The use of extractables data from SUS components for risk assessment
Single-Use Technologies are now established as a suitable alternative to stainless steel as well as emerging within hydrid facilities. Within the expanding SUT industry, intense debate between suppliers and end users of SU components remains on extractables. To this end, BPOG have published a detailed protocol on extractables testing. This paper will describe the extractables studies undertaken on different types of single-use components including platinum cured silicone tubing and polypropylene connectors following the BPOG protocol. 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. 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 the use of extractables data for risk assessment.
About Dr. Sade Mokuolu, she is Group Product Compliance Manager at Watson Marlow Fluid Technologies Group (WMFTG). Prior to joining Watson Marlow, she was employed at Pall providing technical guidance on E & L SUS studies and has presented at international conferences on E & L testing on behalf of the BPSA, as well as delivered training to Australian and European regulators. Additionally, she has extensive pharmaceutical manufacturing experience gained whilst employed by SAFC and Aesica Pharma as a Senior Process, Research and Development chemist.