Cleaning Validation For The 21st Century

By T. Altmann, A. Canhoto, M. Crevoisier, I. Gorsky, R. Kowal, M. Neverovitch, M. Ovais, O. Shirokizawa, and A. Walsh

A collection of articles on the application of Science, Risk and Statistics to Cleaning

This eBook is a collection of articles written from May of 2017 through August 2018 and are part of the “Cleaning Validation for the 21st Century” Series. The purpose of the Series is to provide deeper insight into using the Science-based, Risk-based and Statistics-based approaches to cleaning and cleaning validation that are found in the ASTM E3106-18 “Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation”. The Series started in 2011 with the publication of “Cleaning Validation for the 21 Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part I and Part II” which reviewed the history of setting cleaning validation acceptance limits and introduced the more scientifically justified approach of using the Acceptable Daily Exposure (ADE), now more formally known as the Health Based Exposure Limit (HBEL).