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 all issues and individual articles published by the Journal since 1997.

Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards

Author(s):  Kastango Eric S

Issue:  May/Jun 2008 - Pain Management
View All Articles in Issue

Page(s):  216-229

Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 1
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 2
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 3
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 4
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 5
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 6
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 7
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 8
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 9
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 10
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 11
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 12
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 13
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Page 14

Download in electronic PDF format for $75

Abstract:  The most recent changes to Chapter <797> of the United States Pharmacopeia–National Formulary initiated an intense controversy about the frequency of cleanroom air sampling that is required to prevent the contamination of sterile preparations. For compounders who must purchase an air sampler to use in the cleanroom, choices abound. Included in this article are a review of United States Pharmacopeia–National Formulary requirements that pertain to air sampling, a discussion of how recent revisions to Chapter <797> affect air sampling and patient safety, and, for easy reference, a table that features specifications for various models of microbial air samplers.

Related Keywords: USP, United States Pharmacopeia Chapter <797>, sterile preparations, cleanroom, air quality, microbes, microbial contamination, air sampling devices, device specifications

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

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

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

Microbial Air-Sampling Equipment, Part 2: Experiences of Compounding Pharmacists
Mixon Bill
, Cabaleiro Joe, Latta Kenneth S, Vail Jane
Jul/Aug 2008
Pg. 321-327

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

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

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

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

Implementation of a Viable Air-Sampling Program Using a Volumetric Collection Device
Kennedy Steve
, Siefert Lisa Linn, Lange Matt
Sep/Oct 2010
Pg. 370-372

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

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

United States Pharmacopeia Chapter <797> Timeline: 1989 to 2013
Newton David W
Jul/Aug 2013
Pg. 283-288

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

Quality Control Analytical Methods: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 1
Vu Nicole
, Lou Jessica R, Kupiec Thomas
May/Jun 2014
Pg. 213-221

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

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

Misinterpretation of United States Pharmacopeia Chapter <797>
McElhiney Linda F
Jan/Feb 2012
Pg. 6-10

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

Return to Top