A scientific approach to cleaning validation is robustly explained in this special edition. Cleaning validation as it applies to all aspects of the product lifecycle are discussed, including topics on:

• Equipment cleaning validation
• Cleaning validation documentation
• Total organic carbon analysis
• Detergent selection.

Table of Contents

Equipment Cleaning Validation: Microbial Control Issues
Destin LeBlanc

Cleaning Validation: Maximum Allowable Residue: Question and Answer
William E. Hall, Ph.D.

Development of Total Organic Carbon (TOC) Analysis For Detergent Residue Verification
James G. Jin and Cheryl Woodward

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
Karen A. Clark

Detergent Selection – A First Critical Step in Developing a Validated Cleaning Program
Mark Altier

Analysis Cleaning Validation Samples: What Method?
Hebert J. Kaiser and Maria Minowitz

Control and Monitoring of Bioburden in Biotech/Pharmaceutical Cleanrooms
Raj Jaisinghani, Greg Smith, and Gerald Macedo

A Cleaning Validation Program for the ELIFA System
LeeAnne Macaulay, Jeff Morier, Patti Hosler, and Danuta Kierek-Jaszczuk, Ph.D.

A Cleaning Validation Master Plan for Oral Solid Dose Pharmaceutical Manufacturing Equipment
Julie A. Thomas

Proposed Validation Standard
William E. Hall, Ph.D.