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.

Automated summary

Nowadays, sterilization methods for disposable medical devices have drawbacks in terms of safety, energy consumption, and costs. This study presents a sterilization method using indirect nonthermal plasma treatment, which has advantages in terms of low environmental impact and backward compatibility. The method utilizes reactive species produced by a plasma reactor to achieve sterilization of devices enclosed in protective packaging. Complete sterilization was achieved for various devices using USP and EU-PHARMA protocols, with the need for pretreatment of carton packaging.