ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment PDF

The ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition) has been updated to address a broader selection of containment technologies and processing equipment. It will provide technical guidance and consistent methodologies for evaluating the particulate containment performance (particulate emissions) of pharmaceutical equipment and systems.

This Guide aims to define current good practices, providing information to allow organizations to benchmark their practices and improve on them. Specifically, the Guide provides a methodology to derive data associated with handling of pharmaceutical ingredients that is useful in the assessment of potential risks.