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.

Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control

Author(s):  Summers Amy, Stephens Pat

Issue:  Jan/Feb 2023 - Volume 27, Number 1
View All Articles in Issue

Page(s):  39-46

Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control Page 1
Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control Page 2
Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control Page 3
Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control Page 4
Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control Page 5
Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control Page 6
Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control Page 7
Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control Page 8

Download in electronic PDF format for $75

Abstract:  Whether sterile compounds are prepared in a brand new state-of-the-art cleanroom suite or in an aging space, compounders rely heavily on their primary and secondary engineering controls when sterilizing or maintaining sterility of the final preparation. With the release of the latest revision to United States Pharmacopeia Chapter <797>, organizations that prepare sterile compounds must now sample and test each classified area for the presence of microbiological contaminants at a higher frequency. Facilities that are not purpose-built, as well as those that do not operate within a state of control, are predicted to repeatedly exceed action levels as set by the United States Pharmacopeia Convention, Inc. Before the United States Pharmacopeia revision becomes active and enforceable, it is advised that sterile compounding practice sites undergo an environmental-baseline study to gather statistically significant data to demonstrate how the cleanroom(s) perform and to assess whether or not dynamic operations increase the levels of bioburden.

Related Keywords: compounded sterile preparations, cleanroom, engineering controls, sterility, microbiological contamination, United States Pharmacopeia Chapter <797>, USP, environmental baseline study, cleanroom air monitoring, cleanroom surface monitoring, microbial contaminants, particulate contamination, environmental monitoring, sampling locations, static testing, dynamic testing

Related Categories: ENVIRONMENTAL , STERILE PREPARATIONS, UNITED STATES PHARMACOPEIA CONVENTIONS, INFORMATION RESOURCES

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control
Summers Amy
, Stephens Pat
Jan/Feb 2023
Pg. 39-46

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 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

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

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

Sterile Basics of Compounding: Contamination Control Strategies, Part 2
Summers Amy
Nov/Dec 2022
Pg. 497-504

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

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 13: Environmental Quality and Control
Allen Loyd V Jr
, Okeke Claudia C
May/Jun 2009
Pg. 234-238

Advanced Compounding; How to Investigate Microbiological Excursions at a Sterile Compounding Facility
Summers Amy
Mar/Apr 2023
Pg. 114-121

Expecting the Expected: Planning Considerations for Cleanroom Construction
Roberts Patricia A
, Kroon Laura
Jul/Aug 2021
Pg. 276-281

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

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

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

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

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

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

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 9: Immediate-Use Compounded Sterile Preparations
Allen Loyd V Jr
, Okeke Claudia C
Sep/Oct 2008
Pg. 440-443

Basics of Compounding: Considerations for Implementing USP Chapter <797> -- Sterile Preparations, Part 19: Storage and Beyond-Use Dating, Maintaining Sterility, Purity, and Stability of Dispensed and Distributed Compounded Sterile Preparations
Okeke Claudia C
, Allen Loyd V Jr
May/Jun 2010
Pg. 232-238

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

Return to Top