Cleaning and Cleaning Validation

A Biotechnology Perspective

Nonfiction, Health & Well Being, Medical, Medical Science, Pharmacology
Cover of the book Cleaning and Cleaning Validation by Jon Voss, CRC Press
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: Jon Voss ISBN: 9781351460330
Publisher: CRC Press Publication: May 4, 2018
Imprint: Routledge Language: English
Author: Jon Voss
ISBN: 9781351460330
Publisher: CRC Press
Publication: May 4, 2018
Imprint: Routledge
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

More books from CRC Press

Cover of the book Procedure Manual for the Diagnosis of Intestinal Parasites by Jon Voss
Cover of the book Renewable Energy in the Countryside by Jon Voss
Cover of the book Intermittent and Nonstationary Drying Technologies by Jon Voss
Cover of the book Introduction to Product Design and Development for Engineers by Jon Voss
Cover of the book The Chemistry of Cereal Proteins by Jon Voss
Cover of the book MIMO Wireless Communications over Generalized Fading Channels by Jon Voss
Cover of the book Nonlinear Partial Differential Equations in Engineering and Applied Science by Jon Voss
Cover of the book Naturally Ventilated Buildings by Jon Voss
Cover of the book Neuro-Fuzzy Equalizers for Mobile Cellular Channels by Jon Voss
Cover of the book Offshore Mechatronics Systems Engineering by Jon Voss
Cover of the book Emerging Security Algorithms and Techniques by Jon Voss
Cover of the book Optical and Wireless Communications by Jon Voss
Cover of the book Innovative Earthquake Soil Dynamics by Jon Voss
Cover of the book Routledge Revivals: Easy Lessons in Einstein (1922) by Jon Voss
Cover of the book Building Surveys by Jon Voss
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy