Risk assement of irradiation Chondroitin materials

There are some risk factors in irradiation chondroitin materials as follows:

1. In China, the irraidaiton orgin is strictly regulated by government. So if irradiation process is used, the materials should be shipped into the specified company and it means the materials is out of cGMP control of the manufactures including the facility environment, irradiation procedure, dose and time and so on.

2. From cGMP perspective, irradiation is one of contamination source.

3. Residual irradiation is a risk factor to health, especially when the whole procedure cannot conform to the FDA regulation.

4. Mutation of microorganism is a potential risk factor to health because the irradiation is a main method to let microorganism mutate.

5. Irradiation maybe make some changes (reduction or destruction) in the package materials and release some hazard substance that were not originally present and requires the strict control of radiation levels.