5Display for count resultsXL-10B viable particle counter (sensor unit)Sample liquid flowcontrollerBiofluorescent particle counting systemThe initial measurement system consisted of independent units: the XL-10B viable particle counter, a deep UV irradiation unit, a sample liquid flow controller, and a personal computer for displaying the count results.Deep UV irradiation unitit is important to understand through trend analysis that the number of micro-organisms is below 10 cfu/100 mL. "The rapid microbiological method (RMM) in real-time is a very good approach for early detection of deteriorating trends in pharmaceutical water systems. It is also very helpful in reducing the workload of QC staff."certify the sensitivity in detection, but to document the testing process and to prove that the data hadn’t been altered,” explains Minakami of the Development Department of the Particle Counter Division.Minakami attended pharmaceuti-cal conferences, carrying the new prod-uct, in search of ways to persuade phar-maceutical companies to accept it. While some innovative groups within the pharmaceutical industry showed eager-ness to try new products like this, most remained skeptical.Minakami sought to improve the per-formance of the counter and to achieve the accuracy as high as obtained by the culture method. One day, a researcher of a pharmaceutical company who had been testing a demonstration unit sub-mitted the following observation: “We took measurements of various bacte-ria species, but we couldn’t measure this one at all.” Upon further investigation, Minakami found that the bacteria spe-cies in question was much smaller than normal bacteria; this was the bacteria species used by pharmaceutical compa-nies to check the performance of their fil-ters. Minakami studied the bacteria and found that Rion’s counters could detect only 2 to 3% of the bacteria compared to the culture method.Then Minakami added a deep UV irradiation unit to the system. Deep UV irradiation was typically used by phar-maceutical companies for sterilization, but it was discovered that when bacteria were exposed to UV light, not only did they stop multiplying, but the intensity of the fluorescence they emitted became enhanced due to the oxidation of ribofla-vin (an autofluorescent substance found within the cells). The enhanced autofluo-rescence made it possible to clearly detect bacteria that had previously been unde-tectable. This new technology, for which Rion obtained a patent later, was com-pleted around 2016. Minakami promptly incorporated the process of irradiating deep UV light before feeding the sample liquid into the sensor section. This result-ed in the system configuration shown in the figure below.“Rion’s particle counter has excellent detection sensitivity.”It didn’t take long before an increas-ing number of pharmaceutical compa-nies expressed praise like this.A new path in business discovered with withdrawal plans underwayIn spring 2019, Rion established the New Business Promotion Section within the Particle Counter Division. After dis-cussing the fields to focus on, the deci-sion was made that continuing business in the pharmaceuticals field would be dif-ficult. The main challenge was ensuring data integrity (DI), which is required to certify that test data has not been altered. Building a DI assessment system from scratch would require more budget and time. Ultimately, it was decided to focus efforts on water purification, where good results had already been achieved.The world’s first biofluorescent par-ticle counter (BFPC) developed by Rion and its introduction to the pharmaceu-tical industryIn 2013, Rion embarked on a new ven-ture by developing a BFPC. This ground-breaking product was the world's first of its kind, capable of automatically mea-suring microbes in liquids continuous-ly and in real-time. The device oper-ates by detecting the autofluorescence of enzymes in bacteria when a laser beam irradiates the liquid, enabling accurate microorganism counts. Rion was uniquely positioned to develop this product, drawing on its extensive experience in manufacturing various particle counters used for clean-liness control in manufacturing process-es and clean rooms across industries such as electronics, pharmaceuticals, and food manufacturing. Since its development, Sasaki has actively promoted this product at com-pany seminars and events, recognizing its potential to become an indispensable instrument in the pharmaceutical indus-try.Pharmaceutical companies, howev-er, didn’t respond immediately. Backed by their long tradition, they are cautious by nature and not known to leap even after looking. The industry was reluctant to adopt the latest technologies too early. Moreover, another reason prevented the adoption of this new technology.“We still had extreme hurdles to over-come, including the need not just to XL-M4B Microbial Particle CounterThe XL-M4B is a biofluorescent particle counter(BFPC) for general bacteria capable of measuring biological particles suspended in liquids. It’s used to measure biological particles in water for injection, purified water, and other applications at pharmaceutical plants. It complies with the reference information on rapid microbial methods specified in the 18th edition of the Japanese Pharmacopoeia and is the ideal solution for reducing work burdens related to pharmaceutical water management. The real-time continuous monitoring enables swift actions. The deep UV irradiation technology allows the detection of even starved bacteria (with reduced colony-forming capabilities). Both on-line and off-line measurement modes are available to allow the early detection of problems on production lines and investigations of their causes. It can operate at sample temperature and humidity up to 90°C. The system complies with both FDA 21 CFR Part 11 and data integrity standards. Rion supports validation (IQ, OQ, PQ) tasks and offers documentation services for them.
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