We support industry-accepted sterilization methods, selected based on material compatibility, product design, and regulatory requirements: 

• Gamma Sterilization (SAL 10⁻⁶ | ISO 11137 Compliant) – Validated Gamma sterilization programs achieving a Sterility Assurance Level (SAL) of 10⁻⁶, in alignment with ISO 11137, the international standard for the development, validation, and routine control of radiation sterilization processes.
• Ethylene Oxide (EtO) Sterilization – Suitable for complex assemblies and temperature-sensitive materials, with validated cycles and controlled processing tomaintainmaterial performance and product functionality.
• Validated Third-Party Sterilization Management – End-to-end coordination of qualified sterilization partners, including cycle validation, documentation control, batch release, and full traceability, ensuring regulatory alignment and supply chain continuity.