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 intermediatesm 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.
• 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 Sartopore^® 2 sterilizing-grade filter with 0.45 | 0.2 μm membranes.
• 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