Conference Dates
March 20 – 23, 2022
Abstract
With single-use technologies playing a pivotal role supporting the rapid development and scale-out of vaccine manufacturing, the experience has highlighted benefits resulting from standardization of SUT requirements and identified key challenges ahead for SUT, including the availability of gamma irradiation capacity. This cobalt-60-dependent gamma irradiation market is led by a relatively small number of market providers, and underpins the entirety of the single-use bioprocess supply chain, regardless of integrator. As the demand for gamma irradiation has quickly outstripped the available industry capacity, significant collaborative industry efforts have been underway to qualify X-ray irradiation as an equivalent alternative to gamma irradiation, such that qualified SUS can be irradiated by either gamma or X-ray, depending on which modality as more readily available at the time of manufacture. In addition to highlighting an industry risk assessment and testing approach, which relies on prior knowledge of the irradiation physics, materials testing, and standardized component testing; data will be shared characterizing the impact of gamma and X-ray irradiation on SUS identifying any similarities and differences in the modalities.
Recommended Citation
James Hathcock, "Qualifying X-ray irradiation of single-use systems to address new challenges associated with single-use growth" 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/54