STD Flexboy® 50L (OPTA,LT/TC)
Flexboy® 2D Bags are available in bag chamber volumes between 5 mL and 50 L. They are supplied sterile and ready to use for an easy and convenient process implementation. The versatile range of Flexboy® Pre-Designed Solutions (PDS) allows for sterile filtration, storage and transfer of all biopharmaceutical fluids. Multiple configurations are provided for flexible incorporation in all process steps and are qualified against extensive biological, chemical,physical, extractable and cell growth testing.
Item no.: FFB128334
When you select Flexboy® Pre-Designed Solutions (PDS), you benefit of the best assurance of quality supply, robustness, ease of use, closure integrity and biocompatibility for every media, buffer, harvest & downstream intermediates, drug substance and drug product process steps. You can use our intuitive digital brochure to select your Flexboy® PDS in a few seconds. PDS help speed up process design, reduce the numbers of stock keeping units (SKU’s) and hence reduce inventory management complexity and costs.
- The performance and assurance of supply are based on the complete control of our manufacturing process from the resins, the film, the bags, the filters and the assembly. Other fluid-contact components are secured by strategic partnerships, long term contracts and quality agreements and are available off-the-shelf to provide best delivery reliability.
- A Proven robustness: the strength and flexibility of Flexboy® bags make them robust and suitable for all process steps. Combining material science and film expertize in partnership with our suppliers, we have selected the best raw materials and extrusion process parameters to obtain consistent robustness in the entire film extrusion design space
- The closure integrity of Flexboy® 2D bags has been ensured for the last two decades using multiple qualification tests, process controls and a 100% in-process leak test resulting in 20 million 2D bags safely used worldwide. The assurance of integrity is the result of the control of the manufacturing process along the entire product lifecycle. Our new Supplier Integrity Test (SIT) and FlexAct® BT point of use leak test will continue to improve the process, product, operator and patient safety of Flexboy® 2D bags used in critical process steps.
- An excellent and reproducible cell growth: the resins and additives used for the film of Flexboy® 2D bags are optimized to ensure excellent and reproducible growth. The control of our entire process guarantees consistent lot-to-lot cell growth after short and long term media storage.
Application AreaLiquid Storage & Shipping
Process StepDrug Substance Purification
Quality Standards100% visual inspection; 100% Bag Chamber Leak Testing
Inlet Line⅜" Opta® SFT female + ⅜" × ⅝" Silicone Tuflux® 300 mm (12") + ⅜" × 15/32" EVA 100 mm (4") + Clipster® in a separate pouch
Line LeakTest¼" × ⅜" Clear C-Flex® 300 mm (12") + Midisart® BV 0.2 μm + ¼" × 7/₁₆" Silicone Tuflux® 100 mm (4") + ¼" Tri-Clamp
Outlet Line⅜" HB Tri-Clamp ¾" sanitary flange with gasket, cap & union + ⅜" × ⅝" Silicone Tuflux® 300 mm (12") + ⅜" × 15/32" EVA 100 mm (4") + Clipster® in a separate pouch
Sampling LinesClave connector + ³/₁₆" Luer Lock Female + ³/₁₆" × ¼" EVA 50 mm (2")
Materials of Construction
Film MaterialFilm S71: Ethylene-vinyl acetate (EVA)
Maximum Allowable Working Temperature45 °C (113 °F)
Tray and Rack Systems are designed to facilitate handling of both individual and manifold Flexsafe®, Flexboy® and Flexel® 2D Bags from 5 L to 20 L within biopharmaceutical manufacturing processes.