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May 2001

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Subject:
From:
"Guardino, Robert F." <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Wed, 2 May 2001 15:30:45 -0400
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Answers to your questions:

1. Depends on what you mean by volume. We typically direct transfer less
than 1 g of product per medium bottle. For reconstituted product we usually
transfer 1 to 2 ml. Regarding the number of samples, we have tested up to
100 samples per medium (for a dose verification).

2. Single solid dose (or reconstituted sample) per 200 mL of medium.

3. 100 mg of sample to 200 mL of medium.

4. Clean room.

5. none

Bob

Robert F. Guardino
Associate Director Microbiology
AAI International
2320 Scientific Park Drive
Wilmington, NC 28405
Phone:  (910) 254-7635
Fax:    (910) 254-7416
e-mail: [log in to unmask]

> -----Original Message-----
> From: Scott Sutton [SMTP:[log in to unmask]]
> Sent: Thursday, April 26, 2001 8:22 AM
> To:   [log in to unmask]
> Subject:      [PMFLIST] Direct Transfer Sterility Test
>
> All,
>
> We have been looking at different "alternate technologies" to assist
> with steriity testing by membrane filtration.  I am also getting
> interested in looking at some that would be useful for direct transfer
> testing.  Obviously I would like to spend time on technologies that
> others have found useful and are supporting in their respective
> companies.
>
> A question for the group - actually several questions - about
> sterility testing by direct transfer:
>
> 1.  What is the largest volume that you handle in sterility testing by
> direct transfer?
>
> 2.  What is the normal ratio of sample to recovery medium used?
>
> 3.  What is the smallest ratio (sample/recovery media) that you have
> had to use to get adequate B/F results?
>
> 4.  Do you perform direct transfer testing in an isolation chamber or
> a clean room?
>
> 5.  What "rapid methods" or "alternate technologies" have you looked
> at for direct transfer testing, if any?
>
> Thanks for the help.
>
> Scott Sutton
>
>
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