ISPE originally published the ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment in 2005 to help engineering, design, and containment equipment professionals evaluate the performance of containment equipment and systems. A second edition was published in 2012. Both were widely known in the industry as the “SMEPAC” Guide.
Technology and medicinal ingredients have evolved rapidly, so it was time for a new edition, and a new title. The ISPE Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems, 3rd Edition addresses the differences between the containment performance of individual components versus a complex process. It provides updated technical guidance and standardized methodologies for evaluating the particulate containment performance (particle emissions) of pharmaceutical equipment and systems.
“The ISPE SMEPAC Guide is seen as the industry standard and has been used to assess the verify containment performance for pharmaceutical equipment and containment systems for 19 years,” said Guide Co-Lead George Petroka, Principal, IES Engineers. “In addition, the experience gained performing numerous containment performance assessments (CPAs) since the second edition identified topics in the Guide that required additional explanation such as data analysis, sampling strategy, sample types, sample locations, and liquid surrogates. The third edition also addresses improvements in pharmaceutical manufacturing technologies such as continuous processing and integrated containment systems and updated containment performance protocols to assess these systems.”
“The active pharmaceutical ingredients that companies produce to treat patients are becoming more and more potent, making CPAs very important,” said Guide Co-lead Karen Whitaker, Associate Director, Industrial Hygiene Center of Excellence, Merck. “This Guide outlines a framework to assess containment performance and verify that it meets the agreed-upon target between the equipment vendor and the purchaser.”
This Guide is intended to be used by industry professionals for the selection, containment performance, and operation of pharmaceutical equipment. “This Guide can be used to evaluate equipment both before it is purchased or anytime during its life cycle,” said Guide Co-Lead Rainer Nicolai, PhD, Product Owner Engineering Consulting, F. Hoffmann-La Roche AG.
“It was researched, written, and reviewed by subject matter experts from all over the world,” Nicolai said. “In addition to chapters on sampling strategy principles and analysis, interpretation, and documentation of data, it includes containment equipment test protocols for a variety of containment systems including downflow booths, unidirectional airflow booths, isolator/glove boxes, and flexible-film enclosures. It should be helpful to identify limitations of equipment or provide data that the equipment is working as intended.”
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