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Updated: Aug 30, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Sterile Basics of Compounding: Contamination Control Strategies, Part 1
1Restore Health Consulting, LLC, Laguna Beach, California. info@restorehealthconsulting.com.
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.
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