Publications by authors named "Tom Weller"

2 Publications

  • Page 1 of 1

Dry-heat Depyrogenation Ovens for Pharmaceutical Compounding Facilities.

Int J Pharm Compd 2015 May-Jun;19(3):182-92

Sterilization kills microorganisms in compounded preparations, on the implements used to prepare them, and on the vessels that contain them, but depyrogenation incinerates the remaining debris and renders the treated tool, container, or meditation pyrogen free. Depyrogenation is thus an essential step in the preparation of sterile compounds, and the pharmacist who dispenses those formulations is directly responsible for ensuring their safety, potency, and purity. Dry heat provided by a depyrogenation oven or tunnel is the pharmaceutical gold standard for ensuring the elimination of pyrogens. In this report, we describe several depyrogenation ovens that are compliant with Current Good Manufacturing Practice standards and are appropriate for use in aseptic-compounding facilities that meet the guidelines set forth in United States Pharmacopela Chapter <797>.
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February 2016

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