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 Airflow.

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 particle concentration with size distributions.
• The system should be kept ON 2hrs before starting measurements.
• Ensure that the floor and area as well as equipment is visually cleaned.
• Use a calibrated particle counter and carry out particle counting at corners and centers of the Laminar Airflow 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 airflow velocity, volume, and uniformity, to determine the air supply volume flow rate.
• Clean the instrument with IPA and the system should be kept ON before starting the measurements.
• Measure the air velocity near the HEPA filter at a distance of 6 inches below the filter.
• Carry out measurements by using a calibrated Anemometer. Check the velocity at the corners and center of the HEPA – Filter. The limit is 40-80 fpm.

DOP Test:

• DOP Test is performed by introducing DOP aerosol upstream of the HEPA – filter and searching for leaks by scanning the downstream of the HEPA filter with a calibrated photometer probe.
• Measure the upstream aerosol concentration using a 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.

Frequency: Particle Count: 6 months, Air Velocity: 12 Months, DOP Test: 24 Months.

Note: DOP Test, Air Velocity Measurement, and particle count monitoring testing should be carried out by an authorized external agency.

Check the effectivity of the UV tube by the 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 minutes.
• 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 the incubation period count the cfu and record the results in the format “Verification of efficiency of UV”
• After incubation, cfu should be nil in all plates.

Frequency: Once 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

ALSO READ: SOP for Preparation and Sterilization of Microbial Media