Published: May 2012
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 provides technical guidance and standardized methodologies for evaluating the particulate containment performance (particulate emissions) of pharmaceutical equipment and systems.
This Guide aims to define current good practices and provides information to help 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.