Description
This series of products are manufactured in accordance with Chinese Pharmacopoeia 2000 Edition Guidance for Industry:
Stability testing of drug substance and drug products and the standard of GB10586-89
The drug test chamber,with the scientific approaches,creates a good environment for the test of drug invalidity that needs long-term stability of
temperature and humidity,it is the best selection for pharmaceutical enterprises to conduct drug stability test,applicable for drug long term test,
high temperature test and high ligh irradiation test,etc.
The microcomputer controller and intelligent LCD are used to control and display the temperature and humidity respectively,with the stability,accuracy and reliability.
Unique air circulating system ensures the uniform distribution of air in the working chamber.
The freezing machine adopts the imported original,full-enclosed compressor can switch automatically,to ensure long term continuous operation of test equipment,
with the features of stability,security and reliability.
The internal bladder is made of stainless steel and four semi-circular corners take convenience for easily cleaning
RS-485 interface(optional) is available,which enables the incubator to be connected to the recorder or computer,to record the temperature and humidity for a long term.
A testing hole(optional) of diameter 25mm is available on the left of chamber body.
Conditions for stability test
In the respects of functionality,performance and documents in Guidance of ICH,GMP and FDA defined the requirements.Meanwhile,European,
Japan and USA had reached an agreement about a common stability test,this test is to collect the information,which is used for recommendation
of raw material and drug stability,then to prove the drug validity under being exposed in some temperature humidity illumination or comprehensive environment.
Storage conditions for the stability test of long reserved sample
Temperature: +25℃ +-2℃
Humidity:60+-5%RH
Time:12 months
Storage conditions for accelerating stability test
Temperature: +40℃ +-2℃
Humidity:75+-5%RH
Time:6 months
Brightness under high light irradiation condition:4500+-5000LX
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Changsha Samy Instrument & Equipment Co., Ltd.
Year Established:2013
Business Type:
Management Certifiation:
Operational Address: Room 432, Building 19, Changfang Times City, No. 138, West Tongzipo Road, Wangchengpo Street, Yuelu District, Changsha, Hunan, China (Mainland)
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