International Journal of Pharmaceutical Compounding

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.

LEARN MORE

Basics of Sterile Compounding: Particulate Matter

Author(s): Akers Michael J

Issue: Sep/Oct 2017 - Volume 21, Number 5
View All Articles in Issue

Page(s): 395-404

Basics of Sterile Compounding: Particulate Matter Page 1

Basics of Sterile Compounding: Particulate Matter Page 2

Basics of Sterile Compounding: Particulate Matter Page 3

Basics of Sterile Compounding: Particulate Matter Page 4

Basics of Sterile Compounding: Particulate Matter Page 5

Basics of Sterile Compounding: Particulate Matter Page 6

Basics of Sterile Compounding: Particulate Matter Page 7

Basics of Sterile Compounding: Particulate Matter Page 8

Basics of Sterile Compounding: Particulate Matter Page 9

Basics of Sterile Compounding: Particulate Matter Page 10

Download in electronic PDF format for $75

Abstract: This article focuses on the requirements for particulate matter in sterile products. Topics include particles and quality, particulate matter standards (large- and small-volume injectables), development of the small-volume injectable test, electronic (light obscuration) and microscope testing, and special requirements for particulate matter in biopharmaceutical preparations.

Related Keywords: compounded sterile preparations, sterile compounding, aseptic processing, particles, particulate matter, quality control testing, injectable solution preparations, parenteral products, particulate matter standards, light obscuration particle count, United States Pharmacopeia Chapter <788>, USP, contamination, large-volume injectables, LVI, small-volume injectables, SVI, biopharmaceuticals, package insert, filters, filtering

Related Categories: STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

Printer-Friendly Version

Title/Author (Click for Abstract / Details / Purchase)	Issue/Page View/Buy
Related Articles from IJPC
Basics of Sterile Compounding: Particulate Matter Akers Michael J	Sep/Oct 2017 Pg. 395-404
Sterile Basics of Compounding: Particulates in Parenteral Preparations: Sources, Minimization, and Detection Allen Loyd V Jr	May/Jun 2022 Pg. 219-228
Compounding in the Pharmacy Curriculum: Beyond the Basics Hinkle Amanda R, Newton Gail D	May/Jun 2004 Pg. 181-185
Quality-Control Analytical Methods: Particulate Matter in Injections: What is It and What are the Concerns? Tran Tuan, Kupiec Thomas C, Trissel Lawrence A	May/Jun 2006 Pg. 202-204
Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations McElhiney Linda F	Jul/Aug 2013 Pg. 307-311
Compounding Enclosures: Ensuring Safety During the Preparation of Sterile and Nonsterile Formulations Ashe Krystina, Baskett Dustin	Sep/Oct 2018 Pg. 387-398
Sterile Basics: Intravenous Admixture Preparation Considerations, Part 4: Particulates Allen Loyd V Jr	May/Jun 2020 Pg. 215-220
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
Basics of Sterile Compounding: Intravenous Admixture Preparation, Part 11: Particulate Issues --- Silicone Oil in Vials, Cartridges, and Syringes Allen Loyd V Jr	Sep/Oct 2021 Pg. 403-408
Basics of Compounding for Sterile, Nonsterile, and Quality Control Compounding: Process Analytical Technology: Appropriate for Sterile and Nonsterile Compounding? Allen Loyd V Jr	Mar/Apr 2019 Pg. 123-130
Microbiologic Testing for 503A Sterile-Compounding Pharmacies Mixon William, Roth Abby	May/Jun 2017 Pg. 193-203
Basics of Sterile Compounding: Sterile Basics of Compounding Intravenous Admixtures, Part 4: Physicochemical Considerations Allen Loyd V Jr	Sep/Oct 2023 Pg. 397-409
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
Overview of Chapter <797> "Pharmaceutical Compounding - Sterile Preparations": The Potential Impact for Compounding Pharmacists Rahe Hank	Mar/Apr 2004 Pg. 89-94
Basics of Sterile Compounding: Aseptic Processing Akers Michael J	Jan/Feb 2015 Pg. 49-56
Basics of Compounding: Compounding Irrigation Solutions for Sterile and Nonsterile Preparations Allen Loyd V Jr	Nov/Dec 2017 Pg. 481-486
Particulates in Parenterals Allen Loyd V Jr	Jan/Feb 2000 Pg. 43
Sterile Basics: Compounding Sterile Preparations with Cyclodextrins Allen Loyd V Jr	Jan/Feb 2022 Pg. 41-49
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
Current Topical Treatments in Wound Healing - Part 1 Helmke Christopher D	Jul/Aug 2004 Pg. 269-274
Return to Top