Problems associated with microbiological validation of sterilization by ionizing radiation.
Potential solutions to some of the practical problems experienced when validating products processed by radiation sterilization are discussed in this article. The standards for validation and routine control of radiation sterilization are to be revised next year and there is now an opportunity for the industry to influence the effectiveness of those revisions. Medical device manufacturers are encouraged to make views known to help ensure a simpler standard that is widely implemented.
Harries
J E
JE
Isotron, Elgin Industrial Estate, Swindon, UK.
D001419:Bacteria / Q000528:radiation effects; D003365:Costs and Cost Analysis; D004307:Dose-Response Relationship, Radiation; D004866:Equipment Contamination / Q000517:prevention & control*; D011356:Product Labeling; D011785:Quality Assurance, Health Care; D011829:Radiation Dosage; D011839:Radiation, Ionizing; D011874:Radiometry / Q000191:economics; D015203:Reproducibility of Results; D013242:Sterilization / Q000379:methods* / Q000592:standards