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Products

The products listed here are for overseas markets, not for Japan domestic.

RION Liquid-borne Particle Counters KL-05

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.

Liquid-borne Particle Counters

Model:

KL-05

Maker:

RION CO., LTD.

Features

  • 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)

Specifications

Item Specifications
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

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about Nihon Denkei Co., Ltd.