X-ray sterilization of biopharmaceutical manufacturing equipment-Extractables profile of a film material and copolyester Tritan™ compared to gamma irradiation.

ABSTRACT: The biopharmaceutical industry gains enormous flexibility in production processes by using sterilized preassembled single-use devices. Gamma irradiation is an established sterilization technology that may be restricted in the future by the availability of ⁶⁰ Co as irradiation source and irradiation capacities. X-ray technology is considered an alternative type of radiation for sterilizing SU equipment. In the context of extractables and leachables-one concern connected with the use of single-use process equipment-the effect of X-ray irradiation on the extractables profile of the materials needs to be compared to established gamma irradiation to qualify this alternative technology. An approach is presented to obtain robust and comprehensive extractables data for materials used in

SUBMITTER: Menzel R 

PROVIDER: S-EPMC9286515 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature