Sterilisation

Single use sterile medical devices are dominating the medical device market. Even some legacy industries, such as orthopedic or dental that were providing non-sterile devices to be autoclaved in hospitals, have changed into sterile packing. Externalized sterilization provides multiple advantages starting from safety and detailed traceability to ease of use and convenience for the final user. Most popular sterilization methods that are outsourced to specialized companies are:

•  Gamma irradiation
•  Ethylene Oxide (ETO)
•  X-ray
•  E-beam
•  Steam

Sterilization by irradiation (Gamma, X-ray, E-beam) enables full penetration of the finally packed device without any limitations on the final packaging. As some materials (especially plastic) can change properties after irradiation they are subjected to different sterilization method using gas – by Ethylene Oxide which requires permeable packaging materials and additional testing during validation for residuals after sterilization.

Customer projects can be half-way through their lifecycle when they are externalized and set up at an outsourced partner. It is worth making sure the new supplier takes over the validated cycle and existing sterilization solution to ensure a complete, safe and regulatory compliant process is provided.

SteriPack has the capability to coordinate all relevant quality assurance tests and provide the documentation needed to complete validation of the sterilization management for medical devices. SteriPack has an on-site independent ISO 17025 accredited microbiological lab, which provides test method validations as well as routine tests for bioburden, sterility and endotoxin testing.

We offer a 360-degree approach to the sterilization process and have the flexibility to work with a customer’s existing partner. SteriPack has more than two decades experience in managing, implementing and executing sterilization validation and the routine sterilization process for medical devices. Throughout our experience we have validated all sterilization methods.

Interdisciplinary knowledge from various therapeutic areas enables us to recommend the most suitable sterilization method and recommend the right external sterilization house. Within SteriPack’s services we offer:

•  Recommendation of the most suited sterilization method for a specified device
•  Cost-effective packaging materials that are compatible with a chosen sterilization method
•  Sterilization validation and routine post-sterilization releases of the batches