Abstract

Quality-Control Analytical Methods: Sterility Failure Investigations

Author(s): Venti Eden M

Issue: Sep/Oct 2006 - Dermatology

Page(s): 372-375

Download in electronic PDF format for $75
  • Quality-Control Analytical Methods: Sterility Failure Investigations Page 1
  • Quality-Control Analytical Methods: Sterility Failure Investigations Page 2
  • Quality-Control Analytical Methods: Sterility Failure Investigations Page 3
  • Quality-Control Analytical Methods: Sterility Failure Investigations Page 4

Abstract

Sterility testing is an important step in verifying that the aseptic process has rendered a preparation sterile. Ensuring sterility involves the oversight and control of many factors, including compounding personnel, pharmacy environment, equipment and materials used in the compounding of sterile preparations, and compounding and aseptic methods. A pharmacy should have a standard operating procedure in place for investigating sterility failures, and an important focus in the procedure should be good documentation. Routine evaluations of a pharmacy’s compounding practices should be considered even though such evaluations may present a challenge to the pharmacy’s quality control system. Proper training and encouragement of staff to present possible sterility problems could make the difference in avoiding compounding failures.

Related Keywords

  • sterile preparations
  • sterility testing
  • quality control
  • USP

Related Categories

  • STERILE PREPARATIONS
  • QUALITY CONTROL
  • UNITED STATES PHARMACOPEIA CONVENTIONS

Printer-Friendly Version

Related Articles from IJPC

Issue/Page
View/Buy		 Title/Author
(Click for Abstract / Details / Purchase)
Sep/Oct 2006
Pg. 372-375
Quality-Control Analytical Methods: Sterility Failure Investigations
Author(s): Venti Eden M
Sep/Oct 2007
Pg. 400-403
Quality-Control Analytical Methods: A Discussion of United States Pharmacopeia Chapter <71> Sterility Tests
Author(s): Kupiec Thomas C
Jul/Aug 2013
Pg. 307-311
Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations
Author(s): McElhiney Linda F
Jan/Feb 2007
Pg. 52-55
Quality Control Analytical Methods: The Quality of Sterility Testing
Author(s): McGuire Jason, Kupiec Thomas C
May/Jun 2004
Pg. 223-227
Quality-Control Analytical Methods: High-Performance Liquid Chromatography
Author(s): Kupiec Thomas C
Jul/Aug 2004
Pg. 305-309
Quality-Control Analytical Methods: Gas Chromatography
Author(s): Kupiec Thomas C
Jul/Aug 2020
Pg. 299-303
Quality Control: Rapid Sterility Testing for Compounding Pharmacies
Author(s): Taylor Andrew
Jan/Feb 2004
Pg. 61-64
Quality-Control Analytical Methods: Selecting an Analytical Method
Author(s): Allen Loyd V Jr
Jan/Feb 2005
Pg. 47-49
Quality-Control Analytical Methods: Microbial Testing Aspects of USP <797> for Compounded Sterile Preparations
Author(s): Kupiec Thomas C
Mar/Apr 2005
Pg. 136-138
Quality-Control Analytical Methods: Chemical Testing Aspects of USP <797> for Compounded Sterile Preparations
Author(s): Kupiec Thomas C
Sep/Oct 2009
Pg. 412-418
Quality-Control Analytical Methods: Designing a Quality-Control Potency Testing Program for a Compounding Pharmacy
Author(s): Zolner William J
Sep/Oct 2016
Pg. 381-386
Quality Control Analytical Methods: Method Validation
Author(s): Klang Mark G, Williams LaVonn A
Nov/Dec 2003
Pg. 477-480
Quality-Control Analytical Methods: Specific-Gravity Determinations of Liquids and Semisolids
Author(s): Allen Loyd V Jr
Mar/Apr 2004
Pg. 143-145
Quality-Control Analytical Methods: Osmolality and Osmometry
Author(s): Allen Loyd V Jr
Jul/Aug 2006
Pg. 281-284
Quality Control Analytical Methods: A Guide to Quality Control Testing for the Compounding Pharmacist
Author(s): Zolner William J
Jul/Aug 2019
Pg. 299-303
Summary of Quality-Control Testing for Sterile and Nonsterile Compounded Preparations, Part 2: Microbiological Testing
Author(s): Allen Loyd V Jr
Jul/Aug 2005
Pg. 300-302
Quality-Control Analytical Methods: Glossary of Quality Control/Quality Assurance Terms in Pharmaceutical Compounding
Author(s): Kupiec Thomas C, Okeke Claudia, Allen Loyd V Jr, Denison Clay
Nov/Dec 2008
Pg. 524-528
Quality-Control Analytical Methods: Overview of Beyond-Use Dating for Compounded Sterile Preparations
Author(s): Trissel Lawrence A
May/Jun 2015
Pg. 215-221
Quality Assurance and Quality Control, Part 2
Author(s): Akers Michael J
Nov/Dec 2007
Pg. 487-490
Quality-Control Analytical Methods: In-House Quality Control of Simple Compounds
Author(s): Trusley Craig