Technical Reports: Electronic

PDA Technical Report 22, (TR 22) Revised 2011 Process Simulation for Aseptically Filled Products (single user digital version)

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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Format: PDF (1 file - 565 KB)

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Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Process Simulation Concepts and Principles
  4. Process Simulation for Sterile Dosage Forms
  5. Documentation
  6. Microbiological Environmental Monitoring
  7. Elements of Aseptic Process Simulations
  8. Interventions
  9. Personnel Qualification
  10. Acceptance Criteria
  11. Considerations for Investigation
  12. Ongoing Process Evaluation
  13. Appendices
  14. Suggested Readings
  15. References
  16. Figures and Tables Index

Date of Publication: December 2011
ISBN Number: 9780939459353
Format: PDF
Number of Pages: 50
Binding: