Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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4 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 P h a r mTe c h . c o m Aseptic Processing Viewpoint S ince the mid-1980s, regulators worldwide have increased scrutiny of environmental monitoring in aseptic processing and raised the bar several times by adding more stringent requirements. FDA's Guideline on Sterile Drug Products Produced by Aseptic Processing, published in 1987, outlined moni- toring expectations for critical areas in which sterilized materials are exposed to potential contamination from personnel and envi- ronmental factors (1). These recommendations were originally developed for Class 100 environments, and now also apply to International Organization for Standardization (ISO) 5 environments. Excerpts from recent regula- tory guidance include the following: • "Samples from Class 100 (ISO 5) environments should normally yield no microbiological contaminants (1). • "For grade A, the expected result should be 0 cfu (colony forming units) recovered; any recovery of 1 cfu or greater should result in an investigation (2)." These requirements, and related perspectives on environmental monitoring, are based on the erroneous belief that microbial moni- toring of low populations of microorganisms, whether in the air or on surfaces, is an exact and precise measurement of the 'true' degree of contamination present. Sampling, recovery, and enumeration limitations In reality, significant sampling, recovery, and enumeration limitations preclude the accuracy of environmental monitoring technology. In ad- dition, a single, defined microbiological medium cannot recover all microorganisms that might be present in a given environment (3,4,5). Lies That Environmental Monitoring Systems Tell James Agalloco, Russell Madsen, and James Akers Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing? James Agalloco, jagalloco@; Russel Madsen; and James Akers are consultants who specialize in aseptic pharmaceutical processing. DMITRY K ALINOVSKY/SHUTTERSTOCK.COM

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