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October 1999


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Simon Rusmin <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Sun, 10 Oct 1999 12:22:20 -0400
text/plain (88 lines)

Theoretically, a "batch" or "lot" of product
is made from one single mix of homogeneous
materials, is processed in the same equipment
and conditions within a limited time, and is filled
or packaged into the same containers or
packaging materials. Therefore each individual
unit is the 'same' as the others. This is to legitimize
testing samples for product release, since a
sample truely repersents the whole lot.

In practice, the above 'ideal' situation may not
hold true. For example, a lot may include
a processing step using different equipment,
e.g. autoclaving the lot in portions using the same
(but different runs) or different autoclaves.
In that case, we assign 'sub-lot's for tracking
and later testing (i.e. sterility test of each sub-lot).

There are other occasions in which, because of
equipment limitation, several lots are made.
Then these lots are blended homogeneously to
make ONE big lot. e.g. in BPC (bulk pharmaceutical
chemical) manufacturing.

Definitions of 'lot' less than 'homogeneity'
of its unit members (having SINGLE set
of variability characteristics) are not acceptable.
This is a necessity to make Quality Control as well
as Traceability for product recalls possible
(in manufacturing drugs, devices, and cars).

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

----- Original Message -----
From: Barbara Spears <[log in to unmask]>
To: <[log in to unmask]>
Sent: Monday, October 04, 1999 4:28 pm
Subject: [PMFLIST] What is considered a Lot

> Greetings!
> I have a question regarding the term "lot" as stated in the FDA LAL
> When "pyrogen-free" is stated on the label claim for medical devices. Each
> must be tested. Is this a strict or loose interpretation of the term
"lot"? Does
> this mean each production lot must be tested? Or can  "lot" be interpreted
as a
> "sterilization load" (consisting of more than one production lot), or can
> be further broadened  to mean the number of products (regardless of the
> of production lot numbers and product configurations) that are produced in
> specified increment of time (i.e. all products produced in a day or week)?
> Is it mandatory that product be sterilized prior to conducting the LAL
> product test?
> Thank you in advance for your responses.
> Barbara
> ------------------
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