An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), Clean-in-Place for Biopharmaceutical Processes illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities.

Offering reader-friendly descriptions of the various types of equipment and materials found in typical CIP processes, Clean-In-Place For Biopharmaceutical Processes takes the guess-work out of CIP development, and illustrates all one needs to know for the establishment and optimal functioning of a CIP system.

Features:

• examines the knowledge from experts in the field, regarding the vast array of equipment required for the pharmaceutical process, and combines that knowledge with those who have had experience in the successful application of CIP to a variety of non-pharmaceutical and pharmaceutical processes
• analyzes unit operations and considers whether CIP is a preferred method of cleaning in specific situations
• recognizes new and innovative technologies in the field

Contents

1. Introduction
2. Project Planning for the CIPable Pharmaceutical or Biotechnology Facility
3. Water for the CIP System
4. Cleanable Systems and Components
5. Cleaning Mechanisms and Agents
6. Cleaning Cycle Sequences
7. CIP Systems, Components and Design
8. CIP System Instrumentation and Controls
9. Cleaning Agent Dosing Systems
10. Spray Devices
11. CIP Distribution Piping Systems
12. Materials of Construction and Surface Finishes
13. Cleanable In-Line Components
14. Cleanable Liquids Processing Equipment and Systems
15. Cleanable Solids Processing Equipment and Systems
16. Cleanable API Processing Equipment and Systems
17. Waste from the CIP System. Cleaning Validation Strategies
18. CIP System Troubleshooting and Maintanence
19. U.S. Regulations
20. International Regulations

Index

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