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Regulators have exaggerated expectations for simulated media fills.
In the late 1970s, media fill studies began to be used in aseptic processing for the expressed purpose of evaluating sterility assurance levels in filling activities. These initial studies were simplistic. In response to regulatory expectations, the activity grew in sophistication to address perceived vulnerabilities (1).
Read this article in Pharmaceutical Technology eBook: Biologics and Sterile Drug Manufacturing, May 2020, May 2020 Pages: 10–14
Pharmaceutical Technology eBook: Biologics and Sterile Drug Manufacturing
When referring to this article, please cite it as J. Agalloco, “Complications in Process Simulation Execution," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2020).