We and our partners are experts in the following sterilization technologies and related regulations:

   - Ethylene Oxide (ISO 11135 and ISO 10993-7 including Amd.1:2019 and related AAMI TIRs)
   - Radiation (ISO 11137 and related AAMI TIRs)
   - Steam (ISO 17665)

Our typical services include:
   - Execution of sterilization validations (IQ, OQ and PQ) inhouse or with your contract sterilizer
   - Support for selection and qualification of new contract sterilizers
   - Support on routine control, cycle review and releasing process
   - Reviewing of existing sterilization process for compliance with regulations
   - Optimization of EO/ECH residual levels, also with regards to Amendment 1 (neonates and children)
   - Optimization of sterilization process e.g. with regards to efficiency or product integrity
   - Development of sterilization related QM topics
   - Parametric release
   - Project management