For pharmaceutical Products
Liquid-Borne Particle Counter
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.
- Large 10.4 inch LCD panel provides information in an easy to read format.
- Integrated SSD storage improves data access speed.
- 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.
- Light source uses semiconductor laser with three-year guarantee. (under normal use and proper handling)
|Optical system||Light-obscuration method|
|Light source||Laser diode (rated output 4.5 mW, wavelength 790 nm)|
|Fluid-contacting materials||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)
|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. 370 (H) x 375 (W) x 236 (D) mm|
|Weight||Approx. 10 kg|