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Enigl enigl at aol.com
Mon Jan 12 08:40:14 EST 1998


In article <199801011841.NAA19220 at mail.cybernex.net>, yersinia at CYBERNEX.NET
(Yersinia) writes:

> can anyone compare 
its concept and usage with that of Vitek and API? 

For pharmaceuticals and environmental isolates,  I like Vitek better, because>>
FDA likes Vitek better, because >> Vitek is easier to get validated.  API is
the backup to Vitek in my SOP.  Biolog is the backup to Vitek and API in my
SOP. MIDI is totally out of the running (so far).

Davin

--------------------------------------------------------------------------
------------------------------
Davin C. Enigl,  Microbiology Consultant,
MEAS-Master of Environmental Arts and Sciences.

1.  Discovered heat resistance in mold: _Talaromyces trachyspermus_ (Published
w/USDA)

2.  Co-author (with Kent M. Sorrells), Water Activity and Self-Preserving
Formulas,
In:  _Preservative-Free and Self-Preserving Cosmetics and Drugs_, Kabara and
Orth, editors.  Copyright 1997,
Marcel-Dekker, ISBN 0-8247-9366-8, Telephone: 1-800-228-1160

3.  Water System Design and Validation for FDA regulations

4.  Preservative Formulation and Stability Testing

5.  FDA Validation Protocols: aseptic, sterilization, laboratory methods

6.  Hazard Analysis and Critical Control Points (HACCP)

7.  Current Good Manufacturing Practices (cGMP)  Audits

Web Site:  http://members.aol.com/enigl/

January 11, 1998
9:55 am PACIFIC
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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