Microbiological Swabbing Technique--Need Info

enigl at aol.com enigl at aol.com
Fri Mar 21 12:28:25 EST 1997


Has your new rapid detection system been validated?  The validation conditions must (required by FDA) simulate and test actually doing the work.  And not validating under "worst case" is often cited in FD 483s.

DEFINITION of VALIDATION
1.	Data providing proof that a system functions as designed and intended 
2.	Documentation ensuring a system consistently conforms to predetermined specifications and quality attributes

PERFORMANCE ACCURACY of Counts and/or detection limits
1.	Quality Control ATCC using both conventional and new swab rapid detection method
2.	Other ATCC you normally find in your plant using both conventional and new swab rapid detection method
3.	Unknown environmental isolates from your plant using both conventional and new swab rapid detection method

REPRODUCIBILITY of Counts and/or detection limits
1.	Same test ATCCs and environmental isolates
2.	Triplicate tests each on a different day
3.	Run in triplicate on the same saline preparation on the same day

HOW FAR DO YOU HAVE TO GO?
1.	Depends on HACCP 
2.	Hazard analysis of your product
3.	Critical control points of your process
4.	Consequences of errors not detecting contamination
5.	How likely is harm to product/customer? 


Davin C. Enigl, (Sole Proprietorship) MEAS
President-Microbiologist

Microbiology Consulting,  Hazard Analysis and
Critical Control Points (HACCP), CGMP, and Validations
for the Food, Cosmetic, Nutritional  Supplement, and Pharmaceutical Industry

enigl at aol.com
http://members.aol.com/enigl/index.html

March 21, 1997
9:16 am



More information about the Microbio mailing list