Jacqueline Miller, Technical Operations Services, Accugenix, Inc., 223 Lake Drive, Newark, DE 19702 and Melissa K. Ruch, Marketing, Accugenix, Inc., 223 Lake Drive, Newark, DE 19702.
The accurate identification of microorganisms in industrial settings is an important part of a comprehensive environmental monitoring program. Thorough characterization of the microbial population of the manufacturing environment allows for rapid and definitive resolution of sterility failures and other excursions. Standard tracking and trending EM programs using the species name alone for tracking microorganisms does not always provide enough information to make definitive conclusions in an investigation or provide the appropriate information to develop a response to the contamination. In cases where the microorganism cannot be identified to the species level, reliance on the closest species name may be either inappropriate or inconclusive. This study describes the advantages of using 16S rDNA sequences to track isolates of bacteria. The use of 16S rDNA sequences negates the need to characterize the microorganism by phenotypic means, using the DNA sequence as a tool for identification as well as a unique identifier. Additionally, in some instances single species of bacteria can be further divided into several subgroups based on their unique DNA sequences, which further helps the tracking process.