Sartorius Stedim Biotech (SSB) has developed a new polyethylene film and the Flexsafe® family of bags. The complete control of the resins, film, bags, and their final assembly, as well as dedicated supply chain and quality management for critical fluid-contact components, provides assurance of supply, reliable performance, and a consistent extractable/leachable profile of Flexsafe across all process steps.
Designed for storage and shipping of biopharmaceutical fluids, SSB’s new Flexsafe 3D Pre-designed Solutions (PDS) meet all the functional and validation requirements of the biopharmaceutical industry. These products feature the appropriate components, functionalities, and quality controls that meet the specific requirements of each step in upstream and downstream processing and in final filling. Fluid-contact components are available off the shelf, and their availability is backed by at least 24-month change notification to provide delivery reliability and business continuity.
The three-dimensional, single-use bags are available in a range of sizes from 50 L to 1,000 L and are made of exceptionally robust yet highly flexible 400-µm thick co-extruded film. The strength of this film reduces the risk of damage to the bag, and its flexibility ensures easy installation and self-deployment of bags in containers, such as SSB’s stainless steel or plastic Palletanks®.
The robustness of Flexsafe bags has been demonstrated by shipping tests conducted in both airplanes and trucks and by applying the most stringent ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems. This standard is designed to reflect worst-case conditions at several temperatures.
