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Enigl enigl at aol.com
Tue Jan 13 18:54:51 EST 1998

In article <01bd203f$e9931180$c9179e83 at ROGERS.AFRRI.USUHS.MIL>, "Jim Rogers"
<rogersj at nmripo.nmri.nnmc.navy.mil> writes:

>I like Biolog because their database of strains is larger and
being added to frequently.>>

The problem is that the reproducibility is not there.  If you run the "same"
isolate ten times, you get ten different I.D.s--according the FDA validation
studies, that is why FDA did not approve BIOLOG (yet).

 They are adding an anaerobe database
>soon, and
is potentially field deployable.>>

Vitek has had an anaerobe clinical data base for years and there system flies
on the Space Shuttle--so, I guess that is the ultimate in "field deployable." 
the Vitek also has a system that was scheduled to go to Mars to search for life
and run biochemical tests on any isolates found--I saw the system--very "cool."

<<  They also seem to be the choice
>of a
number of researchers when analyzing mixed populations in

Yes I've seen those reports.  The only thing that I find troubling is that the
reproducibility of BIOLOG is so poor, how can those reports generate usable

<<  And finally, it is reasonable to do stats on your
and to make up your own databases that are based on your

Yes, that is also what the Vitek database does, even unknowns that were not in
the database--mostly water environmental isolates.

<<  The downside is that it is not approved by the
agencies and their database on BL-3 level organisms is pretty small.
>It is
also a little expensive on a per test basis.>>

Vitek has the same downsides--very expensive.  Vitek has two data bases, one
for clinical and one for industrial--a wise move.

On the upside, BIOLOG _themselves_ have finally had a validation protocol
written by a microbiology consultant (not me, although I write them too) to try
and get the FDA to accept BIOLOG as a valid pharmaceutical test method--no word
on if it has been successful yet.

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

1.  Discovered heat resistance in mold: _Talaromyces trachyspermus_ (Published

2.  Co-author (with Kent M. Sorrells), Water Activity and Self-Preserving
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 13, 1998
2:01 pm 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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