US standards for Cleanroom environments

stone at pda.org stone at pda.org
Wed Aug 9 17:45:29 EST 1995


In article <DD0J9L.2G8 at ecf.toronto.edu>, <ngcheuk at ecf.toronto.edu> writes:
> Hi, sorry if this is the wrong group...
> 
> Does anyone know where I can get documentations,
> or more information on the US standards for
> cleanroom environments?...
> eg. class 100, class 10,000 etc.
> 
> I'm particularly interested in the biological
> limits... eg. collony counts, etc. and
> also how they came up with the standard.
> 
> Hope some can provide me some info on this
> or points me a direction...
> 
> Thanks in advance,
> 
> David
> ngcheuk at ecf.toronto.edu
> 
I would be glad to help.  The current US standard is Federal Standard 209E.  
There are, however, a number of other relevant guidance documents.  In 
particular, there is an ISO TC (technical committee) 209 (the number is just a 
coincidence) with several working groups that are developing proposed 
international cleanroom standards. Additionally, if you are interested in 
health care products (I assume you might be since you posted to bionet) there 
are documents specific to the health care industry that focus on 
microbiological contamination, personnel issues, cleaning, monitoring, etc.

For example, the EC (European Commission) has just proposed a revision to 
their "sterile products annex" that would contain microbiological moonitoring 
standards.

If you want details on how to buy these documents, or how to get more 
information, e-mail me at stone at pda.org.
Suzanne Stone
Parenteral Drug Association
Bethesda, MD USA
fax 301-986-0296




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