Scope of Application

※This is a comprehensive stability test box with photostability test. It is an instrument and equipment for GMP certification for pharmaceutical and cosmetics companies, and it complies with the photostability test conditions in the ICH guidelines. Create a long-term stable temperature, humidity environment and light environment for drug failure evaluation in a scientific way, which is suitable for pharmaceutical companies to accelerate tests, long-term tests, high-humidity tests and strong light tests for drugs and new drugs. The best must-have product for stability testing.

Features

※Structural features of the box

LCD touch screen controller, fuzzy PID control, programmed multi-segment parameter setting;

The material in the studio is made of SUS304 stainless steel plate, which is acid-resistant and corrosion-resistant, and the semi-circular arc design of the four corners is easy to clean;

The inner tank of the box adopts a special V-shaped design, which can conveniently and effectively discharge the accumulated water caused by humidity in the box;

Studio door] frame two imported silicone rubber sealing strips; the door is equipped with a built-in multi-layer hollow glass observation window, which is more convenient for observation;

The unique circulating air duct ensures uniform wind distribution inside the studio. There is a test hole with a diameter of 50mm on the left side of the box;

With data storage function, it can be connected to a printer or USB interface to directly export data;

※Air conditioning system

PID regulation, completely independent heating system, does not affect the refrigeration and control circuit;

High-efficiency finned evaporator air cooling method, forced air circulation and balanced temperature adjustment;

Imported high-performance fans and imported high-precision temperature and humidity sensors are used.

※Lighting system

The illuminance is steplessly adjustable, the illuminance value can be set, and the light sensor is used for monitoring to reduce the illuminance attenuation and test error caused by the aging of the lamp;

Light value instrument real-time display, support printing;

The professional ultraviolet lamp meets the light stability test requirements of Q1B new raw materials and new preparations in ICH. Select the ultraviolet lamp lamp holder that can operate under high humidity conditions. The professional ultraviolet lamp has the characteristics of stable quality and uniform spectral power, and the spectral power distribution of the light source will not attenuate as the lamp ages, and can repeat more test results.

※Humidification and dehumidification system

It adopts the micro-motion humidification system (internal humidification system) in the electronic parallel mode, and the automatic water replenishment system for the wet water;

With overheating and overflow double protection device, water level control adopts mechanical float valve to prevent electronic misoperation; adopts evaporator coil dew point temperature (ADP) laminar flow contact dehumidification method, humidification and dehumidification system are completely independent.

※Cooling System

Two sets of imported compressors switch automatically, fluorine-free refrigeration, frequency conversion refrigeration system, and the temperature and humidity recover quickly after opening the door;

※safety devices

Compressor overpressure protection, overcurrent protection, overheat protection; independent temperature limit alarm system, which can prompt the operator with sound and light alarm;

With functions of over-temperature, sensor failure, leakage, shutdown protection, door opening protection, water shortage alarm, call recovery

The performance parameters are tested under no-load conditions: the ambient temperature is 20°C, the ambient humidity is 50%RH, and RT is the ambient temperature.

Technical Parameters

Model: SFS-500Z

Volume: 500L

Temperature control range: 0-65°C when there is no light, 5-65°C when there is light

Temperature resolution: 0.1°C

Temperature fluctuation: ≤±0.5℃

Temperature uniformity: ±1°C

Humidity control range: 30-95%RH

Humidity fluctuation: ±3%RH

Light source configuration: cool white fluorescent lamps are similar to D65/ID65 and UVA near ultraviolet fluorescent lamps

Meet the test standard: ICHQ1B instruction, cool white fluorescence ≥ 1.2×106Lux.hr, near ultraviolet fluorescence ≥ 200w.hr/m ²

Light intensity: 0-8500LX stepless adjustable

Lighting error: ±500LX

UV spectral range: 320-400nm

UV error: ±15%

Timing range: 1-9999min

Temperature and humidity regulation method: balanced temperature and humidity regulation method

Working environment temperature: 5-35℃

Power supply: AC220V/50Hz

Studio size (mm): 640×650×1200

Dimensions (mm): 784×912×1900

Carriers (standard): 4

optional features

※GPRS SMS alarm function;

※Partition-type lighting module, the illuminance is steplessly adjustable, (multi-layers can be controlled separately);

※Universal paperless recorder;

※Provide 3Q verification and calibration services