Cold sterilization enables low temperature molecular stabilization protection — for products that contain heat-sensitive ingredients and yet require sterilization or bioreduction.
Refrigeration can be provided at a range of 1° to 5°C, and frozen storage is offered at a range of -24° to -18°C. Additionally, same-day turnaround using the customer’s own refrigerated vehicles is available.
Our process is precisely controlled by advanced electronics and monitored using state of the art film dosimeters. We typically process 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.
The processing is completed in just minutes–this is only possible with e-beam! This means your product spends the least amount of time removed from cold storage as possible, so the temperature increase is minimal.
Who E-Beam Cold Sterilization Is For:
E-beam cold 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.
- 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:
- 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)|