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Abstract:  Several sections of the recently published USP<797> chapter of the United States Pharmacopeia (USP) address the use of automatic compounding devices (ACDs) and offer guidelines for ensuring that they operate properly and within acceptable tolerance limits. ACDs are designed to accurately transfer volumes of fluid from one container into another. All pharmacies using ACDs must develop a quality system to ensure the safety and accuracy of formulations prepared by ACD. A quality system should incorporate a hazard analysis, critical control points plan, which involves definition of steps in any ACD compounding process and identification of potential hazards in the process. The pharmacy also must document appropriate maintenance, calibration, and functioning of the ACD equipment as well as training of personnel to carry out these activities. One section of USP<797> focuses on the accuracy and precision of ACDs in preparing parenteral nutrition solutions. Optimal operating characteristics of an ACD for preparation of these solutions are discussed.

Related Keywords: Eric S. Kastango, MBA, RPh, FASHP, automatic compounding devices, quality control, hazard analysis, contamination control points plan, HACCP plan, United States Pharmacopeia, USP Chapter <797>, parenteral nutrition

Related Categories: PARENTERALS, STERILE PREPARATIONS, TECHNOLOGY, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, FDA, HAZARDOUS DRUGS

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