The E-Beam Method of Medical Device Sterilization
Electron beam sterilization (e-beam sterilization) is a safe, effective, and efficient processing technology used to sterilize a wide variety of disposable medical devices. E-Beam’s medical device sterilization methods are the most efficient and proven solutions in the industry, offering many advantages over other processes, such as ethylene oxide gas and gamma sterilization.
The E-Beam method of medical device sterilization uses a process that is precisely controlled by advanced electronics and monitored by advanced film dosimeters. We typically sterilize medical products in their final packaging, giving us the ability to ship direct to customers, thereby saving you time and money. The rapid sterilization process and low cost pricing allows you to practice just-in-time inventory by scheduling shipments when you need them, as often as you need them.
E-BEAM Services prides itself on delivering solutions that provide safe, standardized, and effective processing while maintaining product integrity. With our experienced team of electron beam experts, we can guide you through the regulatory requirements needed to market your sterile medical devices. Validation is consistent with ANSI/AAMI/ISO guidelines, FDA Standards, and GMP Compliance.
Who E-Beam Medical Device Sterilization Is For:
E-beam sterilization is a safe, effective, and efficient processing technology used to sterilize a wide variety of disposable medical devices and pharmaceuticals. Processing at E-BEAM is the most cost-effective method for low to medium density products, but not a good fit for extremely dense materials.
As the largest contract electron beam provider in the U.S., we offer capacity for large volume processing and provide a team of experts to deliver support.
- Drug containers
- Pipette tips
- Test tubes and swabs used in kits to test for coronavirus
Advantages of e-beam over ETO (also referred to as EO, ethylene oxide, ethylene oxide gas):
- E-beam provides quick-turn terminal sterilization with simple, clean, on/off technology. There is no carcinogenic gas needed and there are no residuals, so product is able to be immediately released for distribution.
- E-BEAM Services is capable of handling any shipment size, from single boxes to multiple truckloads, and no expensive breathable packaging is required.
- E-BEAM Services can provide step-by-step guidance for starting with e-beam, or the conversion from ETO to electron beam.
Advantages of e-beam over gamma:
- E-beam provides quick-turn terminal sterilization with simple, clean, on/off technology. There are no radioactive sources needed, so there are no security, transportation or disposal concerns.
- The supply of electrons will never be in danger of running out, unlike the source of gamma photons, Cobalt 60.
- E-beam has a faster dose rate than gamma, so there is a reduced risk of product damage. E-beam can even be used on sensitive products like pharmaceuticals and tissue products.
- E-BEAM Services can provide step-by-step guidance for starting with e-beam, or the conversion from gamma to electron beam.
Why it Matters to You:
|Fast turnaround||Less material degradation than gamma|
|Greater mixed lot flexibility||Uniform, precise, & controlled dosing|
|No residuals or quarantine||Environmentally friendly|
|Processed in original packaging||Expedited processing available|
|Cost effective for low to medium density products||Refrigerated/frozen sterilization available|
|Technical expertise and consultation services||Regulatory compliance (FDA, AAMI/ISO, GMP, EU GMP)|