Dry-heat Depyrogenation Ovens for Pharmaceutical Compounding Facilities
Author(s): Weller Tom, Kragseth Rolf, Dullinger Roger, Illum Henrik, Perry Alan
Issue: May/Jun 2015 - Volume 19, Number 3
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Page(s): 182-192
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Abstract: 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 medication 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 Pharmacopeia Chapter <797>.
Related Keywords: Tom Weller, Rolf Kragseth, Roger Dullinger, Henrik Illum, Alan Perry, depyrogenation, pyrogens, compounded sterile preparations, endotoxins, aseptic compounding, dry heat oven, cleanroom equipment, Current Good Manufacturing Practice regulations, United States Pharmacopeia Chapter <797>, USP, ISO Class 5 standards, sterilization
Related Categories: ENVIRONMENTAL , STERILE PREPARATIONS, UNITED STATES PHARMACOPEIA CONVENTIONS