model:GL-F-0000A-P
Meets standards: The 2010 edition of the Pharmacopoeia provides guidelines for drug stability testing, the EU ICH Pharmacopoeia, and manufacturing provisions related to GB/T10586-2006, which comply with domestic GMP and European and American FDA requirements.
Storage conditions for long-term stability testing of retained samples:
Temperature:+25 ℃± 2 ℃
Humidity: 60+5% RH
Time: 12 months
Meet the storage conditions for accelerated stability testing:
Temperature:+40 ℃± 2 ℃
Humidity: 75+5% RH
Time: 6 months
Strong light irradiation conditions: Illumination level: 4500+500LX
characteristic:
1. Adopting internationally renowned imported compressors to ensure long-term continuous operation of drug testing without any malfunctions, breaking through the defect of domestic drug testing chambers being unable to operate continuously for a long time.
2. Key components such as temperature and humidity controllers, sensors, and circulating fans are all imported and have the characteristics of long-term stable operation, safety, and reliability.
3. The independent temperature limit alarm system can provide sound and light alarms to alert the operator, ensuring that the laboratory operates smoothly without any accidents.
4. An independent data printing system that can print temperature and humidity data in real-time, facilitating the retention of GMP data for analysis.
We can provide 3Q validation 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 a wireless communication alarm system (SMS alarm system). When the device encounters an abnormality, the system promptly collects the fault signal and sends it to the designated recipient's mobile phone via SMS, ensuring timely troubleshooting, recovery testing, and avoiding losses.
22
