(156b) An Integrated Process Automation System in API Manufacturing: Key Characteristics and Case Study
AIChE Annual Meeting
2020
2020 Virtual AIChE Annual Meeting
Pharmaceutical Discovery, Development and Manufacturing Forum
PD2M Poster Session: Pharmaceutical Discovery Development and Manufacturing
Monday, November 16, 2020 - 8:00am to 9:00am
Such automation system includes sophisticated solution and cutting-edge tools. According to the recipe and process of the product, the consultant optimizes the control strategic with expertise to enhance the safety and meet the regulation requirements. The process control modules or batch control program are deployed in DCS system for the purpose of multifunctional and flexible manufacturing. In case study it gives example of the mixing control strategic in the reactors which is critical and should consider all concerned factors. Usually the geared motor electricity is ignored to monitor, the absence may interfere the cooling system activation in time, its real time monitoring and interlock with cooling media are necessary; another example is the utility facilities configuration and interlock with automatic systems which should be tuned duly to eliminate the hidden trouble. The integrity of safety instrumented functions (SIFs) should be determined through risk assessment tools and rating tools, such as HAZOP (Hazard and Operability Analysis) and LOPA (Layer of Protection Analysis). The related case study reports sharing control components between SIS and DCS will increase the possibility of failure, which should be validated. The allocation of center control room and controller assignment should be concerned with HSE guideline. It also discusses the roadmap of information technology and MES (Manufacture Execution System) for API manufacturing. Our implementation shows that the integrated process automation system can help to reach instinct safety, which increase the productivity and improve the quality of products with regulatory compliance.
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