Filter integrity testing is a crucial requirement in biopharmaceutical production processes. Automatic test units perform indirect tests to verify the pore size to be as specified for a sterilizing-grade membrane filter. Different test methods are established for which a specific test pressure is applied to a wetted membrane.
The Supply Chain Information Sharing and Analysis Center's primary mission is to facilitate communication among supply chain dependent industry stakeholders in order to help secure the global supply chain. Towards this end, the SC-ISAC has created a vetted group of trusted community including manufacturers, shippers, distributors, consignees, law enforcement, and insurance entities, where critical information impacting the supply chain is shared.
The transportation and logistics world is accustomed to complying with regulations, from the Department of Transportation, to the International Air Transport Association and country-specific import and export regulations. With the implementation of Good Distribution Practices in the European Union, it is inevitable that the U.S. will follow suit and the Food and Drug Administration will adopt GDP as well.
Attend any major conference on the cold chain logistics industry, and you'll see similar emerging topics for debate. For example, around supply chain visibility, temperature monitoring and delivering proof of product integrity.