Electron beam radiation has been used for more than half a century to sterilize medical devices due to several key benefits, including: low cost, high reliability, turnaround time, safety, and relative ease of validation.
E-BEAM Services operates 150 kW accelerators which can sterilize a truckload of medical devices in only an hour or two. High throughput translates to low cost. The e-beam process is also more flexible in sterilizing small quantities – say, only a pallet load – than gamma or ethylene oxide sterilization technologies. Again – lower cost!
Electron beam radiation sterilization is a technology that was proven many decades ago and has become well-established with contract providers located around the United States. It is used in-house by a number of large medical device manufacturers. On-time delivery from E-BEAM Services is more than 98%.
It’s fast! With today’s high energy electron beam accelerators and the efficiency of our sterilization process, we can process a truck full of your product in just hours! Another benefit of the high processing speed is often there is less of an effect on materials when compared with other irradiation techniques.
Electron beam sterilization results in products that have no sterilant residues, are not radioactive, and have a demonstrable sterility assurance level. It means that the products are available for immediate use by the final user without additional testing.
Ease of Validation:
The validation method for using electron beam sterilization is defined in ISO 11137. The ease of qualification and validation is a straightforward process. There are a couple of methods that can be used, with the simplest requiring a relatively small quantity of medical devices for fully validating the sterilization process.
Once again, I hope this was helpful. I look forward to hearing your questions!