Chlorine Dioxide Sterilization

Looking to the Future

  • CD sterilization is a highly penetrative gaseous process – equivalent to Ethylene Oxide (EO) sterilization in many aspects
 
  • CD sterilization was originally developed by Johnson & Johnson
    • CD has been in use for decades on products and components across various industries, including the food industry
 
  • CD sterilization process validations are identical to those of EO
 
  • The CD sterilization process is identical to that of EO
    • The product can be processed in pouches or product cartons
    • The product is loaded into chambers
    • The product is exposed to CD
    • Confirmation of processing is performed at the end of the cycle
 
  • Key differences between EO and CD:
    • CD is non-carcinogenic
    • CD is non-flammable at concentration levels used for sterilization
    • CD is non-explosive
    • Sterile products and packaging may be handled immediately after cycle completion
    • CD does not require a long aeration process
    • Process Characterization – Contact Phoenix DeVentures for more information
    • Residual Testing – CD is more generic and currently has more limited lab availability
 
  • CD is a S. EPA-registered sterilant
 
  • In Q1 2024, Phoenix DeVentures expects to have sterilization validation completed for at least one customer using CD
 
  • Current challenges of using CD for medical devices:
    • No existing standards dedicated specifically to CD sterilization, unlike EO and irradiation
      • The current validation process for CD aligns to ISO 14937, incorporating requirements from ISO 11138 and ISO 11737
    • Limited devices with 510k approval utilizing CD
    • Processing of products in cardboard shippers requires a robust cycle using more CD
    • Limited availability of validated facilities
 
  • The future looks promising for CD over EO, considering the recent lawsuits and settlements paid out by large sterilization companies due to carcinogenic fallout from EO
    • To compensate for added legal and fiscal risks, costs will likely rise for EO processing
    • Smaller independent facilities will close, as the risk of potential fallout becomes too costly
    • Gamma processing costs are increasing significantly as many seek non-gas alternative sterilization methods
    • The EPA is tightening restrictions on EO facilities, with new regulations scheduled to be implemented by March 1, 2024

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