New S80 film features consistent cell growth, robustness and high quality
Flexsafe 3D Pre-designed Solutions meet all the functional and validation requirements of the biopharmaceutical industry
Sartorius Stedim Biotech (SSB), an international supplier to the biopharmaceutical industry, has developed a new polyethylene film and the Flexsafe family of bags that provide outstanding quality and significantly facilitate implementation of next-generation single-use factories.
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, the firm says.
Designed for storage and shipping of biopharmaceutical fluids, the new Flexsafe 3D Pre-designed Solutions (PDS) meet all the functional and validation requirements of the biopharmaceutical industry. They 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 the best delivery reliability and business continuity.
The 3D single-use bags are available in sizes from 50L to 1,000L and they are made of a robust, yet highly flexible, 400µm thick co-extruded film structure. 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 planes 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.
'With our Flexsafe PDS, customers can easily select and safely implement single-use solutions proven for each process step. They will fully benefit from excellent cell growth in upstream, robustness in downstream and a consistent extractable profile in final drug products,' said Jean-Marc Cappia, Vice President of Marketing for Fluid Management Technologies at SSB.