The system principle of temperature stability and humidity control of the drug stability test chamber :
1. Control method of temperature system: By means of forced circulation ventilation, BTC is balanced. In this method, the control system controls the output of the heater through the PID automatic calculation output according to the set temperature point, finally reaching a dynamic balance;
2. Humidity system control mode: The humidity controller passes the internal PID integrated block electronics to output the controlled solid state relay signal, and then the normal state relay normally closed and the normally open control humidifier power supply when the PT100 direct sensing reaches the SV setting. At the time of temperature, the humidifier stops humidifying and stays in constant humidity;
3, air heating method: the use of nickel-chromium wire heater, good material with corrosion resistance and humidity resistance, while the speed response greatly exceeds the heating tube efficiency;
4, humidification: Stainless steel heating pipe, direct water heating extraction humidity, at the same time in the design plus an over-temperature protection system;
5, humidification system: The use of tap water automatically through the carbon and rod filter to filter, and then there is a solenoid valve water level float switch control water;
First, the use of the equipment stability test box :
The equipment is used in the pharmaceutical, medical, and biotechnology industries and there are all research experiments involving related industries in the life sciences. Suitable for GMP certified users. The drug stability test is an important process to understand whether the quality of drugs (raw drugs and finished drugs) changes and changes with time under different storage conditions. Through experiments, according to the obtained measurement data, pharmaceutical companies can determine the packaging and storage conditions of drug products and establish a safe and effective use period. According to relevant requirements, APIs and finished drugs must undergo accelerated and long-term stability tests; innovative APIs and finished drugs must undergo drug-strengthened stability tests; water-based drug products packaged in LDPE containers must undergo water loss tests; New drug substances and finished drugs must be tested for light stability.
Second, the implementation of standards:
Equipment is satisfied with CP2010, according to GB/T 10586-2006 standards.
Third, the equipment structure features:
1. The equipment adopts imported components to ensure long-term continuous operation and stable and reliable performance;
2. The new air duct system design is adopted, and the imported circulating fan is adopted so that the temperature and humidity uniformity in different locations inside the box is good;
3, the use of imported fully enclosed compressor, high efficiency, low noise, to ensure long-term continuous operation of equipment;
4, the test lead hole on the left side of the studio, when you can open the hole cover;
5, the shell of the equipment adopts the steel plate spray treatment, which is beautiful and elegant; the liner adopts the SUS304 mirror stainless steel, and the pollution-free source is easy to clean;
6. The design of the illumination system is easy to install and disassemble. The fluorescent lamp has a long service life and is highly efficient and energy-saving.
7, light source type: fluorescent lamp
8, light source control: switch control
9, controller: dedicated controller
Fourth, drug stability test chamber heating and insulation system:
1. Nickel-chromium alloy electric heater is used for heating equipment;
2. The equipment insulation adopts rigid polyurethane foam;
Fifth, air circulation system:
1, imported circulating motor (low noise)
2, stainless steel multi-wing centrifugal wind wheel
3, single cycle
Sixth, refrigeration and humidification dehumidification system:
1, Refrigeration / dehumidification compressor: imported fully enclosed compressor
2. Refrigerant: Import R134A
3, condenser: air-cooled coil
4, evaporator: fin type
5, other accessories: refrigeration filter, solenoid valve
Seventh, control system
1, special controller, simple operation, high control accuracy
2, the equipment is implemented in a balanced thermostat
VIII. Safety Protection Measures
1. Safe and reliable grounding protection device;
2. Independent studio over-temperature protection;
4 compressor overheating, overpressure, overload, lack of water protection;
5. Heater short circuit, overload protection.
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