28. Biotechnology Facility Design and Process Validation
- H.-J. Rehm2,
- G. Reed3
Published Online: 26 MAY 2008
DOI: 10.1002/9783527620845.ch28
Copyright © 1993 VCH Verlagsgesellschaft mbH
Book Title
Biotechnology: Bioprocessing, Volume 3, Second Edition
Additional Information
How to Cite
Beatrice, M. G. (2008) Biotechnology Facility Design and Process Validation, in Biotechnology: Bioprocessing, Volume 3, Second Edition (eds H.-J. Rehm and G. Reed), Wiley-VCH Verlag GmbH, Weinheim, Germany. doi: 10.1002/9783527620845.ch28
Editor Information
- 2
Institut für Mikrobiologie, Universität, Münster, Corrensstraße 3, D-48149 Münster
- 3
2131 N. Summit Ave., Apartment #304, Milwaukee, WI 53202-1347, USA
Publication History
- Published Online: 26 MAY 2008
- Published Print: 28 OCT 1993
ISBN Information
Print ISBN: 9783527283132
Online ISBN: 9783527620845
- Summary
- Chapter
- References
Keywords:
- utilities;
- specifications;
- validation;
- biotechnology;
- utility
Summary
This chapter contains sections titled:
The Master Validation Plan
Benefits of Validation
Biologicals versus Pure Chemical Drugs
Initiating the Validation Program
Production Variables and Good Manufacturing Practice
Multiple-Use Facilities
Open versus Closed Systems
Presenting Plants to the Regulators
The Biologics Regulatory Process
Planning for Facility Expansion
Construction Validation Phase
Utilities
The HVAC System
Production Water Systems
Installation and Operational Qualification
Process Validation
Cleaning Validation Studies
Validation of Decontamination and Discharge Streams
Environmental Monitoring
Personnel Monitoring
Computer System Validation
Revalidation and Process Changes
Final Approval
Summary
References