Drug Delivery Device Design and Compatibility with Nitrogen Dioxide Gas Sterilization

Area of Science:

• Materials Science
• Polymer Chemistry
• Medical Device Sterilization

Background:

• Polymeric materials are crucial for prefilled syringes, drug delivery systems, and medical devices.
• Terminal sterilization using nitrogen dioxide (NO2) gas is employed for these systems.
• Material compatibility is essential to ensure product integrity and specifications post-sterilization and throughout shelf life.

Purpose of the Study:

• To evaluate the compatibility of commonly used polymers with NO2 sterilization.
• To understand the chemical reactions occurring between NO2 and polymers at sterilization conditions.
• To provide data for selecting appropriate materials for NO2-sterilized medical devices.

Main Methods:

• Selection of polymers based on chemical structures relevant to medical devices.
• Exposure of selected polymers to NO2 sterilization process.
• Comprehensive evaluation of materials for chemical, mechanical, and biocompatibility properties post-exposure.

Main Results:

• Polymers containing carbonyl, unsaturated ester, and ketone groups demonstrated compatibility with NO2 sterilization.
• Amorphous Polyester, Polysulfone (PSU), Polycarbonate (PC), PolyEtherEtherKetone (PEEK), PolyArylEtherKetone (PAEK), and Polypropylene (PP) showed no significant changes after NO2 treatment at 20°C.
• Low sterilization temperatures (20°C) minimize NO2 reactions with polymers due to activation energy requirements.

Conclusions:

• Material compatibility with NO2 sterilization varies and requires specific evaluation.
• The study provides crucial guidance for device designers and regulators on material selection for NO2-sterilized drug delivery devices.
• Pre-validation of polymer compatibility is necessary before implementing NO2 sterilization for new medical devices.