Title

Preliminary evaluation of PendoTECH® single use sensors post X-ray irradiation

Conference Dates

March 20 – 23, 2022

Abstract

With the ongoing growth of the biopharmaceutical, vaccine, and cell and gene therapy markets, and the increasing demand on existing sterilization facilities for materials required in manufacturing processes, X-ray irradiation for sterilization has caught the eye of the industry. As an innovative industry leader, PendoTECH has evaluated the compatibility of its various Single Use Sensors with X-ray irradiation for sterilization. This poster details a preliminary study performed on PendoTECH Single Use Pressure, UV/Turbidity, and Temperature sensors. A small sample size of sensors was X-ray irradiated at 41.5 to 44.6 kGy, and then checked for physical integrity (via leak testing) and accuracy to validate the performance of the sensors. All pressure, UV/turbidity, and temperature sensors were demonstrated to be reliable, and were within specification post X-ray irradiation. Although this is a preliminary study, these results suggests that PendoTECH sensors are compatible with X-ray irradiation and they are expected to pass the full qualification currently in progress.

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