Abstract

Sterile Basics of Compounding: How to Implement a Robust Visual-inspection Program

Author(s): Summers Amy

Issue: Jul/Aug 2022 - Volume 26, Number 4

Page(s): 309-315

Download in electronic PDF format for $75
  • Sterile Basics of Compounding: How to Implement a Robust Visual-inspection Program Page 1
  • Sterile Basics of Compounding: How to Implement a Robust Visual-inspection Program Page 2
  • Sterile Basics of Compounding: How to Implement a Robust Visual-inspection Program Page 3
  • Sterile Basics of Compounding: How to Implement a Robust Visual-inspection Program Page 4
  • Sterile Basics of Compounding: How to Implement a Robust Visual-inspection Program Page 5
  • Sterile Basics of Compounding: How to Implement a Robust Visual-inspection Program Page 6
  • Sterile Basics of Compounding: How to Implement a Robust Visual-inspection Program Page 7

Abstract

Dispensing compounded sterile injectable drug preparations that contain particulates can have serious patient-safety implications. While there is a lack of controlled human studies to demonstrate the clinical concerns that particles can be carriers for microbiological contamination, they have been shown to potentially block blood vessels. Anecdotal studies found that foreign body emboli and granulomas are the most common result of particulate matter present in intravenous solutions. The compounding of absolutely particle-free injectable preparations is nearly impossible under real-life conditions. Hence, inspection of each filled and sealed compounded injectable drug before it is labeled and dispensed is mandatory. To avoid a noncompliance observation, this article aims to outline the regulatory expectations, visual inspector training and qualification program, and adequate visual-inspection procedures and equipment.

Related Keywords

  • compounded sterile preparations
  • sterile injectable drug preparations
  • particulates
  • contaminants
  • drug safety
  • microbiological contamination
  • foreign body emboli
  • granulomas
  • United States Pharmacopeia Chapter <790>
  • regulation
  • regulatory expectations
  • visual inspection test methods
  • manual visual inspection
  • automated visual inspection
  • visual inspectors
  • visual inspection training
  • inspection equipment

Related Categories

  • LEGAL
  • PARENTERALS
  • STERILE PREPARATIONS
  • QUALITY CONTROL
  • UNITED STATES PHARMACOPEIA CONVENTIONS
  • ADVERSE DRUG EVENTS

Printer-Friendly Version

Related Articles from IJPC

Issue/Page
View/Buy		 Title/Author
(Click for Abstract / Details / Purchase)
Jul/Aug 2022
Pg. 309-315
Sterile Basics of Compounding: How to Implement a Robust Visual-inspection Program
Author(s): Summers Amy
May/Jun 2022
Pg. 219-228
Sterile Basics of Compounding: Particulates in Parenteral Preparations: Sources, Minimization, and Detection
Author(s): Allen Loyd V Jr
Sep/Oct 2018
Pg. 387-398
Compounding Enclosures: Ensuring Safety During the Preparation of Sterile and Nonsterile Formulations
Author(s): Ashe Krystina, Baskett Dustin
May/Jun 2016
Pg. 217-222
Basics of Sterile Compounding: Clinical Hazards of Injectable Drug Administration
Author(s): Akers Michael J
May/Jun 2020
Pg. 215-220
Sterile Basics: Intravenous Admixture Preparation Considerations, Part 4: Particulates
Author(s): Allen Loyd V Jr
Sep/Oct 2022
Pg. 411-418
Sterile Basics of Compounding: Contamination Control Strategies, Part 1
Author(s): Summers Amy
Jan/Feb 2022
Pg. 41-49
Sterile Basics: Compounding Sterile Preparations with Cyclodextrins
Author(s): Allen Loyd V Jr
Sep/Oct 2017
Pg. 395-404
Basics of Sterile Compounding: Particulate Matter
Author(s): Akers Michael J
Mar/Apr 2004
Pg. 89-94
Overview of Chapter <797> "Pharmaceutical Compounding - Sterile Preparations": The Potential Impact for Compounding Pharmacists
Author(s): Rahe Hank
Jul/Aug 2013
Pg. 307-311
Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations
Author(s): McElhiney Linda F
Nov/Dec 2021
Pg. 491-496
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
Author(s): Allen Loyd V Jr
Sep/Oct 2019
Pg. 399-402
Sterile Basics: Pharmaceutical Waters Used in Sterile and Nonsterile Compounding
Author(s): Allen Loyd V Jr
Sep/Oct 2023
Pg. 397-409
Basics of Sterile Compounding: Sterile Basics of Compounding Intravenous Admixtures, Part 4: Physicochemical Considerations
Author(s): Allen Loyd V Jr
Jul/Aug 2015
Pg. 268-278
Safer Sterile Compounding: Choosing and Using Disinfectants for the Cleanroom
Author(s): Kastango Eric S, Douglass Kate, Patel Kedar, Givehchi Babak, Brister Paul, Postlewaite Jay, Taraban Laura
Nov/Dec 2022
Pg. 497-504
Sterile Basics of Compounding: Contamination Control Strategies, Part 2
Author(s): Summers Amy
Mar/Apr 2017
Pg. 133-142
Accuracy Considerations in Sterile Compounding
Author(s): Akers Michael J
Jul/Aug 2014
Pg. 313-317
Basics of Compounding Sterile Preparations: Nomenclature and Considerations
Author(s): Allen Loyd V Jr
Mar/Apr 2017
Pg. 95-102
U.S. Food and Drug Administration Inspections: Guide to a Successful Outcome for 503A Sterile Compounding Pharmacies
Author(s): Yoch Doug
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
Nov/Dec 2020
Pg. 460-465
Establishing a Structured Pharmacy Training Program in Sterile Compounding
Author(s): Dirbas Muhannad, AbuSara Aseel K, Whiyabi Shatha, Harb Rema, Telfah Shorouq