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Depyrogenation Options for the Compounding Cleanroom

Author(s):  Weller Tom, Bell Jeff, Dullinger Roger, Allen Vern, Anthenat Bruce

Issue:  Nov/Dec 2014 - Volume 18, Number 6
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Page(s):  446-454

Note:  Electronic version includes supplemental material.

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Abstract:  Compounding pharmacies, especially those awarded 503B status under the U.S. Federal Food, Drug, and Cosmetic Act that resulted from the Drug Quality and Security Act, must meet increasingly strict standards for the preparation of sterile formulations. Depyrogenating the containers and tools used in such compounding is essential to meeting those standards and ensuring patient safety. Although pyrogens are relatively thermally stable, treating asepticcompounding glassware and implements in a dry-heat oven or tunnel is the most common method of depyrogenation. Depyrogenation tunnels are used at larger facilities in which automation and a higher throughput can justify the cost of that equipment, but a small batch oven is an inexpensive and appropriate solution to meeting sterilization and depyrogenation requirements in a smaller compounding pharmacy. In this article, we discuss the appropriate use of depyrogenation ovens and tunnels, compare those types of equipment, and describe the selection and use of a cleanroom oven in a compounding pharmacy.

Related Keywords: Tom Weller, Jeff Bell, Roger Dullinger, Vern Allen, RPh, Bruce Anthenat, compounding cleanroom, compounded sterile preparations, pyrogens, microbial contamination, contaminants, dry-heat oven, depyrogenation tunnel, glassware sterilization, equipment decontamination, United States Pharmacopeia Chapter <1211>, endotoxins, standards, temperature, maintenance, calibration

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

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