1st Edition
Validated Cleaning Technologies for Pharmaceutical Manufacturing
By Destin A. LeBlanc
Copyright 2000
304 Pages
by
CRC Press
304 Pages
by
CRC Press
304 Pages
by
CRC Press
Also available as eBook on:
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 external regulatory audits. Designed for use in the... Read more
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.
Biography
LeBlanc, Destin A.
