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 gained through AAMI TIR17, Compatibility of Materials Subject to Sterilization, which covers a variety of materials and sterilization methodologies. (See also the blog Is my product compatible with e-beam sterilization?).
However, conducting a trial on the actual product is almost always necessary – not only because you need to understand the impact of the e-beam irradiation on the product, but also because the standard on sterilization of health care products using radiation, ISO 11137, requires you to establish a maximum allowable dose. With a good experimental design, the maximum dose can be established during the same trial to determine material compatibility. For such a trial, we will expose a number of your samples to a range of doses so you can see the effect of the radiation. The samples are often processed in a single layer to ensure a uniform dose, and then sent back to you for evaluation by your company or a test laboratory. The number of samples needed for such a trial ultimately comes down to the number of samples needed for the evaluation or testing to be conducted.
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