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Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 2

Author(s):  Wagner James T

Issue:  May/Jun 2006 - Hormone Replacement Therapy
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Abstract:  The Controlled Environment Testing Association guide focuses on isolator applications that are appropriate for use in facilities that compound sterile preparations. Owing to the fact that there are no uniform industry standards for the manufacture of barrier isolators, the purpose of this guide is to increase pharmacists’ awareness of the need to establish procedures addressing issues unique to isolators. In the future, Controlled Environment Testing Association will publish a guide—not a testing “standard”—for industry procedures for testing and commissioning isolators, as no published industry procedures are available at this time.

Related Keywords: James T. Wagner, Controlled Environment Testing Association, CETA, barrier isolators, barrier isolation, environmental controls, engineering controls, compounded sterile preparations, airflow, United States Pharmacopeia, ISO standards, aseptic compounding, controlled environment, sterile preparations

Related Categories: LEGAL, STERILE PREPARATIONS, SUPPORT, TECHNOLOGY, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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