Interview and article by Ryosuke KobayashiPROJECT STORYA Documentary of Product Development at Rion4with a maximum of 10,000 bacteria per 100 mL.Robert Koch, the German physician hailed as the father of modern bacteri-ology, devised a method for identifying and quantifying specific bacterial spe-cies within a sample. Known as the cul-ture method, this fundamental approach involves multiplying the bacteria popula-tion in a petri dish and visually counting the colonies. Since its inception 130 years ago, the culture method has remained a cornerstone of bacteriological analysis, utilized worldwide for its reliability and effectiveness.There has always been demand from the pharmaceutical industry for a device capable of performing instant and auto-matic measurement of bacteria and microbe counts in liquids.“To comply with pharmaceutical reg-ulations, microbial monitoring was being conducted by growing colonies in a cul-ture medium,” explains Sasaki. “But this process was time-consuming. Therefore, by the time any water contamination was discovered, drug production would have moved forward and the manufacturing process could not be reversed. The ideal solution would be to monitor microbes in real-time.”According to Sasaki, obtaining results from the culture method took more than five days. He says, "Unlike sterility test-ing, which proves the absence of microor-ganisms, in the case of water for injection, In 2021, Rion developed the XL-M4B, a product capable of au-tomated, real-time measurement of microbes in liquids. This instrument adheres to standards compliant with the rapid microbial methods outlined in the Japanese Pharmacopoeia. Here, we delve into the journey of developing this instrument, poised to play a vital role in the pharmaceutical industry.The “culture method” established by Koch 130 years ago remains in use todayClean water plays a crucial role in pharmaceutical manufacturing. Accord-ing to Tsuguo Sasaki, a former GMP expert of the Office of Manufacturing Quality for Drugs of the Pharmaceuticals and Medical Devices Agency (PMDA) and current advisor to Rion, "The stan-dards for water for injection formula-tions are among the strictest." As per the Japanese Pharmacopoeia, the bacteria count for water used in injections must not exceed 10 per 100 mL. In comparison, tap water is limited to 100 bacteria or less per milliliter. This requirement translates to water for injection needing to contain 1,000 times fewer bacteria than tap water, Exploring the Development of "Microbial Particle Counter XL-M4B" for the Pharmaceutical IndustryHow might Biofluorescent Particle Counters Revolutionize the Pharmaceutical Industry?
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