（405 nm）7States. Suzuki responded to requests for customization from pharmaceutical peo-ple, including requests related to the for-mat of the logged data and additional functions, and made the necessary mod-ifications to the program.During these sales activities, Suzuki focused his efforts on one major pharma-ceutical company. This happened to be the company that inspired Minakami to come up with his idea.“I was placed in charge of sales with this company. It was great motivation for me to find myself suddenly working with this pharmaceutical giant. On the other hand, I was anxious because I knew if I failed here, it would be the end.”Ultimately, the counter became an innovative product that integrated a sen-sor unit, a control PC, a flow controller unit, and a deep UV irradiation unit. The integrated design of these units eliminat-ed the need to perform validation work independently for each unit, significantly reducing the time required for such tasks. The integration of multiple units was important for the pharmaceutical users because portability and work efficien-cy are essential at sites that manufacture water for drug use.The response from a major pharmaceutical company toward the product after a series of improvementsOne day, several months after Suzu-ki was assigned to sales, as he was going through a stack of demonstration eval-uations, he visited the pharmaceutical giant. The person in charge at the compa-ny informed him that a decision to adopt the product had been finalized.“I was overjoyed to hear the news. At the same time, I felt the weight of respon-sibility knowing I would have to con-stantly provide after-sales services for this newly-developed product.”Meanwhile, Sasaki had been observ-ing the development and adoption pro-cess of the product from the outside. Sasaki, who has worked at the National Institute of Infectious Diseases for a long time, had provided expert advice to Rion regarding the rules in the pharmaceuti-cal industry and the functions required in a BFPC. He is one of Japan’s leading experts, deeply knowledgeable in both the Japanese Pharmacopoeia and global standards.“Of all the standards related to drugs, the European standards are the most stringent,” comments Sasaki. “The Euro-pean Directorate for the Quality of Med-icines & HealthCare (EDQM) is now actively encouraging the adoption of the rapid test method. I’m certain the rest of the world will follow.”The rapid test method Sasaki speaks of is 'Rapid Microbial Methods' described in the Japanese Pharmacopoeia. This is the measurement method used by the XL-M4B developed and productized by Rion.In Japan, the adoption of this prod-uct by one of the leading pharmaceutical companies is promoting its adoption by other pharmaceutical companies.“In this age when people have landed on the moon and iPS cells have been dis-covered, it’s hard to comprehend that the method established by Koch 130 years ago is still in use,” says Sasaki. “The time has come to adopt the rapid test devices. Definitely.”Data loggerDisplay for count results Semiconductor laserand control panelPatented technologyCooling sectionSample feeding portDeep ultraviolet irradiation sectionExamples of display screens and functionsThe SMARTDAC+ (GX10) manufactured by Yokogawa Electric Corporation, with a proven track record, has been adopted as the display unit for this system. Extended security features provide a secure and traceable data management system and support data integrity compliant with PIC/S and ALCOA+ principles, the latter being referenced by WHO, MHRA, and FDA. It also provides encrypted binary data management, an electronic signature (sign-in) function, an audit trail function, and operator management authorization functions. Various types of results can be displayed on an easy-to-view screen. Sample flow controllerPressure gaugeFlow cellDeep UV lamp• Specifically enhances autofluorescence from microbes.• Reduces false positive counts.• Reduces risk of microbial contamination within the equipment.Check valveDetects autofluorescence of bacterial flavin enzymes and counts the microbesOptical filterPhotodetectorSensor unit* Detects autofluorescence of individual microbesTakashi MinakamiDevelopment Department, Particle Counter Division. Joined Rion in 1997. As a member of the BFPC development team, he played a central role in the project to design and develop the XL-M4B. He had the idea of incorporating a deep UV irradiation unit to improve ac-curacy and to use a third-party data log-ger. He is a member of an academic society in the pharmaceutical industry (Parenteral Drug Association, PDA). Waste liquidInternal configuration of the XL-M4BAfter the sample is fed into the instrument, it is irradiated with deep UV light that specifically enhances microbe autofluorescence. This reduces the number of false positive counts and lowers the risk of microbial contamination within the device. It also allows the detection of starved microbes. In the sensor section, the sample liquid is irradiated with a semiconductor laser. An optical filter and a photodetector are used to detect the autofluorescence of the bacterial flavin enzyme and to count the number of microbes. The result is displayed on a monitor and recorded with a data logger. The deep UV irradiation unit is a patented Rion technology.Tomohiro SuzukiNew Business Promotion Section, Parti-cle Counter Division. Joined Rion in 2014. After working in Sales Section 2 for pharmaceuticals, he was assigned as a regional sales representative for parti-cle counters before being assigned to his current department. He is a member of the sales staff in charge of the phar-maceutical business.
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