Particle Counter
For Pharmaceutical Products
KL-05
Liquid-borne Particle Counters
Serves for measurement of insoluble particles in injections, for example at pharmaceutical plants.
- Compliant with insoluble particulate matter testing for injections in accordance with the Japanese Pharmacopeia (JP), United States Pharmacopeia (USP),European Pharmacopeia (EP), Korean Pharmacopeia (KP) and Chinese Pharmacopoeia (ChP).
- Supports small volume measurement (USP 787). Special small size sample stand available as option, for 10 mL syringes and ampoules etc.
- Compliant with FDA’s 21 CFR Part 11. Comprehensive operator and password management functions, as well as electronic signature support.
- Serial communication function allows output of measurement data to a Laboratory Information Management Systems (LIMS) etc.
- Measurement results can be output as PDF or text file (tab delimited) format.
- Measurable particle size range 1.3 µm to 100 µm, flow rate 25 mL/min (10 mL/min available as factory option),with up to 20 particle size range settings.
Specification
| Optical system | Light-obscuration method |
|---|---|
| Light source | Laser diode (rated output 4.5 mW, wavelength 790 nm) |
| Materials of parts exposed to sample fluid | Flow cell：Synthetic quartz Syringe：Borosilicate glass, PTFE Syringe pump：Kel-F (PCTFE), PTFE Tube, packing, joint：PFA, PTFE, PCTFE, Perflo (special fluorine rubber) |
| Measurement size range | 1 to 20 ranges from 1.3 μm to 100 μm (in 0.1 μm steps) |
| Flow rate | 25 mL syringe：25 mL/min 10 mL syringe：10 mL/min＊Factory option |
| Maximum particle number concentration | 10,000 particles/mL(10 μm vicinity PSL particles, coincidence loss max. 10%) |
| Power requirements | 100 V to 240 V AC, 50/60 Hz, approx. 80 VA |
| Dimensions | Approx. 366 (H) x 360 (W) x 236 (D) mm |
| Weight | Approx. 10 kg |
