Save Time And Costs In Biopharma Production With Fully Characterized and Certified ProductsSource: Saint-Gobain Performance Plastics
Saint-Gobain Performance Plastics' products reduce validation costs and allow biopharmaceutical processes to start up in less time. Fully characterized and certified products also reduce regulatory compliance risk, such as missing documentation, which can shut down operations. To learn more about any of the services mentioned above or to request a complimentary Validation Guide CD, please contact your local distributor or Saint-Gobain contact.
For biopharmaceutical companies, the total cost of current good manufacturing practice (cGMP) compliance has become a significant percentage of the cost of goods sold. Some of the cost is driven by increasing regulation. Validating products for use in manufacturing and maintaining proper documentation to meet these regulations requires significant time and capital resources. Saint-Gobain Performance Plastics' line of biopharmaceutical single-use tubing, assemblies and components are fully characterized with all biological and physicochemical tests available on Validation Guide CDs. The CDs include test reports from third-party laboratories following United States Pharmacopoeia, ISO 10993, European Pharmacopoeia and Japanese Pharmacopoeia testing guidelines, performed on finished products.
Most Saint-Gobain products are also shipped with certificates that document the part number, lot number, date of manufacture, regulatory compliance and a brief physical material analysis. Special certifications regarding customer requirements such as animalderivative free, RoHs, latex-free, and shelf life are available upon request.