Instrument introduction:

A new generation of drug stability testing equipment, integrating the company's many years of design and production experience, and introducing and digesting German technology. Break through the defect that the existing domestic drug test chamber cannot operate continuously for a long time is a pharmaceutical factory GMP A must-have device for certification.

Usage overview: 

Using scientific methods to create a temperature, humidity and light environment that requires a long-term stable evaluation of drug failure. It is suitable for accelerated tests, long-term tests, high humidity tests and strong light irradiation tests by pharmaceutical companies. It is the best choice for pharmaceutical companies to conduct drug stability tests. Features:

◆ Humanized design 

● The new fluorine-free design has high efficiency, low energy consumption, and promotes energy conservation, so that you can always be at the forefront of a healthy life.

● The microcomputer controller has stable, accurate and reliable control. It uses a 304 stainless steel inner liner with four corners and semicircular arc shape, which is easy to clean and easy to operate.  

● Unique air duct circulation ensures even wind power distribution in the studio. There is a diameter of 25 on the left side of the box mm test hole.

◆ Continuous operation guarantee 

● The two sets of imported compressors automatically switch to ensure that the drug tests will not fail for a long period of continuous operation. Break through the defect that domestic drug test chambers cannot operate continuously for a long time.

● There is no need to defrost during continuous operation, avoiding the temperature and humidity fluctuations in the box during use.

◆ Quality assurance 

● Key components such as temperature and humidity controllers, compressors, and circulating fans are all imported products, and have the characteristics of stable, safe and reliable operation for a long time.

◆ Safety features 

● Independent temperature limit alarm system, it can alert the operator to the sound and light alarm to ensure that the laboratory operates safely without accidents.

● Low or high temperature and overtemperature alarms, high and low humidity alarms.

◆ Imported humidity sensor 

● Choose a humidity sensor that can operate in a high temperature state to avoid the troubles caused by frequent replacement of dry and wet bulb wet belts.

◆ UV sterilization system (optional) 

● The ultraviolet sterilization lamp is placed on the back wall of the box, which can regularly disinfect the inside of the box, which can effectively kill the floating sterilization of air circulating in the box and the steam of the humidified plate, thereby effectively preventing contamination during drug testing.

◆ Automatic monitoring and control of illuminance (optional) 

● Break through the defect that the light illumination cannot be monitored and controlled by the existing domestic stable test chamber, use light sensors for monitoring and are steplessly adjustable, reducing the light illumination attenuation and test errors caused by the aging of the lamp.

◆ Data records and fault diagnosis display 

● When the test chamber fails, the dynamic display screen will have fault information, and the test chamber operation failure will be clear at a glance.

● It can be connected to the printer or 485 communication interface, and the temperature and time curve can be recorded using the computer and printer, providing a strong guarantee for the storage and playback of the test process.

Programmable touch screen controller (Selection ) 

● It adopts an ultra-large screen touch screen, making the screen operation simple and program editing easy.

● The controller operation interface is available in Chinese and English, and the real-time operation curve can be displayed on the screen.

● It has a capacity of 100 sets of programs with a 999 cycle step, and the maximum value is set to 99 hours and 59 minutes per period.

● After inputting data and test conditions, the controller has a screen lock function to avoid shutdown due to human touch.

● have P.I.D Automatic calculation function can immediately correct the temperature and humidity changes, making the temperature and humidity control more accurate and stable.

● have RS-232 or RS-485 Communication interface, which can design programs on the computer, monitor the test process and perform functions such as power switches.

Implement and meet standards: 

2010The Guidelines for Drug Stability Test of Pharmacopoeia and GB/T10586-2006 Related terms and conditions

★Stability test conditions: 

exist ICH In the guide, in terms of functionality, performance and documentation, GMP and FDA Define requirements. Europe, Japan and the United States

Agree to develop a common stability test, which aims to collect information as a formulation of a related material or

Recommended drug stability, the ultimate goal is to prove that drug exposure to temperature, humidity, light or comprehensive in a specified period

Effectiveness in the environment.

★Storage conditions for long-term sample retention test: 

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

High light illuminance: 4500 ±500LX

※The above relevant data is for reference only

Technical parameters:

Provide 3 Q Verification and calibration services:

※Can provide customers with IQ(Installation confirmation )、OQ(Run Confirm )、PQ(Performance confirmation )A series of services such as this ensure the performance and indicator requirements of the drug box. The long-term stability deviation of temperature and humidity signal acquisition in the drug box is relatively large, so calibration must be carried out to ensure the long-term accuracy of temperature and humidity data and meet the production process requirements.

※Can provide third-party test reports of Shanghai's authoritative metrology department ( RMB2500 ) Optional

Optional purchase: (Increase the delivery time of optional parts for 7 days )