Preliminary evaluation of PendoTECH® single use sensors post X-ray irradiation
March 20 – 23, 2022
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.
Please click Additional Files below to see the full abstract.
Nick Troise and James Furey, "Preliminary evaluation of PendoTECH® single use sensors post X-ray irradiation" in "Single-Use Technologies V: Building The Future", Magali Barbaroux, Sartorius, France; Martina Micheletti, University College London, UK Eds, ECI Symposium Series, (2022). https://dc.engconfintl.org/sut_v/7