Flexsafe® Palletank® 100 L (OPTA®,TPE/GAMMASART®,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.: FIS126827
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.
- 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 1-1/2"" 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
- 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
Application AreaLiquid Storage & Shipping
Process StepDrug Product Formulation
Inlet Line1/2" Opta® SFT Female + 1/2" ID TPE (C-Flex®) 0.5 m (20") + 1/2" ID Silicone (Tuflux® SIL) 1 m (40")
Line LeakTest1.5" Tri-Clamp sanitary flange + 1/2" ID TPE (C-Flex®) 1.5 m (60") + Sartopore® Air filter 0.2 μm size 7
Outlet Line3/8" Gammasart ATD™ + 3/8" ID TPE (C-Flex®) 0.5 m (20") + 1/2" ID Silicone (Tuflux® SIL) 2 m (80")
Sampling LinesClave needleless sampling port + 3/8" ID Silicone (Tuflux® SIL) 0.1 m (4")
Materials of Construction
Film MaterialFilm S80: Polyethylene (PE)
Product Contact Layer MaterialPolyethylene (PE)