Science and Risk-Based Cleaning Validation – ASTM E3106 and E3219

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This webinar discusses some of the history and drivers that began the movement from compliance-based approaches to the science-based, risk-based and statistics-based approaches to cleaning validation introduced in the American Society for Testing and Materials (ASTM) E3106 “Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation” and the ASTM E3219 “Standard Guide for Derivation of Health Based Exposure Limits (HBELs)” and provides an overview of both Standards as well as other ASTM standards in development.


Part 1 – Background on Science, Risk and Statistics-Based Cleaning Process Development and Validation

  • Historical drivers
  • Proposed 1996 Revisions to the GMPs
  • Risk-MaPP and origin of ASTM E3106


Part II – Introduction to ASTM E3106

  • Cleaning risk (hazard) identification
  • Setting HBEL derived cleaning limits
  • Cleaning process development
  • Risk-based selection of analytical Methods
  • Cleaning Process Capability
  • Cleaning control strategy using visual inspection
  • Risk review and new product introduction


Part III – Introduction to E3219

  • What is a Health Based Exposure Limit (HBEL)?
  • How are HBELs derived?
  • Adjustment factors
  • “Qualified expert”


Top Ten Reasons to Attend:

  • What is risk and how can you measure it?
  • What is an HBEL?
  • Who is qualified to determine an HBEL?
  • What is the “toxicity scale”?
  • What is the CEF and “cleanability scale”?
  • What are the “detectability scales” ?
  • What is the “Cpu-based process capability scale”?
  • What is the Shirokizawa Matrix?
  • How to qualify visual inspection
  • New product introduction



Andrew Walsh

President, Center for Pharmaceutical Cleaning Innovation (CPCI); Adjunct Professor, RAQA Graduate Program, Temple University School of Pharmacy

Andrew Walsh is President of the Center for Pharmaceutical Cleaning Innovation (CPCI) a not-for-profit research organization and laboratory whose purpose is to support the implementation of the ASTM E3106 Standard. The CPCI laboratory performs research into cleaning issues and developing new technologies (1 Patent & 1 Patent Pending). CPCI provides educational offerings (publications, courses and workshops), consulting and laboratory services and offers internship opportunities for students.

Andrew is an Adjunct Professor in the Temple University School of Pharmacy Regulatory Affairs and Quality Assurance Program and teaches a Graduate level course in "Cleaning Validation" as a part of their Certificate in Validation Science. Prior to Temple University, Andrew was Industry Professor in the Pharmaceutical Manufacturing and Engineering Graduate Program at Stevens Institute of Technology from 2008 to 2015 where he created and taught courses in Pharmaceutical Validation and Lean Six Sigma.

Andrew has over 30 years of "hands-on" validation experience working in companies such as Johnson & Johnson (three companies), Schering-Plough and Hoffmann-La Roche. Prior to joining the Pharmaceutical industry Andrew worked for 10 years at the Colgate-Palmolive and Clorox companies as an Analytical Chemist and Microbiologist.
Andrew was a co-author of the ISPE Risk-based Manufacture of Pharmaceutical Products (Risk-MaPP) Baseline Guide and led the team that wrote the ASTM E3106 Standard and is the Technical Contact for the team that wrote the ASTM E3219 Standard.. Andrew is still leading the same ASTM team and are now are writing several other Standard Practice Guides on Calculation of Cleaning Validation Limits, Qualification of Visual Inspection and Using Total Organic Carbon Analysis and is on the Team that is re-writing the PDA Technical Report #29 "Points to Consider for Cleaning Validation". Andrew is also working on a textbook for Science, Risk and Statistics-based Cleaning Process Development and Validation for use in his class and then CPCI certified SME Course.

Andrew has a B.S. and M.S. in Biology (Microbiology) and is a certified Lean Six Sigma Black Belt and accredited Trainer. Andrew can be contacted at: