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.
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, our 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.
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, our 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 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 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 was the Chair of the Team that wrote the proposed ISPE Baseline Guide "Cleaning Process Development and Validation" (ISPE decided not to publish this Guide for undisclosed reasons). Andrew is chairing a team that wrote the new ASTM E3106-17 Standard for Science-based and Risk-based Cleaning and Cleaning Validation and is working on other ASTM Standards for Cleaning Validation such as Determination of Health-Based Exposure Limits (HBELs), Evaluation of Cleaning Agents, Preparation of Coupons for Evaluation of Cleaning Agents, and several more proposed Standards for Total Organic Carbon (TOC) and Visual Inspection.
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 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 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 was the Chair of the Team that wrote the proposed ISPE Baseline Guide "Cleaning Process Development and Validation" (ISPE decided not to publish this Guide for undisclosed reasons). Andrew is chairing a team that wrote the new ASTM E3106-17 Standard for Science-based and Risk-based Cleaning and Cleaning Validation and is working on other ASTM Standards for Cleaning Validation such as Determination of Health-Based Exposure Limits (HBELs), Evaluation of Cleaning Agents, Preparation of Coupons for Evaluation of Cleaning Agents, and several more proposed Standards for Total Organic Carbon (TOC) and Visual Inspection.
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.
