Selecting a sterilisation subcontractor.
Medical device manufacturers who need contract sterilisation services sometimes lack extensive knowledge of the technical aspects of sterilisation processes. For this reason, they may have problems assessing quality requirements for subcontractor sterilisation services. This article discusses important quality issues that should be considered when selecting a sterilisation subcontractor.
Donawa
M
M
Donawa & Associates Ltd. donawa@srd.it www.donawa.com
D002568:Certification; D003284:Contract Services / Q000191:economics / Q000592:standards*; D004866:Equipment Contamination / Q000517:prevention & control; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000382:microbiology / Q000592:standards*; D005060:Europe; D006801:Humans; D015397:Program Evaluation; D012680:Sensitivity and Specificity; D013242:Sterilization / Q000191:economics / Q000379:methods / Q000458:organization & administration* / Q000592:standards; D014481:United States