Principles of Parenteral Solution Validation
A Practical Lifecycle Approach

As part of the Expertise in Pharmaceutical Process Technology series, this book covers compliance, regulatory considerations and new process design trends

Igor Gorsky (Edited by), Harold S. Baseman (Edited by)

9780128094129

Paperback, published 27 November 2019

298 pages
22.9 x 15.1 x 2 cm, 0.48 kg

Approx.288 pages

1. Aseptic Process Validation, Part 1: Design and Planning 2. Aseptic Process Validation Design, Part 2: Aseptic Process Simulation Design 3. Quality Risk Management of Parenteral Process Validation, Part 1: Fundamentals 4. Equipment Cleaning Process 5. Quality Risk Management of Parenteral Process Validation, Part 2: A Risk-Based Quality Management System 6. Use of Statistics in Process Validation 7. Process Validation Stage 1: Parenteral Process Design 8. Process Validation Stage 2: Parenteral Process Performance Qualification 9. Process Validation Stage 3: Continued Process Verification 10. Preuse/Poststerilization Integrity Testing of Sterilizing Grade Filter 11. Environmental Monitoring 12. Isolators 13. Post Aseptic Fill Sterilization and Lethal Treatment

Subject Areas: Industrial chemistry [TDC], Biochemical engineering [TC], Pharmacology [MMG]