Rion Liquid-borne Particle Counters KL-05

Serves for measurement of insoluble particles in injections, for example at pharmaceutical plants.

Designed for pharmaceutical quality control applications, the system complies with the requirements of Japanese Pharmacopeia (JP), United States Pharmacopeia (USP), European Pharmacopeia (EP), Korean Pharmacopeia (KP) and Chinese Pharmacopoeia (ChP) for insoluble particulate matter testing of injections. It supports small-volume measurements in accordance with USP 787 and can be equipped with an optional sample stand for 10 mL syringes and ampoules. Compliance with FDA 21 CFR Part 11 ensures secure operator management, password protection, and electronic signature functionality. The instrument also supports serial communication for data transfer to Laboratory Information Management Systems (LIMS) and allows measurement results to be exported in PDF or tab-delimited text formats. With a measurable particle size range of 1.3 μm to 100 μm, a standard flow rate of 25 mL/min (10 mL/min optional), and up to 20 configurable particle size ranges, it offers flexibility and reliability for advanced particle analysis applications.