About CPCI
CPCI™ is a not-for-profit research organization created by Andrew Walsh.
Our Vision is to become the top provider of research, education and consulting in Cleaning Process Development and Cleaning Validation for Pharmaceutical, Biotech, Cosmetics and Medical Device companies.
Our Mission is to enable the implementation of the American Society for Testing and Materials (ASTM) E3106-17 Standard Guide to "Science-Based and Risk-Based Cleaning Process Development and Validation" through our research, the development of new patented technologies, our publications and presentations, and our educational offerings.
Our Vision is to become the top provider of research, education and consulting in Cleaning Process Development and Cleaning Validation for Pharmaceutical, Biotech, Cosmetics and Medical Device companies.
Our Mission is to enable the implementation of the American Society for Testing and Materials (ASTM) E3106-17 Standard Guide to "Science-Based and Risk-Based Cleaning Process Development and Validation" through our research, the development of new patented technologies, our publications and presentations, and our educational offerings.
About Andrew Walsh
Prior to joining the Pharmaceutical industry Andrew worked for the Colgate-Palmolive and Clorox companies as an Analytical Chemist and Microbiologist for 10 years where he gained insight into detergent chemistry, analytical methods (wet and instrumental) including method development manufacturing processes and statistical quality control.
Andrew then gained over 25 years of "hands-on" Validation experience working for Pharmaceutical and Biologics companies such as Johnson & Johnson companies RWJ Pharmaceutical Research Institute, Ortho-McNeil and Orth-Biotech (10 years), Schering-Plough (1 year) and Hoffmann-La Roche (5 years). Andrew's Validation and Qualification experience ranges from Equipment and Utility Qualification to Cleaning Validation to Process Validation to Spreadsheet and Computer Systems Validation.
During this time, Andrew gained experience in all aspects of Cleaning Validation; including writing policies and masterplans, developing cleaning procedures, writing and executing protocol and developing reports, calculating acceptance limits, developing and validating TOC and HPLC methods and developing and qualifying Visual Inspection. Andrew has presented on all of these topics for over 20 years at conferences with organizations such as Barnett, IIR, IPA, IVT, ISPE, Patheon, PharmaEd, KENX and also with the FDA.
After leaving Hoffmann-La Roche in 2007, Andy founded a consulting company, Clean6Sigma, LLC and has been providing training and consulting using Lean and Six Sigma techniques to large and small pharmaceutical companies including Actavis, Bristol-Meyers Squibb, C.R. Bard, Novartis and Johnson and Johnson. In 2012, Andy decided to merge Clean6Sigma, LLC with Rocky Mountain Analytical to create PharmaClean Group, LLC. The PharmaClean Group was dissolved on December 31st 2015. The "Center for Pharmaceutical Cleaning Innovation" (CPCI) was officially incorporated as a not-for-profit organization and started on January 1st 2016 and operates a research and educational laboratory in Hillsborough, NJ.
Andrew was also an Industry Professor from 2008 - 2015 in the Pharmaceutical Manufacturing and Engineering Graduate Program at Stevens Institute of Technology where he created and taught courses in Pharmaceutical Validation and Lean Six Sigma. While at Stevens, Andrew also founded and directed the Stevens Pharmaceutical Research Center (SPRC) from 2009 - 2015 which focused on Cleaning and Cleaning Validation topics
From 2004 until present, Andrew has been involved with several industry initiatives concerning Cleaning Validation and was an author of ISPE’s Risk-based Manufacture of Pharmaceutical Products Guideline (Risk-MaPP) and led the ASTM teams that wrote the:
Andrew became an adjunct professor at Temple University in 2019 and teaches the "Cleaning Validation" course in their Regulatory Affairs and Quality Assurance Program.
Andrew has a B.S. in Biology and an M.S. in Biology (specializing in Microbiology) and is also a certified Lean Six Sigma Black Belt (license # GR7764000076AW) and an Accredited Lean Six Sigma Trainer.
Prior to joining the Pharmaceutical industry Andrew worked for the Colgate-Palmolive and Clorox companies as an Analytical Chemist and Microbiologist for 10 years where he gained insight into detergent chemistry, analytical methods (wet and instrumental) including method development manufacturing processes and statistical quality control.
Andrew then gained over 25 years of "hands-on" Validation experience working for Pharmaceutical and Biologics companies such as Johnson & Johnson companies RWJ Pharmaceutical Research Institute, Ortho-McNeil and Orth-Biotech (10 years), Schering-Plough (1 year) and Hoffmann-La Roche (5 years). Andrew's Validation and Qualification experience ranges from Equipment and Utility Qualification to Cleaning Validation to Process Validation to Spreadsheet and Computer Systems Validation.
During this time, Andrew gained experience in all aspects of Cleaning Validation; including writing policies and masterplans, developing cleaning procedures, writing and executing protocol and developing reports, calculating acceptance limits, developing and validating TOC and HPLC methods and developing and qualifying Visual Inspection. Andrew has presented on all of these topics for over 20 years at conferences with organizations such as Barnett, IIR, IPA, IVT, ISPE, Patheon, PharmaEd, KENX and also with the FDA.
After leaving Hoffmann-La Roche in 2007, Andy founded a consulting company, Clean6Sigma, LLC and has been providing training and consulting using Lean and Six Sigma techniques to large and small pharmaceutical companies including Actavis, Bristol-Meyers Squibb, C.R. Bard, Novartis and Johnson and Johnson. In 2012, Andy decided to merge Clean6Sigma, LLC with Rocky Mountain Analytical to create PharmaClean Group, LLC. The PharmaClean Group was dissolved on December 31st 2015. The "Center for Pharmaceutical Cleaning Innovation" (CPCI) was officially incorporated as a not-for-profit organization and started on January 1st 2016 and operates a research and educational laboratory in Hillsborough, NJ.
Andrew was also an Industry Professor from 2008 - 2015 in the Pharmaceutical Manufacturing and Engineering Graduate Program at Stevens Institute of Technology where he created and taught courses in Pharmaceutical Validation and Lean Six Sigma. While at Stevens, Andrew also founded and directed the Stevens Pharmaceutical Research Center (SPRC) from 2009 - 2015 which focused on Cleaning and Cleaning Validation topics
From 2004 until present, Andrew has been involved with several industry initiatives concerning Cleaning Validation and was an author of ISPE’s Risk-based Manufacture of Pharmaceutical Products Guideline (Risk-MaPP) and led the ASTM teams that wrote the:
- ASTM E3106-17 "Standard Guide for Science-based and Risk-based Cleaning Process Development and Validation"
- ASTM E3109 "Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)"
- ASTM’s G121 “Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents" update to include pharmaceuticals and Medical Devices
- ASTM G122 “Standard Test Method for Evaluating the Effectiveness of Cleaning Agents and Processes" update to include pharmaceuticals and Medical Devices
- ASTM E3263 “Standard Practice for Qualification for Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues"
- working on several more proposed Standards including for Total Organic Carbon (TOC).
Andrew became an adjunct professor at Temple University in 2019 and teaches the "Cleaning Validation" course in their Regulatory Affairs and Quality Assurance Program.
Andrew has a B.S. in Biology and an M.S. in Biology (specializing in Microbiology) and is also a certified Lean Six Sigma Black Belt (license # GR7764000076AW) and an Accredited Lean Six Sigma Trainer.
