SUS: Interchangeable Parts
Biomanufacturers and single-use systems suppliers working together to address the current lack of industry consensus on how to assess and qualify SUS component and assembly equivalence/interchangeability.
Enabling greater process efficiency and supply resilience through component interchangeability
Currently, there is no industry consensus or agreed standards on how to evaluate and qualify alternate components within a single-use systems assembly. Criteria are developed at a company level and complexity is further increased by supply chain constraints requiring dual-sourcing strategies to mitigate supply continuity risks.
Reaching consensus on how to evaluate component equivalency will enable proactive and reactive flexibility of assembly components and build flexibility by design. This will reduce the number of changes and support faster evaluation of best practice based on risk assessment and data-driven defense of change with regulators.
SUS: Interchangeable Parts 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.
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