63 Process safety One of the biggest challenges faced in bringing new drugs to market is scale-up: taking small, lab-based syntheses through a pilot plant, to full-scale manufacture. Implementing robust process safety across three broad areas is an important step to reducing manufacturing risks. The process development phase must deliver a comprehensive approach to hazard evaluation and importantly mitigation, taken against these consistent scenarios: • A full exploration of the desired reaction • Avoidance of reaction thermal runaway • Modifying operating conditions to reduce identified risks Hazards need to be identified, assessed, and mitigated at each stage of product development. Designing safety into all development processes minimizes the risks involved and delivers confidence for a safe and efficient scale-up to manufacture. It is crucial to consider when, how, and why testing is carried out. We have integrated process safety testing throughout the product workflow (process development to scale-up) to ensure safe and productive preparation. During process development, the raw materials and intermediates that are used to synthesize all desired molecules are screened for potential hazards. With scale-up always in mind, the desired main reaction is assessed and characterized, and any potential additional thermal and pressure hazards that may occur in operation are identified. This early stage is the preferred time to evaluate potentially unsafe materials or synthetic routes, and inform the selection of alternative, lower risk options. We have DSC, TSU and micro-scale calorimetry to quickly screen the thermal properties of raw materials, intermediate reaction mixtures and distillation crude. If process is finalized a detailed and compressive safety testing is done with SRC and ARC instruments to get complete thermal, pressure and off-gassing data to define Basis of safety (BoS) and safe operating conditions in plant scale. All these details are captured in CPHE (Chemical process Hazards Evaluation report). We also perform powder safety testing to understand flammability, explosivity behaviours of solid compounds. We use a wide variety of tools to identify, assess and then mitigate the potential hazards at each stage of process development, to ensure safe and robust process for scale-up. The Plant process team will conduct a detailed Risk assessment/HAZOP assessments by using Process hazards information from process safety lab, to define and implement control strategies. Pre-Start-Up Safety Review Our commitment to safety is unwavering, and a critical element of this commitment is the rigorous implementation of Pre-Start-Up Safety Review (PSSR). This comprehensive process ensures that all new and modified equipment and facilities undergo a thorough safety assessment before they are commissioned for use, emphasizing our dedication to the well-being of our employees and the integrity of our operations. The below table represent the summary of average numbers of PSSR recommendations per month and the percentage of recommendations closed for all the units. Unit No. of PSSR recommendations given (Monthly average) % of PSSR recommendations closed Unit 2 169 99 Unit 3 88 92 Unit 4 524 89
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