The reliable supply of biological-based medicinal therapies is highly dependent on a robust, well-planned, and risk-managed supply chain. Learn how a partnership built on technical expertise and trust is helping to secure the supply of a single-use film built for bioprocessing.
The need for a film constructed specifically to meet the complex bioprocessing nature of a multitude of biologics was great. Fortem film is purposefully designed and developed with a carefully selected raw material, incorporating advanced manufacturing technology with an overarching focus on transparency along the entire supply chain.
The challenge of designing a universal film requires a number of competing properties, and the functional requirements of every application must be balanced against one another. A number of considerations must be measured while doing so. These include choice of polymers, film thickness, flexural properties, degree of crystallinity, resistance to gas transmission, and many more.
As it stands, there are no current standards in place for the testing of single-use extractables and leachables (E&L). Organizations such as the Bio-Process Systems Alliance (BPSA) have adopted their own set of standards for E&L testing, though the need for a standard approach is clear — particularly where end users using single-use equipment as a manufacturing strategy are concerned.
Application Performance: Single-Use Platform Film
To design a single-use platform film that stretches across bioprocessing the functional requirements of every application must be balanced against one another while weighing a host of considerations: choice of polymers, film thickness, flexural properties, degree of crystallinity, resistance to gas transmission, and many more.