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Flexsafe 3D Pre-Designed Solutions feature appropriate components, functionalities, and quality controls that meet the specific requirements of each step in upstream and downstream processing and in final filling.
Sartorius Stedim Biotech (SSB) has developed a new polyethylene film and the Flexsafe family of bags for single-use implementation in biopharmaceutical manufacturing processes. Proper control of the resins, film, bags, and their final assembly, as well as dedicated supply chain and quality management for critical fluid-contact components, provide assurance of supply, reliable performance, and a consistent extractables and leachables profile of Flexsafe across all process steps.
The company launched its new Flexsafe 3D Pre-designed Solutions for storage and shipping of biopharmaceutical fluids on Oct. 15, 2015. According to SSB, these solutions feature 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. In addition, their availability is backed by at least 24-month change notification to provide the best delivery reliability and business continuity.
The three-dimensional single-use bags are available in a range of sizes from 50L to 1,000L and are made of robust but highly flexible 400-µm thick co-extruded film structure. The strength of the film reduces the risk of damage to the bag, and its flexibility ensures easy installation and self-deployment of bags in containers. The robustness of Flexsafe bags has been demonstrated by shipping tests conducted in airplanes and trucks and by applying stringent ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems, designed to reflect worst-case conditions at several temperatures.
Source: Sartorius Stedim Biotech