In article (<01bbdcd3$054a82c0$2f6860cc at quantum>, "Wayne Dail"
<wd90157 at itec.net> writes):
>Subject: Pseudomonas
>From: "Wayne Dail" <wd90157 at itec.net>
>Date: 28 Nov 1996 02:05:14 GMT
>>Can anyone tell me the most effective way to eliminate Pseudomonas
>from a water system. Engineering tried a clorax solution but it was
>ineffective.
>>
Heat is the only fast and sure way I have ever discovered to kill existing
contamination. That's why 100% of the perenteral drug companies use it.
Heat is the only legal FDA approved method for them. Chemical
(Clorox-chlorine, ozone, hydrogen peroxide) sanitization does not work
_consistently_ enough. I have been consulting in this field for 20 years
and have seen alternatives to heat fail time and time again.
Engineering of the water system is the key. I have not met any (in 20
years) engineer who can design a microbiologically stable water system
without help from a microbiologist. Your company may wish to hire my
services.
-----------------------------------------------------------
FDA Validation and cGMP
for Foods, Drugs and Cosmetics
RE: Microbiological Services and Training
I am a microbiologist helping companies with FDA validation regulations
and current good manufacturing practices (cGMP). I have been consulting
in the industry for over 20 years. If you think I could help your
company, please contact me.
Thank you,
Davin C. Enigl, MS-MEAS
President-Microbiologist
HACCP Validations Hazard Analysis and Critical Control Point Validations
(916) 989-8264 Voice and Voice Mail
(916) 989-8205 Fax
---------------------------------------------------------------
Microbiology Technical Services and Training:
FDA current good manufacturing practices, cGMP
Pharmaceutical, food, cosmetic microbiology technical services
+++++Validation Protocols for water systems +++++++
Current Good Manufacturing Practices (cGMP):
FDA Regulations and Plant Audit Help
Equipment validation protocols:
Incubators, Autoclaves, Identifications Systems (such as Vitek®)
+++++Water systems: protocols, microbial control, design and validation:
HACCP Validations for Water Systems, WFI and PW-USP++++++
Critical Control Point environmental monitoring:
HACCP Validations for the Pharmaceutical Industry
Product Formulation, with and without preservatives
Microbiological Shelf Life and Stability validation
Rapid (D-value) and USP Preservative Efficacy Testing research and
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Nutritional Supplements Efficacy, Toxicology, USP 23 CGMP, validation,
protocols, SOPs and Quality Assurance
Laboratory Start-Up: Validation, SOPs, Test Methods and Training
Water Activity Testing: aw
------------------------------------------------------------
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
Web site: http://members.aol.com/enigl/index.html
November 30, 1996
9:04 am
