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Flexsafe® 3D Bag for Palletank® 100 L

Flexsafe® 3D Bags are designed for storage and shipping of large volume of biopharmaceutical fluids in Palletank®. The large range of Flexsafe® Pre-Designed Solutions (PDS) from 100 L to 3000 L allows for storage, sampling, transfer and shipping in all process steps.

Item no.:  FIS301530

 

* 72 Hours Turnaround Time

When you select Flexsafe® Pre-Designed Solutions (PDS), you benefit of the best assurance of supply, robustness, ease of use and biocompatibility for every media, buffer, harvest & downstream intermediates, drug substance and drug product process steps. 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 Flexafe® 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 superior strength and flexibility of Flexsafe® bags make them safe for critical liquid shipping applications. The robustness of Flexsafe® bags for Shipping is proven by applying extensive qualification regimes that combine the most stringent standard ASTM D4169 testing and real shipping conditions.
  • The high flexibility of Flexsafe® bags and the self-deploying accessory ease the installation and the filling of Flexsafe® storage solutions, saving operator time and eliminating risky bag manipulations. The self-deploying accessory is compatible with the Palletank® for Storage and for In-Process Fluid Handling from 100 L to 1,000 L.
  • An excellent and reproducible cell growth: the resins and additives used for the film of Flexsafe® 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.

Flexsafe® bags are available as stand-alone bags and as filter & bag assemblies incorporating a variety of filter and bag sizes allowing easy adaptation to process volumes.

Inlet Filters and Connectors

Flexsafe® PDS are available with four sterilizing filtration options.

  • Sartopore® 2 sterilizing-grade filter with 0.45 | 0.2 μm membranes optimized for buffer filtration
  • Sartopore® 2 XLG sterilizing-grade filter with 0.8 | 0.2 μm membranes optimized for media filtration, cell harvest & downstream intermediates
  • Sartopore® 2 XLM filter with advanced 0.2 | 0.1 μm pore size distribution and asymmetric prefilter membrane optimized for mycoplasma retention in media
  • Sartopore® Platinum sterilizing-grade filter with 0.45 | 0.2 μm membranes optimized for drug substance and drug product filtration. The outstanding wetting properties of the modified membrane reduce by ten times the flushing volumes required prior to integrity testing

The filter line is either connected with Opta® or welded with Biowelder® TC and subsequently disconnected for integrity using Biosealer®.

Another option is to perform an aseptic connection under Laminar Air Flow (LAF) using CPC quick couplers.

Outlet Connectors

  • Opta® SFT Male enables sterile connections to other single-use systems
  • STCII Steamthru valve allows for steaming and sterile transfer to stainless steel systems
  • CPC quick couplers are used for either sanitary connection or aseptic connection under ISO5 laminar air flow to single-use systems
  • Tri-Clamp 1.5" sanitary flange are used for either sanitary connection or aseptic connection under ISO5 laminar air flow to stainless steel systems
  • Clave needleless sampling port enables for sterile sampling

Tubes

  • Tuflux® silicone tubing enables sterile disconnection with Clipster®
  • Clear C-Flex® tubing allows for sterile weld connection with Biowelder® TC and sterile seal disconnection with Biosealer®

Applications

  • Application Area
    Liquid Storage & Shipping

Connections (Physical)

  • Inlet Line
    1/2" Opta® SFT Female + 1/2" ID TPE (C-Flex®) 0.5 m (20") + 1/2" ID Silicone (Tuflux® SIL) 1 m (40")
  • Line LeakTest
    1.5" Tri-Clamp sanitary flange + 1/2" ID TPE (C-Flex®) 1.5 m (60") + Sartopore® Air filter 0.2 μm size 7
  • Outlet Line
    1/2" Opta® SFT Male + 1/2" ID Silicone (Tuflux® SIL) 1 m (40") + 1/2" ID TPE (C-Flex®) 0.5 m (20")

Materials of Construction

  • Film Material
    Film S80: Polyethylene (PE)

Product Information

  • Brand
    Flexsafe® 3D
  • Pack Size
    3

Sterility

  • Delivery Condition
    Sterile

Volumes

  • Volume
    100 L
Palletank® for Shipping
Item no.
M_Palletank_for_Shipping

Palletank® for shipping are specifically developed for secure and convenient shipment of bulk pharmaceutical fluids. It is available in volumes of 100 L, 200 L and 500 L. The system is composed of two basic elements, the Palletank® container and the associated shipping kit.

Palletank® and Drums for Storage
Item no.
M_Palletank_for_storage

Palletank® and drums for storage are containers designed for the safe and robust storage of biopharmaceutical fluids such as high value drug substances contained in Flexsafe® 3D Bags. They are available in volumes of 50 L, 100 L, 200 L, 500 L, 1,000 L, 1,500 L, 2,000 L, 2,500 L and 3,000 L.