The Containment Manual

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The topic of containment (ranging from light to high levels) is moving the pharmaceutical industry. Many newly introduced drugs are effective even in low doses – their active ingredients are highly potent. For patients, this development is an opportunity; for manufacturers, it is also a challenge. Low occupational exposure limits and complex toxicological assessments require special measures to ensure process safety. Additionally, new regulations such as the expanded EU-GMP guidelines, which came into force on March 1, 2015, are in place.
This growing awareness drives the technological advancement of containment systems in pharmaceutical production and laboratories. The trend is towards more protection rather than less.

An ISPE DACH Community of Practice (CoP) on Containment regularly addresses this topic. As a result of current and practical considerations of regulations and technology, this 168-page 'Containment Handbook' has been created.

The handbook covers topics such as risk assessment, containment lifecycle, process requirements, technical systems, validation, cleaning, and personnel. Each chapter of the handbook begins with a definition or introduction; concepts, processes, and technologies are identified and described in the form of best practices or illustrated examples.