In the development of a drug substance, the timely identification and mitigation of potential risks and hazards are critical factors that can significantly impact the overall success of the process. Failing to address these challenges promptly can lead to unsafe conditions and various negative consequences.
Our advanced process engineering and safety laboratories undertake process simulation with miniature lab reactors and associated engineering tools. Process safety parameters are evaluated using reaction calorimeter (RC1e), accelerating rate calorimeter (ARC), differential scanning calorimeter (DSC), thermal screening unit (TSU) and rapid screening unit (RSD). Our process safety engineers analyze experimental data to prepare a chemical hazard evaluation summary, ensuring that safety and compliance issues are addressed during the scale-up activities at the kilo lab and pilot plant stage. Our facilities are also designed to handle HPAPIs up to kilo scale.
Process Safety: Methodology for assessing NCE development
Process Safety Laboratory – Infrastructure
Powder Safety Testing in House capability
