Advanced Aseptic Processing Technology

Overview

The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies for aseptic processing that will markedly reduce the level of contamination risk for sterile products and includes coverage on:

• The use of isolator and barrier concepts for aseptic processing and assembly.
• The application of robotics as an alternative to gowned personnel.
• The increasing reliance on automation to minimize or eliminate operator intervention.
• The design, operational, monitoring and compliance changes necessary for success with advanced aseptic processing.

Advanced Aseptic Processing Technology is an essential reference for anyone working with sterile products, and is recommended for individuals in manufacturing,, compliance, regulatory affairs, microbiology, environmental monitoring, sterility testing, sterilization, validation, engineering, development, facility and equipment design, component and equipment suppliers, automation, and robotics.

Contents

1. An Introduction to Advanced Aseptic Processing Technology
2. Getting Started, Establishing an Aseptic Processing Systems Technology Group
3. Aseptic Processing Facility Design
4. Innovations in Aseptic Processing Technology
5. Ergonomics in Enclosure Design
6. Design & Engineering of Enclosures for Containment Applications
7. Design and Engineering of Isolators
8. Definition of Restricted Access Barrier Systems
9. Rapid Transfer Port Systems
10. Aseptic Processing Transfer Systems
11. Disposable Equipment in Aseptic Technology
12. A Comparison of Capital and Operating Costs for Aseptic Manufacturing Facilities
13. Risk Assessment and Mitigation in Aseptic Processing
14. Sterile Product Manufacture Using Form Fill Seal Technologies
15. Genesis of the Closed Vial Technology
16. Aseptic Containment
17. Points to Consider - Filling Isolator
18. Sterility Test Isolators- A User’s Perspective
19. Advanced Aseptic Processing Fill Finish Trends
20. Process Simulation for Advanced Aseptic Processing
21. Qualification / Validation of Aseptic Processing Environments, Systems & Equipment
22. Isolator Integrity Leak Inspection
23. Environmental Monitoring of Advanced Aseptic Processing
24. Decontamination of Advanced Aseptic Processing Environments
25. Hydrogen Peroxide Gas Decontamination
26. Isolation Technology: Hydrogen Peroxide Decontamination
27. Single Injection Vapor Phase Hydrogen Peroxide Decontamination of Isolators and Cleanrooms
28. Chlorine Dioxide Decontamination / Sterilization
29. FDA Regulatory Perspective
30. The Evolution of Advanced Aseptic Processing for Pharmaceutical Manufacturing: Perspectives of a Regulatory Scientist
31. A Perspective on European Regulations for Advanced Aseptic Processing
32. Advanced Aseptic Processing Technologies in Japan
33. Pilot Plants and Isolation Technology
34. High Speed Aseptic Filling
35. Kit Assembly
36. Radiopharmaceutical Filling Line
37. Powder handling installation for high potent bulk pharmaceutical ingredients
38. Isolator Technology for Aseptic Filling of Anti-Cancer Drugs
39. RABS Case Study
40. Innovation in Aseptic Processing: Case Study through the Development of a New Technology
41. Isolated Robotics
42. The Future of Aseptic Processing

Authors

James Agalloco is President of Agalloco & Associates. Since the formation of Agalloco & Associates in 1991, Jim has assisted more than 100 firms in the areas of validation, sterilization, aseptic processing and compliance. . He is a past President of the Parenteral Drug Association and a member of United States Pharmacopeia’s Microbiology and Sterility Assurance Expert Committee since 200 He has authored or co-authored 43 book chapters and over 100 papers, and has lectured extensively on process validation, aseptic processing, sterilization and isolation technology at various industry meetings, domestically as well as internationally. He also co-edited the book Validation of Pharmaceutical Processes, 3rd edition, Informa Healthcare, 200

James E. Akers Ph.D. is President and Co-Owner of Akers Kennedy & Associates and a Technical Consultant to Shibuya Kogyo, Co. LTD. Dr Akers received his BA in Biology from the University of Kansas in 1971 and his Ph.D. in Medical Microbiology from the University of Kansas, School of Medicine in 197 He is past president of the Parenteral Drug Association (PDA) and has participated on many PDA Task Forces. He has written over 100 articles and 28 book chapters on subjects including aseptic processing, validation, biologics manufacturing, isolation technology, and environmental monitoring. Dr Akers is a Chairman of the Microbiology and Sterility Assurance Committee of Experts for the United States Pharmacopeia and has 35 years of experience working in, evaluating and providing design input for clean environments used in research and manufacturing applications.