Publications

Journals:

Ruijin Song, Alfredo Canhoto, Ph.D. and Andrew Walsh, "Cleaning Process Development: Cleanability Testing and "Hardest-To-Clean" Pharmaceutical Products" Pharmaceutical Online  January 2019 Download (3.2 Mb pdf)

Walsh, Andrew, Thomas Altmann, Alfredo Canhoto, Ph.D., Ester Lovsin Barle, Ph.D., Joel Bercu, Ph.D., David G. Dolan, Ph.D. Andreas Flueckiger, M.D. Igor Gorsky, Jessica Graham, Ph.D., Robert Kowal, Mariann Neverovitch, Mohammad Ovais, Osamu Shirokizawa "Health-Based Exposure Limits: How do the EMA's Q&A Compare with the New and Forthcoming ASTM Standards?" Pharmaceutical Online  November 2018 Download (817 Kb pdf)

Walsh, Andrew, Dongni (Nina) Liu, Mohammad Ovais, "Justification and Qualification of Visual Inspection for use in Cleaning Validation for a Low Risk, Multi-Product Facility" Pharmaceutical Online  August 2018 Download (984 Kb pdf) - Metadata Analysis Download (934 Kb pdf)

Kaminagayoshi, Takashi, Kosuke Takenaka, Tomohiro Doi, Shunsuke Omori, Makoto Sadamitsu, Yoshiaki Miko, Osamu Shirokizawa, and Andrew Walsh "The statistical evaluation of cleaning processes using process capability and its application to new product introduction" May 2018 Pharmaceutical Technology 42(5):48-51 Download (8.5 Mb pdf)

Walsh, Andrew, Thomas Altmann, Alfredo Canhoto, Ester Lovsin Barle, David G. Dolan, Andreas Flueckiger, Igor Gorsky, Jessica Graham, Ph.D., Robert Kowal, Mariann Neverovitch, Mohammad Ovais, Osamu Shirokizawa and Kelly Waldron "Measuring Risk in Cleaning: Cleaning FMEA and the Cleaning Risk Dashboard," PharmaceuticalOnline April, 2018 Download (1.73Mb pdf).

Walsh, Andrew, Thomas Altmann, Alfredo Canhoto, Ester Lovsin Barle, David G. Dolan, Andreas Flueckiger, Igor Gorsky, Robert Kowal, Mariann Neverovitch, Mohammad Ovais, Osamu Shirokizawa and Kelly Waldron "A Swab Limit-derived Scale for Assessing the Detectability of Total Organic Carbon Analysis," Pharmaceutical Online January, 2018 Download (316 kb pdf).

Walsh, Andrew, Thomas Altmann, Alfredo Canhoto, Ester Lovsin Barle, David G. Dolan, Andreas Flueckiger, Igor Gorsky, Robert Kowal, Mariann Neverovitch, Mohammad Ovais, Osamu Shirokizawa and Kelly Waldron "An MSSR-derived Scale for Assessing the Detectability of Visual Inspection," Pharmaceutical Online December, 2017 Download (434 kb pdf).

Lovsin-Barle, Ester and Andrew Walsh "Are High Potency Active Pharmaceutical Ingredients (HPAPI) also High Risks for Cross Contamination?" Chimica Oggi 35(6) December 2017 Download (570 kb pdf)

Desai, Parth and Andrew Walsh "Validation of Visual Inspection as an Analytical Method for Cleaning Validation" Pharmaceutical Online August, 2017 Download (354 kb pdf)

Walsh, Andrew, Ester Lovsin Barle, David G. Dolan, Andreas Flueckiger, Igor Gorsky, Robert Kowal, Mohammad Ovais, Osamu Shirokizawa and Kelly Waldron "A Process Capability-derived Scale for Assessing the Risk of Compound Carryover in Shared Facilities," Pharmaceutical Online August, 2017 .  Download (526kb pdf)

Thomas Altmann,  Alfredo Canhoto, Michel Crevoisier,  Igor Gorsky, Robert Kowal, Mariann Neverovitch, Mohammad Ovais, Osamu Shirokizawa, and Andrew Walsh "Developing a Science- Risk- and Statistics-based Approach to Cleaning Process Development and Validation" Pharmaceutical Online June, 2017 .  Download (504kb pdf)

Walsh, Andrew,  Michel Crevoisier, Ester Lovsin Barle, Andreas Flueckiger, David G. Dolan, Mohammad Ovais, Osamu Shirokizawa, and Kelly Waldron "An ADE-derived Scale for Assessing the Risk of Compound Carryover in Shared Facilities," Pharmaceutical Online May 22, 2017 .  Download (363kb pdf)

Wang, Xi (Dylan), Takashi Kaminagayoshi,Tomohiro Doi, Kosuke Takenaka, Yoshiaki Miko, Osamu Shirokizawa and Andrew Walsh (2016) "Development of a Technique for Quantifying Protein Degradation" Biopharm International, November 2016  Download (5 Mb pdf)

Walsh, Andrew,  Michel Crevoisier, Ester Lovsin Barle, Andreas Flueckiger, David G. Dolan, Mohammad Ovais (2016) "Cleaning Limits—Why the 10-ppm and 0.001-Dose Criteria Should be Abandoned, Part II," Pharmaceutical Technology 40 (8) .  Download (715kb pdf)

Walsh, Andrew. (2015). "Cleaning Validation for the 21st Century: Can Alternative Approaches to the PDE/ADE be Justified?", BioPharm International, November 2015. Download (5.7 Mb pdf)

Weideman et.al. (2015) "Deriving Health-Based Exposure Limits in the Pharmaceutical Industry" Contract Pharma, September 2015 Download (5.97Mb pdf)

Walsh, Andrew, Mohammad Ovais, Thomas Altmann and Edward V. Sargent (2013). "Cleaning Validation for the 21st Century: Acceptance Limits for Cleaning Agents", Pharmaceutical Engineering, November/December 2013. Vol. 33 (No. 6), Download (750 kb).

Walsh, Andrew. (2011). "Cleaning Validation for the 21st Century: Overview of the New ISPE Cleaning Guide", Pharmaceutical Engineering, November/December 2011. Vol. 31 (No. 6), Download (470 kb pdf).

Walsh, Andrew. (2011). "Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part I", Pharmaceutical Engineering, July/August 2011. Vol. 31 (No. 4), Download (1174 kb PDF).

Walsh, Andrew. (2011).  "Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part II", Pharmaceutical Engineering, September/October 2011. Vol. 31 (No. 5), Download (1514 kb pdf).

Book Chapters:

Andrew Walsh. (2011). "Microbial Aspects in Cleaning Validation", Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices , Madhu Raju Saghee, Tim Sandle and Edward C. Tidswell, Business Horizons.