Sartorius Stedim Biotech (SSB) has developed a new polyethylene film and the Flexsafe range of bags for storage and shipping of biopharmaceutical fluids.
SSB’s new Flexsafe 3D Pre-designed Solutions (PDS) are three-dimensional single-use bags in different sizes ranging from 50l to 1,000l.
Made out of highly flexible, 400µm thick co-extruded film structure, the single-use bags are compliant with all the functional and validation requirements of the biopharmaceutical industry.
The robustness of the 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, SSB said.
The bags offer suitable functionalities and quality controls that are required for upstream and downstream processing and in final filling of the biopharmaceutical fluids.
SSB fluid management technologies marketing vice president Jean-Marc Cappia said: "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."
The Flexsafe bags have undergone shipping tests conducted in both airplanes and trucks and by applying the ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems, which is designed to reflect worst-case conditions at several temperatures.
Based in France, SSB provides equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry.
The company’s solutions include solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies.
Image: The Flexsafe bags are made out of highly flexible, 400µm thick co-extruded film structure. Photo: courtesy of B3C newswire / Sartorius Stedim Biotech.