Thursday 1 August 2013

Validating a microbial ID system for cleanroom bacteria

A new paper of interest has been published. The paper concerns the validation of a phenotypic microbial identification system to understand how efficiently the system works with cleanroom bacteria. Although the paper concerns a specific system (the GEN III OmniLog® ID System), the paper is designed to act as a case study.

The paper has been published in the European Journal of Parenteral & Pharmaceutical Sciences.

The abstract reads:

“Accurate microbial identification is of importance in assessing product and environmental risks in pharmaceutical manufacturing. Identification is important to assess the origin of contamination and to formulate corrective actions for contamination events. Many of the systems available either require manual manipulation and subjectivity in reading, and are, therefore, prone to errors, or consist of databases than err towards the clinical setting. This paper outlines the validation steps for the evaluation of a microbial identification system capable of screening industrial microflora: the GEN III OmniLog® ID System.”

Tim Sandle, Kerry Skinner, Jennifer Sandle, Barbara Gebala, Pavitra Kothandaraman (2013): Evaluation of the GEN III OmniLog® ID System microbial identification system for the profiling of cleanroom bacteria, European Journal of Parenteral & Pharmaceutical Sciences 18(2): 44-50

Posted by Tim Sandle

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