Introduction to x-ray and gamma sterilization methods

Biopharmaceutical manufacturing uses a lot of single-use systems (SUS) in the processing and development of drug products. SUS equipment is generally designed to be used once (for a single manufacturing process, such as a large plastic bag within a bioreactor and then discarded). Because SUS is so closely associated with the biomanufacturing process, all components, which are primarily plastic must be delivered sealed
and sterilized to drug manufacturers.

At the moment, the primary sterilization modality for SUS is gamma irradiation. There is a high global demand for gamma-irradiation sterilization and this could potentially cause problems within the biomanufacturing supply chain. Given the demand for drug products involving sterilized SUS, there could easily be a situation where demand outstrips supply.

It is therefore sensible to consider different sterilization modalities, alongside gamma, to provide a range of options for biomanufacturers and to support surety of drug production and supply. This introduction considers one alternative
x-ray as one similar yet different alternative. This paper provides a lay person’s introduction to the need for change, the basic physics involved and a high-level comparison between x-ray and gamma.

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• Create Date 11th August 2021
• DOI https://doi.org/10.46220/2021SP002
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