Insoluble particles (English name: sub visible particles/particulate matter) correspond to visible particles, referring to particles that are insoluble in water or organic solvents, non metabolic, and invisible to the naked eye. Generally refers to particles with a diameter of less than 50 μ m. In some applications, such as injections, medical devices, cleanrooms, etc., insoluble particles should be avoided as much as possible. But in some applications, such as grinding fluid and ink, particles are actually used.

The hazards of insoluble particles in injections:

Infusion containing a large amount of insoluble particles can directly cause an increase in body temperature, faster heartbeat, and even shock when entering the human body. This is caused by the accumulation of insoluble particles in a certain part of the body. The main symptoms include: vascular obstruction, irritant inflammation, granulomas, blood clotting, etc. The FDA recently expects companies to have a detection limit of 2um

AccuSizer 780SIS series instruments

It is a product designed by PSS Particle Sizer Company in the United States specifically for accurate particle size analysis of quantitative samples. Its simplest and most user-friendly system and operation can accurately count and calculate particle size distribution of samples. It has up to 512 high-resolution detection channels, and users only need to click the mouse to complete the detection.
The 780 SIS sampler with injection volume ranging from 0.5mL to 25mL and precise injection pump device is a perfect module in modular device households.

Suitable for the pharmaceutical industry, such asSmall and high-dose injections. And it has software and supporting documents that comply with 21CFR Part 11 regulations, which can establish a cGMP standard operating procedure (SOP) for enterprises.

Technical principle:

When particles pass through the photosensitive region, they obstruct a portion of the incident light, causing a decrease in the intensity of the light reaching the detector. The attenuation amplitude of this signal is theoretically proportional to the cross-section of the particles. In the instrument, the light intensity signal is converted into an electrical signal, which is manifested as a voltage value. Different particle sizes produce different voltage values. Based on the corresponding relationship, a calibration curve for standard particles and particle size can be established. This is the principle of traditional photoresist method (also known as light extinction or light obscuration) for detecting particle size. The lower limit of the traditional photoresist method is generally up to 1.8 μ m. PSS pioneers the organic combination of photoresist signals and dispersion signals, achieving a larger particle size detection range through the photoresist effect, and increasing sensitivity to small particles through light scattering, greatly expanding the lower limit of single particle counting to 0.5 μ m.

Technical advantages:

1. Wide detection range 0.15-5000 μ m
2.512 Data Channel
3.32 Custom Channel
4. Ultra high resolution
5. Micro injection (optional)
6. Automatic injection (optional)
7. Compatible with both aqueous and organic phases
8. Modular design, easy to upgrade products 9. Sensor on-site calibration, no need to return 10. Built in ISO, USP, CP and other system standards, and customizable standards