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. 2014 Nov-Dec;18(6):446-54.

Depyrogenation options for the compounding cleanroom

Tom Weller, Jeff Bell, Roger Dullinger, Vern Allen, Bruce Anthenat
  • PMID: 25906620

Depyrogenation options for the compounding cleanroom

Tom Weller et al. Int J Pharm Compd. 2014 Nov-Dec.

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 aseptic-compounding 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.

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