LIYI 1000L Standard Integrated Drug Stability Test Chamber For Pharmaceutical Industry

LIYI 1000L Standard Integrated Drug Stability Test Chamber For Pharmaceutical Industry
 
       1000L Standard Integrated drug stability test chamber factory directly offer provide the pharmaceutical industry with a long time stable environment of temperature, humidity and illumination for the medicine invalidation evaluation. It’s applied in the medicine accelerating test, growth test, high humidity test and high illuminance test.
 
Stability test conditions:
      In ICH guidelines, GMP and FDA define requirements in terms of functionality, performance and documentation. Europe, Japan and the United States have agreed to develop a common stability test that aims to gather information as a recommendation for the stability of raw materials or drugs, with the ultimate goal of proving the effectiveness of drug exposure to temperature, humidity, light or integrated environments over a specified period of time.
 
Storage conditions for long-term stability tests:
Temperature: +25 (+2 (+)
Humidity: 60 + 5% RH
Time: 12 months
 
Storage Conditions for Accelerated Stability Tests
Temperature: +40 (+2 (+)
Humidity: 75 + 5% RH
Time: 6 months
Intense illumination condition illumination: 4500 +500LX
 
 
Machine Features:
1. Imported high-quality components are adopted to ensure long-term continuous operation and stable and reliable performance.
2. Intelligent temperature and humidity controller imported from Japan has stable control, convenient operation and long service life.
3. Imported high-precision humidity sensor, high linear accuracy, small drift, no maintenance.
4. Equipped with micro printer, it can print temperature and humidity curve and data in real time.
5. Equipped with RS-485 interface, it can monitor single or multiple instruments and real-time record and backup of data through computer.
6. Equipped with temperature and humidity out of tolerance, power off SMS alarm function, one mobile card can know the operation status of multiple instruments.
7. The door shall be equipped with key lock to prevent irrelevant personnel from opening the door and affecting the test.
8. Imported totally enclosed heat-resistant compressor, R134a non fluorine environmental protection refrigeration, low noise, long service life.
9. Meet the requirements of FDA, ICH and national pharmacopoeia for accelerated, long-term, intermediate, high temperature and high humidity test.
10. The unique redundant refrigeration system can guarantee the normal operation of the test in time when the main refrigeration fails.
11. Circulating water supply system solves the problems of frequent water addition, water tank cleaning and no drainage pipe.
12. Meet the low humidity test of 40 ℃, 20% RH and 25 ℃, 40% RH for special drugs such as large infusion.
13. LED light source is used for light and near UV, and the light and UV are controlled automatically to avoid error due to long-term operation attenuation.
 
Chamber structure:
*Outer wall material: cold rolled steel plate electrostatic spray.
*Inner wall material: mirror stainless steel plate.
*Shelf: 5 layers of mirror stainless steel shelf, adjustable shelf height.
*Door observation window: hollow glass.
*Test hole: ф 50 is used as verification hole.
*Door lock device: the door is equipped with key lock to prevent irrelevant personnel from opening the door and affecting the test.
*Studio Lighting: fluorescent.
*Mobile caster: four mobile casters, two of which are equipped with brake.
 
Cooling system:
*Air conditioning mode: forced ventilation, internal circulation, balance, temperature and humidity regulation.
*Air circulation device: blower system × 3 sets.
*Heating mode: electric heater.
*Humidification method: electric steam humidifier.
*Water supply mode: automatic circulating water supply system, equipped with a set of special water tank with automatic submersible pump and water inlet system device.
*Refrigeration mode: 3 sets of imported heat-resistant refrigeration compressor unit, controlled by two groups (one group is for standby), R134a environmental protection refrigerant.
 
Specifications: