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Basics of Sterile Compounding: Aseptic Processing

Author(s):  Akers Michael J

Issue:  Jan/Feb 2015 - Volume 19, Number 1
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Abstract:  This article discusses factors that affect the assurance of sterility of an aseptic process operation and balances what is required/practiced in the pharmaceutical industry via the U.S. Food and Drug Administration and European aseptic processing guidelines and what is required/ practiced in compounding pharmacies via the United States Pharmacopeia (USP) General Chapter <797>

Related Keywords: Michael J. Akers, PhD, aseptic processing, compounded sterile preparations, U.S. Food and Drug Administration, FDA, United States Pharmacopeia, USP, terminal sterilization, filtration, cleanroom environment, International Organization for Standardization, ISO air classification, ISO class, airflow, HEPA filters, personnel qualification, staff training, microbial monitoring, bacterial contaminants, microbial contamination, containers, endotoxin control, process validation, equipment qualification, process simulations, media fill studies, environmental monitoring program, laboratory controls, microbe identification, sterility testing

Related Categories: ENVIRONMENTAL , LEGAL, PACKAGING, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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