Sartorius, FZB115289, Celsius® Pak - Opta® - Opta® - Midisart® BV - 16.6 L

Celsius®CFT (Controlled Freeze & Thaw) is a platform technology for controlled-rate freezing and thawing of biopharmaceutical products. Celsius®CFT features Celsius® Paks which are sterile, pre-assembled and ready to use single-use bags designed to fit into reusable structural frames. Celsius®CFT minimizes cryo-concentration during freeze & thaw cycles. Celsius®CFT processes up to 100L of product per cycle in the Celsius®FT100 system and offers well-qualified shipping solutions for transferring frozen drug substances around the world.
Maximum Product Security:
Extensive functional qualification in real process conditions
Optimized logistics from fill through drain
Minimize cryo-concentration and stabilize drug substances
Excellent Process Reliability:
Total integration with monitoring of critical process parameters and process control
Pre-qualified shipper (ASTM D4169 AL1 mechanical ISTA7D extreme summer thermal performances)
Excellent reproducibility of the freeze and thaw cycles
Creates Process Flexibility:
Improves production management
Facilitates any process transfer
Reduces process time with fast freeze and thaw processes
Scalable:
In performances: Benchtop (30mL) to production (100L)
In capacity: Flexible production platform (up to 100L with Celsius®FT100)
In contact material: Same film for all Celsius®products for easy scale-up
Celsius®Paks are available in sizes of 1L, 2L, 8.3L and 16.6L nominal fill volumes and feature a variety of connections to allow fluid transfer across the entire drug manufacturing process.
Inlet and outlet connectors
Opta®SFT Male enables sterile connections to other single-use systems
CPC quick couplers are used for either sanitary connection or aseptic connection under ISO5 laminar air flow to single-use systems
Press in plug equipped with clear C-Flex®for sterile weld connection with BioWelder® TC and sterile seal disconnection with BioSealer®
Celsius®Pak feature a venting line which is used after filling to pressurize the Celsius®Pak with air or nitrogen to guarantee performances of the controlled-rate freeze and thaw process:
Midisart®BV Air Filter for sterile venting
CPC quick couplers are used for non-aseptic venting with sanitary connection
Thermowell
For non-invasive product temperature measurement during freezing and thawing operations, Celsius®Paks are equipped with a thermowell, a sealed-end EVA tube with a luer connector to monitor critical process parameters at the last point to freeze.
Tubes
Liveo™ Pharma 50 silicone tubing
Clear C-Flex®tubing allows for sterile weld connection with BioWelder®TC and sterile seal disconnection with BioSealer®
EVA tubing enables sterile seal disconnection with Vante™ sealer
All fluid-contact components of Celsius®Pak PDS are secured by supply contracts and quality agreements to provide:
Exceptional quality, change control and business continuity with at least 24 months change notification
Exceptional delivery reliability with available stocks
Compliance to quality standards such as USP <87> and USP <88>, TSE-BSE, REACH