As the biopharmaceutical industry continues to adopt risk-based approaches to material qualification, USP <665> and USP <1665> provide important guidance for evaluating polymeric components used in process systems. These standards help manufacturers better understand the potential impact of materials on product quality and patient safety through extractables and leachables risk assessments.

Rubber Fab is prepared to support our customers’ USP <665> and USP <1665> initiatives.

Through comprehensive extractables testing, detailed material documentation, and technical expertise, Rubber Fab provides the information needed to support component qualification, risk assessments, and validation activities. Our testing programs generate scientifically based data that can be applied to customer-specific process conditions and product requirements.

While USP <665> and USP <1665> place responsibility for risk assessment and qualification with the end user, Rubber Fab serves as a trusted partner by providing the technical data and product knowledge needed to facilitate informed, science-based decision making.

Benefits to Customers

• Comprehensive extractables data packages
• Material traceability and supporting documentation
• Support for risk assessment and validation programs
• Enhanced confidence in component selection
• Alignment with current biopharmaceutical industry expectations

Rubber Fab remains committed to helping pharmaceutical and biotechnology manufacturers simplify qualification efforts while supporting product quality, regulatory compliance, and patient safety.