REVOX Advantage: Low Temperature Sterilization Options - Peracetic Acid Vapor Sterilization vs. Gamma Irradiation

  • Posted on: 6 July 2015
  • By: REVOX Steriliza...

Low temperature sterilization is often the only option for manufacturers of heat-sensitive products, and until recently, manufacturers only had one option for room temperature sterilization; gamma irradiation.  Gamma irradiation is most often used to sterilize disposable surgical instruments; metal, plastic, and rubber items; and liquid pharmaceuticals.

Gamma irradiation works by allowing high-energy photons emitted from a radioactive isotope (usually Cobalt-60) to interact with an object. This causes ionization (disruption of electrons), killing organisms at a molecular level. This process is thorough and powerful, and takes place at room temperature. However, its aggressive mechanism of action can produce cross-linking, which can damage some types of polymers, enzymes, delicate proteins and other large-molecule biologics.

Cross-linking is an actual physical change to the molecular structure of the material. Polymeric cross-linking relates to the cross linking of covalent or ionic bonds. This could cause, for example, discoloration or brittleness of the material. Protein cross-linking is a protein-to-protein interaction. In contrast, the room temperature REVOX™ sterilization process avoids cross-linking. In fact, the REVOX® Sterilization Solutions team has a growing list of compatible materials and successful feasibility trials on a wide array of device types including biologics, electronics (including batteries and sensors), narrow lumen tubing sets, and many more intricate device designs—all with no cross-linking affects.

Other “low temperature” gas sterilization methods, such as critical CO2 (carbon dioxide), NO2 (nitrogen dioxide), and H2O2 (Hydrogen peroxide), offer potential alternatives to room temperature gamma irradiation. But only the REVOX sterilization process fills all of the requirements of a full manufacturing process, including true room temperature sterilization, broad materials compatibility, safe, scalable, on-site processing options, and a proven regulatory pathway.   

By its nature, gamma irradiation also requires significant infrastructure and safety assurance investments, which largely limits its use to dedicated off-site service providers. REVOX Sterilization Solutions, on the other hand, offers multiple and/or custom chamber size options, enabling efficient scaling to your current and future processing needs with the added efficiencies of safe, on-site, in-line operation.