Fluoropolymers play a critical role in the storage, freezing, and shipping of critical bioprocess fluids. Not all fluoropolymers are ideally suited for all applications, so it is important to understand the characteristics of each and the benefit of using one over another for your specific application. Most Common Fluoropolymer Materials Fluoropolymers have more commonalities than differences. Such characteristics include: Extremely high purity compared with other plastics used in bioprocessing, including very low or no measurable leachables or extractables Inert and…
Author Archives: by Eric Isberg
An Industry Proposal for Change Notification Practices for Single-Use Biomanufacturing Systems
Current practices for change notification in the biopharmaceutical industry are neither efficient nor conducive to accelerating the adoption of single-use systems (1, 2). Drug manufacturers (end users) often observe that supplier change data packages lack technical content or detail and that the time allowed for change implementation is too short. Occasionally, customers (end users or next tier in supply chain) learn of changes after the fact, possibly even by happenstance. Suppliers, however, can find the potential affect of a change…