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.

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