BPSA White Paper – X-Ray Sterilization of Single-Use BioProcess Equipment

The BPSA (Bio-Process Systems Alliance) has published it’s White Paper ‘X-Ray Sterilization of Single-Use BioProcess Equipment: Part 1 – Industry Needs, Requirements and Risk Evaluation’.

The document highlights sterilisation capacity constraints and how X-ray technology is positioned as a highly similar alternative to gamma.  It discusses issues such as qualification of alternative technologies such as X-ray and the increased flexibility that this may bring including the ability to meet spikes in sterilisation demand and the possibility of less unwanted effects on plastics. Technical similarities and differences between X-ray and gamma are reviewed as well as a risk-based testing strategy for evaluation of X-ray sterilisation of single-use systems. The consensus testing strategy indicates the types of data that may be generated by single-use suppliers on representative single-use materials and is expected to confirm that existing gamma-irradiation validation packages can be considered applicable to X-ray.

The White paper can be downloaded from the BPSA website at https://bpsalliance.org/pdf-download-form-xray-part1/

It is understood that BPSA will publish a Part II that will contain shared qualification data from multiple manufacturers.


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