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 lab […]
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 […]
Often, the first step in the qualification process is to determine the compatibility of your product with e-beam radiation. Some materials can experience a change in their properties with e-beam, so it is important to ensure the stability of your material and packaging at the beginning of the qualification process. Some initial guidance can be […]