A new method for controlling radiation sterilisation.
A new statistical process control method for gamma and electron-beam sterilisation processes has been established to meet new requirements to take measurement uncertainty into account when product is released. The method, outlined here, uses probability-based data to determine the appropriate target dose for each type of product and thereby avoid unnecessary product rejections.
D001610:Beta Particles; D002138:Calibration; D004866:Equipment Contamination / Q000517:prevention & control; D005720:Gamma Rays; D017408:Guidelines as Topic; D006801:Humans; D007390:International Agencies; D007391:International Cooperation; D015233:Models, Statistical; D011786:Quality Control; D011829:Radiation Dosage; D013242:Sterilization / Q000379:methods / Q000592:standards*; D035501:Uncertainty