Alternative to Gamma
This workstream is currently focused on seeking to develop an industry-wide validation package and change notification process to introduce X-ray sterilization for single-use systems, alongside gamma irradiation, acceptable to regulators and customers. It is leveraging BioPhorum and BPSA best practice around change notification and regulatory quality by design (QbD) to support best practice across the industry. There is also interest in looking at alternative solutions and at operational efficiencies that will mean that sterilization will not become a constraint on growth or a risk to the surety of supply for our industry.
Capacity and risk concerns
- Capacity concerns in a growing market for Irradiation services – no more Gamma capacity is to be built
- Fixed locations of facilities exacerbate regional issues
- Unstable supply chain for Cobalt 60 source materials
- Difficult materials to handle – Sustainability issues longer-term
- Material compatibility – not all SUS materials are suitable (non-homogenous)
- Biological materials – sensitivities, viral load considerations (e.g., serum)
- Performance and cosmetic issues – because of the operating limitations
Reducing supply risks
- Access to use of alternative sterilization approaches in other regions of the world – Pandemic resilience!
- Long-term future and viability of single-use
- More suppliers available
- Easier to start up an X-ray facility vs a gamma facility
Process improvement and Lead time:
- Lead times
- Option to sterilize close to manufacture – better-located facilities for sterilization (not contingent on cobalt 60 acceptance)
- Sustainability – Environment – Positive impact on cost – Total Cost of Ownership
Flexibility for accepted sterility options:
- Materials may have better outcomes from alternative sterilization – e.g., Less extractables –opportunity for other materials to be used in SUS Technology?
- Alternative for raw materials as biological materials will behave differently
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.
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