Sterilisation is a critical and final phase in medical device development — the last safeguard before a product reaches the patient. It ensures long-term safety and efficacy, but selecting the optimum process requires a deep understanding of product requirements, material compatibility, and packaging design. Navigating complex ISO standards, preserving device performance, and meticulously documenting each step can place a significant burden on your teams. The stakes are high — for regulatory compliance, operational efficiency, and most importantly, patient safety. Yet sterilisation validations are fundamental to gaining market approval.
Eurofins Sterile Packaging provides comprehensive sterilisation services using gamma radiation and ethylene oxide (EO), supported by our in-house EO sterilisation facilities and a network of accredited partners. Our sterilisation validations cover both biological and physical cycles, and are tailored to the chosen method. For gamma radiation, this includes bioburden examination, subdose irradiation, and sterility testing. For in-house ethylene oxide (EO) sterilisation, we carry out half cycles, sublethal cycles, physical cycles, and residual gas analyses. Our in-house ethylene oxide (EO) sterilisation facilities enable tighter control, faster turnaround times, and reduced risk. Where required, we also offer alternative methods such as steam and X-ray sterilisation through our external partners.
In compliance with ISO 11135, ISO 11137/ CFR820, our team performs full validation services including cycle development, process qualification, and batch release qualification using EO sterilisers (including 3M EO systems). Every validated process is documented, and a sterilisation certificate is issued with each delivery. Every step, from feasibility through to performance qualification, is managed by experts who understand regulatory expectations and how to meet them efficiently.
Our EO and gamma validation capabilities include:
- Bioburden examination
- Subdose irradiation
- Sterility testing
- Half cycles and sublethal cycles
- Residual gas analysis
- Full validation qualification reports
- Product validation support
- Validation for process or product changes
- Pre-conditioning and aeration qualification (US)
- PCD (Process Challenge Device) qualification
We also conduct EO exposure testing on packaged products for validation, verification, and R&D purposes, ensuring compatibility with biocompatibility and functionality requirements. Sterilisation programmes are further supported by essential microbiological testing. Endotoxin testing, detects bacterial endotoxins following EO sterilisation and quantifies any residual sterilising agents to confirm safety prior to release.
