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Validation d'emballage pour dispositifs médicaux



Ethylene Oxide Residual Analysis

Because of its broad material compatibility, ethylene oxide (EO) is frequently used to sterilize medical equipment. It’s possible for EO to leave a residue on the material being sterilized. The following are the residues that may remain following sterilisation:

  • Ethylene Oxide (EO) is a possible byproduct of processing.
  • Ethylene Chlorohydrin (ECH) is a potential by product of EO’s interaction with free chloride ions.
  • Ethylene Glycol (EG), a byproduct that may result from the interaction of EO with water. eo residual analysis

Ethylene Oxide (EO) Sterilization Validation

Prior to beginning routine ethylene oxide sterilisation, a product with a sterile claim needs to complete a validation process to ensure the Sterility Assurance Level claimed is met according to ISO 11135.

An Ethylene Oxide (EO) Sterilization Validation is designed to assist the manufacturer in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed. Medistri « Ethylene Oxide (EO) Sterilization Validation.»

Medistri drives sharp increase in sterilisation of medical devices with integrated electronics during Research & Development phases.

 Medistri’s Switzerland Plant in Domdidier is optimised to help innovative companies scale faster and remove friction to their development cycles. And many of the Medical Devices most complex and innovative products contain electromechanical parts. Medistri « Sterilization for Medical Devices with Integrated Electronics.»

Medistri’s Biocompatibility Testing for Medical Devices impacts healthcare companies in mpre than 20 countries around Europe.

The company’s laboratory provides Biocompatibility Testing for Medical Devices according to ISO 10993. Working primarily with customers across Europe in Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Norway, Denmark, Israel, Switzerland, Luxembourg, Croatia, the Netherlands, Portugal, Hungary, and the UK. Medistri « Biocompatibility Testing According to ISO 10993»