Medical Device

Most widely used medical device materials handle typical E-Beam sterilization doses very well. PEEK, polycarbonate, TPU, silicones, polyethylene, and polypropylene are commonly processed with no loss of function. Adhesives, coatings, elastomers, and colorants vary more, so a quick max dose study is the fastest way to confirm performance at your required dose. Many MedTech devices transition from Gamma or EO to E-Beam with no packaging or material changes. Check out our Material Compatibility Chart for more detailed info on many materials.

Yes. Electron beam sterilization is designed specifically for the final packaged product. Devices in Tyvek pouches, thermoformed trays, cartons, or multi unit kits can be sterilized in their finished packaging. Penetration depends on geometry and density, which is why dose mapping is performed early to confirm that your final pack receives the required minimum dose throughout the load.

Both Gamma and E-Beam are radiation sterilization methods described under ISO 11137, so most 510(k)-approved devices can transition with a technical justification supported by dose mapping, material evaluation, and a verification dose audit. EO to E-Beam transitions typically require new validation under ISO 11137 since the sterilization mechanisms differ. The level of regulatory submission depends on device classification and claim language, but many companies complete the transition without a full resubmission. For more guidance on rapid switches for FDA 510(k)-approved devices, we reference a FDA flowchart describing the process.

Often yes. If multiple SKUs share similar materials, geometries, packaging formats, and dose requirements, they can often be grouped into a single validation family. Dose mapping and bioburden data determine whether SKUs can be bracketed together. This approach can significantly reduce time and cost for kit based or high SKU count portfolios. At NextBeam, we will create product “families” whenever possible for our clients to offer increased processing flexibility and reduced validation costs.