Compatibility of Polyvinyl Chloride (PVC) Medical Devices and Other Polymeric Materials with Reactive Ion Etching (RIE) and Inductively Couple Plasma (ICP) Sterilization Using a Quality by Design (QbD) Approach

Purpose The sterilization process for medical devices is an important step due to microbiological quality requirements of polymeric products. Irradiation and ethylene oxide sterilizations, traditional techniques, may compromise safety and efficacy of medical devices due to oxidation/alkylation or due to the presence of residues in polymeric materials. Alternatively, reactive Ion etching (RIE) and inductively coupled plasma (ICP) may be used for this purpose; however, the compatibility of polymeric materials with these processes and their lethality must be addressed.