Process Safety & Engineering Assessment

Process safety is critical in drug substance development to ensure manufacturing processes are safe and reliable. At Neuland, we partner with customers to understand their specific needs and develop customized process safety solutions. 
 

Neuland offers calorimetric studies, thermal screening unit studies to check the adiabatic temperature and pressure rise. We also use RSD if multiple samples need to be analyzed quickly. Our process safety team also conducts the safety DSC which is detailed in HIRA and HAZOP reports utilized for plant scale up batches. The process engineering team uses this data to provide proper utility controls for plant scenarios. We get all powder safety studies from externally approved vendors for MIE, MIT, bulk powder resistivity and dust explosion class details.

Process safety capabilities:

• Chemical reaction hazard testing, identification, and mitigation
• Explosive property identification and dangerous goods classification
• Engineering simulations, such as mixing and heat transfer
• Vent sizing calculation to meet engineering requirements and to prevent potential explosion
• Powder safety studies for the intermediates and APIs for the safety studies
• Reaction mass DSC, TSU, and rapid screening devise studies
• Reaction calorimetry studies to evaluate the heat release of a chemical reaction over time, and to safely transfer it from lab to plant
• Operational hazard evaluation including flammability & static electricity/dust explosion
• Compatibility of materials evaluation with corrosion testing
• Hazard and operability studies and documentation for process scale-up and technology transfer