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Basics of Sterile Compounding: Sterilization Methods in Sterile Product Manufacturing

Author(s):  Akers Michael J

Issue:  Mar/Apr 2015 - Volume 19, Number 2
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Abstract:  Sterilization methods to produce sterile preparations include heat, gas, radiation, and filtration. This article focuses on heat, gas, and radiation sterilization, plus a brief introduction to bright-light sterilization. Microbiology basics and microbial death kinetics, key to understanding why these sterilization methods work, will also be briefly discussed. Filtration sterilization will be covered in a separate article.

Related Keywords: Michael J. Akers, PhD, United States Pharmacopeia Chapter <797>, compounded sterile preparations, sterilization methods, parenteral manufacturing, thermal sterilization, dry heat, wet heat, moist heat, steam, filtration, radiation, light, chemical sterilization, gas, microbiology, microorganisms, bacteria, fungi, fungus, yeast, molds, virus, microbial death kinetics, bioburden, D-value, Z-value, F-value, autoclaves

Related Categories: ENVIRONMENTAL , STERILE PREPARATIONS, UNITED STATES PHARMACOPEIA CONVENTIONS

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