Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

Decontamination Technology: The Missing Element

Author(s):  Rahe Hank

Issue:  May/Jun 2013 - Volume 17, Number 3
View All Articles in Issue

Page(s):  193-199

Decontamination Technology: The Missing Element Page 1
Decontamination Technology: The Missing Element Page 2
Decontamination Technology: The Missing Element Page 3
Decontamination Technology: The Missing Element Page 4
Decontamination Technology: The Missing Element Page 5
Decontamination Technology: The Missing Element Page 6
Decontamination Technology: The Missing Element Page 7

Download in electronic PDF format for $75

Abstract:  Understanding decontamination technology as it applies to compounding sterile preparations and its role in achieving an acceptable level of sterility assurance in compounded preparations is essential. Delivering safe preparations to patients requires the key elements that make up an acceptable sterility-assurance level. Those key elements are decontamination of the preparation components and the environment in which they are compounded, aseptic technique, and proper air quality of the compounding environment. This article explores the concept of sterility assurance as it applies to sterile preparations.

Related Keywords: Hank Rahe, BSIM, MSE, compounded sterile preparations, drug safety, environmental contamination, sterility assurance level, aseptic technique, air quality standards, United States Pharmacopeia Chapter <1211>, primary engineering controls, packaging, disinfectants, sterilants, disinfection, sterilization, decontamination

Related Categories: ENVIRONMENTAL , LEGAL, STERILE PREPARATIONS, TECHNOLOGY, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Decontamination Technology: The Missing Element
Rahe Hank
May/Jun 2013
Pg. 193-199

Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice
Kelley Brian
Mar/Apr 2021
Pg. 115-124

Compounding Enclosures: Ensuring Safety During the Preparation of Sterile and Nonsterile Formulations
Ashe Krystina
, Baskett Dustin
Sep/Oct 2018
Pg. 387-398

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

Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 3: Risk Levels
Allen Loyd V Jr
, Okeke Claudia C
Sep/Oct 2007
Pg. 404-410

Adventures in the Environmental World and Environmental Microbiology Sampling of Air for Pharmaceutical Sterile Compounding
Ligugnana Roberto
May/Jun 2017
Pg. 182-190

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

Basics of Compounding: Implementing United States Pharmacopeia Chapter <1163> Quality Assurance in Pharmaceutical Compounding, Part 1
Allen Loyd V Jr
Mar/Apr 2012
Pg. 146-150

Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 1
Martin Matt
Sep/Oct 2018
Pg. 401-404

Quality Control: Testing for "Micromonsters": Viable Air and Surface Sampling in Aseptic Compounding
Mulder Kyle
May/Jun 2021
Pg. 211-216

Quality-Control Analytical Methods: A Discussion of United States Pharmacopeia Chapter <71> Sterility Tests
Kupiec Thomas C
Sep/Oct 2007
Pg. 400-403

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 6: 2008 Revisions to Chapter <797>
Allen Loyd V Jr
, Okeke Claudia C
Mar/Apr 2008
Pg. 136-144

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 7: Microbial Contamination Risk Levels, 12-Hour Use, and Immediate Use
Allen Loyd V Jr
, Okeke Claudia C
May/Jun 2008
Pg. 252-257

Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards
Kastango Eric S
May/Jun 2008
Pg. 216-229

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 13: Environmental Quality and Control
Allen Loyd V Jr
, Okeke Claudia C
May/Jun 2009
Pg. 234-238

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>, <797>, and <825>: Part 2
Allen Loyd V Jr
May/Jun 2020
Pg. 180

Basics of Sterile Compounding. Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 2
Martin Matt
Nov/Dec 2018
Pg. 475-478

Quality Assurance and Quality Control, Part 2
Akers Michael J
May/Jun 2015
Pg. 215-221

Update on the Proposed Revision Process for United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations
Okeke Claudia C
Jul/Aug 2007
Pg. 302-305

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 14: Environmental Quality and Control (Continued)
Okeke Claudia C
, Allen Loyd V Jr
Jul/Aug 2009
Pg. 322-329

Return to Top