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
View All Articles in Issue
Page(s): 182-192
Download in electronic PDF format for $65
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
Printer-Friendly Version
Related Articles from IJPC |
Title/Author
(Click for Abstract / Details / Purchase) |
Issue/Page
View/Buy |
Dry-heat Depyrogenation Ovens for Pharmaceutical Compounding Facilities
Weller Tom, Kragseth Rolf, Dullinger Roger, Illum Henrik, Perry Alan
|
May/Jun 2015
Pg. 182-192
|
Depyrogenation Options for the Compounding Cleanroom
Weller Tom, Bell Jeff, Dullinger Roger, Allen Vern, Anthenat Bruce
|
Nov/Dec 2014
Pg. 446-454
|
Basics of Sterile Compounding: Intravenous Admixture Preparation, Part 12: United States Pharmacopeia Chapters Referenced in the Current United States Pharmacopeia Chapter <797> Pharmaceutical Compounding -- Sterile Preparations
Allen Loyd V Jr
|
Nov/Dec 2021
Pg. 491-496
|
Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations
Allen Loyd V Jr
|
May/Jun 2013
Pg. 210-219
|
Expecting the Expected: Planning Considerations for Cleanroom Construction
Roberts Patricia A, Kroon Laura
|
Jul/Aug 2021
Pg. 276-281
|
Compounding in the Pharmacy Curriculum: Beyond the Basics
Hinkle Amanda R, Newton Gail D
|
May/Jun 2004
Pg. 181-185
|
Basics of Compounding: Application of the United States Pharmacopeia Bacterial Endotoxins Test to Compounded Sterile Preparations
Dawson Michael F
|
Jan/Feb 2006
Pg. 36-39
|
Operation of a Dry-Heat Sterilizing Oven and Validation of this Procedure
Allen Loyd V Jr
|
Nov/Dec 1999
Pg. 488-489
|
Basics of Sterile Compounding: Sterilization Methods in Sterile Product Manufacturing
Akers Michael J
|
Mar/Apr 2015
Pg. 127-138
|
PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>,<797>, and <825>: Part 1
Allen Loyd V Jr
|
Mar/Apr 2020
Pg. 92
|