N.78 – Microbial isolates identification according USP 38

TRIO

Identification of microbial isolates

Identification according USP 38 – The United States Pharmacopeial – Document (1116) Aseptic Processing Environments -Page 1201

A successful environmental control includes an appropriate level of identification of the flora obtained in sampling. A knowledge of the flora in controlled environments aids in determining the usual microflora anticipated  for the facility and in evaluating the effectiveness of the cleaning and sanitation procedures, methods, agents and recovery methods. The information gathered by and identification program  can be useful in the investigation of the source of contamination, especially when recommended detection frequency are exceeded.

Identification of isolates from critical and immediately adjacent areas should take precedence over identification of microorganisms from noncritical areas. Identification methods should be verified and ready to use kits should be qualified for their intended purpose.

REFERENCE

USP 38 – The United States Pharmacopeial – Document (1116) Aseptic Processing Environments -Page 1201