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July 1999

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Subject:
From:
Tony & Roz Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Wed, 21 Jul 1999 22:07:09 -0400
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My collaegues and I wish to ask about the industry practice for
growth-promotion testing soybean-casein digest broth used in media fills.

What is the best practice?

1. Using the USP growth-promotion test for soybean-casein digest broth which
I believe is S. aureus, C. albicans and A. niger incubated at 20-25 degree C
for 5 days.

2. Using an appropriate range of organisms such as B. substilis, S. aureus,
C. albicans and A. niger at the media fill incubation conditions, i.e., 7
days at 20-25 degree C followed by 7 days at 30-35 degree C.

3. Using say B. substilis, S. aureus incubated at 30-35 degree C for 7 days
and C. albicans and A. niger at 20-25 degree C for 7 days.

Is it OK to use media fill vials for growth-promotion currently with the
media fill incubation or do you need to conduct the the growth-promotion
test after the 14 days of incubation?

Tony Cundell
Wyeth-Ayerst


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