(1997), in association with the Foreign Insoluble Matter Test. The standards for performance testing differ between the Japanese Pharmacopoeia and the United States Pharmacopeia, so our goal was to develop a product that complied with both.”In an Age Where Advances Can Be Achieved by Changing the OS: A New Model Brings ConsistencyThe OS for the KL-04 released in 2001 shifted from Microsoft Windows (used by KL-03) to open-source Linux.“Windows had frequent updates in OS versions, which carries the risk of unexpected malfunctions. For pharmaceutical products, reliability and safety are major concerns. So we moved to Linux. It was a revolutionary change in the history of liquid-borne particle counters.”Another major change was the all-in-one design of the sensor, sampler, and PC. Additionally, the flow rate increased from 10 mL/min for the KL-03 (system) to 25 mL/min with the KL-04. Minor changes in 2010 for the KL-04A involved a change of the recording medium from a floppy disk or tape drive to USB memory. This model also enabled quality management in compliance with Korean and Chinese Pharmacopoeia, in addition to the Japanese and western pharmacopoeia. The latest model, the KL-05, was released in 2018. While the basic design concept remained the same as for the KL-04A, it offered a large 10.4-inch LCD screen that made it much easier to read information during measurement. The model also adopted an SSD for internal storage for faster operational speeds.“Another feature of the KL-05 is the sample stand adapter for small containers like 10 mL syringes and ampules for small-volume measurements. I’ve been a part of the R&D since the KL-03 (system). Looking back, I think the most difficult task was developing the sensor. Particle size resolution refers to the instrument’s capacity to distinguish differences in particle size. It was quite a challenge to achieve the performance and stability required by the pharmacopoeias. Another hard problem was designing the circuit for pulse height analysis. In designing the KS-70 particle sensor for the KL-03 (system), we integrated the circuits for the sensor and the multi-channel pulse height analysis to minimize factors that would lead to electrical errors.”Unlike ordinary products, the demand for liquid-borne particle counters for the pharmaceutical industry remains relatively constant. That’s why stability and reliability in measurement precision are essential product features.“We’ve had customer requests for a built-in auto-sampling function that would change samples automatically. The feature would require a large-scale device, which would definitely cost more. I think such major model changes might be considered at some point in the future when major changes occur in the pharmacopoeias. But for now, we’ll focus on validating the products currently used by our customers and on providing support to our customers to assure them they can rely on precise measurements over the product lifetime.”9[KL-04] (2001), [KL-04A] (2010)From the KL-04, released in 2001, the OS went from Windows to Linux, an open-source operating system. The measurement flow rate increased to up to 25 mL/min, from a rated flow of 10 mL/min of the KL-03. The model also allowed processes to be controlled in compliance with the Japanese Pharmacopoeia, United States Pharmacopeia, European Pharmacopeia, Korean Pharmacopoeia, and Chinese Pharmacopoeia. The KL-04A successor model allowed results to be output to external devices. The KL-04 uses USB memory to copy and back up measurement data.(Photo shows model KL-04A.)[KL-05] (2018)Released in 2018, the KL-05 adopted a large, 10.4-inch LCD panel, which let users view information easily during measurement. In response to requests from manufacturers, the model featured a sample stand adapter for small volume samples capable of holding 10 ml syringes and ampules. An SSD was adopted as the internal storage device to increase operational speeds. The latest 2021 model has a measurable particle size range of 1.3 μm–100 μm. Up to 20 particle size ranges can be set for measurement.What is validation?Validation is the process of verifying scientifically whether methods of inspection and analysis and work processes are adequate, to ensure the quality expected of the product, as well as documenting and storing the results. Rion supports validation work for particle counters and multi-point monitoring systems.
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