Improved practice for microbiology labs

Published: 13-Dec-2011

Microbiological issues in pharmaceutical plants can result in plant shutdowns and products withdrawn from the market. Failures are common in environmental monitoring, media fill, sterilisation, aseptic practice and gowning. Introducing lean practices can determine optimal batch size and lead to a decreased number of test sessions for bioburden, endotoxins and sterility testing, while taking a risk-based approach to determining objectionable micro-organisms may ease the cost and burden of unnecessary testing but requires a better understanding of the processes and risks involved.

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The annual Pharmig conference in Nottingham, UK, revealed how greater understanding of microbial risks has increased the role of microbial testing labs, but also highlighted why there is a need for practice improvements. Susan Birks reports.

Microbiology services are crucial for trouble-free operation in pharmaceutical plants as microbiological issues can be hugely significant, resulting in plant shutdowns and products withdrawn from the market. Recent recipients of the FDA’s 483 forms show that no company is too big to fail. With this in mind, the two-day Pharmig conference held in Nottingham in November offered several best practice presentations on microbiology. From a full and informative programme three presentations have been chosen to highlight some common failings and some of the new methods for achieving improvements for the sector.

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