1984: Rion Markets the First Domestic Liquid-borneParticle CounterInjections are fluids administered directly into the human body, and the size and number of insoluble particles contained in them are stipulated in pharmacopoeia. In contrast to other industries, defective pharmaceutical products can’t be detected at the factory, and in worst-case scenarios, such products can lead to adverse effects on patients. This means manufacturing and inspection processes must scientifically demonstrate veracity in the methods used, to ensure injections are free of insoluble particles, microbes, and contaminants.Rion currently offers the KL-05, the most advanced model dedicated to injection quality management, which makes use of a light obscuration particle counter. The development history of liquid-borne particle counters in Japan goes back to around 1980. At that time, foreign-made liquid-borne particle counters were bulky systems with numerous components, and were quite expensive, with price tags of over 10 million yen per unit. Against this background, our development goal was to produce an all-in-one, portable liquid-borne particle counter with exchangeable particle detection components. In 1984, we brought the KL-01 to market—Japan’s first domestic liquid-borne particle counter. It could measure particles in liquids ranging from pure water to hydraulic oils. Together with the KS-60 sensor, the system was priced at 4 million yen. Equipped with the KS-60 light obscuration particle sensor, the KL-01 marked the first in a line of liquid-borne particle counters designed for quality management of injections. With this product, Rion succeeded in producing a model superior to foreign-made particle counters, from both functional and cost perspectives. With this as a starting point, we went on to develop a liquid-borne particle counter capable of measuring particles in hydrofluoric acid, a highly corrosive acid used in semiconductor manufacturing. In 1998, we introduced the KL-03 (system), a liquid-borne particle counter dedicated to the measurement of insoluble particles in injections suitable for on-site use at pharmaceutical plants. The KL-03 system consisted of the KS-70 particle sensor, KL-03 sampler, and a PC with KF-10 software installed.“The KL-03 (system) expressly targeted the pharmaceutical industry. The Japanese Pharmacopoeia and the United States Pharmacopeia set strict limits on the number and size of particles allowable in pharmaceutical agents such as injections and infusions administered directly into the human body. They also stipulate methods for calibration and performance testing of particle counting instruments. The KL-03 was released to comply with the light obscuration particle count test method described in Supplement I of the 13th edition of the Japanese Pharmacopoeia 8[KL-01] (1984)The KL-01 was developed by Rion in 1984 in response to growing demands from the pharmaceutical industry and other industries for an affordable instrument capable of measuring liquid-borne particles. It was the first domestic liquid-borne particle counter capable of measuring particles in liquids ranging from pure water to hydraulic oils. The KL-01 was an all-in-one, portable model with exchangeable particle detection components. We were able to offer higher functionality at a lower cost, eventually gaining the trust of users in the pharmaceutical and hydraulic oil industries. With this product, Rion eventually succeeded in gaining a solid share of the particle counter market.[KL-03 (system)] (1998)In 1998, Rion introduced the KL-03 (system) liquid-borne particle counter. This device was capable of measuring insoluble particulate matter in injections at pharmaceutical plants. It was released as a model that complied with the test method using light obscuration automatic particle counters specified in the Japanese Pharmacopoeia as an insoluble particulate matter test for injections. It also complied with the United States Pharmacopoeia and European Pharmacopoeia.Yukihiro KimotoGeneral Manufacturing Manager, Particle Counter Manufacturing Engineering Depart-m ent. He has participated in the develop-ment of liquid-borne particle counters since the KL-03 (system) and is mainly involved in sensor and mechanical R&D.
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