Select sampling point as mentioned on Table-1.
• Expose sterile CSDA and SDA plate for 30 minutes under LAFWS at different location as per sampling points.
• After sampling, cover all plates with the glass lids.
• Incubate all CSDA plate at (30 to 35)⁰C for 72 hours and SDA plate at (22 to 25)⁰C for 5 days including positive control & negative control plate.
• After incubation, count the CFU per plate.
• Report in Laminar Air Flow Validation Report, Annexure-I.
• Perform this test yearly.

 Detection of Air Velocity

• Disinfect outer surface of Anemometer with the help of 70% IPA before transferring into LAF.
• Measure distance 6” from HEPA.
• Take air flow reading of HEPA of LAF by moving smoker from left to right & top to down.
• Check that any deviation of reading found for air velocity. If found mark that point.
• Report Air Velocity & Filter Integrity Test Report of Laminar Air Flow, Annexure-II.

Filter Integrity Test

• Set DOP Test Meter with DOP test port of LAF.
• Run machine as per SOP of DOP Test Meter.
• Take air by smoker of DOP Test & record the reading.
• Check any deviation of reading.
• Report Air Velocity & Filter Integrity Test Report of Laminar Air Flow, Annexure-II.

Validation Frequency

Perform LAF Validation once in a year.

 

Corrective Action:

[] If growth obvers in anyone plate, inform the test result to concerned department & Engineering Department for corrective action.

[] If the test result found out of specification in Air Velocity Test or Filter Integrity Test, Engineering department shall take necessary action.

[] Microbiology Section and Engineering Department shall perform the complete test.

Download All Annexure Here:

Annexure I Air Velocity & Filter Integrity Test Report of Laminar Air Flow Biosafety Cabinet
Annexure II Laminar Air Flow Bio-safety Cabinet Validation Report