Vitek Saline

Enigl enigl at aol.com
Thu Nov 20 12:13:02 EST 1997


In article <199711190205.VAA26630 at pop.cybernex.net>, yersinia at CYBERNEX.NET
(Yersinia) writes:

>Well, I'm just really curious about this, hope someone out there knows! 
>Thank you for your time.
>
>Infectionately,
>Yersinia.
>
>

Vitek did this experiment already and could not validate the identifications on
a consistent basis.  Even the 0.45% solution is suspected of causing
conflicting identifications due to inaccuracies in preparation and/or saline
contamination.  
Also. . .  it is unwise to experiment with an already validated identification
system.  Even if you could show on a limited basis, that 0.85% works just as
well as 0.45%, the FDA already has the full Vitek experimental data that proves
0.85% really does NOT work as well as 0.45%.  

The experimentation was empirical, so, you might need several experiments to
find out _why_ some bacteria will not consistently ID using 0.85%.  (It
probably has to do with injured bacteria (enzyme systems, cell walls,
etc.)--mostly seen from environmental samples).   Even ATCC cultures will not
validate is you don't follow the Vitek recommended rehydration procedures.   I
hardly think it's worth the time and money to duplicate the already extensive
Vitek data proving 0.85% is unvalidatable.

You can probably get the data from Vitek by emailing then at bmxvitek at vitek.com

(I write the validate protocols for some of their clients).

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/

November 20, 1997
9:11 am PACIFIC



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