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There is a growing number of drug-delivery devices being used in medicine today. The fields of bioengineering and tissue engineering are developing new combination products that contain natural and synthetic materials. The list of biological materials and therapeutics used in these novel combination products continues to grow.

As these combination products become more technical and refined, it becomes vital to utilize a sterilization process that maintains the physical characteristics and biologic qualities of the material being sterilized.

NovaSterilis’ scCO2 sterilization process has been utilized to sterilize innovative regenerative materials with little to no negative functional effects on the devices. NovaSterilis has a growing data set that supports scCO2 sterilization as a solution for these types of materials.
Combination Product, Drug Delivery
Challenges in Drug Delivery using Combination Products:

Sterilization: The combination of a therapeutic(s) and a natural/synthetic polymer(s) used in a single device can limit the ability to sterilize such devices using traditional sterilization methods.

Solution: scCO2 sterilization is broadly compatible with a spectrum of materials and therapeutics making it a more effective option for sterilizing combination products to the highest standard. 

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Impregnating Bioactives into Combination Products: Traditional impregnation techniques (such as liquid soaks) often result in uneven and incomplete loading of the therapeutic into the substrate. This inconsistency can compromise the efficacy and reliability of the drug delivery process.

Solution: Supercritical CO2 allows for a uniform deposition of biotherapeutics/APIs making it a safer and more effective solution.

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Why NovaSterilis: