Description
When you select Flexsafe®Pre-Designed Solutions (PDS), you benefit from a reliable assurance of supply, robustness, ease of use, and biocompatibility for every media, buffer, harvest/downstream intermediate, drug substance, and drug product process step. PDS help speed up process design and reduce the numbers of stock keeping units (SKU’s), hence minimizing costs and complexity related to inventory management.
Our assurance of supply is based on the fact that we retain complete control over our manufacturing process for 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. These are available off-the-shelf to provide users additional delivery reliability.
A proven robustness: Combining material science and film expertise in partnership with our suppliers, we have selected quality raw materials and optimal extrusion process parameters to obtain consistent robustness. This has been proven by several extensive qualification regimes, combining stringent ASTM D4169 testing standards along with real shipping conditions.
The exceptional strength and flexibility of Flexsafe®bags make them suitable for all process steps. They are a reliable choice for transportation of critical liquid by land and air.
The flexibility of Flexsafe®bags in combination with the self-deploying accessory ease the installation and filling of Flexsafe®storage solutions, thus 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 1000 L.
The resins and additives used for the film of Flexsafe®bags are optimized to ensure excellent and reproducible cell growth. Our control over our entire manufacturing 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 to allow for 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 produce a tenfold reduction in 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
AseptiQuick®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 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®
