Measurement of insoluble particles in injectable preparations at pharmaceutical factories: "Japanese Pharmacopoeia Test Method for Insoluble Particles in Injectable Preparations, Method 1: Light Obscuration Particle Counting Method."
The liquid particle counter 'KL-05' is an automatic measuring device that can measure fine particles with a diameter of 1.3 to 100 μm using a light obscuration method. It is suitable for measuring insoluble fine particles in injectable preparations in pharmaceutical factories. 【Features】 ■ Complies with the insoluble particle test for injectable preparations as specified by the Japanese Pharmacopoeia (JP), United States Pharmacopeia (USP), European Pharmacopoeia (EP), Korean Pharmacopoeia (KP), and Chinese Pharmacopoeia (ChP). ■ Supports small volume measurements (USP 787). Small volume sample holders such as 10 mL capacity syringes and ampoules are available (optional). ■ Complies with FDA's 21 CFR Part 11. Enhanced operator and password management features. Also supports electronic signatures. ■ Measurement results can be output to LIMS and other systems via serial communication. ■ Measurement results can be output as PDF or text files. ■ Uses SSD as built-in storage to improve operational speed. ■ Measurable particle size range of 1.3 μm to 100 μm, rated flow rate of 25 mL/min (optional factory setting for 10 mL/min), and customizable particle size classification of up to 20 stages. ■ The semiconductor laser light source is guaranteed for three years. *For more details, please refer to the catalog. Demonstrations are also available, so feel free to contact us.
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【Specifications】 ◆ Light source: Semiconductor laser (rated output: 4.5mW, wavelength: 790nm) ◆ Laser product class: Class 1, IEC 60825-1 ◆ Light receiving element: Photodiode ◆ Material of liquid contact parts ・ Flow cell: Synthetic quartz ・ Syringe: Borosilicate glass, PTFE ・ Syringe pump: Kel-F (PCTFE), PTFE ・ Tubing, seals, fittings: PFA, PTFE, PCTFE, Perfluoro (special fluorine rubber) ◆ Particle size classification: 1.3 to 100μm in 1 to 20 steps (0.1μm increments) ◆ Counting efficiency: 100% ± 5% ◆ Maximum particle number concentration: 10,000 particles/mL (10μm PSL particles in pure water, counting loss 10%) ◆ Minimum measurable volume: 0.2mL (it is necessary to add the dead volume capacity to the amount of air suction based on the sampling tube used) ◆ Maximum sample pressure: 50kPa (gauge pressure) ◆ Power supply: AC100-240V, 50/60Hz, approximately 80VA ◆ Operating temperature and humidity range: 15-30°C, 20-80% RH ◆ Size and weight: Approximately 370(H) × 375(W) × 236(D) mm, approximately 10kg *For more details, please refer to the catalog. Feel free to contact us with any inquiries.
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[Application] ■Measurement of insoluble particles in injection preparations, etc. Corresponds to the Japanese Pharmacopoeia's test method for insoluble particles in injection preparations, Method 1 "Light Obscuration Particle Counting Method." *For more details, please refer to the catalog. Demonstrations are also available. Please feel free to contact us.
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