Sterilization method

Even if all of these factors have been adequately controlled and are appropriate to the end use, the method of sterilization could introduce problems from incomplete sterilization or damage of the material during sterilization. There are a number of serious limitations that certain materials place on sterilization conditions. For example, the intraocular lens cannot be irradiated since it introduces coloration in the lens, nor can it be heat sterilized because the shape (and optics) of the rigid poly(methyl methacrylate) (PMMA) lens would change above the glass transition temperature of the PMMA. Ethylene oxide also cannot be used in a number of cases because of solubility within and/or reactivity with the biomaterial. These limitations are sometimes so severe that the sterilization protocol may not adequately sterilize the device. Incomplete sterilization, of course, can lead to infection and failure.

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