Sartorius, FZB129260, Celsius® Pak - MPC - MPC - MPC - 1 L

Celsius® CFT is an industry-leading platform technology that controls freezing and thawing rates to minimize cryo-concentration in biopharmaceutical products.
This platform ensures substances are well-protected and offers flexibility by processing up to 100L in single-use Celsius® Paks.

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

Specifications
Applications:
Application Area: Frozen storage & shipping
Process Step: Cell Harvest & Downstream Processing Intermediates; Drug Substance Purification; Drug Product Formulation; Bulk Drug Substance Freezing and Thawing; Process Intermediates Freezing and Thawing

Connections (Physical):
Connector Inlet: MPC
Connector Outlet: MPC
Connector(s): MPC
Inlet Line: MPC Male + Sealing Cap + 1/4" ID ‎Silicone (Liveo™ Pharma 50) 0.3 m (12")
Outlet Line: MPC Male + Sealing Cap + 1/4" ID ‎Silicone (Liveo™ Pharma 50) 0.3 m (12")
Vent Port Connection: MPC for non-aseptic venting
Venting Lines: MPC Male + Sealing Cap + 1/4" ID ‎Silicone (Liveo™ Pharma 50) 0.1 m (4")

General Specifications:
Design: bag in frames
Temperature Range: -70 °C - + 45 °C (for use at lower temperatures contact Sartorius)

Materials of Construction:
Film Material: Film S71: Ethylene-vinyl acetate (EVA)

Product Information:
Brand: Celsius® Pak
Freezer Technology: Vertical plate freezing
Pack Size: 8

Sterility/Purity:
Delivery Condition: Sterile

Volume:
Volume: 1L
Working Volume: 0.25 – 1 L