Laminar air flow & biosafety cabinet validation

Validation
1

What should be frequency for LAF & biosafety cabinet validation? Is it to be done once in a year? is there any standard which specifies this?

2

LAF and biosafety cabinet has HEPA filters therefore, frequency should be once in six months.

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3

Normally the purpose of LAF & Biosafety cabinet is to ensure maximum protection & minimize the contamination i.e. protection of the worker, product and environment from exposure to microbiological agents

For that certain Performance specifications have been established by NSF/ANSI Standard 49 for the evaluation of Class II laminar flow biological safety cabinets. Various tests have been established within these standards to confirm biological safety cabinet is operating at a standard level.

Tests such as down flow and inflow velocity, airflow smoke patterns, filter leak, light intensity, vibration, noise level, and UV light integrity will be performed by an accredited field certifier at least on an annual basis to certify the integrity of biosafety cabinet system is running at peak performance levels.

You can perform on annual basis but as a control majors & looking in to the handling and operational aspects generally in industry this activity performing on six monthly basis.

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4

Dear all,

Thank you for your reply.

Regards,
Aparna Jagadale

5

Hi,
We are using two equipment as follows:

  • Laminar for sampling material: designed as class C, velocity 0,36 - 0,54m/s
  • Biosafety cabinet in microbial lab: class A, velocity 0,2 - 0,4m/s
    Is this acceptable? I mean is it acceptable if velocity of the first one is larger than the second?
    Many thanks.
6

It is recommended to use 0,36 - 0,54 m/s unless otherwise justified scientifically

2020 draft EU Annex 1:
Unidirectional airflow systems should provide a homogeneous air speed in a range of 0.36 – 0.54 m/s (guidance value) at the working position, unless otherwise scientifically justified in the CCS. Airflow visualization studies should correlate with the air speed measurement.
https://ec.europa.eu/health/sites/health/files/files/gmp/2020_annex1ps_sterile_medicinal_products_en.pdf

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