Drug stability testing box

Drug stability testing boxAdopting the German temperature and humidity control system and intelligent control software, it can provide a stable temperature and humidity environment, simulate various climate conditions, and is very suitable for conducting drug stability tests and long-term tests in accordance with ICH guidelines. It can meet the durability and photostability test requirements specified in ICH, FDA, GMP, and GLP standards. The ultra large capacity system storage meets the temperature and humidity requirements in test data, event data, and file management records.

Drug stability testing boxMeet the standards:

1. Meet the new guidelines for drug stability testing

2. Long term test: 25 ℃± 2 ℃/60% RH ± 5% RH, or 30 ℃± 2 ℃/65% RH ± 5% RH (stored for 12 months)

3. Accelerated test: 40 ℃± 2 ℃/75% RH ± 5% RH, or 30 ℃± 2 ℃/65% RH ± 5% RH (stored for 6 months)

4. Strong light irradiation test: 4500 ± 500LX (placed for 10 days)

5. Meet the irradiation test requirements of Q1B in ICH; Total illumination ≥ 1.2 * 10 ^ 6LUX. hr

6.近紫外能量≥200W.hr/㎡

7. Light and UV amplitude tests can be completed simultaneously

Drug stability testing boxProduct Features:

1. Electronic PID control, programmable multi-stage settings.

2. Intelligent operating system, high-performance processor, simple and user-friendly operation.

3. Adopting a true color LCD touch screen and an easy to understand menu operation guide.

4. Data recording and storage function, capable of storing experimental data for 3 years (recorded once per minute). The original data can be exported through an Up drive and cannot be modified.

5. Historical temperature and humidity data or real-time curves (from the past 8-10 hours) can be viewed.

6. Audit tracking function, which can store 16000 operation and alarm logs, and store the data in the system. It can be exported through a USB flash drive and cannot be modified for traceability.

7. Permission management, administrators can create five users and assign different permissions.

8. It has multi-point temperature correction function to avoid linear mismatch of multi-point temperatures.

9. Adopting the brand Danfoss (SECOP) compressor and German EBM condensing fan, environmentally friendly refrigerant.

10. Variable frequency refrigeration system, saves energy consumption, has small temperature and humidity fluctuations, and quickly recovers when opening the door.

11. Capacitive humidity sensor, accurate and reliable, no maintenance required.

12. The insulation material of the box adopts polyurethane integral one-time foaming technology, which scientifically and effectively improves the insulation performance and overall strength of the box, saving more than 40% energy consumption compared to similar products.

13. The right side of the box is equipped with a silicone plug inlet with a diameter of 50mm.

14. The design of the double door structure includes tempered glass for the inner door, which allows for observation of the testing conditions inside the studio.

15. The box is reserved with standard communication interfaces USB, RS485, RS232, which can be integrated into the EMS system.

16. Chinese English menu switching function.