Steri-Tek E-Beam Sterilization | Terminal Sterilization with E-Beam
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E-Beam

E-Beam/X-ray irradiation is a proven and accepted form of terminal sterilization. The mechanism for sterilization is the effect of high energy electrons striking and breaking up the RNA/DNA of the bioburden.

The relationship between the flexibility of E-Beam/X-ray and the sterilization requirements for sensitive materials/complex devices is rapidly evolving to become a key advantage to manufacturers of combination products, drugs/biologics, bioabsorbables, implantables and other complex products.

 

E-beam sterilization of pharmaceuticals by Steri-tek
How E-Beam Sterilization works
steri-tek-background

Advantages of E-Beam

  • FDA approved. Recognized and accepted by international standards organizations
  • Processing conditions for E-Beam are easily specialized and allow for greater control
  • E-beam offers more flexibility in processing of sensitive materials and drugs/biologics
  • Flexibility in processing conditions allowing sterilization optimization for drugs and sensitive materials
  • Environmentally friendly. No hazardous or radioactive materials
  • No quarantine required / safe to handle following processing
  • Fast turnaround / high throughput time • High reliability – high level of consistency in achieving sterilization
  • Causes no damage to sterile seals on product packaging;
  • Delivers well-controlled (narrow) dose range;
  • Delivers dose rapidly, which protects a product’s function.
  • Low material degradation when compared to gamma;
  • Compatible with most types of materials (especially plastics and its packaging);
  • Penetrates all types of product packaging including foils;
  • Allows control of temperature during irradiation;
  • Ease of validation