Radiation sterilization of a bifunctional cement formulation of hydroxilapatite-plaster-polymers.
A sterilization method based on the use of gamma ionizing radiation was applied to a cement formulation of hydroxilapatite, plaster and polymers to be used in bone restorations in dental, aesthetic, and neurological surgery. After the cement was exposed to a dose of 21.5 kGy it reached the sterility assurance level which was necessary for its employment in surgical applications as specified by International Standard ISO ordinate 11137: Radiation Sterilization of Health Care Products. No variation in the initial cement composition or processing parameters, such as working or setting time and molding quality was observed due to sterilization. Its characteristics as a drug delivery system were also not affected. Therefore, radiation sterilization provides a feasible alternative to conventional sterilization methods such as dry/wet heat and ethylene oxide.
Sainz Vidal
D
D
Department of Radiobiology and Irradiation Techniques, CEADEN, Miramar, C. Habana, Cuba.
Rodriquez Napoles
D
D
Fuentes Estevez
G
G
Guerra
M
M
Arcis Soriano
W
W
Peon Aves
E
E
Diaz Argota
J M
JM
Zaldivar Silva
D
D
D001672:Biocompatible Materials; D001843:Bone Cements; D005720:Gamma Rays; D006882:Hydroxyapatites; D011108:Polymers; D013055:Spectrophotometry, Infrared; D013242:Sterilization / Q000379:methods*
D001672:Biocompatible Materials; D001843:Bone Cements; D006882:Hydroxyapatites; D011108:Polymers