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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 two 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. The first segment uncovered the origin of cleanroom contamination, the various facility controls required to prevent the ingress of contaminants and cross-contamination, and the costs and implications associated with cleanroom contamination. This second part concentrates on personnel and processes that support the same initiative.

Related Keywords: Amy Summers, PharmD, BCSCP, compounded sterile preparations, aseptic compounding, sterile environment, primary engineering controls, cleanroom contamination, personnel training, worker safety, personal hygiene, personal protective equipment, consistent established procedures, cleanroom admission, materials storage, material transfer, cleaning supplies, media-fill simulations, International Organization for Standardization, ISO Class 5 cleanroom, end-use containers, aseptic technique, microbial contamination, ISO Class 7 cleanroom, ISO Class 8 cleanroom, disinfection

Related Categories: ENVIRONMENTAL , STERILE PREPARATIONS, QUALITY CONTROL

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