Validation of an indirect nonthermal plasma sterilization process for disposable medical devices packed in blisters and cartons

Nowadays, the majority of the processes used to sterilize disposable medical devices have several drawbacks in terms of safety, energy consumption, and costs. In this work, a sterilization method based on an indirect nonthermal plasma treatment is presented. The main advantages of this method are low environmental impact, absence of harmful chemical compounds' storage, and backward compatibility relative to production, sterilization, and shipping chain. The sterilization of disposable devices, enclosed inside their protective packaging, is achieved by exploiting reactive species produced by a Dielectric Barrier Discharge plasma reactor. Various devices have been subjected to a 2-h treatment, achieving complete sterilization based on USP and EU-PHARMA protocols. Pretreatment of carton packaging has been necessary to guarantee a complete sterilization process.