ISPE Updates Standards for Assessing Particulate Containment Performance of Pharmaceutical Equipment

The Guide has been updated to address a broader array of containment technologies and covers new technologies introduced within the past 10 years. It also introduces a methodology that can be applied to additional types of equipment other than those referenced in the document.

“Having a good understanding of how your containment system is performing is vital for both equipment suppliers and facility personnel,” said Guide Author James Wood. “What's great about this new revision is that it can be used both to evaluate new equipment prior to purchase and to assess the ongoing performance of equipment that is already in use. It helps vendors and end-users accurately assess equipment and creates a true standard for containment systems performance.”

The ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment provides a standardized method and expanded set of principles that both vendors and end-users can use to measure the effectiveness of containment equipment. The Guide can be applied to both new and existing equipment, so that facility personnel can continually monitor particulate containment performance of equipment already in use, thereby reducing the risk of cross-contamination and preventing regulatory and safety hazards resulting from faulty containment systems. The Guide also allows companies to gather the necessary data to demonstrate to regulators that their containment systems are performing properly.

The ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment is available for purchase from ISPE here.