PT  - JOURNAL ARTICLE
AU  - Garfinkle, Barry
AU  - Cochran, Joann
AU  - Snyder, John
AU  - Thrasher, Geraldine
AU  - Thompson, Barbara
AU  - Orlowski, Stanley
AU  - Harwood,*, Richard J.
AU  - Cohen, Edward M.
TI  - Validation of a Radiosterilization Procedure for Sterilization of a Solid-State Ophthalmic Insert System
DP  - 1985 Nov 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 246--250
VI  - 39
IP  - 6
4099  - http://journal.pda.org/content/39/6/246.short
4100  - http://journal.pda.org/content/39/6/246.full
SO  - PDA J Pharm Sci Technol1985 Nov 01; 39
AB  - 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.