Particle Counter KL-05 with Light Obscuration
The RION KL-05 is a compact liquid particle counter designed for analyzing insoluble particles in small-volume liquids, such as injection solutions, infusions, or WFI. Samples are drawn using a syringe and passed through the measurement cell at a flow rate of 10 ml/min (optionally 25 ml/min). The measurement is based on the light obstruction (extinction) principle caused by particles suspended in the liquid. Sampling is fully automated, with individually configurable alarm thresholds, making the KL-05 ideal for quality assurance applications. Both particle size and count are accurately measured, and custom reports can be easily exported in PDF or TXT format for further processing. The KL-05 enables analysis with sample volumes as low as 0.2 ml, making it particularly suitable for applications with limited liquid availability. Advanced features include an audit trail for full traceability and operator management to restrict device access. The KL-05 complies with all relevant regulations, including USP <787>, FDA 21 CFR Part 11, Ph. Eur. 2.9.19, and the Japanese Pharmacopeia (JP). With a particle size range of 1.3 µm to 100 µm, customizable SOPs, 20 freely definable channels with selectable alarm limits, and an integrated performance test, the KL-05 provides maximum flexibility and safety for demanding pharmaceutical applications.
Specifications
| Optical system | Light-obscuration method |
| Light source | Laser diode (rated output 4.5 mW, wavelength 790 nm) |
| Laser product class | Class 1, IEC 60825-1 |
| Light detector | Photodiode |
| Flow cell | Synthetic quartz |
| Syringe | Borosilicate glass, PTFE |
| Syringe pump | Kel-F (PCTFE), PTFE |
| Tube, packing, joint | PFA, PTFE, PCTFE, Perflo (special fluorine rubber) |
| Particle size ranges | 1 to 20 ranges from 1.3 μm to 100 μm (in 0.1 μm steps) |
| Counting efficiency | 100 % ±5 % |
| Maximum particle number concentration | 10,000 particles/mL concentration (10 μm vicinity PSL particles, coincidence loss max. 10%) |
| 25 mL syringe, flow rate 25 mL/min | within ±2 % (when measuring 10 mL) |
| 25 mL syringe, flow rate 10 mL/min ＊Factory option | within ±2 % (when measuring 10 mL) |
| 10 mL syringe, flow rate 10 mL/min ＊Factory option | within ±5 % (when measuring 0.5 mL) |
| Minimum measurable volume | 0.2 mL *Depending on sampling tube in use, dead volume must be |
| Maximum sample fluid pressure | 50 kPa (gauge pressure) |
| Maximum sample fluid viscosity | 30 mPa-s (at 25°C) |
| Power requirements | 100 V to 240 V AC, 50/60 Hz, approx. 80 VA |
| Environmental condition for operation | 15°C to 30°C, 20% to 80% RH (no condensation) |
| Dimensions and weight | Approx. 369 (H) x 375 (W) x 236 (D) mm, approx. 10 kg |
| Supplied accessories | PFA sampling tube set (2 mm dia. x 4 mm dia., length 10 cm) Drain tube set (2 mm dia. x 3 mm dia., length 150 cm) USB flash drive (8 GB), power cord (Japan domestic, 2.5 m), mouse, Keyboard, ferrite core, cell cleaning brushes (in case), cable clamp |
| Optional accessories | ● PFA sampling tube set (2 mm dia. x 4 mm dia., length 10 cm) (with nut) KL-04-S14 |