E-Beam Sterilization
One of the fastest production sterilization methods available
An electron beam is generated through the use of electromagnetic fields in a vacuum to gather and propel electrons to a very high speed. This beam is then quickly scanned up and down over a product as it is moved down a conveyor, resulting in a fully packaged and sterilized end-product.
Mechanism of Action
As the high energy beam comes in contact with would-be contaminants, it ionizes and alters the structure of their DNA, eliminating their ability to function and reproduce.
General Process Capabilities
This process can penetrate most types of low-density packaging and will leave no chemical residue or radiation behind. Though it is the fastest production method for high throughput device sterilization, it is limited by the density of the material that it can penetrate and the potential for material property changes caused by the induced static charge from the electron beam.
Benefits
- Lower potential for material degradation when compared with Gamma Irradiation
- Controlled dose duration and beam energy level allows for a sterilization process that is specifically optimized for each product, minimizing exposure time and potential for material breakdown
- Environmentally friendly; no hazardous or radioactive materials used or created
- Temperature is not a key parameter and sterilization is effective even with frozen items
- Does not require any permeable membrane packaging that is necessary with HPGP or Ethylene Oxide Sterilization allowing fully packaged materials, even liquids, to be sterilized
Limitations
- During prolonged exposures there is the potential for breakdown of product material from induced internal static charges. This leads to 'chain scission' of polymers, causing embrittlement, discoloration and degradation.
- Induced static charge may damage semiconductors and other electronics
- Will not penetrate dense packaging and product materials
- Not suitable for products with complex geometries
Our Alliance Partner
Eagle Medical works with Steri-Tek in Fremont, California to provide our customers with fast and reliable contract E-Beam sterilization in accordance with the ISO 11137 standard.