The medical device market is increasingly dominated by single-use sterile products. Even industries that traditionally offered non-sterile devices for hospital autoclaving, like orthopedics and dental, are shifting to sterile packaging. Outsourced sterilization provides advantages such as safety, traceability, and convenience.
Popular sterilization methods include:
- Gamma irradiation
- Ethylene Oxide (ETO)
- X-ray
- E-beam
- Steam
Irradiation sterilization methods (Gamma, X-ray, E-beam) ensure full penetration of the final packed device without limitations on packaging. For materials that may change properties after irradiation, Ethylene Oxide gas sterilization is used, which requires permeable packaging and additional testing for residuals.
While CTL Biotec does not handle the sterilization process in-house, they collaborate closely with professional external sterilization labs. CTL Biotec manages and validates all sterilization processes externally, ensuring that all work aligns with the client’s requirements and regulatory standards. They provide comprehensive documentation to ensure regulatory compliance and safety.
CTL Biotec’s sterilization service offerings include:
- Sourcing cost-effective packaging materials compatible with chosen sterilization methods
- Coordinating and validating the sterilization process through external partners
- Managing routine post-sterilization batch releases