Alexander M. Harmon - Clinton NJ, US Laura J. Brown - Hamilton Square NJ, US Charles J. Buckle - Hillsborough NJ, US Frederick Halperin - Hillsborough NJ, US Stanko Bodnar - Whitehouse Station NJ, US
Assignee:
DePuy Synthes Products, LLC - Raynham MA
International Classification:
C12N 1/06
US Classification:
4353171, 424520
Abstract:
Provided are methods for sterilizing a material comprising a biologically-active agent comprising irradiating said material with ionizing radiation at a dose of about 5 kGy to about 25 kGy while maintaining said material in an atmosphere comprising at least 95% by volume inert gas and at a temperature of about 4 C. or lower. Also provided are sterilized materials comprising a biologically-active agent, wherein said materials exhibit substantially the same amount of biological activity as a non-sterilized control.
Methods For Sterilizing Materials Containing Biologically Active Agents
Alexander M. Harmon - Clinton NJ, US Laura J. Brown - Hamilton Square NJ, US Charles J. Buckle - Hillsborough NJ, US Frederick Halperin - Hillsborough NJ, US Stanko Bodnar - Whitehouse Station NJ, US
Assignee:
Ethicon, Incorporated - Sommerville NJ
International Classification:
B01J 19/08
US Classification:
20415821
Abstract:
Provided are methods for sterilizing a material comprising a biologically-active agent comprising irradiating said material with ionizing radiation at a dose of about 5 kGy to about 25 kGy while maintaining said material in an atmosphere comprising at least 95% by volume inert gas and at a temperature of about 4 C. or lower. Also provided are sterilized materials comprising a biologically-active agent, wherein said materials exhibit substantially the same amount of biological activity as a non-sterilized control.