Sterilisation (ISO 11135 & ISO 11137)
Proper sterilisation is critical for device safety and regulatory approval. We offer expert support across both ethylene oxide (EO) and radiation sterilisation methods, aligned with:
ISO 11135:2014 – Ethylene Oxide Sterilisation
This standard governs EO sterilisation processes including parameter selection, validation of sterilisation cycles and EO residual monitoring.
Apotech provides:
- Process development and validation
- EO sterilisation training
- Documentation and audit prep
- QMS alignment with ISO 11135
Trusted by top-tier teams worldwide
ISO 11137-3:2017 – Radiation Sterilisation
This standard sets dosimetry and validation protocols for gamma and e-beam sterilisation.
Our services include:
- Dose audits
- Radiation validation protocols
- Regulatory compliance documentation
- Quality assurance process development
Featured case studies
Process and Test Method Validation Review and Improvement
Process and Test Method Validation Review and Improvement Introduction Cardiac Devices Our client is a leading manufacturer of Class III minimally invasive cardiac devices, based in Germany and selling to 85 countries worldwide. Apotech consultants Our consultants implemented a risk-based approach to improve quality and compliance, and implement practical solutions for the organisation. Standards &…