The KL-04A 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.
- 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
- Fully integrated system comprising sampler, sensor, controller and data storage
- Built-in hard disk can hold over ten years’ worth of measurement data