Journal of Radiation Research and Radiation Proces ›› 2015, Vol. 33 ›› Issue (2): 20501-020501.

### Research on sterilization dose setting of bioburden using maximum dose slope method

GONG Pin  TANG Xiaobin  CHEN Da

1. (Department of Nuclear Science and Engineering, Nanjing University of Aeronautics & Astronautics, Nanjing 210016, China)
• Received:2014-10-28 Revised:2014-11-28 Online:2015-04-20 Published:2015-01-21

Abstract:

In this paper, coordinate of log-reduction(LR) is selected to solve the problem of radiation sterilization dose setting of bioburden for non health care products. Bioburden having standard distribution resistances(SDR) is used to perform the calculations. “D10 values” of bioburden are fitted according to traditional method from data of total 56 experimental dose selection plans with dose range from 0-1 to 0-20kGy and dose interval from 1 to 10kGy. Afterwards, the corresponding sterilization dose curves under the coordinate of log-reduction are calculated. The calculations show that the effective range of sterilization dose set by traditional method is LR≤LRmax, and LRmax is LR value corresponding to maximum dose(Dmax) in the incremental dose experiment. Within this effective range, the sterilization dose of bioburden set by the slope of maximum dose(Dmax / LRmax) is much closer to the theoretical value than that by “D10 value” of bioburden. Usage of maximum dose slope method could reduce the number of experiments significantly and the sterilization dose of bioburden is more accurate that can reduce the unnecessary radiation dose compared with traditional method. The maximum dose slope method is a great improvement on traditional method.

CLC Number:

• TL99