Key Elements to Consider When Packaging Parenteral Products
Jeffrey Reid
Wednesday, May 4, 2016
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Chapters
Introduction
Content
Common standards for parenteral products
Particulate Cleaning-Background
Particulate Cleaning-Particulate matter
Particulate Cleaning-Process and variables
Particulate Cleaning-Comparing common water types
Particulate Cleaning-Test methods
Particulate Cleaning-Method I
Particulate Cleaning-Method II
Particulate Cleaning-Particle count limits
Depyrogenation-Background
Depyrogenation-Process and variables
Depyrogenation-Batch oven vs. continuous tunnel
Depyrogenation-Batch vs. continuous
Depyrogenation-Test methods
Depyrogenation-LAL cascade
Depyrogenation-Gel-clot method
Depyrogenation-Turbidmetric & chromogenic methods
Sterilization-Background
Sterilization-Comparing methods
Effects of Sterilization on Extractables-Comparing extractables and leachables
Effects of Sterilization on Extractables-Headspace GC-MS Analysis
Effects of Sterilization on Extractables-GC-MS Analysis
Summary
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