From lab to plant: Process safety data sheets as the key to safe scale-up

Mario Toubes-Rodrigo, Global Applications Leader, H.E.L Group highlights that process safety testing is essential in API manufacturing to safely scale production from lab to industrial levels. Advanced techniques help identify and mitigate hazards, ensuring safe, compliant, and efficient processes

- Mr Rajeev Kumria

The pharmaceutical industry faces unique challenges as it progresses from R&D bench-scale to plant production, moving from milligram quantities to tons. High-quality active pharma ingredients (APIs) must be produced cost-effectively and in compliance with regulatory requirements for safety and consistency. As such, process safety remains fundamental in order to meet these demands and mitigate potential hazards linked to large-scale production.

Why is process safety testing critical?

Identifying and managing hazards that might occur during industrial production is essential. A proactive approach to process safety is crucial to avoid potential incidents with catastrophic consequences, disregard of which has led to many industrial accidents. Among the causes of such accidents are thermal runaway-derived explosions, dust explosions, or unanticipated chemical reactivity. Comprehensive safety testing is a powerful tool that helps companies to understand the behavior of materials under different conditions. The compiled results will, in turn, guide safe production practices and ensure regulatory compliance.

In practice, this process involves applying a combination of assessments at various stages, starting with basic tests, such as thermal screening. As the process progresses from the R&D lab towards the kilo lab, pilot plant, and full-scale manufacturing, more advanced techniques, such as isothermal calorimetry, are required. Each step adds layers of insight, from initial thermal stability to explosivity and reaction calorimetry, providing scientists with the data they require to guarantee process integrity and safety.

Safety testing techniques for process scale-up

To support safe scale-up, companies can use a combination of different techniques. Each tool plays a unique role in gathering critical safety data.