SUS: X-Ray Sterilization
Biomanufacturers and single-use systems suppliers working together to mitigate risk in the introduction of X-ray as an additional sterilization technology for single-use systems.
No standard approach to evaluating the introduction of X-ray irradiation
With the requirement to implement X-ray irradiation as an additional irradiation technology becoming urgent due to capacity constraints, it is not feasible for single-use systems end users to perform an in-depth risk assessment of every component subject to the change. The lack of a standard approach is leading to a risk of individual companies interpreting and approaching the change and submitting filing changes in diverse ways.
A data-driven, risk-based, harmonized approach was required to proactively evaluate equivalency between Gamma and X-ray treated products to ultimately reduce or mitigate any specific risk assessment needs at local manufacturing sites. The approach introduces key concepts and tools to simplify the application of the previously published BPSA data. It will also provide the regulators with well-documented, consistent and aligned reports to support filing changes, to simplify their review and acceptance.
Accelerate implementation through collaborative bioassay studies using sensitive cell lines
The study will complement existing data showing equivalence between Gamma and X-ray irradiation and is anticipated to confirm that X-ray irradiated Single-use technology (SUT) materials has no detrimental effect on sensitive cell line growth and productivity when compared with gamma. Currently, the potential for any cytotoxic leachables to be generated during X-ray irradiation is unknown.
This approach will present the greatest opportunity to generate applicable data across a large number of cell lines, covering and replicating a number of polymer constructions whilst spreading the risk and enabling testing to be completed in parallel.
SUS: X-Ray Sterilization deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
To find out more about how BioPhorum can help your business, enter your details below and a member of our team will be in touch.