Validated Cleaning Technologies for Pharmaceutical Manufacturing: 1st Edition (Paperback) book cover

Validated Cleaning Technologies for Pharmaceutical Manufacturing

1st Edition

By Destin A. LeBlanc

CRC Press

304 pages

Purchasing Options:$ = USD
Paperback: 9780367398873
pub: 2019-09-19
Hardback: 9781574911169
pub: 2000-02-28
eBook (VitalSource) : 9780429135934
pub: 2000-02-28
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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 overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

Table of Contents

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.

About the Author

LeBlanc, Destin A.

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
SCIENCE / Chemistry / General