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December 2003

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Subject:
From:
"Daniel L. Prince" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 15 Dec 2003 18:50:29 -0500
Content-Type:
text/plain
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With all do respect, I don't think that your approach is consistent with
cGMP. If the balance has a tolerance of, for example 0.01 grams, then you
should easily be able to accurately weigh 10 grams plus or minus 0.01 grams.

The fact that a 0.5 log may be appropriate to a microbial count does not
mean it is the a priori measurement of error for other microbial tests
especially if they involve the use of analytical instrumentation.
Sincerely,

Daniel Prince, Ph.D.
Gibraltar Laboratories, Inc.
122 Fairfield Road
Fairfield NJ 07004-2401
973-227-6882 x519
www.gibraltarlabsinc.com
----- Original Message -----
From: <[log in to unmask]>
To: <[log in to unmask]>
Sent: Tuesday, November 25, 2003 6:35 PM
Subject: Re: [PMFLIST] Microbial Limits Testing: Sample Weights Question


> As far as the limits and enrichment testing is concerned, I have taken the
> information in the Informational Chapter (I think it is <1112>) which
states
> that a method is considered valid provided that the test material allows
recovery
> of 70% of organisms as compared to a positive control, to mean that the
error
> rate that the USP accepts is ~0.5 log.  Therefore, we have used a +/- 10%
(so
> if a test requires 10 gms of material, a range of 9-11 gms is acceptable;
if
> a test requires 5 gms of material, a range of 4.5-5.5 gms is acceptable).
> This seems reasonable especially since the informational chapter implies
that the
> acceptable range of counts is within 0.5 log.
>
> Vic Mencarelli
> Microbiologist
> DEL Labs, Inc.
> [log in to unmask]
>
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