LIFE – Sterilization protocol ready for the production line

The Lifecare organization is working on preparations for automated production after a successful pilot production at the end of Q1. Part of these preparations has also been to finalize a procedure for sterilizing the sensors, including both the advanced chemistry and sensitive electronics. In our early product development, we have applied Gamma radiation as sterilizing method, being costly and complex in a logistics perspective.

Lifecare has now concluded on a protocol for a sterilization based on exposing the implant for UV-light and Ozone. The method is gentle, timesaving and very cost-effective, compared to alternative sterilization methods.

- This method can easily be implemented in the production line and scaled up in an automated production. The method of combining UV-light and Ozone is well proven, cost efficient and only takes a few minutes, says CEO Joacim Holter at Lifecare.

Lifecare, in collaboration with the Norwegian University of Life Sciences (NMBU), has carried out trials and analysis, and can therefore document that the method meets the high standards necessary for our medical device. Finalizing the sterilization protocol has also been important in the preparations towards the planned longevity studies (veterinary), as the sensor with electronics will be fully implanted under the patient's skin. In both perspectives the implant must be sterile to not cause infection or irritation.

Lifecare's required specifications for sterilization has been clear all along for this important part of sensor production. In the sterilization process, Lifecare is dependent not to expose the sensor's advanced chemistry and electronics to damage. Therefore, we have spent a lot of resources over a period of time to conclude a method that satisfies the requirements for sterilization and is gentle enough for the sensor. We have tested various methods, and our investigations show that heat, pressure, gamma radiation, chemicals and gas cannot be used.