TY - JOUR T1 - Validation of a Radiosterilization Procedure for Sterilization of a Solid-State Ophthalmic Insert System JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 246 LP - 250 VL - 39 IS - 6 AU - Barry Garfinkle AU - Joann Cochran AU - John Snyder AU - Geraldine Thrasher AU - Barbara Thompson AU - Stanley Orlowski AU - Richard J. Harwood,* AU - Edward M. Cohen Y1 - 1985/11/01 UR - http://journal.pda.org/content/39/6/246.abstract N2 - 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. ER -