Cleanroom microbiology

sysop at microbiol.org sysop at microbiol.org
Thu Sep 28 07:14:11 EST 1995


ND>Hi,

ND>I am looking for information about, or contacts with people who have some
ND>knowledge or experience with, setting airborne microbial limit
ND>specifications in biomedical cleanrooms.  I am interested in validating
ND>test methods and determining what is an "acceptable" number of organisms
ND>per cubic meter and the statistical validity and significance of methods
ND>used in these types of assays.  Thanks.  Any steering in the right
ND>direction would be apprecieated.  There seem to be no published standards
ND>for this parameter.  Best regards.   Phil McIntosh.  NDPM at aol.com


No published standards?  Look to the USP (United States Pharmacopeal
Convention), the Parenteral Drug Association (PDA), the Association for
the Advancement of Medical Instrumentation (AAMI) for starters.  I am
replying by E-mail to give you my address.  Feel free to contact me by
Email - I serve on the USP Subcommittee of Revision, and would be happy
to help if I knew more about what you wanted.

Look forward to hearing from you.

Scott Sutton

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