Publications by authors named "Bruce Anthenat"

2 Publications

  • Page 1 of 1

Depyrogenation options for the compounding cleanroom.

Int J Pharm Compd 2014 Nov-Dec;18(6):446-54

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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June 2015

Vial washers for the compounding pharmacy: ensuring preparation safety.

Int J Pharm Compd 2014 Jul-Aug;18(4):270-6

The safety and effectiveness of customized formulations have always been priorities for compounding pharmacists, perhaps even more so since a tragic outbreak of meningitis in 2012 was traced to preparations from the New England Compounding Center in Framingham, Massachusetts. Since that time, pharmaceutical compounding in the U.S. has been the focus of renewed interest from the public and from government organizations and regulatory bodies created to ensure patient safety. As a result, responsible compounders have responded to ensure--to even greater levels--the purity and safety of the formulations they prepare. One tool useful in doing so is the mechanical vial washer, which can produce cleaner vials (and/or ampules, syringes, and cartridges, depending on the washer model) more consistently than does washing vessels by hand. In this article, several such washers appropriate for use in a compounding pharmacy are profiled, and a pharmacist's experience in using one of those models is described.
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January 2015
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