The steps to e-beam sterilization: 1. After product is received and checked in, boxes are loaded in a single layer on the carts. 2. Product passes through a curtain of electrons and is sterilized. 3. Product is released per ISO 11137/13485 & FDA guidelines and quickly returned to the customer.
How E-Beam Sterilization Works:
The e-beam is able to penetrate medical devices and pharmaceutical products in their final shipping containers. The e-beam inactivates microorganisms either by causing microbial death as a direct effect of the destruction of a vital molecule or by an indirect chemical reaction. Advanced electronics precisely control the use of electrons in the sterilization of medical devices and pharmaceuticals.
The process involves accelerating a beam of electrons to near light speed where it passes through a scan chamber and then transitions into a curtain of electrons. Materials moving through the chamber on a conveyor system are showered with these high-energy electrons, which penetrate the material with a precise, predetermined dose.
Who E-Beam 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.
Advantages of e-beam over ETO (also referred to as EO, ethylene oxide, ethylene oxide gas):
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- 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.
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- E-BEAM Services is capable of handling any shipment size, from single boxes to multiple truckloads, and no expensive breathable packaging is required.
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- E-BEAM Services can provide step-by-step guidance for starting with e-beam or the conversion from ETO to electron beam sterilization.
Advantages of e-beam over gamma:
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- 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.
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- The supply of electrons will never be in danger of running out, unlike the source of gamma photons, Cobalt 60.
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- 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.
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- E-BEAM Services can provide step-by-step guidance for starting with e-beam, or the conversion from gamma to electron beam.
Why E-Beam Sterilization 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) |