We provide comprehensive sterilization support as part of our full-service CDMO offering for single-use medical devices. Ensuring the sterility and regulatory compliance of your product is critical, and we work closely with our clients to manage both sterilization validation and routine production cycles.
We support a wide range of sterilization modalities, including:
- Ethylene Oxide (EtO) sterilization
- Gamma irradiation
- Beta irradiation (e-beam)
- X-ray irradiation
Our sterilization services include:
- Development of sterilization strategies adapted to your product’s material, packaging, and intended use
- Coordination and execution of sterilization validation protocols (ISO 11135, ISO 11137)
- Management of bioburden and sterility testing in collaboration with certified laboratories
- Support for routine sterilization processes, including batch release and documentation
- Integration of sterilization constraints during the design and development phases to ensure compatibility and efficiency
Our team ensures that sterilization is not just a final step, but an integral part of the product lifecycle, from early feasibility to full industrialization.
With proven experience in regulatory compliance and sterility assurance, we are your partner for safe, validated, and efficient sterilization processes that meet global standards.
