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SOP for Validation of Laminar Air Flow

Purpose
To describe a procedure for carrying out validation of LAF and to check the effectivity of UV light.

Scope
This SOP is applicable to the validation of Laminar Air flow.

Responsibility
Microbiologist or QC -In charge.

Procedure
Validate the laminar flow by following tests:

Particle count:
  • This test method specifies the measurements of air born particles concentration with size distributions.
  • System should be kept ON 2hrs before starting measurements.
  • Ensure that the floor and area as well equipments is visually cleaned.
  • Use calibrated particle counter and carry out particle counting at corners and centers of Laminar Air flow unit.
  • The limit is :
  1. 0.5 μ NMT 100 particle/ft3 of air
  2. 5.0 μ NIL particle/ft3 of air
  • Record the mean particle count in the format for “Report of Validation of Laminar Air Flow”.

Air Flow Velocity Measurement:
  • This test is performed to determine the average air flow velocity, volume, and uniformity, to determine air supply volume flow rate.
  • Clean the instrument with IPA and system should be kept ON before starting the measurements.
  • Measure the air velocity near the HEPA filter at a distance of 6 inch below the filter.
  • Carry out measurement by using calibrated Anemometer. Check the velocity at corners and center of the HEPA – Filter. The limit is 40-80 fpm.


DOP Test:
  • DOP Test is performed by introducing DOP aerosol at up stream of HEPA – filter and search for leaks by scanning the downstream of HEPA filter with calibrated photometer probe.
  • Measure the upstream aerosol concentration using calibrated photometer. Adjust tested and search the area for any leakage.
  • DOP Test passes with penetration less than 0. 003 %.
  • The report of DOP testing will be attached and received from the authorized agency.

F
requency: Particle Count: 6 months, Air Velocity: 12 Months, DOP Test: 24 Months.
Note: DOP Test, Air Velocity Measurement & Particle count monitoring testing should carried out by authorized external agency.

Check the effectivity of UV tube by following procedure:
  • Prepare Soyabean casein digest agar plates; incubate the plates for 24 hours at 30-35°C to check the sterility of the medium. Discard the contaminated plates, if any.
  • Clean the surface of Laminar Air Flow with 70% IPA.
  • Put ON the UV light for 30 min.
  • Label the plates for the following:
  1. Name of the place
  2. Date of exposure
  • After 30 min. put OFF UV light put ON normal light and Laminar Air Flow.
  • Expose the Soya bean Casein Digest Agar plates for 1 hr.
  • Incubate the plates at 35°C for 48-72 hrs.
  • After completion of incubation period count the cfu and record the results in format “Verification of efficiency of UV”
  • After incubation cfu should be nil in all plates.

Frequency: Once in a month.

Abbreviations
DOP : Dioctyl Pthalate
HEPA : High Efficiency Particulate Filter
LAF : Laminar Air Flow
UV : Ultra Violet
CFU : Colony Forming Unit
FPM : Feet Per Minute
IPA : Iso Propyl Alcohol

Revision History
Nil

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