High-Dose Sterilisation Effects on Photopolymer Materials: Gamma, Electron Beam, Chemistry and Requalification

Radiation sterilisation is controlled by absorbed dose, dose distribution and process validation, but product qualification adds a separate question: whether the printed polymer and assembled device retain required performance after the intended sterilisation history. Gamma, electron beam and X-ray can produce similar bulk dose while differing in penetration and dose-rate characteristics. Polymer response can include chain scission, crosslinking, oxidation, colour change, modulus drift or loss of elongation, and those responses may depend on package atmosphere and ageing after irradiation. ER-388 therefore does not select a sterilisation route; that comparative decision remains outside its scope. Instead it defines how to requalify a photopolymer material or device after a declared radiation process using pre/post chemistry, thermal and mechanical evidence tied to functional requirements.