Application of statistical process control in medical devices quality control of electron beam irradiation sterilization

The irradiation sterilization process for medical devices must ensure that the maximum and minimum accepted doses for medical devices are between the maximum acceptable dose and the sterilization dose of the product. To ensure that the absorbed dose for each batch of medical devices meets the requirements, dose monitoring of the effect of each irradiation sterilization batch is required. This study adopts the statistical process control method to analyze monitored dose values and provides scientific quality management methods for medical device manufacturers and irradiation sterilization providers. The results show that the application of statistical process control methods can help to find abnormal fluctuations in time and to control the sterilization process to a stable state, thereby ensuring that the quality of medical device products is stable and reliable, as well as enhancing the predictability of quality management. (authors)