title: Dry-heat Depyrogenation Ovens for Pharmaceutical Compounding Facilities.
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 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>.
authors.forename: Tom
authors.initials: T
authors.lastname: Weller
authors.forename: Rolf
authors.initials: R
authors.lastname: Kragseth
authors.forename: Roger
authors.initials: R
authors.lastname: Dullinger
authors.forename: Henrik
authors.initials: H
authors.lastname: Illum
authors.forename: Alan
authors.initials: A
authors.lastname: Perry
mesh_terms: D004203:Disinfection / Q000295:instrumentation* / Q000592:standards; D004339:Drug Compounding / Q000295:instrumentation* / Q000592:standards; D004340:Drug Contamination / Q000517:prevention & control*; D004867:Equipment Design; D017408:Guidelines as Topic; D006358:Hot Temperature; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards; D011749:Pyrogens / Q000032:analysis*; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000295:instrumentation* / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations; D011749:Pyrogens