Abstract

Basics of Sterile Compounding: Sterilization Methods in Sterile Product Manufacturing

Author(s): Akers Michael J

Issue: Mar/Apr 2015 - Volume 19, Number 2

Page(s): 127-138

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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

  • 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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