Single-use systems (SUS) are increasingly popular in biomanufacturing. For patient safety, biomanufacturers must systematically assess and mitigate risks posed by extractables and leachables (E&L) in these systems.

In the absence of official E&L guidance, manufacturers are fulfilling regulatory expectations by following the BioPhorum (formerly BPOG) protocol. Readily available extractables data helps manufacturers using single-use technology to accelerate product qualifications, risk assessments, and process optimization.​

In this whitepaper, you'll find:​

• An overview of the single-use systems landscape
• Guidance for evaluating SUS for extractables and leachables (E&L)
• Strategy for E&L validation
• Case study: A risk-based approach to E&L assessment of final sterilization, single-use assembly