The use of Extractable data from Single Use components for risk assessment

The use of Extractable data from Single Use components for risk assessment

04/18/2018, 11:30 AM - 12:15 PM

Technical Conference Stage 3, Booth 1376, Exhibit Hall

It has been over a decade since the first single use components were utilised with biopharmaceutical manufacturing. Single-Use technologies are now established as a suitable alternative to stainless steel as well as emerging within hydrid facilities. Single use systems comprises of tubing, connectors, gaskets, filters and biocontainers. These components have been used to manufacture a range of diverse biopharmaceuticals such as vaccines and therapies for rheumatoid arthritis, cancer and diabetes. The method of qualifying these components has been developed over the years as their use within biopharmaceutical manufacturing has increased. Within the expanding SUT industry, intense debate between suppliers and end users of SU components remains on extractables. Knowledge of the extractables profile can be immensely aid risk assessment strategies. They can be used to understand whether there are any components or compounds that leach and will present a potential safety concern. Within the biopharmaceutical industry there has been a growing requirement for more extensive detail around the extractables packages of single use components. In 2014, BPOG have published a detailed protocol on extractables testing. This protocol provided a framework for testing including the range of extraction solvents to be used, pre treatment of the components, extraction temperature and extraction time. Since then, USP have published a draft guidance which adopts a multi solvent extraction approach. The paper presented at this conference will describe the extractables studies undertaken on different types of single-use components in particular fluidpath products such as platinum cured silicone tubing and polypropylene connectors. It will highlight the methodology taken, and detail the range of analytical techniques used to provide an extractables profile for fluid contact single-use components. It detail how different extraction solvents can provide a range of unique extractables profile. In particular, how organic solvents can be more extracting than aqueous based solvents. Unique discussion points will also include the differences in the extractables profile depending on sterilisation methods and the effect that post curing of silicone tubing has on the presence of cyclosiloxanes. There will be a section on how to use extractables data to present a risk assessment strategy to a regulatory body to demonstrate that the safety and quality of the drug product is not impacted by the utilisation of polymeric components within the manufacturing process.


  • Sade Mokuolu




    Biography: Dr. Sade Mokuolu is Group Product Compliance Manager at Watson Marlow Fluid Technologies Group (WMFTG). Prior to joining Watson Marlow,...

Type of Session

  1. Type of Session

Learning Objectives

  1. Learning Objectives 1. Understand what is an extractable and a leachables. Know how to differentiate between extractables and leachables data. Understand how extractables data can facilitate future leachables studies. 2. Knowledge on how extractables data can be used to provide information on whether a multiple component polymeric manufacturing system contain any potential leachates of a safety concern to the patient. 3. Knowledge on the different approaches to risk assessment strategies and Quality by Design qualification techniques for the polymeric systems used in biopharmaceutical manufacturing.


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