New ISPE Containment Good Practice Guide - GMP and Occupational Safety Requirements Working with High Potent Substances |
There are an increasing number of highly potent compounds handled within the pharmaceutical industry, a trend that has continued for over 20 years to the point where most modern products require some degree of containment or other exposure control to maintain safety.
The ISPE Good Practice Guide: Containment for Potent Compounds covers all aspects of pharmaceutical containment including background to safe working levels and the mechanisms of exposure and how such exposure can be controlled. There are chapters on typically applied approaches used in containing exposure for commonly applied process systems across all elements of pharmaceutical development and manufacturing.
Developed by a multinational team of experts consisting of engineers, toxicologists, hygienists, and analysts from major pharmaceutical companies and suppliers, this Guide aims to consolidate this widely dispersed knowledge base into one document. It describes and discusses the containment methodologies, processes, and technologies commonly used in the pharmaceutical industry when handling potent compounds.
The Guide contains numerous photos on the wide range of technologies presented, such as isolators, process interfaces and transfer ports, air locks, filtration systems, containment performance assessments, and cleaning/waste treatment. Additional topics include GMP aspects, containment systems’ lifecycle, unplanned emission/spillage recovery procedures, and the development of a containment strategy.
Head of Corp EHS Regulatory Intelligence,
Boehringer Ingelheim Corporate Center GmbH