The particle detector uses a high-precision laser sensor based on the principle of photoresist, which is suitable for the detection of the size and quantity of insoluble particles in transparent liquids (colorless, colored, and non-emulsion).
The particle detector uses a high-precision laser sensor based on the principle of photoresist, which is suitable for the detection of the size and quantity of insoluble particles in transparent liquids (colorless, colored, and non-emulsion). Meet the requirements of the latest edition of the Chinese Pharmacopoeia and the United States Pharmacopoeia
Purpose: To standardize the use and maintenance of the particle detector, operate the instrument correctly, extend the service life, and ensure the normal production.
Scope This procedure applies to the operation and maintenance of particle detectors. The responsible production department and the equipment operators and equipment personnel are responsible for the implementation of this regulation. Content. Confirmation before production. 1 and whether the equipment is clean and in good condition, there is a clean and functioning status mark. 2 Check the appearance of the equipment for any abnormalities and carry out all the daily maintenance. Operation Step 2.1 After repeatedly cleaning the test cup and the stirring rotor with water for injection, add 100 ml or more of the particulate detecting water to the sample cup. 2.2 Turn on the power switch, the instrument performs self-test on the sensor, sampler and lifting device. After the self-test is normal, press the “confirm†button to enter the main interface, and press the “clean†button to perform the cleaning operation.
It is advisable to perform channel setting and detection setting according to the detection requirements and adjust the rotation speed of the agitator so as not to stir up the bubble vortex.
(Note: The system settings are automatically stored. If you repeat the same type of test, you don't have to set it.)
The sample to be tested shall be processed according to the requirements and methods of the Chinese Pharmacopoeia 2010 (Part 2) "Insoluble Particle Detection Method", and after processing, it shall be placed in the test cup.
Application and principle
Particle detector application
The particle detector is used in drug testing, and the insoluble particles in the injection solution for intravenous drip (with a capacity of 100 mL or more) are inspected by light barrier technique, and the particles containing 10 μm or more per 1 mL should not exceed 25 particles, including No more than 3 particles of 25 μm or more. In the 2010 edition of the Chinese Pharmacopoeia, the Insoluble Particles Inspection Act stipulates the use of the principle of the light barrier method to check the size and quantity of insoluble particles in intravenous injections and sterile bulk drugs for intravenous injection.
Principle of particle detector
The principle of the sensor in the light barrier method: the liquid to be detected passes through a specially designed flow chamber, and the incident light beam perpendicular to the flow direction of the liquid is weakened by the particles in the liquid, so that the signal outputted by the sensor changes, and the signal changes and The cross-sectional area of ​​the particles as they pass through the beam is proportional. This proportional relationship can reflect the size of the particles. Each particle passes through the beam to cause a voltage pulse signal, and the number of pulse signals reflects the number of particles.
Particle detectors mainly include: samplers, sensors and computer-controlled detection and data processing systems. The measured particle size range is 2~100um; the detected particle size concentration is 0~10000/ml.
The domestic particle detector for drug detection and the principle of light barrier is independently developed and produced by Tianda Tianfa Technology Co., Ltd. in the mid-1990s.
Instrument characteristics
â— The performance is fully satisfied and better than the requirements of the 2010 edition of the Chinese Pharmacopoeia and the United States Pharmacopoeia. The built-in pharmacopoeia, anesthesia apparatus and infusion set test standards can directly carry out various injections, sterile powders and medical device particles. Pollution filtration rate detection;
â— The built-in calibration curve of the instrument detects the particle size distribution function; the user can set up thousands of particle sizes to detect and analyze the particles in the range of 1.2~100um, and develop their own internal control standards, especially for the multi-species detection of drug research units and testing centers. Has great advantages;
â— High resolution, better than Chinese Pharmacopoeia requirements; advanced precision syringe sampling system, sampling accuracy is better than 1%; sampling volume is at least 0.2ml;
â— It adopts the magnetic stirring method (under stirring) which is common in the international photoresist method, which is not easy to generate bubbles.
â— Close the detection room, detect the environment to prevent pollution, the sampling head automatically raises and lowers, and the lifting position can be set arbitrarily;
It can directly detect various injections (1~500ml bottle, bag, etc.);
â— Large-screen LCD display, touch screen operation, external standard keyboard, friendly interface, Chinese menu prompts;
â— Easy to clean and discharge the sensor;
â— The whole voltage is designed in the range of 100~264V, which can overcome the fluctuation of the power grid. The instrument does not need an external regulated power supply.
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