Drug stability test definition:
The stability of a chemical drug (API or formulation) refers to its ability to maintain physical, chemical, biological and microbiological properties.
The stability study is based on the systematic research and understanding of the API or preparation and its production process. The quality characteristics of the API or preparation are obtained through design experiments under the influence of various environmental factors (such as temperature, humidity, light exposure, etc.) The law of time changes, and accordingly provide supporting information for the determination of the prescription, process, packaging, storage conditions and retest period/expiration period of the drug.
Purpose of drug stability test:
Drug stability test, including influencing factor test, accelerated test and long-term sample retention test.
DRK672 Drug Stability Test Chamber
Drick’s new generation of drug stability test equipment integrates the company’s many years of design and production experience, and introduces and digests German technology. Breaking through the defect that the existing domestic drug test chamber cannot run continuously for a long time, it is an essential equipment for GMP certification of pharmaceutical factories.
Using a scientific method to create a temperature, humidity environment and lighting environment that requires long-term stability for drug failure evaluation The best choice for drug stability testing.
(The performance parameter test is under no-load conditions: ambient temperature 20°C, ambient humidity 50%RH)
Name: Drug Stability Test Chamber
Model: DRK672
Temperature control range: no light 0~65℃
Illuminated 10~50℃
Temperature fluctuation: ±0.5℃
Temperature uniformity: ±2℃
Humidity range: 40~95%RH
Humidity deviation: ±3%RH
Light intensity: 0~6000LX
Lighting error: adjustable ≤±500LX
Timing range: 1~99 hours per segment
Temperature and humidity regulation: Balanced temperature and humidity regulation
Refrigeration system/cooling method: Two sets of independent original imported fully enclosed compressors are automatically switched
Controller: programmable LCD controller
Sensor: Pt100 platinum resistance capacitive humidity sensor
Working environment temperature: RT+5～30℃
Power supply: AC220V±10% 50HZ
Power: 2600W
Dimming method: stepless dimming
Volume: 250L
Inner tank size: 600*500*830mm
Dimensions: 740*890*1680mm
Load tray (standard): 3 pieces
Embedded Printer: Standard
Safety device: compressor overheat protection \ fan overheat protection \ over temperature protection \ compressor over pressure protection \ overload protection \ water shortage protection
DRK637 Walk-in Drug Stability Laboratory
Drick’s walk-in drug stability laboratory is designed and manufactured according to user requirements and with reference to GB/T10586-2006, GB/T10592-2008, GB4208-2008, GB4793.1-2007 and other relevant terms. It is mainly used to manufacture and maintain a space with constant temperature and humidity. The cooling and heating of the device are fully automatically controlled.
Name: Walk-in Drug Stability Laboratory
Specification model: DRK637
Temperature range: 15℃∼50℃
Humidity range: 50%RH~85%RH
Resolution: temperature 0.1℃; humidity 0.1%
Outer size: 2700×5600×2200mm
Inner size: 2700×5000×2200mm
Refrigeration system: Emerson Copeland scroll hermetic compressor is used, two sets of refrigeration systems, one for backup and one for use
Cooling method: air cooling
Power: 20KW
Equipment use conditions:
Power requirements: AC3ψ5W 380V 50HZ
Ambient temperature: 5~38℃
Ambient humidity: < 90%R.H
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Post time: Jul-25-2022