A dose map, or dose distribution study, helps us determine if all of the product within your case is receiving the necessary sterilization dose. In this study, we take a measurement of the internal doses throughout a case of product. The case of product is opened by E-BEAM Services, and our trained lab technicians place dosimeters at […]
The electron beam sterilization process begins with an electron beam accelerator. E-BEAM Services uses high power state of the art accelerators to create a powerful beam of electrons. The beam is scanned back and forth to create a curtain of fast electrons, which shower and safely ionize the materials that they strike. There is […]
Medical device manufacturers want to know if their product is compatible with e-beam sterilization; they can do it by performing a simple experiment. This experiment includes exposing a number of samples to a range of doses to see the effects of the radiation on their product materials and the packaging. Not only will the […]
To claim your product is sterile after e-beam treatment, you must perform several validation steps, as regulated by ISO 11137. This validation process is comparable to that of gamma sterilization and it is simpler than the process for ETO sterilization. If you do not have a microbiology lab in-house, you will need to partner with […]
In order to determine if the necessary sterilization dose is delivered into a case of your product, we first need to perform a dose distribution (dose map) study. This study takes a measurement of the internal doses throughout a case of product. The case of product is opened by E-BEAM Services, and our trained […]
There are many reasons why manufacturers of medical devices or pharmaceutical products often switch to e-beam sterilization, such as the high reliability of the technology, the quick turnaround time, the low cost and the ease of validation. (For more information about the advantages of using e-beam for sterilization, see my blog “Why do companies choose […]
That question is usually answered with a generic “it depends,” but today I’m going to do my best to give you a useful answer, and to identify the key factors on which “it depends.” Hopefully by the end of this blog you’ll be able to make a pretty good estimate of the pricing your product […]