Extractables & Leachables - Single Use System

The proliferation of single-use systems (SUS) in the manufacture of pharmaceuticals and biopharmaceuticals has lowered costs and increased efficiency. Single-use systems, comprised of polymeric materials, offer many advantages over glass and stainless steel. However, selection and qualification of the most appropriate material and vendor can be challenging.

One challenge is that polymeric materials present a leachables risk. A second is that regulatory guidance does not include prescriptive procedures that can be followed in an extractable and leachable study.  It is important to find a partner that can successfully navigate both material selection and qualification for SUS materials.

SUS Product Testing Services

We can help you with single-use system component extractable and leachable analysis to aid in component material selection and qualification. Turn to us to provide you with complete expertise with single use system component testing per either the BPOG protocol or USP <665> and <1665> guidance.

  • SUS Component Selection per BPOG E&L Protocol
  • SUS Component Qualification per USP <665> and <1665>

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BPOG Protocol for Material Selection

Industry collaborations, such as the BioPhorum Operations Group (BPOG), have published protocols to standardize E&L testing of SUS components. The BPOG protocol outlines an extractables test scheme that provides a comprehensive data set, to allow end-users to compare products from multiple vendors.

BA Sciences has experience executing the BPOG protocol on various materials including: bags, tubing, connectors, filters, filtration cassettes, sensors, valves, gaskets, o-rings, mixer parts, and filling needles. Our testing lab can help you generate accurate data following the BPOG protocol.

USP <665> and USP <1665> for Material Qualification

Once a single use system component is selected for use in a manufacturing process, it is critical to adequately qualify it for use with regards to extractables and leachables.  USP chapter <665> Plastic Components and System Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products and the companion chapter USP <1665>  Characterization and Qualification of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products were developed specifically for SUS material qualification. BA Sciences has extensive experience performing E&L testing on SUS components to qualify them for use in a manufacturing process.  We also can work with you to qualify your entire manufacturing process, to ensure unwanted leachables are not migrating from the process component materials into the product during manufacture.

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