ISPE has updated its good practice guide (GPG) on “Assessing the Particulate Containment Performance of Pharmaceutical Equipment” to address a broader array of containment technologies, cover new technologies introduced within the past 10 years, and introduce a methodology that can be applied to additional types of equipment other than those referenced in the document.
The aim of the guide is to set a standard method of measurement for particulate containment systems so that they can be accurately compared and assessed.
Eli Lilly & Company Senior Engineering Consultant James Wood – a primary author of the GPG – commented that “having a good understanding of how your containment system is performing is vital for both equipment suppliers and facility personnel.” He noted that the revision 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 it creates a true standard for containment systems performance.”
The GPG provides a framework to allow facility personnel to continually monitor particulate containment performance of equipment to reduce the risk of cross-contamination and prevent regulatory and safety hazards resulting from faulty containment systems. The GPG also allows companies to gather the necessary data to demonstrate to regulators that their containment systems are performing properly.