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October 1999

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Subject:
From:
"Harder, Joel" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Wed, 13 Oct 1999 10:18:23 -0400
Content-Type:
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In the cGMP notes located at http://www.fda.gov/cder/dmpq/cgmpnotes.htm
<http://www.fda.gov/cder/dmpq/cgmpnotes.htm>  , there is a question relating
to your concern.

http://www.fda.gov/cder/hdn/cnotesd8.pdf
<http://www.fda.gov/cder/hdn/cnotesd8.pdf>
http://www.fda.gov/cder/hdn/cnotes97.pdf
<http://www.fda.gov/cder/hdn/cnotes97.pdf>
http://www.fda.gov/cder/hdn/hdn695.pdf
<http://www.fda.gov/cder/hdn/hdn695.pdf>   (very good one)

I agree with the other responses that the product dictates cleaning
validation requirements.

Some contaminate the equipment with riboflavin. Others actually use
simulated product. It really depends on the situation at hand that you are
addressing. If more information can be shared, a more targeted response can
be offered.

Joel C. Harder
Quality Assurance Associate for Process Equipment Validation, NHQ
* v-mail: 703-351-5942
* e-mail: [log in to unmask]


-----Original Message-----
From:   Dalmaso, Gilberto [mailto:[log in to unmask]]
Sent:   Monday, October 11, 1999 3:24 AM
To:     [log in to unmask]; [log in to unmask]
Subject:        [PMFLIST] Endotoxin on production machine parts

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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