Autoclave Validation

Enigl enigl at aol.com
Fri Jun 26 14:17:59 EST 1998


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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