Technical Report No. 22 (Revised 2011), Process Simulation for Aseptically Filled Products, originally published in 1996.
The Task Force charged with updating the document ensured that the new version reflects the continuing changes that have occurred in aseptic processing technology within the global industry over the last decade and a half. They have attempted to address the subject as fully as possible, recognizing the notable contributions by other organizations, regulators, compendia and individuals who have worked in this area. In addition the report provides guidance where risk-based approaches may be applied.
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Table of Contents:
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- Glossary of Terms
- Process Simulation Concepts and Principles
- Process Simulation for Sterile Dosage Forms
- Microbiological Environmental Monitoring
- Elements of Aseptic Process Simulations
- Personnel Qualification
- Acceptance Criteria
- Considerations for Investigation
- Ongoing Process Evaluation
- Suggested Readings
- Figures and Tables Index