Radiation sterilizable disposable probe and method of quality assurance of a disposable probe

摘要

An irradiation sterilizable disposable probe for a disposable component intended for use in a biopharmaceutical process includes at least one sensor relevant to the biopharmaceutical process, an RFID tag, and a rewriteable memory in which data regarding integrity testing of the disposable probe is stored. A method for quality assurance of such a disposable probe comprises the following steps: providing the disposable probe with an RFID tag and a fundamentally rewritable memory, in particular of the type FeRAM, which is preferably part of the RFID tag; Definition of a measuring principle-specific quality parameter of the disposable probe; Setting a tolerance value for the measuring principle-specific quality parameter; Performing a first part of an integrity test of the disposable probe prior to sterilization of the disposable probe by irradiation, wherein current values of the measuring principle-specific quality parameter are determined and written to the memory; Performing a second part of an integrity test of the disposable probe after the irradiation sterilization, wherein current values of the measuring principle-specific quality parameter are determined; and evaluating the integrity check, whereby the values of the measuring principle-specific quality parameter determined before and after the irradiation sterilization are compared with one another.