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Drug stability test box (aging box)

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Drug stability test box
For pharmaceutical enterprises, scientific research and testing units to accelerate the test of drugs and new drugs, long-term test, high temperature test, high humidity test, and strong light irradiation test. It is the necessary equipment for the above enterprises. The purpose of the experiment is to provide scientific basis for the production, packaging, storage and transportation conditions of drugs, and to establish the limited period of drugs through experiments.
0512-67158275hsy_001@hsy515.cn
  1. Share:

1、 Scope of application:


For pharmaceutical enterprises, scientific research and testing units to accelerate the test of drugs and new drugs, long-term test, high temperature test, high humidity test, and strong light irradiation test. It is necessary for the above enterprises


Preparation. The purpose of the experiment is to provide scientific basis for the production, packaging, storage and transportation conditions of drugs, and to establish the limited period of drugs through experiments.




2、 Product features:


(1) Stainless steel workroom, four corner arc structure, easy to clean.


(2) Two sets of independent original imported compressor units are automatically switched to ensure the continuous and reliable operation of the equipment for a long time.


(3) Programmable temperature and humidity controller, with setting, measuring temperature and humidity double digital display and PID self-tuning function, accurate and reliable control.


(4) The air duct circulation system is composed of low noise fan and suitable air duct, and the air distribution in the working room is uniform.


(5) There is a 25 mm diameter test hole on the left side of the box, which can be used for external test signal line.


(6) The humidity control system formed by automatic humidity generator, preheating water tank and humidity controller is safe and reliable, which can ensure that humidity occurs quickly, with high precision and small fluctuation.


(7) The built-in stainless steel water tank can run continuously for 3 days.


(8) Overtemperature alarm system, sound and light alarm to remind the operator to ensure safe operation without accident.


(9) The stainless steel spare water tank can run continuously for 12 days. (optional)


(10) Ultraviolet germicidal lamp is optional, which can disinfect the interior of the box regularly, so as to effectively prevent the pollution during the drug test. (optional)


(11) LED illuminator can be selected to carry out strong light irradiation test, which can reduce the illumination attenuation and test error caused by the aging of the original lamp tube. (optional)


(12) The embedded printer can print the temperature at different time, which is convenient to query the temperature control situation. (optional)


(13)Temperature programmable controller



advantage:


1) The color screen touch interface is adopted, which is simple to operate and easy to edit.


2) The operation interface of the controller can be selected in Chinese and English, and the real-time operation curve can be displayed on the screen.


3) Multi segment programming function and menu operation interface simplify the test process.


4) After the data and test conditions are input, the controller has screen locking function to avoid shutdown due to human touch.


5) With P.I.D. automatic calculation function, the temperature and humidity change conditions can be corrected immediately, so that the temperature and humidity control is more accurate and reliable.


6) With RS-232 or RS-485 communication interface, the data can be uploaded to the computer, which is convenient to set programs on the computer and monitor the test process.


14. SMS monitoring and alarm system can be installed. If the user is not on site and the equipment fails, the system will collect the fault signal in time and send it to the designated receiver by SMS


15. On the mobile phone, make sure to eliminate the fault in time, recover the test, and avoid causing unexpected loss. (optional)


16. Provide 3Q verification and calibration services. (service to be ordered)


17. It can provide customers with IQ (installation qualification), OQ (operation qualification), PQ (performance qualification) and other services to ensure the performance and index requirements of drying oven. Please contact the manufacturer if necessary.




Technical parameters implementation and compliance standards:


1. Guidelines for drug stability test in Chinese Pharmacopoeia (2010 Edition).


2. GB / t10586-2006.


3. "Guidelines for drug production validation" 2003 Edition


4. Operation manual of YWS drug stability test box.


Stability test conditions:


Storage conditions for stability test of long-term retention samples:


Temperature + 25 ℃± 2 ℃


Humidity: 60 ± 5% RH


Time: 12 months


Storage conditions for accelerated stability test:


Temperature: 40 ℃± 2 ℃


Humidity: 75 ± 5% RH


Time: 6 months


Under strong light condition, the illuminance is 4000 ± 500lux


The above data are for reference only.


Temperature and humidity control range diagram:


                       


3、 Specifications:

※  Under no-load condition, the performance parameters are as follows: ambient temperature 20 ℃, ambient humidity 50% RH.

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