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.