Andersen Products succeeds in terminal sterilization of medicated stents whilst retaining sufficient biological activity.
It has been a long standing challenge to sterilize drug eluting stents after the application of the drug coating, whilst retaining sufficient biological activity. For instance; Lambert et al AAPS PharmSciTech 2011 “EO sterilization can involve high heat and humidity during the sterilization process. For devices utilizing a drug substance or drug formulation, the high heat and humidity can cause degradation of the drug.”
Andersen products has now demonstrated the terminal sterilization of medicated stents using Ethylene Oxide (EtO), whilst retaining the biological activity of the drug. This breakthrough in EtO sterilization technology has been achieved by using extremely gentle flexible chamber technology and running the sterilization cycle at 30oC. The stents were packaged as shown in the picture on the left here and the full cycle parameters may be viewed HERE.