Introducing Medisca Nutraceuticals

Download in electronic PDF format for $25



Search the Complete Journal Archives

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
View All Articles in Issue

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

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
USP Chapter <797>: Practical Solutions for Microbiology, Sterility, and Pyrogen Testing Caputo Ross A, Huffman Anne, Reich Robert Jan/Feb 2005 11-13 Buy
Quality Control: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 2 Vu Nicole, Lou Jessica R, Kupiec Thomas C Jul/Aug 2014 305-310 Buy
Quality-Control Analytical Methods: Microbial Testing Aspects of USP <797> for Compounded Sterile Preparations Kupiec Thomas C Jan/Feb 2005 47-49 Buy
Quality Control Analytical Methods: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 1 Vu Nicole, Lou Jessica R, Kupiec Thomas May/Jun 2014 213-221 Buy
Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations McElhiney Linda F Jul/Aug 2013 307-311 Buy
Quality-Control Analytical Methods: A Discussion of United States Pharmacopeia Chapter <71> Sterility Tests Kupiec Thomas C Sep/Oct 2007 400-403 Buy
Quality-Control Analytical Methods: Chemical Testing Aspects of USP <797> for Compounded Sterile Preparations Kupiec Thomas C Mar/Apr 2005 136-138 Buy
Quality Control Analytical Methods: Pharmacopeial Bacterial Endotoxins Test Chapters Dawson Michael E Jul/Aug 2010 317-320 Buy
A Primer on USP Chapter 797, "Pharmaceutical Compounding - Sterile Preparations," and USP Process for Drug and Practice Standards Newton David W, Trissel Lawrence A Jul/Aug 2004 251 Buy
Basics of Compounding: Application of the United States Pharmacopeia Bacterial Endotoxins Test to Compounded Sterile Preparations Dawson Michael F Jan/Feb 2006 36-39 Buy