Why should disposable reservoirs be irradiated?

The purpose of radiation sterilization is to achieve product sterility assurance, the current disposable reservoir radiation sterilization using the γ rays generated by CO60 for radiation sterilization, the ray has penetrating power, many products have obvious color changes after irradiation, such as obvious yellowing, and produce obvious odor
.
Radiation increases the high polymer content
of the reservoir product migrating to the contact solution.
The sterility of disposable reservoirs is guaranteed to be a visible apparent risk, while leachate migration is a hidden risk
.
Why do you say that? Although everyone in this industry is doing extractable/leachable research, to be honest, many of the technical research reports reviewed by companies in this area have basically not found a really understandable safety evaluation
.
There are mainly the following reasons for this situation: 1.
Leachate research is expensive, even commercial production enterprises, can not do leachate research
on all disposable products in the production process.
2.
Lack of recognized evaluation methods and evaluation standards
in the industry.
For the above reasons, many companies use the extractable data of manufacturers or the extract data of some disposable products in the production process of their own research for isolated evaluation, so it is very one-sided conclusion
.
In addition, the final product inspection of biological products generally does not carry out the test of the polymer content of one-time product migration, so the obvious risk of sterility assurance is identifiable, mainly involving the problem of cost loss, while the leachate content is a hidden risk
that is not easy to identify and difficult to evaluate.
Therefore, in this context, it is called on disposable liquid storage bag manufacturers to stand at a higher height, and reasonably adjust the irradiation dose according to the difference in the bioburden of the reservoir on the basis of ensuring the sterility of the product, so as to achieve better control of the safety
of biological products from the source.