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October 1999

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Subject:
From:
Barbara Spears <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Mon, 4 Oct 1999 15:28:24 -0500
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text/plain
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Greetings!

I have a question regarding the term "lot" as stated in the FDA LAL guideline.
When "pyrogen-free" is stated on the label claim for medical devices. Each lot
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 "lot"
be further broadened  to mean the number of products (regardless of the number
of production lot numbers and product configurations) that are produced in a
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 finished
product test?

Thank you in advance for your responses.
Barbara


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