Abstract

ARE YOUR CLEANROOM SANITIZATION PROCEDURES ADEQUATE?

Sri Krishna Chaitanya Jammalamadaka* and R. Gyana Prasuna

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Abstract

Microbial contamination is one of the major problems that is being faced by pharmaceutical industries throughout the world. Major pharmaceutical firm(s) are receiving warning letters, import alerts, and product recalls due to microbial contamination of drug products. There are several possibilities identified for product contamination, among which development of microbial resistance is one of the major factors having long-term impact on drug product quality. As many as 483 observatory letters and warning letters were issued by the regulatory authorities citing 21 CFR 211.42(c) (10)(v). These were solely related to the failure to produce aseptic conditions, owing to deficient system for cleaning and disinfecting the room and equipment. The present work was to validate the disinfectants and identification of recurrent environmental isolates in cleanrooms. The isolates were used identify any possible resistance development factors. We report the effect of frequent usage of the same disinfectants for long duration in cleanroom sanitization, which thereby results into gradual development of microbial resistance.

Keywords: Cleanrooms; Sanitization; Disinfectants; Microbial Resistance.