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Ethylene Oxide (EO) Sterilization
EO remains a gold standard for sterilizing complex medical devices, especially those with narrow lumens or heat-sensitive materials.
We support you with:
- Execution of sterilization validations inhouse or with your contract sterilizer
- Performance Qualification (PQ) and routine monitoring strategy
- EO residuals testing & interpretation (ISO 10993-7)
- Cycle optimization & troubleshooting
- Audit preparation and gap closure
- Parametric release
- Project management
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Our goal: precise, compliant and efficient EO sterilization with minimal downtime and maximum product safety.
Radiation Sterilization (Gamma & E-Beam)
Radiation sterilization is ideal for high-volume products and polymer-based materials.
We offer consulting for:
- Execution of sterilization validations inhouse or with your contract sterilizer
- Validation according to ISO 11137
- Bioburden method setup and dose mapping
- Dose audit preparation and control
- Dose establishment (VDmax or Method 1)
- Regulatory documentation and justification
​We help ensure robust, scientifically justified radiation sterilization across the product lifecycle.
Steam Sterilization (Moist Heat)
Steam sterilization is the most established method for reusable and some single-use devices.
We assist in:
- Validation and routine control in line with ISO 17665
- Load configuration and challenge device design
- Temperature & pressure distribution studies
- Saturated steam quality and equipment qualification
- Reprocessing validation for reusable instruments
​Our consultants ensure your steam sterilization process meets both safety and efficiency standards.