This series of products is manufactured in compliance with the 2020 edition of the guidelines for drug stability testing of raw materials and pharmaceuticals and the relevant provisions of GB/T10586.

scope of application

※The drug test chamber is a scientific method to create a long-term stable temperature and humidity environment required for drug failure evaluation. It is suitable for long-term tests of drugs and new drugs by pharmaceutical companies, high temperature tests and strong light exposure tests. It is a pharmaceutical company. The best choice for drug stability testing.

Features

※Structural features of the box

LCD color screen intelligent controller, accurate and reliable temperature and humidity control;

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;

Unique circulating air duct ensures uniform wind distribution inside the studio;

Can be connected to a printer or USB interface to export data directly;

※Air conditioning system

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

The air cooling method of high-efficiency finned evaporator, forced air circulation and balanced temperature adjustment.

※Cooling System

Imported compressor, fluorine-free refrigeration, frequency conversion refrigeration system, temperature and humidity recover quickly after opening the door;

※Humidification and dehumidification system

It adopts the micro-movement humidification system (internal humidification system) in the electronic parallel mode, and adopts the automatic water replenishment system for the humidification water; it is equipped with double protection devices for overheating and overflow, and the water level control adopts the mechanical float water valve to prevent electronic misoperation; adopts evaporation The device coil dew point temperature (ADP) laminar flow contact dehumidification method, the humidification and dehumidification systems are completely independent.

※safety devices

Compressor overpressure protection, overcurrent protection, overheat protection;

It has the functions of over-temperature, sensor failure, leakage, shutdown protection, door opening protection, water shortage alarm, and call recovery;

The power supply is equipped with a phase sequence protector, power supply phase loss and phase sequence error protection; leakage protection, heater short circuit and other overcurrent protection.

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

※In the ICH guideline, GMP and FDA define requirements in terms of functionality, performance and documentation. Europe, Japan and the United States agreed to develop a common stability test. The goal of these tests is to gather information as a recommendation on the stability of raw materials or drug products. The ultimate goal is to demonstrate that the drug product is exposed to temperature, humidity, Effectiveness in lighting or synthetic environments.

※Storage conditions for the stability test of long-term reserved samples:

Temperature: +40℃±2℃

Humidity: 75±5%RH

Time: 6 months

※Storage conditions for accelerated stability test:

Temperature: +25℃±2℃

Humidity: 60±5%RH

Duration: 12 months

Technical Parameters

Model: SFS-250Y

Volume: 250L

Temperature control range: 0℃~65℃

Temperature resolution: 0.1°C

Temperature uniformity: ±1°C

Temperature fluctuation: ≤±0.5℃

Humidity control range: 30-95%RH

Humidity fluctuation: ±3%RH

Timing range: 1-9999min

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

Working environment range: 5-35°C

Power supply: AC220V/50Hz

Studio size (mm): 528×480×1000

Dimensions (mm): 672×770×1700

Carriers (standard): 4

optional features

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

※Data storage function;

※ There is a test hole with a diameter of 50mm on the left side of the box;

※Independent temperature limit alarm system, can sound and light alarm to remind the operator;

※The ultraviolet germicidal lamp is located on the back wall of the box, which can regularly disinfect the inside of the box, and can effectively kill the floating bacteria in the circulating air in the box and the water vapor of the humidifying plate;

※GPRS SMS alarm function;

※Universal paperless recorder;

※Provide 3Q verification and calibration services