RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 246
OP 250
VO 39
IS 6
A1 Garfinkle, Barry
A1 Cochran, Joann
A1 Snyder, John
A1 Thrasher, Geraldine
A1 Thompson, Barbara
A1 Orlowski, Stanley
A1 Harwood,*, Richard J.
A1 Cohen, Edward M.
YR 1985
UL http://journal.pda.org/content/39/6/246.abstract
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.