Experiences with microbiological validation of radiation sterilisation.
Apart from process control, the two most critical activities associated with radiation sterilisation of medical devices are the dosimetric and microbiological analyses required to validate the process. This article discusses some of the problems experienced in the field of microbiological validation and highlights the coming changes to the standards.
Harries
John
J
Isotron plc, Elgin Industrial Estate, Moray Road, Swindon SN2 8XS, UK. johnh@isotron.co.uk
D015169:Colony Count, Microbial; D004866:Equipment Contamination / Q000191:economics / Q000517:prevention & control*; D011839:Radiation, Ionizing; D013242:Sterilization / Q000191:economics / Q000379:methods*; D006113:United Kingdom