Extractables & Leachables for Suppliers

If you are a supplier of single-use system (SUS) products or other materials used to manufacture or store pharmaceuticals then you are likely receiving requests from your customers for extractable data. It can be a daunting task to understand the testing that is required, or which will make your products more competitive.

USP is currently working on guidelines for single-use systems used in the pharma/biopharma industry (USP <665>). Additionally, the BioPhorum Operations Group (BPOG) has published a recommended set of extractables tests that each supplier should perform to provide a complete E&L data package to end users. These recommendations are very comprehensive, with extraction by 6 solvents for up to 70 days in duplicate.

Many suppliers choose to perform the complete set of tests, but some prefer an approach guided by the specific needs of their products or customers.

Regardless of whether you need complete USP <665> and BPOG testing or a modified approach, we have the experience and capabilities to design and implement the most efficient study to achieve your commercial goals.

  It was a pleasure working with the entire VR Analytical team!
Engineer,
Leading Biopharma Supply Company

Contact us today for an educational webinar to understand how E&L impacts market dynamics, and how to ensure that your products are competitive as possible.