Medical Device Sterilization

Electron beam (e-beam) irradiation is a versatile technique employing high-energy electrons for various applications. At PolarSeal, this method is harnessed to effectively manage the sterilization of medical devices, utilizing high-energy beams targeted at specific device areas, ensuring meticulous sterilization.

E-beam sterilization is suitable for most materials, with a limited decrease in penetration through denser substances.

PolarSeal possesses the capability to sterilize single-use medical devices and regulate package contamination, minimizing any potential damage to the device during the process.

The sterilization process using Ethylene Oxide involves the application of low-temperature gases to sterilize a diverse array of medical devices. Its ability to function at low temperatures facilitates its penetration into various single-use medical devices and flexible materials. This method ensures the sterilization of a wide range of materials without exposure to heat, moisture, or radiation.

PolarSeal specializes in determining the appropriate sterilization process for your device, taking into account factors such as thickness, packaging, and complexity. We can subject your advanced wound care dressings, fixation devices, and intricate assemblies to this vacuum-based sterilization process, ensuring optimal sterilization outcomes.

Gamma sterilization is commonly utilized for multi-layered devices comprising different materials with varying densities. This method’s high penetration levels make it particularly suitable for thicker, complex devices and packaged products.

The key advantage lies in the capability to deliver a specified dose to regions with higher density. Gamma sterilization is a dependable and highly efficient technique, effectively treating multiple complex devices, even those that are already packaged or pouched.

At PolarSeal, we can streamline your process by taking your pre-packaged medical device and subjecting it to our sterilization procedure, ensuring a hassle-free and market-ready solution.

• Accurate dosage identification through volume and thickness of material and packaging
• Dose mapping
• Process validation
• Gas sterilization for silicone based medical devices
• Bioburden testing
• Transit testing
• Real time aging and accelerated aging testing
• Regulatory assistance
• Final release
• Global warehousing and consignment stock