Instrument Introduction:

The new generation of drug stability testing equipment integrates the company's years of design and production experience, and introduces and digests German technology. Breaking through the defect of existing domestic drug testing chambers that cannot operate continuously for a long time is an essential equipment for pharmaceutical GMP certification.

Usage Overview:

Creating a long-term stable temperature, humidity, and lighting environment for drug failure evaluation using scientific methods is suitable for pharmaceutical companies to conduct accelerated, long-term, high humidity, and strong light irradiation tests on drugs and new drugs. It is the best choice for pharmaceutical companies to conduct drug stability tests. Product features:

◆ user-friendly design

● The brand new fluorine free design ensures high efficiency, low energy consumption, and promotes energy conservation, keeping you at the forefront of a healthy lifestyle.

● Microcomputer controller, stable, accurate, and reliable control, using 304 stainless steel inner liner, four corner semi-circular arc shape, easy to clean,Easy to operate.

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

◆ Continuous operation guarantee

● Two sets of imported compressors automatically switch to ensure that drug testing runs continuously for a long time without any malfunctions. Breakthrough the defect of domestic drug testing chambers being unable to operate continuously for a long time.

● Continuous operation does not require defrosting, avoiding temperature and humidity fluctuations inside the box during use due to defrosting.

◆ quality assurance

● The key components such as temperature and humidity controllers, compressors, and circulating fans are all imported products, which have the characteristics of long-term stable operation, safety, and reliability.

◆ Safety function

● The independent temperature limiting alarm system can provide sound and light alarms to alert the operator, ensuring safe operation of the laboratory without any accidents.

● Alarm for low or high temperature and over temperature, alarm for high or low humidity.

◆ Imported humidity sensor

● Choose a humidity sensor that can operate at high temperatures to avoid the hassle of frequent replacement of wet and dry bulb bands.

◆ 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 and effectively kill floating bacteria in the circulating air and humidification tray water vapor inside the box, thereby effectively preventing contamination during drug testing.

◆ Automatic monitoring and control of illuminance (optional)

● Breaking through the defect of the inability to monitor and control the illumination of existing domestic stable test chambers, a light sensor is used for monitoring and continuously adjustable, reducing the attenuation of illumination and test errors caused by the aging of the lamp tube.

◆ Data recording and fault diagnosis display

● When the test box malfunctions, the dynamic display screen will show fault information, and the operational faults of the test box will be clear at a glance.

● It can be connected to a printer or 485 communication interface to record temperature and time curves using a computer and printer, providing strong guarantees for data storage and playback during the experimental process.

Programmable touch screen controller (optional)

● Adopting a large touch screen display, the screen operation is simple and the program editing is easy.

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

● It has a capacity of 100 sets of programs, 1000 segments, and 999 loop steps, with a maximum time setting of 99 hours and 59 minutes per segment.

● After inputting the data and experimental conditions, the controller has a screen lock function to avoid manual touch and shutdown.

● Equipped with P.I.D automatic calculation function, it can immediately correct temperature and humidity changes, making temperature and humidity control more accurate and stable.

● Equipped with RS-232 or RS-485 communication interface, it can be programmed on a computer to monitor the testing process and perform functions such as power on/off.

Execution and compliance with standards:

Guidelines for Drug Stability Testing in the 2010 Pharmacopoeia and Relevant Provisions of GB/T10586-2006 for Manufacturing

★Stability test conditions:

In the ICH guidelines, GMP and FDA define requirements in terms of functionality, performance, and documentation. Europe, Japan, and the United States

Agree to develop a shared stability test with the goal of gathering information as a basis for developing a study on raw materials or

The ultimate goal of recommending drug stability is to demonstrate that the drug is exposed to temperature, humidity, light, or a combination of factors within a specified period of time

Effectiveness in the environment.

★Storage conditions for long-term stability testing of retained samples:

Temperature:+25 ℃± 2 ℃

Humidity: 60 ± 5% RH

Time: 12 months

★Storage conditions for accelerated stability testing

Temperature:+40 ℃± 2 ℃

Humidity: 75 ± 5% RH

Time: 6 months

Strong light irradiation conditions: Illumination level: 4500 ± 500LX

Provide 3Q verification and calibration services:

We can provide customers with a series of services such as IQ (installation confirmation), OQ (operation confirmation), PQ (performance confirmation), etc. to ensure the performance and indicator requirements of the drug box. The long-term stability deviation of temperature and humidity signal acquisition for drug boxes is relatively large, so calibration is necessary to ensure the long-term accuracy of temperature and humidity data and meet production process requirements.

※ We can provide third-party testing reports from authoritative metrology departments in Shanghai (RMB 2500) for optional selection

Optional items: (Increase delivery time for optional items by 7 days)