Header Ads Widget

SOP for Validation of Laminar Air Flow

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

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

Microbiologist or QC -In charge.

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.

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.

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

Post a Comment