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Sterile Basics of Compounding: Contamination Control Strategies, Part 1

Author(s):  Summers Amy

Issue:  Sep/Oct 2022 - Volume 26, Number 5
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Abstract:  Compounded sterile preparations are required to be at the very least sterile. If not, the parenteral administration of such a preparation can cause serious patient harm, even death. Therefore, cleanroom contamination control strategies must be employed to protect the final preparation and the patient. This article is part one of a two-part series describing a holistic and multi-faceted approach to implementing basic cleanroom contamination control strategies at sterile compounding facilities so that safer pharmaceutical compounds are produced. This segment uncovers where cleanroom contamination comes from, the costs and implications associated with cleanroom contamination, and focuses on the various facility controls required to prevent the ingress of contaminants and cross-contamination. The second part concentrates on personnel and processes that support the same initiative.

Related Keywords: Amy Summers, PharmD, BCSCP, cleanroom contamination control strategies, sterile compounding, drug safety, primary engineering controls, contaminants, environmental monitoring program, aerobic microbes, anaerobic microbes, compounded sterile preparations, facility design, air specifications, water specifications, cleaning, disinfection, US Food and Drug Administration, FDA Guidance for Industry, Insanitary Conditions at Compounding Pharmacies


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