The KL-05 is a Light Obscuration Particle Counter for insoluble particulate matter test for injections according to USP <788>, Ph.Eur2.9.19. and JP <11>, 24 in injection solutions and Parenteralia. It combines the simplest configuration and operation with software integrated in the measuring system. This high-end PA counter enables the sampling of smallest product batches, starting at 0.2 mL.
Features:
Data management principles as specified by Japanese Pharmacopeia ( JP ), United States Pharmacopeia ( USP ), European Pharmacopeia ( EP ).
Can be connected to an external system, such as LIMS ( Laboratory Information
Management System ), to output measurement data ( option )
USB memory is used for data output and system back up
Conforms to 21 CFR Part 11 by the American FDA
Enhanced audit trail and operator management functions
Measurable particle size range: 1.3 to 100 µm, flow rate: 25 mL / min ( 10 mL / min
is factory option ), size range : enables setting of up to 20 channels
Supports automatic measurement and pass / fail evaluation according to pharmacopeia
Specifications
Fully integrated system comprising sampler, sensor, controller and data storage
Built-in hard disk can hold over ten years’ worth of measurement data
