Transforming a pharmaceutical manufacturing facility from a multiple-campaign, multiple established product-based operation, to one that can also accommodate single-development product campaigns is a challenge. Even soCONTROL ENGINEERING China版权所有, this feat was accomplished successfully at one of Eli Lilly’s bulk pharmaceutical production buildings. Historically, this production building provided full batch control of the processes and ran multiple campaigns of the same products. However, due to a shift in the product mix at the site, this facility was also called upon to run single campaigns of development products. These single-run campaigns require a higher level of manufacturing flexibility involving the options available to modify the process as necessarywww.cechina.cn, while maintaining the highest available quality and throughput. The challenge was to maintain the existing ISA88 compliant control system structure for existing product campaignsCONTROL ENGINEERING China版权所有, while accommodating the needs of development product processing into the control system framework, and continuing to minimize the risk of operator error.

　　 This is fine for products you make again and again, but is not flexible enough for single-development product campaigns. Generic batch offers greater flexibility, but without the operator error pitfalls of manual procedures.

　　The active pharmaceutical ingredient (API) manufacturing facility in question has processed multiple products in multiple repeated campaigns over the last 20+ years. Its general control and operational philosophy was full batch control during product processing, and “manual-matic” control during setups and cleandowns. In manual-matic control, the equipment is automated via equipment modules, with the operator responsible for initializing and starting the required modules, using the desired parameter values in the correct sequence. A typical reactor has equipment modules configured for vent/pressureCONTROL ENGINEERING China版权所有, temperaturewww.cechina.cn, agitation, charge header, discharge header, and recirculation/sam