International Journal of Pharmaceutical Compounding

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Basics of Sterile Compounding: Particulate Matter

Author(s): Akers Michael J

Issue: Sep/Oct 2017 - Volume 21, Number 5
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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: Michael J. Akers, PhD, 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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