OEM by Degradable Solutions AG

Sterilization

Sterilization of resorbable implants is an important factor to be considered during development.

Degradable polymers are heat and humidity sensitive.
Gas sterilization using ethylenoxide or formaldehyde requires intensive degassing procedure. Complete removal of residual traces of gas has to be achieved. The used gas may act as a plasticizer for the polymer which might lead to a structural change.
Gamma-irradiation leads to a chain scission of the macro molecules of degradable polymers, leading to a change in molecular weight and thus in mechanical properties and degradation profile.
Plasma sterilization is a surface sterilizing method. Degradable implants however require sterilization of the complete mass.

All these aspects have to be considered when a new implant is designed. DS has the necessary experience in all sterilization methods.

Structural damage to injection molded poly lactic acid rods after gas sterilization (right) as compared to not sterilized rod (left) and gamma irradiated rod (center)