Destin A. Leblanc

Validated Cleaning Technologies for Pharmaceutical Manufacturing

• Broschiertes Buch

Produktbeschreibung

Written by an expert especially for those who must design validatable cleaning processes and then must 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

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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 306
• Erscheinungstermin: 19. September 2019
• Englisch
• Abmessung: 229mm x 152mm x 17mm
• Gewicht: 446g
• ISBN-13: 9780367398873
• ISBN-10: 0367398877
• Artikelnr.: 57814860

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.