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Measurement principle When the particles in the liquid pass through a narrow and narrow detection channel, the light emitted by the person perpendicular to the liquid flow is weakened by the particles, so the signal output by the sensor is reduced. This signal change is related to the cross-sectional area of ​​the particles.
General requirements for the instrument The instrument usually includes three parts: sampler, sensor and data processor.
The measuring particle size ranges from 2 to 100 μm, and the detection particle concentration is from 0 to 10,000 particles / ml.
The instrument used for calibration should be calibrated at least once every 6 months.
(1) Sampling volume After the instrument is stable, take more than the sample volume of particle inspection water in the sampling cup, weigh it, and weigh a certain volume of particle inspection water from the sampling cup through the sampler, and then weigh it again Weight-setting child. The sampling volume is calculated from the difference between the two weighed weights. Measure three times in succession, and the difference between the measured volume and the measured volume should be within ± 5%. The difference between the average value of the measured volume and the indicated value of the measured volume should be within ± 3%. Other suitable methods can also be used for calibration, and the results should meet the above requirements.
(2) The particle count takes standard particles with a relative standard deviation of not more than 5% and an average particle size of 10pm. A suspension containing 1000 to 1500 particles per lml is prepared. Let it stand for 2 minutes to remove bubbles. Turn on the agitator and slowly Stir to make it uniform (to avoid the generation of bubbles), measure 3 times according to the law, record the cumulative count of the 5pm channel, discard the * measurement data, the difference between the average value of the next two measurement data and the known number of particles should be within ± 20%.
(3) The resolution of the sensor is taken as the relative standard deviation of not more than 5%, the standard particles with an average particle size of 10 μm (the standard deviation of the average particle size should not be greater than 1 μm), made into a suspension containing 1000 to 1500 particles per 1 ml , Leave it for 2 minutes to remove bubbles, turn on the stirrer, and stir slowly to make it uniform (to avoid the generation of bubbles), measure the number of particles in the three channels of% m, 10Mm and 12jLtm according to the law, calculate the difference between the 8μm and 10μm channels The difference count of the two channels of 10μm and 12μm, the ratio of the above two difference counts and the cumulative count of the 10mm channel should not be less than 68%. If the measurement result does not comply with the regulations, the instrument should be re-adjusted and calibrated again.
Pharmacopoeia Insoluble Particle Tester Introduction:
The Pharmacopoeia Insoluble Particle Tester can monitor and analyze liquid particle size, cleanliness, and contaminants; pharmaceutical equipment and its daily maintenance and maintenance; abrasion tests in pharmaceutical machine parts; insoluble particle tests in pure solutions and ultrapure water; drugs Package material cleanliness test; human bone adhesion particle monitoring; pharmacopoeia insoluble particle detection;
The Pharmacopoeia Insoluble Particle Tester adopts the core technology of Protea, the "photoresist measurement particle", and can be built with various standards required by the user according to the user's requirements.
The precision plunger pump and ultra-precision flow electromagnetic control system are used to achieve dual control of constant injection speed and accurate injection volume. The sampling volume is 1ml ~ infinitely set at random, accurate and accurate.
The sensor adopts Protea's classic "photoresist measurement particle" sensor, which is more suitable for more than 510 international standards based on this principle.
Built-in threshold, particle size curve and pulse resistance, can set the channel particle size value.
The integrated automatic sampling chamber is equipped with a pressure measurement system, which can realize positive / negative pressure, so that the instrument can achieve sample degassing and high viscosity sample detection.
Adopt large-screen LCD display, touch screen menu operation, keyboard, touch dual input, beautiful appearance and full function.
Rich data processing functions; grades can be given according to the standard, and distribution histograms can be drawn.
Built-in operating system and micro printer, without external computer and printer can be directly tested and printed.
It has a standard serial RS232 port, which can be connected to a computer to store the test results, which is convenient for data classification and retrieval.
It can be calibrated and calibrated according to Chinese Pharmacopoeia, American Pharmacopoeia, ISO21510 and other standards.
According to customer requirements, the calibration report of the Advanced National Northwest Metrology and Test Center can be provided for a fee.
Provide calibration materials (GBW) to assist customers in calibration and measurement once a year.
Pharmacopoeia insoluble particle inspection instrument implementation standards:
US Pharmacopoeia USP35-NF30, USP32-NF27; European Pharmacopoeia EP6.0, EP7.0, EP7.8, EP8.0; British Pharmacopoeia BP2013, BP2012, 2010, 2009; Japanese Pharmacopoeia JP16, JP15, JP14; Indian Pharmacopoeia IP2010 edition ; WHO International Pharmacopoeia IntPh Fourth Edition; Chinese Pharmacopoeia 2010, 2015; GB8368 infusion apparatus; ISO21510; ISO11171 and so on.
The 1000-channel 0.01μm ultra-multi-channel and ultra-high resolution meet the requirements of more than 510 standards worldwide.
According to customer requirements, the corresponding "photoresistance particle size" test and evaluation standards can be implanted.
Pharmacopoeia insoluble particle tester instrument parameters:
Customized requirements: all kinds of liquid testing requirements;
Laser sensor detector: seventh-generation dual laser narrow light detector (light scattering method or light blocking method. Optional);
Test software: P6.4 analysis test software integrated version or PC version;
Control mode: integrated industrial computer control or industrial PC control;
Detection method: meet the standards of Chinese Pharmacopoeia, American Pharmacopoeia, GB8368, etc .;
Operation mode: color LCD touch screen operation;
Detection range: 0.03μm ～ 3000μm (type selection required)
Special detection: custom detection 0.03 ~ 100μm or 4 ~ 70μm (c) particles, 0.01μm or 0.1μm (c) arbitrary detection;
Sampling method: precision metering pump;
Injection accuracy: ± 1%;
Accuracy: ± 3% typical value;
Accuracy of coincidence: 1000 grains / ml (5% coincidence error)
Resolution: 95% (calibrated according to Chinese Pharmacopoeia 2015 edition); <10% (calibrated according to JJG1061) ＜ 10% (calibrated according to USP, ISO21501)
Number of channels: 1000, can be any 4, 6, 8, 12, 16, 32, 64, 128 particle count value range;
Results storage: no less than 20,000 groups (U disk can be connected, unlimited storage)
Test viscosity: 0 ~ 99mm2 / s; press up to 500mm2 / s;
Sampling flow rate: 5mL / min ~ 150mL / min;
Cleaning flow rate: 5mL / min ~ 500mL / min;
Fluid temperature: 0 ℃ ~ 80 ℃;
Ambient temperature: -15 ℃ ~ 50 ℃;
Interface mode: RS232 or RS485 to USB or USB interface or LAN interface; customizable size;
Display operation: color LCD screen
Operation mode: finger touch screen or external keyboard;
Analog output: 1MA ~ 20mA, serial port protocol, MODBUS protocol;
Reporting method: granularity / ml and grade
Input voltage: 100V ~ 265V, 50Hz ~ 60Hz;
Appraisal institution: Zhongte Metrology and Testing Research Institute or National Northwest Metrology and Testing Center of China Metrology Institute;
After-sales service: Protea China Service Center
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