Liquid Particle Counter 'KL-05'
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.
basic information
【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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Applications/Examples of results
[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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We have uploaded the technical information magazine "Shake Hands" vol.11 from Rion Corporation.
●Uploaded the technical information magazine Shake Hands vol.11 by Rion Co., Ltd.! "Shake Hands" is a technical information magazine published by the Environmental Equipment Division of Rion Co., Ltd. It contains various information ranging from the principles of acoustic, vibration, and particulate measurement to application examples. In particular, the feature "Special Feature: Flowing" introduces the "Pico Plankton Counter," which measures plankton online. Please download and take a look!
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[Product Catalog] The Rion Corporation Particle Measurement Instrument Comprehensive Catalog 2019-2020 has been uploaded.
● Uploading the Rion Corporation's Particle Measurement Instrument Comprehensive Catalog 2019-2020! Also included is the newly released liquid particle counter "KL-05," launched in February 2018. The catalog features particle measurement instruments (particle counters) used in various fields such as precision electronic equipment manufacturing and pharmaceutical and food production. In addition to the specifications of each instrument, numerous examples of using each device as part of a system are also introduced. Furthermore, the catalog concisely summarizes the principles of particle measurement and the classification of cleanliness levels throughout, making it a very useful resource for quality managers.
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[Product Catalog] The updated version of the 2018 Rion Corporation Particle Measurement Instruments Comprehensive Catalog has been uploaded.
● Upload the 2018 (Updated Version) Comprehensive Catalog of Rion Co., Ltd.'s Particle Measurement Instruments! The newly released liquid particle counter "KL-05," launched in February 2018, is also included. The catalog features particle measurement instruments (particle counters) used in various fields such as precision electronic equipment manufacturing and pharmaceutical and food production. In addition to the specifications of each instrument, numerous examples of using each device as part of a system are also introduced. Furthermore, the catalog concisely summarizes the principles of particle measurement and the classification of cleanliness levels throughout, making it a very useful resource for quality managers.
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We have uploaded the technical information magazine Shake Hands vol.7 from Rion Corporation.
●Uploaded the technical information magazine Shake Hands vol.7 from Rion Co., Ltd.! "Shake Hands" is a technical information magazine published by the Environmental Equipment Division of Rion Co., Ltd. It contains various information ranging from the principles of acoustic, vibration, and particulate measurement to application examples. We are pleased to announce that Shake Hands vol.7 has been released, so please take a look.
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[Product Catalog] The 2019 edition of the Rion Corporation particle measurement instrument catalog for pharmaceuticals has been uploaded.
●LION's Particle Measurement Instrument Catalog: Latest Version for Pharmaceutical Use Uploaded! The newly released liquid particle counter "KL-05," launched in February 2018, is also included. This catalog features LION's particle measurement instruments (particle counters), particularly those used in the pharmaceutical and food manufacturing sectors. In addition to the specifications of each model, numerous examples of using each model as part of a system are also presented. Furthermore, the catalog concisely summarizes the principles of particle measurement and the classification of cleanliness levels, making it a very useful resource for quality managers.
