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Autoclave Validation

il128 at my-dejanews.com il128 at my-dejanews.com
Sat Jun 27 11:08:44 EST 1998

The F sub o for the Drain (Cold spot) is usually greater than 55. The bags lay
flat with the breather side up.  It may be possible to place fewer stoppers in
each bag but, a single layer isn't possible.  I'm considering a short gravity
cycle before the vaccum pulse cycle starts, I hope this will drive out most of
the air and allow for less sticking.
In article <1998062619175900.PAA26758 at ladder01.news.aol.com>,
  enigl at aol.com (Enigl) wrote:
> In article <6mtjaj$vtp$1 at nnrp1.dejanews.com>, il128 at my-dejanews.com writes:
> > Any suggestions on how
> >to prevent the stoppers from sticking together? Paul
> That is not your problem.  Your heat penetration is failing due to lack of
> dwell time (only 60 minutes is by far too short from my experience).
> Steam penetration is not the only method of kill.  It is simply the more
> powerful method of kill during a pressurized autoclave process.  Radiant heat
> penetration also contributes.  And it is a good thing, because (as you have
> discovered) it is really difficult to keep stoppers from touching (and
> sticking, even worse).  I sympathize with you.
> Remember there will NOT be a 60 minute exposure in the coldest spots (the last
> to heat areas).  These are the most important areas to validate.  Can you
> reorient the bags to a more horizontal (flat) bag configuration (to get one
> layer of stoppers) to reduce sticking and increase steam penetration?  That
> seems to work for me.
> Davin
> Davin C. Enigl, MEAS. Microbiology Consultant for Foods, Cosmetics,
> Pharmaceuticals and Biotechnology. FDA validation protocols, water system,
> autoclave, facility start-up. Author: _Preservative-Free and Self-Preserving
> Cosmetics and Drugs_ Marcel Dekker.

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