The Intact™ containers are closed with a pierceable and self-closing septum. Hence, pre-filling sterilization option includes:
- Gamma or Beta Irradiation
- Autoclave for our silicone closed devices
- Sterilant: contained in the septum closed device, sterilant does not expose operators
MedInstill has developed a safe and proprietary method.
The Intact™ Sterilization has been tested using standard biological indicators (i.e. Bacillus atrophaeus, B. pumilus, Geobacillus stearothermophilus) used in the validation of other sterilization processes.
On-site, fully integrated
The MedInstill Intact™ Sterilization allows for a fully integrated, on-site filling process, from the container molding through the filling.
Like any other sterilant, it requires adequate precautions during handling; however, such precautions are typical and universal.
The sterilant is non-flammable. At the pressure and concentration used by MedInstill, it is classified as “not a special hazard”. It simply requires commonly used ventilation, control and personal protection measures found in manufacturing facilities.
Sterilant is readily available from suppliers around the world.
The cost of Intact™ Sterilization is significantly less than other sterilization methods.