Challenge

A medical device company developing a drug-device combination product encountered regulatory roadblocks while developing a dry powder inhaler (DPI). Previous polymer suppliers failed to meet essential extractables & leachables (E&L) requirements. Some vendors lacked sufficient regulatory documentation or traceable GMP controls, while others failed E&L testing.

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Chemva’s Solution

Chemva implemented a multi-step vendor qualification strategy to identify a reliable source of medical-grade polymer materials.
Our approach included:

• E&L data review provided by the supplier to screen for CMR substances and other harmful extractables.
• Gap assessments against USP <661>, ISO 10993-18, and other material safety standards.
• Technical evaluations of polymer compatibility with the device design to ensure inhaler performance and dose consistency.

Through this structured process, Chemva helped select a supplier that met all regulatory and quality expectations.
The sponsor later performed an E&L study on their finished product which led to passing E&L studies with favorable TRA.

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Impact Delivered

By securing a high-purity, regulatory-compliant polymer source, Chemva helped the partner reduce regulatory delays. In addition to enabling smoother FDA interactions, the selected material improved device reliability and patient safety by eliminating harmful leachables and enhancing performance consistency.