Practical experience of microbiological validation of sterilisation.
The addition of the VDmax method provides manufacturers with a choice of three microbiological validation methods to substantiate a 25 kGy sterilisation dose. This article reports on experiences of applying these methods and suggests ways to handle difficult products.
Harries
John
J
Isotron plc, Swindon, UK. john.harries@isotron.com
D015169:Colony Count, Microbial / Q000379:methods / Q000592:standards; D004583:Electrons; D004866:Equipment Contamination / Q000331:legislation & jurisprudence / Q000517:prevention & control*; D004864:Equipment and Supplies / Q000382:microbiology / Q000592:standards; D005062:European Union; D005720:Gamma Rays; D019983:Guideline Adherence / Q000331:legislation & jurisprudence / Q000592:standards; D007391:International Cooperation; D007928:Lethal Dose 50; D011829:Radiation Dosage; D011839:Radiation, Ionizing; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013242:Sterilization / Q000191:economics / Q000379:methods* / Q000592:standards*