LAF air velocity

Sterile
1

What should be working hight air velocity under LAF.Is there any clear guidelines for it

2

The air flow velocity remains between 0.3 m/s to 0.5 m/s.

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3

Thanks for replying,Is this range for working hight?can you give me any reference

4

The “famous” range for Grade A LAF air velocity is 0.36 - 0.54 m/s

This range is present in FDA guidance for aseptic processing , WHO Annex 6 , current EU (PIC/S) Annex 1 & EU Annex 1 Draft 2017

If you search inside any of these guidelines for key word “m/s” you will reach their statements

All of these guidelines are free on the Internet.

For example the following snapshot is from WHO Annex 6

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However it is advised to wait for the publication of the new approved EU Annex 1 in spring 2019 . This will be considered a global guideline since WHO , PIC/S and EMA and other organizations contributed to it.

5

Thanks for very clear and elaborate explanation with all related reference

1 Like
6

And the following is a useful statement from “FDA guidance for aseptic processing”

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Note:

FDA stated 0.45 m/s ± 20%

This range “equals to” 0.36 - 0.54 m/s

FDA mentioned also that a higher velocity may be used if necessary incase of process generating high levels of particulates

So:
I think it is preferred to adhere to this famous range to be in the safe side during GMP inspections as long as there is no “actual need” for modifying the range which if modified justification (and qualification) for this modified range should be ready to be presented to GMP inspectors upon demand.