The proliferation of single-use systems (SUS) in the manufacturing 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 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 documents specify expectations, but do not include the exact procedures that need to be followed in an extractable and leachable study.

Industry collaborations, such as the BioPhorum Operations Group (BPOG), have published protocols to fill this gap. The BPOG protocol outlines an extractables test scheme that provides a comprehensive data set, to allow end users to compare products from multiple vendors.

Boston Analytical has experience running the BPOG protocol on various materials including: bags, tubing, connectors, filters, filtration cassettes, sensors, valves, gaskets, o-rings, mixer parts, and filling needles. We also can analyze materials per the USP <665> and USP <1665> standards that are being developed. We can help you with the BPOG protocol and/or single-use system extractable and leachable product analysis to aid in product material qualification and selection. Turn to us to provide you with complete BPOG testing expertise including BPOG extractables and leachables.