E-beam sterilization

The e-beam (electron beam) sterilization is a proven and reliable process involving high-energy particles used to sterilize food or pharmaceuticals products and medical devices, with great efficiency and high speed. It operates by directing a continuous flow of electrons through the target material, delivering the required irradiating dose within the product.

The source of radiation, electrons (beta source), is focused to obtain an electron beam. These electrons are produced from a standard electrical current and raised to a high energy in an accelerator, at the exit of which they are directed towards the product to be impacted. The curtain shape of the formed beam and its size ensure striking the product efficiently at a requisite speed.

E-beam technology is used to sterilize or improve products properties within several industrial applications. Various parameters dictate the possible use of this technology. The transition to the use of e-beam involves essential study of the compliance between products and technology. The goal of this study is to assess the feasibility of sterilizing healthcare products, medical devices or pharmaceutical products with e-beam.

Whether the current industrial sterilization method, for various reasons a customer would like to evaluate the possibility to move to e-beam sterilization.

MSE can help you in this feasibility study, following the regular following steps :

Our collaboration can start with a non-disclosure agreement. Then we can have our first substantial meeting by addressing the technical aspects of your project. The target will be to determine the best treatment recipe for your product(s) to be sterilized, according to your standards, specifications and regulatory compliances.

At this stage of the project, MSE can run computer simulations at different settings, known as Monte-Carlo simulations, to model the relevant physical process of particles interactions in the simulation. The material (products) and the e-beam sterilization accelerator (beat source) are modelled on a dedicated software by MSE experts. It will allow to compare the different results and refine the recipes to be used during the real test phase.

After computer simulations, make room for practice. This stage is about irradiating real products at a real e-beam sterilization centre with which MSE collaborates. We will equip the test products with dose measurement dosimeters to capture the effective despite dose inside the products during the tests. The dose mapping will reveal the dose deposited at the places where the dosimeters have been placed, allowing effective and useful measurements, with a view to further refining the theory if necessary, and possibly run additional tests.

AfThis iterative process will lead to a recipe linked to a specific type of accelerator. Then you have all you need to sub-contract the sterilization of your products.

Different e-beam equipment’s can achieve to accelerate electrons, different methods can be used to accelerate electrons; continuous vs pulsed beam. Mainly, electrons are extracted from an electron source at the top of an accelerator line contained in a chamber under vacuum. By design of the magnetic field around this beam line, the electrons are accelerated to a specific speed, and then are focused and scanned to exit the vacuum chamber, through a thin titanium window foil. Eventually, the electrons strike and penetrate the product that is conveyed underneath at a controlled speed.

The energy of the electrons and the quantity of electrons in addition with the line speed are crucial parameters. Together, they ensure a correct recipe necessary to guarantee sterilization of the product.

The entire process is carried out in a bunker or behind biological protection allowing the safety and good health of all, thus containing the radiation in an enclosed and controlled space.

Numerous products can be sterilized with e-beam. Depending on the density of the product, located mainly around 1 g/cm3 for plastic used into pharmaceuticals and medical areas, most of these polymers are compatible with e-beam sterilization process. Thanks to its flexibility, e-beam sterilization constitutes a rapid solution to treat considerable quantities of products.

A wide range of medical products such as gloves and masks, drapes,
wound care products, plasters, bottles, liquid containers

A great variety of tools, items of packaging, raw material or finished products

Food irradiation advantages are similar with other existing treatments
(heat, cold, chemical) but avoids to move temperature. It is used for
cereals, fruits, vegetables, spices

The e-beam is capable to enter medical devices and pharmaceutical products in their ultimate shipping packaging. The beta rays terminate microorganisms either by directly causing microbial death as direct impact on a living molecule or by indirect chemical reaction. The accurately precise tuning and control of the electron accelerator allow the sterilization process of such devices and products.

Density of the products is an important parameters to determine the correct treatment recipe of the accelerator, as it will directly impact the penetration of the beta rays inside the goods. In general, 2 passages under the e-beam are required to uniformly sterilize the products.

Other sterilization process exist, such as Gamma sterilization and ETO, or EO (Ethylene oxide sterilization)

• No radioactive material involved
• Safe when machine is turned off (clean on/off technology)
• Highly reliable & Consistent sterilization irradiation because the dose is precisely repeatable (constant monitoring)
• Fast treatment & Cost effective (for low to medium density products)
• Wide range of polymer compatibility compared to gamma sterilization
• Easy handling of the boxed products compared to complicated conveyor

• No carcinogenic gas-based to handle
• No quarantine time
• No degradation or material incompatibility
• No breathable packaging

MSE has recognized experts in the field of e-beam technology, and has a central place as a service provider, design office, engineering office, supplier of spare parts for industrial electron accelerators. In addition, MSE collaborates with almost all particle accelerator manufacturers worldwide. Contact us.