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October 1999

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Subject:
Endotoxin on production machine parts
From:
"Dalmaso, Gilberto" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Mon, 11 Oct 1999 08:23:48 +0100
Content-Type:
text/plain
Parts/Attachments:
text/plain (19 lines) 
A question for our group:

We have to determinate the pyroburden on our production machine parts as validation program. Is there any internationals procedure/methods or requirements for this porpose? is there any regulatory requirements?
Have we to contaminate (recovery determinations) the piece?
What is the rinsing method? How much LRW I have to use?

As you know production pieces are quite big.

Thank you in advantage


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