IM>Scott, missed you at the last CLI meeting. Will be at the ANSI meetings
IM>in Ohio next week and ASM in May. Whatever proposals you have would be
IM>helpful, as Roger D. doesn't seem to want to let any info out earlier than
IM>the P. Forum (or he has no idea of what's going on!). Anything on
IM>enviromnetal monitoring of barrier isolators? 14 day sterility
IM>incubation? 2 year fungal incubation?!! Also, are any advisory groups
IM>being formed, or will the micro subcommittee only accept formal, written
IM>responses from industry, academia and professional societies?
Hey Mike,
No, Roger does know what is going on, but we are not to give out
specifics until the final drafts of the chapters are completed. As to
your specific questions:
Environmental monitoring of cleanrooms was published in the current PF,
I don't know anything about EM of isolators. However, there is a new
proposal for sterility testing due in the next PF that discusses
isolator technology,
Yes, 14 day incubation for sterility testing will be recommended. This
will bring the USP into harmony with EP, and make the Australians a
little happier. That table has been removed, and the proposed sampling
scheme will be total volume of 20 units (or 10% of batch) without regard
to fill volume.
Responses can come in many forms - I do not know of any advisory panels
being formed, as the elections were just completed and the composition
of the committee has completely changed. Roger Dabbah at the USP takes
phone calls, and he also has an Email address (I'll post later - it's at
work). Or you can call the BBS directly and leave comments in the
"Compendial Microbiology" forum which I will compile and forward on to
the committee.
Scott Sutton
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