Dairy microbiology start-up opinions (was RE: Learning Microbiology)

Enigl enigl at aol.com
Thu Aug 22 18:38:17 EST 1996


I would like to make some general comments to the whole group concerning:
<199608200439.XAA06178 at devm.rmoore.com>, raym at RMOORE.COM (Ray Moore) who
writes:

>milk and cheese products.  I am in the process of becoming licensed
>to manufacture these products.

Follow regulatory methods, see references below below.  Use an accepted
standard method for dairy.  If you do not have your own lab, you should
send to a dairy qualified certified lab.  I have a list of several. 

>3.  Are there other instruments available that provide enough
information,
>visual, or otherwise, to completely identify organisms?

ID is NOT a primary need.  

Follow Standard Methods and I would suggest contacting bioMereux Vitek for
a Vidas and Bactometer demonstration.  Use a total plate count method and
pathogen screens. Call  1-800-638-4835  x5087 if you need help.

>
>4.  What kind of broth and stains do I need to get started in developing
>some lab technique?  I have an analytic balance, will it be useful?
>

A microbiology lab costs a lot ($50K-300K, plus personnel at 30K per year
per person) but it also must be VALIDATED.  This means you must prove you
are complying to government regulations.   Validation would probably take
too much  time ( about a year) and too much of you start-up money.  I
recommend using an outside lab already certified for dairy until you get
settled in dairy business. ( I once worked for a dairy that took 40 years
before they had there own micro lab).

>6.  Am I headed completely in the wrong direction here?

YES you are off track, but that doesn't mean anything because . . .  I
recommend, seeking and hiring personnel who already have experience.  Hire
them to take care of the government technical regulations.   Have these
people teach you, on-site so to speak.  But you can still do a lot:  learn
cGMPs, current good manufacturing practices.

In general comply with regulatory agencies.  This means using _Standard
Methods for the Examination of Dairy Products_, The Conpendium of
Microbiological Methods_ and BAM (FDA Bacteriological Analytical Manual)  

BUT, why do it all yourself?  Take samples and sent them to a certified
lab so you get validated lab results.  The USDA and FDA expect the lab
results to be performed by validated labs.  You should hire a quality
control manager knowledgable in dairy microbiology and quality control in
general.  

The cGMPs are far more important than identifying bacteria.  cGMPs keep
the bacteria out of the product in the first place.  Why identify the
problems when you can pro-actively defend against them?  

Try learning HACCP, the pro-active quality control method.  HACCP stands
for Hazard Analysis and Critical Control Points.  This is what Bill
Clinton signed into law for the seafood, poultry and meat industry in July
this year.  From 1979-1987 I was a QC Manager for a dairy in Wisconsin and
we used HACCP even back then.  I now have my own company that helps people
do this. 

I hope this helps others who might want to get started in this area.

Good luck to all.


Davin

 

Davin C. Enigl, MS-MEAS, President-Microbiologist
HACCP Validations-sm  Hazard Analysis and Critical Control Points for the
Food, Cosmetic, Pharmaceutical, and Nutritional Supplement Industry
Voice: (916) 989-8264,  Fax: (916) 989-8205,  Pager: (714) 725-7695
9040 Erle Blunden Way
Fair Oaks, CA 95628
August 22, 1996
3:59 pm



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