Process Safety and Assurance in Pharmaceuticals at Purdue University
Explore the latest research and advancements in process safety and assurance in the pharmaceutical industry at Purdue University's Process Safety & Assurance Center. Learn about key concepts such as chemical process safety metrics, personnel versus process safety, applicable regulations, toxicants modeling, hazards identification, risk assessment, and more.
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Purdue Process Safety & Assurance Center (P2SAC) - Pharmaceuticals - Ray A. Mentzer Professor of Engineering Practice Associate Director, P2SAC Charles D. Davidson School of Chemical Engineering Purdue University May 10, 2022
May 2022 Conference Registration Sponsors ACC Am Chem Council AcuTech AMGEN Chevron Corteva CountryMark Dow Endress+Hauser ExxonMobil Fauske & Associates GSK Honeywell Kenexis Lilly Marsh Risk Phillips 66 Pfizer SABIC 3M Guests Abbvie ACS ADAMA Agr Solutions Air Products Alliant Insurance Serv AstraZeneca AXA XL Insurance BASF BMS CatSci Ltd CCPS CDC - NIOSH Cenovus Lima Refin Cook Corden Pharma CO* Cummins DS* DNV Dr Reddy s* Evonik ExecuPharma* Exponent Gilead Grace* Huntsman Intact Insurance ioMosaic Johnson Matthey JMJ* LCCI India Langan Eng & Env* Liberty Mutual Ins* Northwestern Univ* Olon Ricerca BioSc PI Industries Process Haz Mgmt Services* Process Safety Core Consulting, LLC* Promega Corp Queen Mary U, London* Sandia Nat l Labs* Smith Burgess Snapdragon Chem Syngenta Crop Protection Tate & Lyle Terminus Data Sci* Thermal Haz Tech Transpek Industry Ltd* Univ of Wisc* Vertex Worley* *denotes 1st meeting On-going dialog with other Depts: ABE, CHEM, IE, IPPH & ME
Growing P2SAC Research at all Academic Levels P2SAC Research Projects 35 30 9 25 4 3 20 9 6 8 4 15 7 6 7 10 6 8 4 4 2 5 9 8 6 5 5 4 3 0 2015 2016 2017 2018 2019 2020 2021 UG PMP PhD Other
Chemical Process Safety - Core Class Process Safety Metrics Personnel vs. Process Safety & Metrics Applicable regulations: OSHA PSM, EPA RMP, etc Source Term Modeling Toxicants & Industrial Hygiene Toxic/Flammable Gas Release Dispersion Modeling Fire & Explosion Protection Chemical Reactivity Relief System Design Hazards Identification (HAZOP, ..) Risk Assessment (Matrix, QRA, ..) Accident Investigations, CSB videos LOPA Frequencies Typical 4x4 Risk Matrix HAZOP 6
Global Process Safety Incidents in the Pharmaceutical Industry PMP / UG Analyzed 73 process safety incidents; 108 fatalities between 1985-2019 Identified and summarized trends between the number of incidents, number of fatalities, location, and contributing factors Highest reported fatalities occurred in 2018 & 2019, 26 & 16, respectively 83% of fatalities occurred in China and India Explosions associated with 71% of incidents, resulting in 89% of fatalities Published: J Loss Prevention in Process Industries, 68, Nov (2020) Number of Fatalities and Corresponding % Number of Incidents vs. Contributing Factors
Predicting Heats of Reactions Common In Pharma Industry UG / PMP Research project used known reaction data from pharmaceutical companies, including Amgen, Corteva, GSK, JM, Lilly, Merck, and Vertex to compare to predictions of CHETAH widely used, licensed by ASTM since 1974, based on Benson groups TCIT novel Purdue methodology, combines quantum chemistry & G4 data Programs calculate the heat of reaction when given the molecular structures Study included: amide coupling, debenzylation, bromination, BOC deprotection, Suzuki coupling, T3P, and halogenation reactions Example bromination reactions shown below, with TCIT parity plot on lower right CONCLUSIONS: TCIT calculations generally within 20% with few exceptions; generally reasonable approximations with CHETAH but limited by substitutions; neither method can currently handle ionic and free-radical groups Finalizing paper for publication
Benefits from Joining P2SAC Direct engagement in suggesting & selecting process safety research projects at all levels PhD, PMP and UG. Priority in serving as mentor for process safety related Professional Masters Project of your choice. Attendance at biannual meetings to review research progress and learn from outside expert presentations. Sharing among companies of process safety learnings and challenges. Contact with students as they develop process safety expertise and enhance the science.
