Abstract
Terminal sterilization of “dry” powder, semi-solid, solid-ophthalmic of parenteral products by gamma irradiation can be a visable alternative to conventional sterilization technology. The development of a validated, convenient cobalt 60 gamma irradiation sterilization procedure for LACRISERT® (Merck Sharp & Dohme) is discussed in this paper. Selection of an irradiation dose of not less than 7 times the D10 value of 0.17 but less than 2 megarads assured product sterility without product alteration.
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