Product Description
Parameters:
Channel setting | 16 channels, Thousands of particle sizes can be customized and the accuracy is 0.1 μ m |
Test range | 1-500 μ m (Segment sensor require) |
Count range | 0 ~ 99999 particles |
Sampling volume | 0.2ml-1000ml |
Accuracy | <±0.5%(0.2ml~1000ml) |
Syring size | 10ml、25ml |
Flow rate | 2~100ml/min, setting by self |
Counting accuracy | <setting value±5% |
Channel resolution | >95% |
Relative standard deviation | RSD<1.5%(standard particle≥1000 /ml) |
Maximum Concentration | 0~18000 /ml |
Mixing speed: | 0 ~ 2000 R / min, adjustable in spinning type |
Work temperature | 10~40℃ |
Power | AC220Ⅴ±10%;50Hz;<80W |
Data output | RS232 |
Dimension | 390*350*460(mm) |
Weight | 20KG |
Software | With audit trail ,can operate in PC |
Operation system | Windows 7, windows 10 |
Futures:
- NBC-36s particle detector can fully meet the design scheme of Chinese Pharmacopoeia (2020Edition) and the requirements of Pharmacopoeia of the United States, for the detection of insoluble particles in small volume injections. It can also be used for the detection of particles in large infusion and infusion equipment, the filtration effect of infusion terminal filter and other fields (such as petroleum, chemical industry, dye, food, etc.) of liquid particles testing.
- High performance imported laser light source and compensation circuit are adopted to ensure the test accuracy of colorless and colored samples, and the samples without electrolyte can be directly detected
- The imported high-pressure injection pump sampling system is adopted, which can be set according to the sample volume of the tested sample varieties, with high injection accuracy, meeting the detection requirements of high viscosity test articles, and not affected by geographical location and other factors, meeting the use requirements of different altitude areas.
- The injection slit and pipeline are made of imported 316L and PTFE materials, which can directly detect organic solvents, oil matrix and other special solutions.
- Different high-pressure injection systems can be replaced according to the demand of injection quantity.
- It is equipped with pharmacopoeia standard infusion test, and the test times can be set arbitrarily.
- There is a special test program for small volume injection (small injection), which can be injected according to the specifications of small injection, and automatically converted into the size and quantity of container particles after the test, which meets the requirements of Chinese Pharmacopoeia and international general requirements.
- It can detect the content of particles in anesthesia bag
- Detection of filtration rate of precision filter
- Detection of particulate pollution in GB8368-2005
- Detection of particulate pollution in GB8368-2018
- Detection of particle content of drug packaging materials
- Detection of particle content of drug packaging materials
- Full channel test (better than the calibration requirements for instruments in Pharmacopoeia)
- The screw type glass agitator is adopted, with uniform speed adjustable, and the mixing speed can be controlled at any time to ensure the uniformity of particles in the container. Improve data accuracy
- Color touch large screen operation: Chinese input, easy and fast operation, powerful function. Multi channel test data can be displayed at the same time.
Sample name storage function: the set sample name is automatically stored, which is convenient and quick to operate. It has automatic data processing and multiple printing modes to meet different printing needs. - It can be connected to the computer and has the function of data automatic transmission computer; it can be connected to the laboratory operation for management, and the special data analysis software is used for data storage and statistics
- Three level authority management
- 32 users operator management
- It has data view function, and can access historical data and operation behavior at any time
AI Product Description
*The following content is generated by AI and is for reference only.
The device described is a high-precision liquid particle detection system designed for the pharmaceutical, biotechnology, and medical device industries. Operating with 8 to 16 independent channels, this instrument enables simultaneous analysis of multiple samples or different size ranges within a single run, significantly enhancing laboratory throughput. Its primary function is to detect and count microscopic particulate matter in parenteral solutions, ophthalmic products, and injectable drugs. This capability is critical for ensuring product sterility and compliance with stringent regulatory standards, such as USP <788>, EP 2.9.19, and JP 4.06, which mandate strict limits on visible and sub-visible particles to prevent patient harm.
A defining feature of this technology is its integrated audit trail. This electronic record-keeping system automatically logs every operational step, including user authentication, parameter changes, calibration events, and test results. By maintaining an immutable history of data integrity, the system supports adherence to FDA 21 CFR Part 11 regulations, ensuring that all testing processes are transparent, traceable, and secure against unauthorized modification. This is essential for passing rigorous regulatory audits and maintaining quality assurance protocols.
When operating this equipment, several precautions must be observed. First, sample preparation requires extreme care; users must avoid introducing external contaminants during filtration or transfer, as even a single stray fiber can skew results. The sampling chamber must be meticulously cleaned between runs using appropriate solvents to prevent cross-contamination. Furthermore, operators should ensure that the fluid path is free of air bubbles, which can interfere with optical sensors and cause false counts. Regular calibration using certified reference materials is mandatory to maintain measurement accuracy over time. Finally, while the system automates much of the process, manual intervention should only occur when necessary, and any deviations from standard operating procedures must be immediately documented in the audit trail to preserve data validity. Proper maintenance and environmental control are also vital to ensure consistent performance and longevity of the sensitive optical components.