Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Using ACDs in the Practice of Pharmacy

Author(s):  Kastango Eric S

Issue:  Jan/Feb 2005 - Sterile Preparations
View All Articles in Issue

Page(s):  15-21

Using ACDs in the Practice of Pharmacy Page 1
Using ACDs in the Practice of Pharmacy Page 2
Using ACDs in the Practice of Pharmacy Page 3
Using ACDs in the Practice of Pharmacy Page 4
Using ACDs in the Practice of Pharmacy Page 5
Using ACDs in the Practice of Pharmacy Page 6
Using ACDs in the Practice of Pharmacy Page 7

Download in electronic PDF format for $75

Abstract:  Several sections of the recently published USP<797> chapter of the United States Pharmacopeia (USP) address the use of automatic compounding devices (ACDs) and offer guidelines for ensuring that they operate properly and within acceptable tolerance limits. ACDs are designed to accurately transfer volumes of fluid from one container into another. All pharmacies using ACDs must develop a quality system to ensure the safety and accuracy of formulations prepared by ACD. A quality system should incorporate a hazard analysis, critical control points plan, which involves definition of steps in any ACD compounding process and identification of potential hazards in the process. The pharmacy also must document appropriate maintenance, calibration, and functioning of the ACD equipment as well as training of personnel to carry out these activities. One section of USP<797> focuses on the accuracy and precision of ACDs in preparing parenteral nutrition solutions. Optimal operating characteristics of an ACD for preparation of these solutions are discussed.

Related Keywords: Eric S. Kastango, MBA, RPh, FASHP, automatic compounding devices, quality control, hazard analysis, contamination control points plan, HACCP plan, United States Pharmacopeia, USP Chapter <797>, parenteral nutrition

Related Categories: PARENTERALS, STERILE PREPARATIONS, TECHNOLOGY, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, FDA, HAZARDOUS DRUGS

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Using ACDs in the Practice of Pharmacy
Kastango Eric S
Jan/Feb 2005
Pg. 15-21

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

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

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

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

A Primer on USP Chapter 797, "Pharmaceutical Compounding - Sterile Preparations," and USP Process for Drug and Practice Standards
Newton David W
, Trissel Lawrence A
Jul/Aug 2004
Pg. 251-263

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

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

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 14: Environmental Quality and Control (Continued)
Okeke Claudia C
, Allen Loyd V Jr
Jul/Aug 2009
Pg. 322-329

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

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

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

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

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

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

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> Pharmacy Compounding Sterile Preparations, Part 17: Elements of Quality Control
Okeke Claudia C
, Allen Loyd V Jr
Jan/Feb 2010
Pg. 60-64

Return to Top