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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
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.