Process Safety in the Pharmaceutical Industry─Part II: Process Safety Labs and Instruments Used in Process Safety Labs for Thermal Hazards

• DOI: 10.1021/acs.oprd.3c00365
• Publication Date: 2024-02-22T22:31:30Z
• Authors: Lady Mae Alabanza; Ayman Allian; Antonio C. Ferretti; Max Sarvestani; Jeffrey B. Sperry; Zhe Wang; Han Xia; Shasha Zhang
• Keywords: Process Safety; Process safety management

Process safety groups in the pharmaceutical industry are important components of active ingredient development through its life cycle, from discovery to commercial manufacturing. The process laboratory staff conduct a series tests identify chemically unstable reagents, intermediates, solvents, reaction mixtures, and high-energy reactions ensure that proposed operating conditions provide sufficient margin onset undesired potentially catastrophic thermal decomposition. Across several companies, methods used for these assessments how results conclusions made widespread (vide infra). A working group was created with members companies within International Consortium Innovation Quality Pharmaceutical Development, goal precompetitive collaboration understand each participating companies' procedures assessment regarding safety. Each company invited input using blind survey format. This done interest making this knowledge accessible wider community other pharma chemical even academic institutions US throughout world. In second article, we focus on instruments characterize hazards laboratories. Detailed information all work together at stage is discussed.