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
Simon Rusmin, Ph.D.
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----- 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.
> Dr. Michael J. Miller
> Director, Biological and Sterilization Sciences
> Bausch & Lomb
> [log in to unmask]
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