Practical Application of Rapid Microbiological Methods to the USP <1116> Contamination Recovery Rate Approach

摘要

The past year has seen a change in the way pharmaceutical manufacturers monitor their aseptic environments with the most recent revision to the guidance chapter <1116> in USP 35/NF 30, now entitled "Microbiological Control and Monitoring of Aseptic Processing Environments." One of the major changes within this chapter is guidance for the assessment of contamination recovery rates (CRR) for environmental monitoring (EM) data, moving away from the Alert and Action level concept. The USP defines contamination recovery rate as "the rate at which environmental samples are found to contain any level of contamination." Use of the CRR recognizes the limitations of traditional microbiological tests, creates a paradigm shift away from long-standing guidance in environmental monitoring, and places a focus on the evaluation of trends versus comparison against the standard colony forming unit count approach. The CRR concept also moves the industry closer to utilizing a strategy that does not rely on a single test methodology, and instead focuses on the incidence of contamination occurrences, making this USP revision highly conductive to implementation of more cost-effective and sensitive microbiological methods that speed the time-to-result and reduce sampling bias.