Electron beam sterilization (e-beam) is a commercially proven technology for sterilizing a wide variety of disposable medical devices with a wide range of densities.
The e-beam radiation inactivates microorganisms either by causing microbial death as a direct effect of the destruction of DNA molecules or by an indirect chemical reaction which results in microbial death.
How It Works
The principle of electron beam technology is similar to that of a television set cathode ray tube. The ebeam accelerator creates a beam of electrons 0.5 inches in diameter and energizes it to near light speed. The beam passes through a scan chamber where a magnet scans it back and forth at 200 Hz, creating a curtain of electrons 4 feet wide. A high-speed conveyor carries cartons containing products to be sterilized under the beam, where an accurate predetermined dose of radiation is delivered.
Why Use Electron Beam?
The sterilization process is precisely controlled by advanced electronics. Process parameters are recorded for accuracy of dose and validation purposes. For many materials, the speed of e-beam processing results in less material degradation than with gamma irradiation.
Typically, medical products are irradiated in the original shipping containers, thus saving the customer time and maintaining package integrity.
Advantages of E-Beam Sterilization Over Ethylene Oxide (ETO)
• Faster turnaround
• No quarantine
• No residuals
• Greater mixed lot flexibility
• One process variable
• Lower cost
Advantages of E-Beam Sterilization Over Gamma Radiation
• Faster turnaround
• No radioactive source
• Less material degradation
• Greater mixed lot flexibility
• No negative public perception
• Lower cost
Product Applications
E-Beam sterilization is routinely used in many applications with a high level of customer satisfaction. Here is a sampling of commercial e-beam sterilized products . . .
- Drug Containers
- Labware
- Bandages
- Syringes
- Catheters
- Tracheostomy Care Kits
- Sponges
- Woven And Non-Woven Goods
- … and many more
Below are just some of the materials that can be sterilized successfully with e-beam processing in sterilizing dose ranges . . .
- Polyethylene
- This material is only processable using electron beam radiation and typically cannot withstand gamma radiation.
- Polystyrene
- Polyethylene Terephthalate (PET)
- Polyamides (Nylons)
- Polycarbonate
- Acrylonitrile-Butadiene-Styrene (ABS)
- Polyimides
- Polyurethane
- Polysulfones
- Polyesters
- Elastomers
- Natural Rubber (Latex)
- High Performance Polymers
- … and others
Product Validation Requirements
E-BEAM Services, Inc. provides a complete validation package consistent with AAMI guidelines, including written protocols and guidance to transfer a given product from its current method of sterilization to the e-beam method. The dosimetry and equipment calibration are traceable to NIST.
Our Services
Some of the services that we offer include:
- Material Compatibility Testing
- Dosemap Testing
- Verification Dose Auditing
In addition to sterilization, E-BEAM Services offers electron beam processing services for crosslinking of plastics, rheology control of polymer pellets, polymer chain and semiconductor enhancement.