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ACHEMA Presentation Provides Focus on the Use of Extractables Data from Single-Use Components for Risk Assessment
publication date: Jun 13, 2018
author/source: Watson-Marlow Pumps Group
A presentation to be delivered at ACHEMA 2018 by the Group Product Compliance Manager at Watson-Marlow Fluid Technology Group, Sade Mokuolu Ph.D, will focus on how to reduce risk in the product development process through the use of validated fluid path solutions.
Dr Mokuolu’s presentation is part of the event Process analytical technology - Bio-chemical processes II.
In her presentation (which takes place on 13.06.18 at 16.00-16.30 in Hall CMF ‘Harmonie 1’) Dr Mokuolu will detail 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 paper will go on to describe 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 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 will also highlight the methodology and the range of analytical techniques used to provide an extractables profile for fluid contact SU components.
Dr Mokuolu will provide 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 will include the differences in extractables profiles using alternative sterilisation methods, and the effect that post-curing of silicone tubing has on the presence of cyclosiloxanes.
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