Stability Test Chamber
The drug stability test chamber is an instrument with long-term stable temperature, humidity and light required for drug failure evaluation. It is used for the accelerated tests, long-term tests, high temperature tests and strong light tests for drugs and new drugs, and it is the best choice for the pharmaceutical enterprises to conduct drug stability tests.
Stability test conditions
1) Storage conditions for stability tests on long-term reserved samples: Temperature: +25°C ± 2°C; humidity: 60+5%RH; duration: 12 months
2) Storage conditions for accelerated stability tests: Temperature: +40°C ± 2°C; humidity: 75+5%RH; duration: 6 months; bright light illumination: 4500+500LX
Characteristics
The characteristics of the drug stability test chamber are as follows:
1. Adopt domestically innovative arc-shaped design, making its overall appearance elegant;
2. Apply the mirror SUS304 steel plate of acid resistance, corrosion resistance and easy-cleaning characteristics as the interior material;
3. Allow position regulation of the specimen holder;
4. Set a test lead hole with a diameter of 25mm at the left side of the chamber, which can be used by opening the hole cover;
5. Use quality door magnetic sealing strips and thermal insulation materials to make the performance of the whole machine superior;
6. Adopt reasonable air duct circulation system capable of maintaining uniformity of internal temperature and humidity to the greatest extent;
Principle
1. Control mode of the temperature system
Balanced temperature control method (BTC) backed with forced circulation ventilation. In this method, the control system controls heating capacity according to the set temperature point with the help of the automatic calculation result of the PID controller, and finally achieves a dynamic balance.
2. Control mode of the humidity system
The humidity controller gives control signals to the solid state relay (SSR) through the internal PID integrated electronic block, and then controls the humidifier power supply through the NC and NO signal of the SSR. When the PT100 sensor directly senses and reaches the SV set humidity point, the humidifier stops humidifying and maintains constant humidity state.
3. Air heating method
Adopt quality stainless steel heater, which is made of good material and has corrosion and humidity resistance effects, with its reaction speed much faster than that of heating tubes.
4. Humidification
Apply stainless steel electric heating tubes that directly heat water and increase moisture, and overheat protection system is adopted.
5. Humidification system
Tap water is automatically filtered through activated carbon filter, and then a solenoid valve is controlled by the float switch to replenish water.
Application
The drug stability test chamber is used for in-depth research in the pharmaceutical industry, medicine, biotechnology, food industry, electronic industry and all related industries involving life sciences. According to the WHO, the requirements of 25°C/60%RH humidity should be met for long-term stability tests. And in accelerated tests, under the condition of 40°C/75%RH humidity, various indexes are tested for six months. Accelerated tests belong to the stability test system field of the pharmaceutical industry, and the chamber mainly simulate temperature, humidity, and light tests in environmental climate, as well as the adaptability tests for drugs stored and used under high and low temperature conditions.
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