WMFTG expert talks about extractables studies on single-use components
A presentation delivered at INTERPHEX 2018 by the Group Product Compliance Manager at Watson-Marlow Fluid Technology Group, Sade Mokuolu PhD, focused on how to reduce risk in the product development process through the use of validated fluid path solutions.
In her presentation, Dr Mokuolu detailed how to qualify single-use (SU) assemblies consisting of tubing, connectors, gaskets and clamps into custom end-to-end fluid paths simplifying compliance with the latest industry regulations and GMP requirements.
Dr Mokuolu’s presentation describes the extractables studies undertaken on different types of SU components, in particular, fluid path products such as platinum-cured silicone tubing and polypropylene connectors.
Dr Mokuolu explains: “There is an intense debate on extractables between suppliers and end-users of SU components. Knowledge of extractables profiles can aid risk assessment strategies considerably and profiles can be used to understand whether there are components of potential concern. My presentation provides an essential forum for learning and discussion on an important topic that impacts on users’ ability to meet stringent regulatory compliance.”
The presentation also highlighted the methodology and the range of analytical techniques used to provide an extractables profile for fluid contact SU components.
Dr Mokuolu provided details on how different extraction solvents can provide a range of unique extractables profiles. In particular, how organic solvents can be more extracting than aqueous-based solvents.
Discussion points also included the differences in extractables profiles using alternative sterilisation methods, and the effect that post-curing of silicone tubing has on the presence of cyclosiloxanes.
Watch the thought leadership series on the use of extractables data from single-use components for risk assessment filmed by Pharmaceutical Technology.