Drug comprehensive stability test box

Product Name:Drug comprehensive stability test box

Product model: XT5418-DPC275

Key features:

1. Effective workspace from 2m2 to 1000m2.

2. Temperature range of 10~65 ° C, humidity range of 40~95% RH, fluctuation of 10.2 ° C, and soil 3% RH.

3. Meet the test procedures of ICH2003Q1A (R2)/Q1B and CP2010 "Technical Guidelines for Stability Research of Chemical Drugs": high temperature face test and high humidity test, accelerated face test, face test, and strong light irradiation test.

4. Depending on the site conditions, ultra-high energy efficiency geothermal heat pump systems or forced air cooling heat pump systems can be selected.

5. Depending on the site conditions, high-energy efficiency capillary radiation end or air duct ventilation end can be selected.

6. Stepper motor control hot air bypass cooling capacity control technology and dynamic precision constant temperature and humidity control system ensure long-term uninterrupted reliable operation and stable temperature and humidity conditions.

7. Instant heating type electric steam humidification device, prevents condensation and dry burning, automatically maintains liquid level balance in the inlet well, ensures stable humidification capacity and long-term uninterrupted reliable operation.

8.7-inch high-resolution touch screen true color multifunctional operation display panel, providing multiple display modes such as graphics, curves, Chinese and English, easy to operate, and clear display of box temperature, humidity, and radiation. Program running data, alarm history, and other instrument operating status.

9. An alarm and recording system that meets GMP, cGMP, GLP, and GSP requirements, including multiple communication recording methods such as email and short message alarms.

10. Provide IQ.0Q and PQ services, calibration and material certification certificates, installation and operation. Maintenance and service manuals, drawings related to on-site wiring, refrigeration, structural installation, etc.

11. Optional backup power supply, refrigeration system, and humidification system.

12. Optional low temperature of 6 ° C and low humidity of 20% RH.

13. Optional visible light and UVA light boxes, sensors, etc. that meet ICHQ1B requirements for continuous exposure measurement and control.

14. Optional data acquisition, transmission, and analysis systems that meet the requirements of FDACFR21 Part 11. Electronic data and electronic signatures that meet the requirements and cannot be changed.

15. Optional fresh air device and air filtration and purification device can be used to improve the working environment of the laboratory.

16. Optional USB and Ethernet interfaces for convenient data download and remote monitoring.

17. Optional auxiliary systems such as sample racks, sample partitions and trays, water supply devices, purified water devices, and drainage devices.

18. Products and engineering that meet the safety requirements of climate and environmental testing equipment in IEC61010-1 and IEC61010-2-012, as well as the EMC requirements of laboratory electrical equipment in 1EC61326-1. Especially suitable for the European and North American markets.

　　Drug comprehensive stability test boxTechnical parameters: