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. The exceptional strength and flexibility of Flexsafe®bags make them suitable for all process steps.
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 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 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®
All fluid-contact components of Flexsafe®PDS are secured by supply contracts and quality agreements to provide:
Exceptional quality, change control, and business continuity with early change notification and last buy option
Exceptional delivery reliability with available stocks
Compliance to quality standards such as USP <87> and USP <88>, TSE-BSE, REACH
