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.

Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 1

Author(s):  Wagner James T

Issue:  Mar/Apr 2006 - Hospice/Palliative Care
View All Articles in Issue

Page(s):  128-133

Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 1 Page 1
Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 1 Page 2
Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 1 Page 3
Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 1 Page 4
Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 1 Page 5
Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 1 Page 6

Download in electronic PDF format for $75

Abstract:  The Controlled Environment Testing Association guide focuses on isolator applications that are appropriate for use in facilities that compound sterile preparations. Owing to the fact that there are no uniform industry standards for the manufacture of barrier isolators, the purpose of this guide is to increase pharmacists’ awareness of the need to establish procedures addressing issues unique to isolators. This article provides critical information on major design features of isolators, including airflow, flow control, dilution control, pressurization, clean zone classification, decontamination/disinfection, gloves/sleeves, closed system versus open system, pass-through considerations, and ergonomic considerations. In the future, Controlled Environment Testing Association will publish a guide—not a testing “standard”—for industry procedures for testing and commissioning isolators, as no published industry procedures are available at this time.

Related Keywords: James T. Wagner, sterile preparations, aseptic compounding, barrier isolators, Controlled Environment Testing Association, controlled environment, airflow, barrier isolation, CETA, compounded sterile preparations, engineering controls, environmental controls, ISO standards, United States Pharmacopeia

Related Categories: ENVIRONMENTAL , QUALITY CONTROL

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 1
Wagner James T
Mar/Apr 2006
Pg. 128-133

Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 2
Wagner James T
May/Jun 2006
Pg. 208-211

Technology Spotlight: Barrier Isolators
Moussa Magdy
, Rahe Hank, Lo Katharine
Jan/Feb 2003
Pg. 42-43

Basics of Sterile Compounding: Barrier Isolator Technologist in Aseptic Processing
Akers Michael J
Jul/Aug 2015
Pg. 315-320

Primary Engineering Controls in Pharmaceutical Compounding, Part 1: Unidirectional-airflow Workstations, Compounding Aseptic Isolators, and Compounding Aseptic Containment Isolators
Mulder Kyle
Nov/Dec 2019
Pg. 447-452

Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations
McElhiney Linda F
Jul/Aug 2013
Pg. 307-311

Barrier Isolators: A New, High-tech Option for the Preparation of Sterile Admixtures
Karolchyk Scott
Nov/Dec 2001
Pg. 422-423

Summary of Quality-Control Testing for Sterile and Nonsterile Compounded Preparations, Part 2: Microbiological Testing
Allen Loyd V Jr
Jul/Aug 2019
Pg. 299-303

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

Sterile Compounding with Barrier-Isolation Technology
Rahe Hank
Jul/Aug 2001
Pg. 254-258

Statistical Analysis of Barrier Isolator/Glovebox Glove Failure
Park Young H
, Pines E, Ofouku M, Cournoyer ME
Jul/Aug 2007
Pg. 338-346

Sterile Basics of Compounding: Contamination Control Strategies, Part 1
Summers Amy
Sep/Oct 2022
Pg. 411-418

Accuracy Considerations in Sterile Compounding
Akers Michael J
Mar/Apr 2017
Pg. 133-142

Using Hospital Laboratory Services to Perform Quality-control Testing on Compounded Preparations
Donnelly Ronald F
Sep/Oct 2015
Pg. 383-386

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

Barrier Isolator/Glovebox Glove Dexterity Study
Park Young H
, Pines E, Cournoyer M E
Nov/Dec 2010
Pg. 526-530

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

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

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

Microbiologic Testing for 503A Sterile-Compounding Pharmacies
Mixon William
, Roth Abby
May/Jun 2017
Pg. 193-203

Return to Top