Pharmaceutical Comprehensive Light Stability Test Chamber

- Achievable temperature range: -10°C to 100°C, humidity range: 10%RH to 95%RH

- 5-level automatic defrost function, stable temperature and humidity without fluctuation, meets GMP and FDA requirements for frost-free operation (above 20°C)

- Manual defrost function

- Logging, audit trail function, and export function (USB encrypted export or host computer serial port export)

- Adjustable wind speed control function

- Illuminance and ultraviolet light intensity total control function (based on pharmacopoeia requirements: 1.2 million LUX strong light and near-ultraviolet light total control of 200 W·hr/m²)

- Electronic signature function that meets FDA requirements, ensuring more objective test data

- Real-time data recording and export function (USB encrypted export or host computer serial port export)

- Fault monitoring, alarm, recording, and export function (USB encrypted export or host computer serial port export)

- 4-level password function: login password, operator password, administrator password, senior administrator password

- Three power failure mode selection functions: power recovery, stop, or restart

- Historical data and historical curve query and download function

- Supports expansion up to 32GB TF storage card, capable of storing data for at least 10 years;

- Ambient temperature detection function

- PDF data export function (exported via host computer software)

- Host computer software monitoring and synchronous control function, supports control of up to 32 devices simultaneously.

- Network function, enables remote monitoring.

- Mobile APP remote monitoring function.

- GPRS SMS alarm function

- Water level monitoring and automatic water replenishment function

- Communication code provided for integration with pharmaceutical enterprise comprehensive equipment management platform

Lighting System:

Meets ICH (Q1A and Q1B) guidelines and the national pharmacopoeia drug stability testing guidelines.

Visible light (VS) D65 light source, 4500±500 lux, near-ultraviolet light (UV) with wavelength of 320~400nm; adjustable light intensity, light and ultraviolet radiation tests can be completed simultaneously.

Visible Light/Ultraviolet Light Detection Sensor:

Computer Monitoring Software

Optional computer monitoring software,设备兼容药企综合设备管理平台的数据接口，能够提供审查要求的数据接入，审计跟踪和电子签名

Temperature and Humidity Range:

Complies with pharmacopoeia drug stability testing guidelines: 40°C/75%RH or 30°C/60%RH for 180 days

25°C/60%RH or 30°C/60%RH for 365 days

Easy to Operate and Use: