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December 2002


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Frank vanderzanden <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Fri, 20 Dec 2002 04:45:32 -0600
text/plain (64 lines)
Dear Johan,

I've got this from the internet, just a proposal to the USP committee. The
table shows that both 19404 and 11437 can be used. So, why bother using the
PhEur strain only. The biochemical differences are not known by me,
however, I think it cannot make a big of a difference. We've performed
studies in conformity with PhEur/USP (combined) and only tested ATCC 19404
as reference strain for growth promotion testing.
I hope this helps you out.


Enclosed are PDA’s comments regarding proposed
changes to General Chapter <71> Sterility
Tests. The proposal appeared in the May-June
1995 Pharmacopeial Forum, pages 595-609.
PDA supports USP’s decision to clarify this
section and offers the enclosed comments to
that end.
Please contact Russell E. Madsen, Vice
President Scientific and Technical Affairs if
there are any questions.

For Thioglycollate Medium
Primary Organisms    Alternative Organisms
Bacillus subtilis ATCC 6633   Micrococcus luteus ATCC 9341
Staphylococcus aureus ATCC 6538P
Candida albicans ATCC 10231   Candida albicans ATCC 2091
Clostridium sporogenes ATCC 11437  Clostridium sporogenes ATCC 19404
Bacteroides vulgatus ATCC 8482


Best regards,

Frank van der Zanden
Bactimm BV -  the Netherlands

ps: maken jullie gebruik van BD afdruk platen (RODAC)? If so, bewaren
jullie deze volgens BD voorschrift of bij kamertemperatuur? Wij bewaren ze
bij kamertemperatuur en hebben veel besmettingen geconstateerd de laatste
maanden. Ik zou graag willen weten of dit bij andere afnemers ook het geval

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