6Sensor status screen“But I just couldn’t give up on the pharmaceuticals field. I’d been working in it, attending academic meetings and participating in committees since 2015, and I was almost sure we could be suc-cessful,” says Minakami.In the summer of that year, while Minakami and a sales representative were going around collecting the demo counter units loaned to pharmaceutical customers, they were also telling them that Rion would be scaling back business in the pharmaceuticals field. On a train ride back from one of the leading compa-nies, an idea occurred to Minakami as he talked to his sales colleague.“Perhaps we could create a parti-cle counter that meets pharmaceuti-cal industry needs, if we combine that device...”“That device” was a data logger made by a third party company, which met data integrity standards in the medicine and pharmaceuticals field. If it were incorpo-rated, Rion’s BFPC would satisfy the data integrity standards of the pharmaceuti-cal industry, which required data man-agement in encrypted binary format, electronic signatures, and audit trails. This was the moment when the idea of integrating DI-compliant functions for the pharmaceutical industry into a Rion product was formulated.To overcome the rigorous restrictions imposed on his work due to the Covid pandemic, Minakami brought home all of the necessary equipment, including the original unit, an oscilloscope, a data logger, and so on. He manually assem-bled devices and tested the results repeat-edly. A room, originally meant for his son who was in the third grade. became Minakami’s workshop.“If I fail here, it’s the end”The resolution of a newly appointed sales representativeSuzuki, who had been transferred to the New Business Promotion Section in the spring of 2020, was among those disappointed to learn about the decision to withdraw from the pharmaceuticals field. Even in comparison to the world of semiconductor manufacturing, which also requires clean water, the pharmaceu-tical industry stands out as a highly spe-cialized field. Suzuki was proud to have been placed in charge of the sales of par-ticle counters and other products for the pharmaceutical industry.At just this time, Minakami’s idea to combine Rion’s existing product with those of other companies came as a sur-prise.“This idea could only have come from the New Business Promotion Section. It would never have occurred to me, as I dealt only with existing Rion products.”Based on his experience, Suzuki believed it was the Development Divi-sion’s job to create the software for Rion products. His belief was upended. His fundamental outlook was shaken. He acknowledged that he needed to think further outside the box and to be more imaginative.That summer, Suzuki and Minakami visited pharmaceutical companies once again, this time with the new demo unit in hand. Rion’s counter had always been recognized for its high sensitivity by the customers. Now, the counter had an added data logger that met the strict requirements of the Ministry of Health, Labour, and Welfare of Japan and the corresponding agencies in the United FeedingWFI production facilityMain measurement screenWaste liquidXL-M4BWFI supply facilityData trend screenRaw waterPurified water production facilityTsuguo SasakiAdvisor to Rion Co., Ltd.; former GMP expert of the Office of Manufacturing Quality of Drugs of the Pharmaceuticals and Medical Devices Agency (PMDA). Doctor of Agriculture, University of To-kyo. After working at the National Insti-tute of Health and the National Institute of Infectious Diseases, he currently of-fers his services as a GMP Technical Ad-visor and is a guest professor at the Graduate School of Engineering, Osaka University. (UF membrane)Schematic diagram of the monitoring system for membrane-processed Water for Injection (WFI)In contrast to the distillation method widely used to generate water for injection, only in 2017 was the membrane method approved by the European Pharmacopoeia (EP). The membrane method has since drawn attention due to the significant reduction in energy consumption that can be achieved compared to the distillation method. On the other hand, the method requires a system for the early detection of membrane damage or microbial growth on the membrane. The following figure depicts a schematic diagram of a monitoring system using XL-M4B when producing water for injection with the membrane method. Numerical fluctuations can be monitored in real-time, allowing immediate action in the event of an abnormality.
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