Clean-In-Place for Biopharmaceutical Processes

ISBN-13: 9780849340697 / Angielski / Twarda / 2007 / 412 str.

Dale A. Seiberling; Seiberling A. Seiberling; Dale A. Seiberling

Opis

An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide 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 will take the guess-work out of CIP development, and illustrate all one needs to know for the establishment and optimal functioning of a CIP system.

Spis treści

Introduction. Project Planning for the CIPable Pharmaceutical or Biotechnology Facility. Water for the CIP System. Cleanable Systems and Components. Cleaning Mechanisms and Agents. Cleaning Cycle Sequences. CIP Systems, Components and Design. CIP System Instrumentation and Controls. Cleaning Agent Dosing Systems. Spray Devices. CIP Distribution Piping Systems. Materials of Construction and Surface Finishes. Cleanable In-Line Components. Cleanable Liquids Processing Equipment and Systems. Cleanable Solids Processing Equipment and Systems. Cleanable API Processing Equipment and Systems. Waste from the CIP System. Cleaning Validation Strategies. CIP System Troubleshooting and Maintanence. U.S. Regulations. International Regulations

O autorze

Dale A. Seiberling