E-beam

Sterilization

E-beam Advantages

E-beam irradiation is a proven and accepted form of terminal sterilization. The mechanism for sterilization is the effect of high-energy electrons (Beta particles (β)) 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.

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Sterilization Methods Overview
SteriTek Company Backgrounder

These advantages include:

  • Processing conditions for E-beam are easily specialized and allow for greater control
  • E-beam offers more flexibility in the processing of sensitive materials and drugs/biologics
  • Environmentally friendly. No hazardous or radioactive materials
  • Fast turnaround / high throughput time
  • High reliability – high level of consistency in achieving sterilization
  • E-beam 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
  • On/Off technology
  • Poses no security risks

With its advantages over almost all other current sterilization techniques, X-ray sterilization is the up and coming sterilization technique and warrants your consideration both for new products and for transition of current products. Already included in international standards and FDA guidelines, the usage of X-ray sterilization is already approved by regulatory bodies. The current, biggest challenge, as with any new technology, is finding facilities that offer this service. This should not be a problem in the years to come.