Chapter 28. Biotechnology Facility Design and Process Validation

  1. Prof. Dr. H.-J. Rehm2 and
  2. Dr. G. Reed3
  1. Michael G. Beatrice

Published Online: 7 MAY 2008

DOI: 10.1002/9783527620999.ch28b

Biotechnology Set, Second Edition

Biotechnology Set, Second Edition

How to Cite

Beatrice, M. G. (2008) Biotechnology Facility Design and Process Validation, in Biotechnology Set, Second Edition (eds H.-J. Rehm and G. Reed), Wiley-VCH Verlag GmbH, Weinheim, Germany. doi: 10.1002/9783527620999.ch28b

Editor Information

  1. 2

    Institut für Mikrobiologie, Universität Münster, Corrensstraße 3, D-4400 Münster

  2. 3

    2131 N. Summit Ave., Apartment #304, Milwaukee, WI 53202-1347, USA

Author Information

  1. Bethesda, MD 20892, USA

Publication History

  1. Published Online: 7 MAY 2008
  2. Published Print: 10 MAY 2001

ISBN Information

Print ISBN: 9783527257621

Online ISBN: 9783527620999

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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