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