The specialist supplier of products for environmental monitoring and process validation published the eBook with practical tips for improving processes
Cherwell Laboratories, the specialist supplier of products for environmental monitoring (EM) and process validation, has put its knowledge to good use publishing an eBook giving an overview and practical guidance for sterility testing. The eBook is titled “Failure is not an option: Why sterility testing is so important”, and is available to download from Cherwell’s website.
The guide offers a full overview of sterility testing including why the sterility test is such an important requirement for the manufacture of sterile products. It also outlines practical steps that will help ensure the standards as set out by the European Pharmacopoeia and GMP are met.
Topics covered within the eBook include: the sterility test principle; what the expectations are within the pharmacopoeia and GMP; key considerations in the sterility testing process; how to tackle a sterility test failure and practical steps to minimise the risk of contamination.
The eBook also addresses the role of environmental monitoring programmes and how these are critical to successful sterility testing, product quality and business reputation.
Andy Whittard, Cherwell Laboratories’ Managing Director said: “While we recognise that sterility testing is a critical step in ensuring that pharmaceutical products are safe for human use, we also all know that the test is not perfect. Therefore, we have put together this eBook to offer some guidance and practical steps to overcome the challenges involved with sterility testing. Our guide will help the reader mitigate the risk of sterility test failure for their facility by using better processes and continuous environmental monitoring methods.”