Quick Details
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. is a professional high-tech company, engaged in the research & development, manufacturing and marketing of laboratory instruments. We have centrifuge, low temperature freeze, intelligent biochemical incubator, electronic balance, electric magnetic stirrer, etc.
With the tenet of "Quality is Life", our company has established an impeccable quality management system, and taken the lead of our industry passing ISO9001:2008 quality management system certification, CE compliant and ISO13485 medical apparatus and instruments quality management system certification.
Products of our company are widely applied in the fields of manufacturing and scientific research, such as military industry, science research institutions, institutions of higher education, central blood banks, hospitals, biological products, pharmacy, bio-chemical examination, agricultural science, environmental protection, petrifaction, etc.
