Do You Know About These New Packaging Sterilization Methods?

While medical device manufacturers and sterilization service companies work on reducing or eliminating emissions from ethylene oxide (EO) sterilization operations, some involved parties are diligently developing promising alternatives.


NovaSterilis designs, develops, and commercializes sterilization equipment based on patented supercritical carbon dioxide (scCO2) technology. The low-temperature process, which uses a peracetic acid-based additive and scCO2, is compatible with sensitive biological materials, biodegradeable polymers used in medical devices, drug-delivery systems, and biologics/ vaccines. NovaSterilis was awarded the Presidential Green Chemistry Challenge Award by the US Environmental Protection Agency (EPA) in 2007.


• The technology offers significant advantages over EO sterilization for applications in which: deep and ubiquitous sterilant penetration is required, low temperature is necessary, and material sensitivity is high.

• The process is uniquely compatible with biologics and bio-materials.

• The scCO2 process is much faster than EO sterilization (up to 6 hours vs. 48 hours, respectively).


The low-temperature, multi-phase process from TS03 (part of Stryker) uses dual sterilants: hydrogen peroxide (H2O2) and ozone (O3). Vaporized H2O2 is the primary sterilant, with O3 added to the sterilization chamber in a subsequent step to reduce residual H2O2. A vacuum created inside the chamber during the evacuation phase removes any residual sterilant. The technology is used in hospitals to sterilize reusable medical devices and instruments.


• Loads of up to 75 pounds, including mixed loads, can be sterilized using

a single, preset cycle.

• The technology is compatible with a range of medical products and

load configurations.

• It has been validated to sterilize some complete instrument sets in a

single cycle.

• A single dynamic cycle adjusts H2O2 delivery to meet load configuration/weight.



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