This relates primarily to components which are manufactured from the same material using the same process. Suppliers are asked to generate data on one size of component and define which components the testing covers along with physical characteristics (component mass and fluid contact area) of the components. Physical characteristics of the test article must also be provided.
The component family template is the recommended format for providing this information.
In cases where an integrator is providing single use assemblies, possibly of different sizes, it is important that a biomanufacturer can identify which components are used in the assembly and which extractables study is relevant for that component. This information should be provided in the assembly family template.
Data Pass through
In order to make the system as efficient as possible integrators should not need to retest components that have been already tested by component manufacturers. This is achieved by component suppliers allowing integrators to pass on data to the customers. This is made frictionless by the removal of 3 way confidentiality agreements (CDA / NDA) between supplier integrator and end user. This approach is described in more details in guidelines or ‘Rules of the Road’ available here.