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Updated: May 11, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Quality control analytical methods: strategies to ensure a robust quality-control microbiology program
Tricia Griffiths1, Anne Connors
1EMD Millipore Corporation, Billerica, Massachusetts 01821, USA. tricia.griffiths@emdmillipore.com
Abstract:
As the regulatory environment for compounding pharmacies continues to evolve, facilities can take immediate steps to strengthen their quality-control microbiology and environmental monitoring programs. Robust programs that are timely, comprehensive, and effective will minimize risk and help support positive patient outcomes. This article provides a roadmap for putting in place a robust quality-control microbiology program in the face of United States Pharmacopeia Chapter 797 standards, and highlights several technologies for environmental monitoring that support a successful program.
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