Is 0.1 micron monitoring required for ISO Class 5 Laminar Air Flow unit ?

[SGquality]

We have some Laminar Air Flow units complying to ISO Class 5 (Class 100) and in the routine monitoring, our supplier monitors for 0.5 and 5.0 micron particles but does not cover 0.1 micron ?

When asked their response was that ISO 14644-1 does not recommend it specifically and its okay to follow any two particle sizes and that most pharma and biomedical corporations perform 0.5 and 5 micron particle monitoring for Class 100 environments.

Pls help

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[Bad Habit]

I am not aware of anyone measuring the .1 micron due to it not having limits in the common regulations (USFDA Sterile Guidance, ISO, and EU) for Grade A or ISO 5 environments.

 

[Kermit Braun]

We have some Laminar Air Flow units complying to ISO Class 5 (Class 100) and in the routine monitoring, our supplier monitors for 0.5 and 5.0 micron particles but does not cover 0.1 micron ?

When asked their response was that ISO 14644-1 does not recommend it specifically and its okay to follow any two particle sizes and that most pharma and biomedical corporations perform 0.5 and 5 micron particle monitoring for Class 100 environments.

Pls help

>SGQuality

The simple answer is, "Yes and no."

1) If your internal policies and procedures require it, then of course the answer is "yes."

2) However, ISO14644-1:1999 does not require sampling for particles >=0.1um. Read the whole standard and you see that a clean zone must be defined by at least one range of sizes under at least one occupancy state and one cleanliness class (ref. section 4.4.d). Also look at the examples in Annex D, example D.1: a CLass 5 example is worked out for only the 0.3um and 0.5um sizes.

3) Finally, standards for drug and medicine applications (EC Annex 1, USP<1116>, USP<797>, etc.) focus on 0.5um and 5um sizes. In the USA, the emphasis on 5um data is waning, largely because the data relaibility any utility at that size is (cough) questionable.

 

[Ajit Basrur]

Welcome to the Cove, Bad Habit and Kermit

Your answers are great and hope to see more participation from you