SMEPAC is an acronym for the International Society of Pharmaceutical Engineers (ISPE) “Standardized Measurement of Equipment Particulate Airborne Concentration” Guideline (First Edition 2005). In 2012, ISPE published its Second Edition and changed the title to “Assessing the Particulate Containment Performance of Pharmaceutical Equipment” (hereafter known as the “Guideline”) and incorporated the document into ISPE’s Good Practice Guide collection. It should be noted that a revised Guideline is expected to be published in 2023-24.
SMEPAC testing provides a standardized methodology to assess the particle containment capabilities of pharmaceutical manufacturing equipment (i.e. isolators, flexible containment, split butterfly valves, downflow booths, etc.) or related equipment such as ventilated balance enclosures. SMEPAC testing (otherwise known as containment validation monitoring) is generally used in factory acceptance testing (FAT) and/or site acceptance testing (SAT), but is often used in the operation of new facilities, and performing potent compound safety gap assessments.
In the pharmaceutical industry, as the percentage of active pharmaceutical ingredients becomes more potent (OELs < 10 µg/m3), in order to prevent occupational (worker) exposure or to prevent cross-contamination, the need for greater containment is required. Therefore, to test the actual performance of containment equipment and devices, testing is required. SMEPAC provides a standard methodology for such testing.
SMEPAC testing is generally performed by positioning industrial hygiene air sampling pumps in specific stationary locations to collect airborne particulate matter of a surrogate compound (lactose, naproxen sodium, mannitol, etc.) on a specific filter media. In addition, surface swipe samples are collected to assess the potential for surface contamination.
In order to ensure the proper calibration of air sampling equipment and the collection of samples, SMEPAC testing should be performed by a Certified Industrial Hygienist or Occupational Hygienist or someone with similar qualifications and/or experience in SMEPAC testing. Furthermore, to ensure the integrity and independence of the analysis of the collected samples, all laboratory analytical work should be performed by an accredited industrial hygiene laboratory that specializes in the pharmaceutical industry.
There are numerous limitations to SMEPAC testing that must be considered. These limitations are as follows:
As the percentage of active pharmaceutical ingredients become more potent, the need for greater containment exists. However, once the containment devices have been designed, built and installed, SMEPAC testing should be performed by an independent firm with qualified personnel to ensure that they meet or exceed the desired containment performance target.
Since 2002, Affygility Solutions has been providing potent compound safety, occupational toxicology and industrial hygiene services to biotechnology, pharmaceutical and medical device companies throughout the world. With Affygility’s longevity in the toxicology industry, you can have confidence you are receiving OEL / PDE monographs you can trust in order to implement risk-management controls. Contact Affygility to discuss how we can become your trusted occupational toxicology service provider.