Review of GMP Standard Requirements in Cold Chain Storage of Biological Products

Continuous Temperature Monitoring Protocols and Smart Systems

Plasma-derived drugs, due to their protein origin, lose their therapeutic efficacy if they exceed the 2 to 8 degrees Celsius temperature range. nojine’s smart cold chain storage is equipped with online temperature and humidity monitoring sensors with real-time alert algorithms that monitor the physical stability of the chain 24 hours a day.

Any minor temperature deviation in cold chain storage can lead to an alteration in the spatial structure of antibodies and a loss of their therapeutic efficacy.

Storage Process Validation Systems

Periodic validation of cold rooms and industrial refrigerators, as well as risk assessment of drug transportation routes, are conducted based on international GDP standards. This ensures product integrity from the factory warehouse to reference hospital pharmacies.