Abstract

Basics of Sterile Compounding: Aseptic Processing

Author(s): Akers Michael J

Issue: Jan/Feb 2015 - Volume 19, Number 1

Page(s): 49-56

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Abstract

This article discusses factors that affect the assurance of sterility of an aseptic process operation and balances what is required/practiced in the pharmaceutical industry via the U.S. Food and Drug Administration and European aseptic processing guidelines and what is required/ practiced in compounding pharmacies via the United States Pharmacopeia (USP) General Chapter <797>

Related Keywords

  • aseptic processing
  • compounded sterile preparations
  • U.S. Food and Drug Administration
  • FDA
  • United States Pharmacopeia
  • USP
  • terminal sterilization
  • filtration
  • cleanroom environment
  • International Organization for Standardization
  • ISO air classification
  • ISO class
  • airflow
  • HEPA filters
  • personnel qualification
  • staff training
  • microbial monitoring
  • bacterial contaminants
  • microbial contamination
  • containers
  • endotoxin control
  • process validation
  • equipment qualification
  • process simulations
  • media fill studies
  • environmental monitoring program
  • laboratory controls
  • microbe identification
  • sterility testing

Related Categories

  • ENVIRONMENTAL
  • LEGAL
  • PACKAGING
  • STERILE PREPARATIONS
  • QUALITY CONTROL
  • UNITED STATES PHARMACOPEIA CONVENTIONS

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