1st step2nd step3rdstepAtsushi Nunome,Consultant for Pharmaceutical Water SystemsThe Six Categories of Impurities and the Three StepsAs a consultant on pharmaceutical water, Mr. Nunome organizes seminars and other events within Rion to share the latest findings. This diagram shows the six categories of impurities encountered in the process of generating tap water to producing water for injection according to Mr. Nunome.Diagram of monitoring system for membrane-processed WFI with XL-M4BIn 2017, the membrane method was approved by the EP (European Pharmacopoeia) as an alternative to the distillation method, the conventional method widely used for generating water for injection. The diagram shows the monitoring process for the generation of water for injection with this membrane method using Rion’s XL-M4B microbial particle counter.This method offers the capacity to monitor fluctuating values in real-time, allowing im-mediate response in the event of an abnormality. The XL-M4B has helped strengthen Mr. Nunome’s recommendations to use the membrane method to generate water for injection.Rion’s business is supported by the many people who work with us. This section introduces the people active in various fields who work with Rion.advice on product specifications and test proce-dures from this standpoint.Mr. Nunome has worked as an advisor to a company that manufactures membranes used to produce water for injections and to Japan’s leading comprehensive chemical manufacturer. Although he is now a prominent expert in the industry in clean water, including ultrapure water, he has ex-perience in wastewater treatment as well.“I once had a hose come loose and I got sprayed over my head with the water seed fungi used at a human waste treatment plant,” he recalls laughing. “I switched from the world of dirty water to the world of clean water.” He is truly a leading figure in the world of water, with experience in both clean and dirty water. We asked Mr. Nunome about his impression of Rion from an outsider’s perspective.“Rion has managed to achieve a great balance between the development and sales of products in various fields, with hearing aids as your main prod-uct. I also had the opportunity to talk to someone in a department other than the Particle Counter Division. They were very enthusiastic, and we could speak very frankly. I feel like Rion is a modern company with young employees, both male and female, playing active roles.”Nunome, too, senses a gradual shift in the once conservative nature of the pharmaceutical industry.“As employees of the new generation rise to positions of responsibility, I sense an atmosphere in which people feel more free to think and do things their own way. In a word, I think the current situation will generate tailwinds for Rion. Both needs and business opportunities are there for measuring instruments like the XL-M4B.”Purpose: PretreatmentTo meet potable water standardsPurpose: DepyrogenationPurpose: DeionizationThe pharmaceutical industry is known to be extremely careful about adopting new technolo-gies and machines. The XL-M4B microbial particle counter developed by Rion was a revolutionary product, performing real-time measurements of pharmaceutical water quality. However, the industry was inclined to place greater trust in con-ventional testing methods—namely, the culture method. Additionally, the XL-M4B was an expen-sive device, making sales inevitably challenging. But Atsushi Nunome stood behind our product, explaining to skeptical users the superiority of the rapid measurement method, which provides prompt results, in contrast to the culture method that can take several days, as well as the reliability of Rion’s equipment.Mr. Nunome has worked with pharmaceutical water and ultrapure water for many years, and currently works as a pharmaceutical water consul-tant. His relationship with Rion began about two years ago when he approached us. At the time, most testing instruments to measure the quality of water for injection were imported. Due to difficul-ties in troubleshooting instruments made abroad, Mr. Nunome was looking for a domestic testing equipment manufacturer. Then he came across the marketing material related to the XL-M4B. As he had made the acquaintance of Rion employees at meetings of the Parenteral Drug Association (PDA) Japan Chapter and other organizations, he approached us and volunteered to promote this new and innovative product to the pharmaceutical industry based on his experience working with many pharmaceutical companies over the years. “I’m closer to the customer and can offer insights on how to customize the instrument to meet the customers’ purposes,” he explains. He offered WaterPurified WaterRaw waterPurified water production facility (UF membrane)FeedingWFIproduction facilityWater for injection14StartParticlesDissolvedPyrogenMicro organismsGasInorganic－ IONOrganic－ IONInterview and article by Ryosuke KobayashiWaste liquidXL-M4BWFIsupplyfacilityRepresentative of the Nunome Professional Engineer Office. He joined Kurita Water Industries Ltd. in 1972, before moving to Nomura Micro Science Co., Ltd. in 1992. In 2011, he founded the Nunome Office, a phar-maceutical water consultancy. As a specialist in phar-maceutical water, he has continued to be active in the development and design of pharmaceutical water and ultrapure water equipment, as well as in providing consulting services for pharmaceutical water. (WFI)WaterA specialist in pharmaceutical waterwho continues to advocate the superiorityof Rion’s productsWORKING TOGETHERCollaborating with Rion in research partnerships
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