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October 1999

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Subject:
From:
Simon Rusmin <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Sun, 10 Oct 1999 13:37:48 -0400
Content-Type:
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Michael:

In my past experience, we did not practice the 'just
rinsing' with the next batch.  I believe, there should
be a complete break between batches of different
compounded mixes (not sub-loting because of
processing constraint).  This will include replacing
in-line processing filters (especially the sterilizing ones).

Releasing a sub-lot before the total batch, I
believe, is OK.  This is a similar rationale for
rejecting  one sub-lot independent of the others,
if the sub-lot fails the sub-processing that creates
it.


Simon Rusmin, Ph.D.
Consultant
[log in to unmask]

----- Original Message -----
From: Dr. Michael J. Miller <[log in to unmask]>
To: <[log in to unmask]>
Sent: Thursday, October 07, 1999 9:17 pm
Subject: Re: [PMFLIST] What is considered a Lot


> Hi all!  I have a question for the group about cascading batches:
>
> Suppose you wanted to fill consecutive batches (i.e., no CIP/SIP between
> sublots..just flush the line with the next batch prior to filling).  Does
> anyone routinely do this, and if so, do you release all the sublots after
> all the sterility tests are in, or do you release each sublot as each test
> comes off.  Also, when would you perform filter integrity tests.  I would
> like to know if there is an industry standard with this practice.  Thanks.
> Michael
>
> Dr. Michael J. Miller
> Director, Biological and Sterilization Sciences
> Bausch & Lomb
> [log in to unmask]
>
>
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