Abstract

Basics of Sterile Compounding: Particulate Matter

Author(s): Akers Michael J

Issue: Sep/Oct 2017 - Volume 21, Number 5

Page(s): 395-404

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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

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