Material safety verification and qualification of single-use consumables is a critical part of assessing the suitability of a drug manufacturing device. We work extensively with our global biotech pharmaceutical customers, leveraging our years of application experience and evolving technology to ensure they have access to the appropriate technical and compliance data to help them manufacture safe medicines in the most consistent way possible.
Our fluid line connection technology provides the latest and industry-leading test data to help our customers meet GMP requirements. As industry requirements for single-use devices continue to increase, our in-house validation experts are constantly monitoring industry regulatory and industry expectations to ensure that our compliance data reflects current market expectations and regulatory standards.We support product technical data and test methods detailed in global pharmacopeias including USP, EP and International Standards. Validation test data and compliance information are listed in our internal repositories, including Validation Summary Guidelines, Compliance Guidelines listing Regulatory Material Claims, and Complete Validation Guidelines.
The Verification Summary Guide is available to all customers seeking detailed information on our products, and can contact our Sales Consultants for a complete Verification Guide and Compliance Guide if required.
