The new German-language ´CONTAINMENT HANDBOOK´ of ISPE D/A/CH

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The topic of CONTAINMENT is affecting the pharmaceutical industry. Many newly introduced and anticipated drugs in the pipeline are effective even in small quantities, with highly active active ingredients. New regulations are tightening requirements.

A working group of ISPE-DACH has thoroughly examined and documented the impacts on production sites, personnel, and machinery. The result: the 'CONTAINMENT HANDBOOK' - State of the Art - Requirements and Trends.

An increasing awareness is driving technological advancements in containment systems in pharmaceutical production and laboratories. The trend is towards more protection rather than less. Low occupational exposure limits and complex toxicological assessments require special measures for process safety. Additionally, new regulations such as the extended EU-GMP guidelines, which came into force on March 1, 2015, impose new requirements for operator protection in pharmaceutical manufacturing.

A working group of ISPE DACH regularly dedicates itself to the topic of containment. As a result of practical regulatory and technological considerations and foreseeable trends, a 168-page German-language 'Containment' Handbook, a best practice guide, and a high-quality reference work have been created.

The handbook is divided into the topics risk assessment, containment lifecycle, process requirements, technical systems, validation, cleaning, and personnel. Each chapter begins with a definition or introduction, identifying concepts, processes, and technologies, described in the form of best practices or illustrated examples. Trends are highlighted. A new standard work on containment.

The ISPE-DACH Containment Handbook is now available for order at www.ispe-dach.org.