Particle measurement in parenterals

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Due to its flexible and highly compact design, the RION KL-04 A® can be integrated into any laboratory environment. All functions are controlled by the integrated device firmware. In addition to complete process control, the device software ensures digital records and signatures in accordance with GAMP and US guidelines (21 CFR 11).

The user-friendly design is based on a minimal tare volume of 0.3 ml and flexible flow rates between 5 ml/min and 100 ml/min. The sample feed accuracy of 0.2 milliliters allows for precise reproducibility of measurement cycles. All data are visualized on the high-resolution display. For documentation purposes, batch protocols can be printed on local or network printers, or optionally backed up via Ethernet interface. User errors are minimized through an intuitive user interface and analysis recipes, especially through the two-button operation.

- Light blockage detector for particle measurement from 1.3 to 100 micrometers
- Complies with USP <788>, Ph.Eur 2.9.19, and JP <11> and <24> with independent calibration parameters
- Automatic rinsing and cleaning routines
- Integrated performance test for interim control
- Up to 20 particle channels - user-adjustable
- Sample volumes from 0.2 ml
- Calibration (based on ISO 21501) once a year
- PMT qualification support and on-site service

From October 8th to October 10th, 2013, the company will be present at SEMICON in Dresden (booth No. 2-029).