Does the in vitro diagnostic reagent business enterprise need to establish a cold storage?

If conditions permit, it is suggested to build a cold storage to store in vitro diagnostic reagents.

According to the performance and requirements of in vitro diagnostic reagents, the cold storage that can store in vitro diagnostic reagents are: normal temperature storage, cold storage and low temperature storage.

In addition, because the humidity and temperature of some in vitro reagents are different, the temperature and humidity of the warehouse should be set according to the actual situation.

The storage temperature of in vitro reagents is mostly stored in a cool drug warehouse, that is, the temperature range is 2℃~8℃.

A few varieties need to be stored at-65438 08℃.

Part of it can be stored at room temperature.

Engineering requirements of in vitro reagent refrigeration

For in vitro reagent refrigeration engineering, the following points should be paid attention to during construction:

(1) The location of the cold storage cannot be set in residential areas, and the cold storage is isolated from the office area and business premises;

② The in vitro reagent cold storage meets the requirements of GSP and GMP, and is equipped with automatic monitoring, control and humidity display devices;

③ The loading and unloading area should have corresponding weatherproof measures, such as canopy;

(4) Before the in vitro reagents are put into the cold storage, the cold storage is cooled, the equipment is tested and the cold storage is disinfected;

Brief introduction of in vitro reagents

In vitro diagnostic reagents refer to in vitro diagnostic reagents managed by medical devices, including reagents, kits, calibrators (substances) and quality control products (used for in vitro detection of human samples (various body fluids, cells, tissue samples, etc.). ) disease prevention, diagnosis, treatment monitoring, prognosis observation, health status assessment and genetic disease prediction in the process.