Testing Frequency for Revalidation of Vertical Laminar Airflow

Cabinet
GOOD VALIDATION PRACTICE (cGVP)

validate1 2016-10-21 04:12:00 UTC #1

Hello All,

There is some deliberation as to the testing frequency/ revalidation of our LAF.

For your information, the cabinet is validated against ISO Class 3 and is located in a Grade D clean room.

For Class 3, ISO 14644-2 (Section 4.2) states a 6 month frequency for particle count tests.
And airflow velocities (down flow) every 12 months.

Could someone please clarify how often we should then revalidate our cabinet?

Thank you in advance.

Boomer_Chemist 2016-10-21 11:15:05 UTC #2

Never, since the previous validation is still appropriate (unless you have changed the manufacturing process). A
‘risk analysis’ will help.

Calibrate (particles and airflow) as required from then on.

P.S. Don’t be confused. Validation (commissioning and qualification actually) can use calibration as a tool. The
purpose is different!

RR410 2016-10-21 12:16:00 UTC #3

I agree with Boomer about validation. LAF Cabinets and Biosafety Cabinets typically get certified annually. On-site
testing following the recommendations for field testing [NSF/ANSI Standard 49], IEST-002, ISO 14644 and
manufacturer’s specifications; must be performed by experienced, qualified personnel. Tests such as:
Air Velocity Profile: Verifies the hood is providing the proper air balance to protect the product from contamination
Integrity Testing of HEPA filters: Assures the existing HEPA filters are free of leaks and are properly sealed to
prevent leakage or possible contamination to the work area
Non-Viable Particle Counting: Testing provided to verify Cleanroom is meeting designed air cleanliness
classification level per ISO 14644 specifications
Viable / Microbial Air Testing: Assures Bioburden levels for bacteria and/or fungi are within acceptable parameters
per the Cleanroom design or client specifications
Viable / Microbial Surface Testing: Assures Bioburden levels for bacteria and/or fungi are within acceptable
parameters per the Cleanroom design or client specifications
Airflow Visualization Profile: Verifies the hood is providing non-turbulent airflow to work area and that airflow is not
escaping the front opening or sash seal at the workface opening
Temperature, Relative Humidity Measurements: Verifies the LFH is operating within its design specifications
Lighting Measurement: Verifies the lighting level is meeting the LFH design level or worker comfort level
Sound Level Measurement: Verifies the sound level is not exceeding the LFH design or worker comfort level

validate1 2016-10-21 13:03:07 UTC #4

Thanks guys, this has helped immensely

Boomer_Chemist 2016-10-21 14:52:46 UTC #5

Remember, it is the equipment that is ‘commissioned and qualified (IQ/OQ/PQ)’. It is the drug product
manufacturing process that is ‘validated (CSV, AMV, CV, PV)’.

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