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.
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