E-Beam Sterilization

Technology

ebeam sterilization infographic

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):

    • 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.

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.

 

 

 


 

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)

About

E-Beam Sterilization

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What If You Had...

The BEST for low to medium density medical devices.

Your business wants to optimize cost and improve efficiency. Electron beam sterilization is the BEST method for low to medium density products because the process itself is the most efficient in terms of time, packaging, and cost. Why? Products are sterilized in their final shipping containers and the process generally takes seconds instead of hours like other methods,resulting in a fast turnaround. The efficiency of performing product sterilization in its packaging saves you money. And with our Express Services you can get your products to market even faster.

The BEST for regulatory compliance.

You need a standardized sterilization process that ensures your medical products get to market safely and reliably. E-BEAM Services' FDA-certified facilities have been in operation since 1984 with a comprehensive quality system registered and compliant with the exacting standards of ISO 9001:2008, ISO 13485:2003 and ISO 11137:2006. This method also allows for no residuals and precise dosing making it a reliable outcome every time. Our team of experts is dedicated to one technology – we offer decades of technical expertise and knowledge to deliver quality driven, reliable, and comprehensive e-beam sterilization services for your medical devices.

The BEST solution for capacity and turnaround.

In today's marketplace fast and reliable delivery into the market are critical to your success. With three locations, multiple accelerators and enough processing power to handle over 1 billion pounds of material (500 kw of processing power) E-BEAM Services offers the best solution for on-time delivery. Add to that a track record of on time delivery in the high 90’s, no quarantines, small to large order specialized handling, personalized service from a right-sized supplier, express processing service options, and your supply chain just got stronger.