PMFLIST Archives

October 1999


Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Steven Richter <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Wed, 13 Oct 1999 22:10:22 -0400
text/plain (45 lines)
Endotoxin testing on machine parts requires some validation studies.  The
studies should concentrate on endotoxin recovery with spiked machine parts.
If the testing is being used for release, then one has to validate the
stability of the endotoxin levels over a time factor.

Steve Richter Ph.D.
[log in to unmask]
-----Original Message-----
From: Dalmaso, Gilberto <[log in to unmask]>
To: [log in to unmask] <[log in to unmask]>
Date: Monday, October 11, 1999 9:00 AM
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
>The PMFList ( is operated from
>The Microbiology Network ( and supported by
>our sponsors ( as a service to
>the scientific community.

The PMFList ( is operated from
The Microbiology Network ( and supported by
our sponsors ( as a service to
the scientific community.