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Flexsafe® Palletank 500 L (MPX,TPE/Opta®,TPE/Sampling)

Flexsafe® 3D Bags are designed for storage and shipping of large volume of biopharmaceutical solutions in Palletank from 100L to 1,000 L. They are supplied sterile and ready to use for an easy and convenient process implementation. The versatile range of Flexsafe® 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.:  FIS126748

Availability:  On Request

   

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. You can use our intuitive digital brochure to select your Flexsafe® 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 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

Alternatively, PDS are available with a sterile connection to another filter line to provide more flexibility.

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 1½” 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®

All fluid-contact components of Flexsafe® PDS are secured by supply contracts and quality agreements to provide:

  • Best quality, change control and business continuity with at least 24 months change notification
  • Best delivery reliability with available stocks
  • Compliance to quality standards: USP<87>& USP<88>, TSE/BSE, REACH

 

  • Bag Volume
    500 L
  • Filter
    Yes
  • Gas Barrier Layer Material
    Ethylene vinyl alcohol (EVOH)
  • Number of Lines
    1 filling line + 1 sampling at the top, 1 line at the bottom
  • Product Contact Layer Material
    Polyethylene (PE)
  • Sterilization Method
    • Sterile via gamma irradiation 25-45kGy
    • Gamma Irradiatable
  • Sterilization Procedures
    Gamma Irradiation: with 25-45 kGy, 1 Cycle

 

  • Connector Inlet
    Sterile weld or sanitary connection
  • Connector Outlet
    Sterile connection to other single-use Bioreactor; Sterile connection to downstream step
  • Materials of Construction
    Flexsafe® S80 film
  • Process Step
    • Media
    • Buffer
    • Cell Harvest & Downstream Processing Intermediates
    • Drug Substance Purification
  • Tubing
    • Top and bottom lines with 1/2" ID Silicone TuFlux® 1m (40") + 1/2" Clear C-Flex® 0,5m (20")
    • 5m (20")
Palletank for Shipping, 500 L
Palletank for Shipping, 500 L
Item no.: FXC106609

The Palletank for shipping is specifically developed for secure and convenient shipment of bulk pharmaceutical fluids such as media, buffers, drug substances or product intermediates. 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 for Storage, 500 L, Stackable Up to 2 units, 79 kg, 1,215 × 805 × 1,086 mm

Palletank for storage are stainless steel containers designed for the safe and robust storage of biopharmaceutical fluids contained in Flexsafe® 3D Bags. They are available in volumes of 200 L and 500 L. The Flexsafe® 3D Bags are manufactured according to a qualified design that precisely fits the Palletank.

Palletank for Storage, 500 L, not stackable, 92 kg, 1,192 × 792 × 1,060 mm

Palletank for storage are stainless steel containers designed for the safe and robust storage of biopharmaceutical fluids contained in Flexsafe® 3D Bags. They are available in volumes of 200 L and 500 L. The Flexsafe® 3D Bags are manufactured according to a qualified design that precisely fits the Palletank.

Palletank® Shipping Kit
Palletank® Shipping Kit
Item no.: FXC102478

The Palletank® for shipping is a qualified system that is specifically developed for safe and robust shipment of sterile 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 Dolly
Palletank Dolly
Item no.: FXA116631

The Palletank Dolly is a stainless steel caster built on wheels allowing to move around the Palletank.

Palletank Dolly
Palletank Dolly
Item no.: FXS102256

The Palletank Dolly is a stainless steel caster built on wheels allowing to move around the Palletank.

Palletank Dolly
Palletank Dolly
Item no.: FXS102257

The Palletank Dolly is a stainless steel caster built on wheels allowing to move around the Palletank.

Palletank In-Process Fluid Handling, 500 L, Stackable Up to 3 units, 111 kg

Palletank for In Process Fluid Handling are specifically developed for users who wish to leave the containers in close proximity to process equipment. It is available from 100L up-to 3,000L.