In day-to-day operations, when E-BEAM uses electron beams to sterilize products, we do not verify that sterilization has occurred. This might sound a little scary, but fear not. We have a process to ensure that the desired bioreduction has taken place.
The first step is a round of extensive testing conducted between E-BEAM Services and the certified microbiology laboratory that the client designates (if the client doesn’t have a lab in mind, E-BEAM can recommend a trusted partner lab). This phase is called Dose Mapping. Through this, we establish the precise dose of electron beam radiation required to achieve the elimination of bioburden for that specific product, inside of that specific packaging. Once that dose is established, we can reproduce the same result every time.
Throughout the Dose Mapping process, dosimeters are present to establish how much radiation is penetrating the packaging and reaching the products.
Here is a dosimeter in its original packaging.
Here is a dosimeter after exposure.
A dye is activated by the electron beam radiation, ranging in intensity from pale to dark pink.
Once the required dose is known, it’s E-BEAM’S job to consistently deliver the same levels according to the density of the product and packaging.
This process is repeatable. During both validation and routine processing, dosimeters are strategically placed throughout the product load to measure absorbed dose. After exposure, the dosimeters are analyzed using specialized instruments that measure light absorption at specific wavelengths.
The film is calibrated by exposing samples side-by-side with transfer dosimeters from a national standards organization, such as NIST or Phoenix National Laboratory, and developing calibration curves. These results enable us to translate the colored film into a precisely measured dose, and to certify that your product received the proper dose to be considered sterile.
In other words, while we are not testing each product for sterility after processing, we are verifying that every load receives the validated dose that has been demonstrated to achieve the required level of sterilization assurance.
Interested in starting the process for your product? Contact our team to set up an introductory meeting.
