In these unprecedented times, COVID-19 is affecting populations worldwide in several aspects and continuously challenging health care professionals and the medical device industry. The need for specific materials for testing or sanitizing purposes has skyrocketed, while manufacturing and sterilization capacity has not necessarily increased at the same pace.

Why is medium-voltage technology an alternative?

Medium-voltage electron beam accelerators (5 MeV), an FDA cleared technology, may enable the sterilization of products in a reduced time-period, presently with considerable capacity throughout North America, which remains “unexplored” by the industry.

Unlike other sterilization modalities, medium-voltage electron beam offers incredible throughput. The reference sterilizing dose (25 kGy) can be delivered in minutes or seconds, as opposed to hours or days using other terminal sterilization modalities such as gamma or ethylene oxide, which leads to extremely quick processing. Medium-voltage electron beam is a proven and reliable alternative to meet the time demands of the market.

So, what kind of COVID-19 related materials could be easily converted or qualified using the e-beam sterilization modality?

Examples include components used for the test kits, whether via PCR or the antibody test, which include vials, caps, swabs, microplates, vaccine kits, wipes, and personal protective equipment such as gloves, masks, and other related materials. Particularly medium to low-density products are in the sweet spot.

What steps is E-BEAM Services taking to ensure sterilization is not a bottleneck in COVID-19 related products?

E-BEAM Services Inc. is currently taking steps towards increasing and expanding its processing capacity beyond the 5 beams already under operation across North America, in anticipation of the growing demand.

E-BEAM Services Inc. is under a superior management directive for expedited scheduling related to qualifying and sterilizing COVID-19 related products. E-BEAM Services offers flexible processing capabilities in a response to the excessive lead times for gamma sterilization and the growing demand for sterilization observed in the marketplace.

How do I qualify my product for sterilization using medium-voltage E-beam?

• 1. Set up a call with a Tech Service representative to discuss getting started.
  2. Once a processing date is set, samples are then sent to us at E-BEAM Services to be exposed at two or three different dose levels to confirm compatibility.
  3. Dose maps and validations are performed to determine the processing parameters and validate the process according to the ISO 11137 standard.
  4. A verification run is performed to verify the sub-lethal dose and prove that the process is suitable to reach the desired sterility assurance level.
  5. Product is ready for production.

Want to learn more? Here at E-BEAM Services, our team of experts and highly trained professionals are available to assist medical device industries, labs, nuclear power plants, and other facilities in meeting their testing and production needs. Contact us to discuss your product needs.

Ionizing radiation is the second-largest method of choice when it comes to the industrial sterilization market, accounting for almost 45%. While gamma and e-beam are the traditional favorites, newer to the game is x-ray.

What are the similarities?

All three technologies are capable of providing sterility and are all governed by the same ISO 11137 standard.

The same dosimetry system may be used, and in practical terms, 25 kGy of gamma is the same as 25 kGy delivered by an electron beam accelerator or by an x-ray machine.

So, what are the differences between the three sterilization modalities?

Gamma radiation is comprised of photons generated by the decay of a radioactive nucleus (cobalt-60 for instance), and therefore the dose rate is governed by the decay. Photons have no mass and may penetrate deeper into matter, but no changes can be made to affect its energy spectrum. As a result, medium- to high-density products are ideal for gamma processing.

E-beam radiation refers to machine-generated high-energy electrons. As electrons have mass, the penetration is limited by the energy. This makes the use of electron beam technology very useful for low- to medium density products and more favorable for box processing as opposed to whole pallets.

Also, given the nature of the technology, e-beam is a great fit for sensitive products as the dose can be delivered significantly faster than gamma or x-ray – we’re talking seconds or minutes rather than hours. The detrimental effects are then also reduced as the lifetime for the reactions to take place are several orders of magnitude smaller.

Industrial x-rays are generated via the use of an electron beam accelerator coupled with a metal target. When the electrons hit the metal target, x-rays are created. X-rays are also comprised of photons (but with different energies than gamma), so x-ray is also a potentially good fit for medium- to high- density products.

The dose rate is also higher than gamma, as they are also machine-powered, but limited or slower compared to e-beam. For instance, to deliver the standard sterilization dose of 25 kGy, it would take about 2.5 hours or more of processing using gamma radiation, as opposed to 45 mins to an hour using x-rays and seconds to minutes using e-beam technology.

How do I determine if my product is a good fit for e-beam sterilization?

Here at E-BEAM Services, our team of experts and highly trained professionals are available to assist nuclear plants, labs, medical device manufacturers, and others in meeting their testing and production needs. Contact us to set up a free consultation call with Tech Services!

With an increasing demand for sterilized products on the market, one question we get often is: how does E-BEAM ensure my products will be sterilized and ready for consumer use quickly? Well, there are a number of factors that go into that.
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