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Quality Control: Testing for "Micromonsters": Viable Air and Surface Sampling in Aseptic Compounding

Author(s):  Mulder Kyle

Issue:  May/Jun 2021 - Volume 25, Number 3
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Abstract:  A fundamental principle of aseptic compounding involves the enumeration, identification, and continuing control of biological contaminants in the cleanroom. To accomplish those tasks, a robust and consistent program of environmental sampling must be implemented and the results of such testing used to guide required remedial action in all areas dedicated to sterile compounding. In this article, the surveillance of “micromonsters” (microorganisms that contaminate areas dedicated to aseptic compounding) in the cleanroom is discussed, the implementation of a sustainable program for viable air and surface sampling is examined, and the value of that testing in maintaining an acceptable level of aseptic control is considered.   Basics  A diluent is an inert filler used to create the desired bulk and flow properties of capsules, as well as compression characteristics of tablets. Diluents, as well as other excipients, must meet certain criteria in a formulation. Many excipients used in oral solid-dosage formulations have many uses, and a thorough understanding of their properties and limitations is necessary in order to use them rationally. This article discusses the physicochemical properties and the chemical and physical incompatibilities of diluents. Also provided is a list of commonly used diluents in solid-drug dosage forms and a list of the physiochemical characteristics of selected capsule and tablet diluents.

Related Keywords: Kyle Mulder, NSF, CETA SCF, NEBB CPT CP, quality control, micromonsters, micro-organisms, aseptic compounding, environmental monitoring, cleanroom, viable samples, viable sampling, air particle sampling, surface sampling, compounded sterile preparations, biological contaminants, microbiological contamination, direct compounding area, primary engineering controls, United States Pharmacopeia Chapter <797>, United States Pharmacopeia Chapter <800>, USP, personnel competency, contamination alert level


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