Destin A. Leblanc

Validated Cleaning Technologies for Pharmaceutical Manufacturing (eBook, PDF)

• Format: PDF

Produktbeschreibung

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and exter

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 304
• Erscheinungstermin: 28. Februar 2000
• Englisch
• ISBN-13: 9781420025880
• Artikelnr.: 53191093

Autorenporträt

LeBlanc, Destin A.

Inhaltsangabe

o Cleaning Objectives. Cleaning and Cleaning Agents. Cleaning Methods.
Process Parameters in Cleaning-Part I. Process Parameters in Cleaning-Part
II. Cleaning Cycle Development. Grouping Strategies. Setting Acceptance
Criteria. Analytical Methods for Cleaning Validation. Sampling Methods for
Cleaning Validation. Microbial Issues in Cleaning Validation. Change
Control and Revalidation. Special Topics in Cleaning Validation. FDA
Expectations. Appendices.