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

Abstract

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