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USP Chapter <797>: Practical Solutions for Microbiology, Sterility, and Pyrogen Testing

Author(s):  Caputo Ross A, Huffman Anne, Reich Robert

Issue:  Jan/Feb 2005 - Sterile Preparations
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Abstract:  The advent of USP<797>, the recently published United States Pharmacopeia (USP) chapter titled “Pharmaceutical Compounding—Sterile Preparations” has left the compounding pharmacist with the job of implementation. Many contract laboratories are well equipped to conduct finished-product testing for compounding pharmacies. Contract laboratories offer trained, experienced management, a quality system environment, and efficient processing of samples for environmental monitoring, sterility testing, and pyrogen (ie, bacterial endotoxin) and potency testing. These laboratories also have all of the validated procedures, methods, and equipment required for USP<797> compliance. Media-fill testing, used to assess the competency of compounding personnel and aseptic processing procedures, is one of the most powerful tools in the compounding pharmacy quality program.

Related Keywords: Ross A. Caputo, PhD, Anne Huffman, BS, Robert Reich, BS, MS, United States Pharmacopeia, USP Chapter <797>, contract laboratories, media fill testing, microbiology testing, sterility testing

Related Categories: STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, FDA

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