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Cleaning and Cleaning Validation A Biotechnology Perspective 1st Edition by Jon Voss ISBN 9780939459506 0939459507

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Cleaning and Cleaning Validation A Biotechnology Perspective 1st Edition Jon Voss Digital Instant Download

Author(s): Jon Voss
ISBN(s): 9780939459506, 0939459507
Edition: 1
File Details: PDF, 9.89 MB
Year: 2006
Language: english
SKU: EB-7160758 Category: Tag:

Cleaning and Cleaning Validation A Biotechnology Perspective 1st Edition by Jon Voss – Ebook PDF Instant Download/Delivery:  9780939459506, 0939459507
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Product details: 

ISBN 10:   0939459507

ISBN 13:  9780939459506

Author: Jon Voss

This book is intended to serve as a source of practical, technicalinformation for those persons in the biotechnology industry. Casestudies and/ or actual industry examples are used to support the textwherever possible. While much of the material contained within thistext is equally applicable to nonbiopharmaceutical processes, theemphasis has been focused directly upon biopharmaceuticalmanufacturing.Section I provides an in-depth analysis of the design concepts thatlead to cleanable equipment. Also covered in the tirst section arecleaning mechanisms and cleaning systems. The first section isparticularly useful to those persons faced with the task of designingsystems that will be cleaned and also provides the biochemicaloockground of the mechanisms associated with the removal of commonbiotechnology soils.Section II focuses on cleaning validation concepts. While thematerial is equally useful for single product cleaning, emphasis isplaced upon multiproduct cleaning validation. Included in Section IIare general validation principles as thex apply to cleaning validation,detailed analxsis of cleaning process validation, sampling techniques,analytical methods and acceptance criteria. The material in this sectionwill be useful to anyone responsible for the development of a cleaningvalidation program.The final section, Section Ill, provides an overview of multiproductbiotechnology manufacturing procedures. Included in this section is ananalysis of tne risk-to-benefit scenarios associated with the various formsof product manufacturing, analysis of changeover programs, ~uipmentconsiderations, and material transfer systems as they are affected bymultiproduct manufacturing strategies.

Table of contents: 

Part I: Design Concepts

  • Designing for Cleanability

  • Cleaning Mechanisms

  • Cleaning Systems​

Part II: Cleaning Validation Concepts

  • General Validation Principles

  • Cleaning Process Validation

  • Sampling Techniques

  • Analytical Methods

  • Acceptance Criteria​

Part III: Multiproduct Biotechnology Manufacturing

  • Risk-to-Benefit Analysis

  • Changeover Programs

  • Equipment Considerations

  • Material Transfer Systems​

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Tags: Jon Voss, Cleaning and Cleaning, A Biotechnology Perspective