Describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasizes testing methodologies for the evaluation of package integrity, finished product contamination, and sterility.

Contents

Sterility Testing

• Sterility and Sterility Test Regulations
• Sampling for Sterility Testing
• Culture Media
• Time and Temperature of Incubation
• Sterililty Test Methods
• Sterility Retesting
• FDA Guidelines on Sterility Testing
• Sterility Testing of Different Sterile Products
• Sterility Testing of Antibiotics and Proteins
• Control in Sterility Testing
• Validation of the Sterility Test
• Limitations of the USP/NF Referee Sterility Test
• Isolation Chambers and Robotic Sterility Test Units
• Support Techniques and Procedures for Sterility Assurance
• Alternatives to the Compendial Sterility Test

Pyrogen Testing

• History
• Specific Requirements of the USP Rabbit Pyrogen Test
• The Limulus Amebocyte Lysate Test
• Modifications of Rabbit and LAL Tests for Pyrogens

Particulate Matter Testing

• Background of Particulate Matter Concerns in Parenteral Products
• Nature and Source of Particulates
• The Reality of Particulate Matter Contamination in Parenteral Solutions
• Particulate Matter Standards
• Visual Inspection: Manual Methods
• Visual Inspection: Automatic Methods
• Current Issues with Visible Particle Detection and Inspection Procedures
• USP Test for Subvisible Particulate Matter in Large-Volume Injections for Single-Dose Infusion and Small-Volume Injections
• Electronic Particle Counters
• Light Obscuration Particle Count Test
• Microscopic Particle Count Test
• Automated Microscopic Particulate Matter Test
• Comparison of Microscopic and Electronic Particle-Counting Methods
• Current Issues with Electronic Particle Counters
• Factors Affecting Accurate Particle Testing
• International Compendia Standards for Particulate Matter Content in Parenteral Solutions

Package Integrity Testing

• Regulations and Guidances
• Leakage
• Establishing Leak Rate Specifications
• Package Integrity Test Methods
• The Changing Pharmaceutical Industry
• Package Integrity and the Product Life Cycle

Appendices

1. Example of Standard Operating Procedure for Sterility Testing by Direct Inoculation
2. Example of Standard Operating Procedure for Sterility Testing by Membrane Filtration
3. Aseptic Procedures at the Laminar Flow Workbench

Index

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