Celsius® Pak 2L (MPC/MPC/BV)

Celsius^® CFT is a platform technology for controlled-rate freezing and thawing of biopharmaceutical products. Celsius^® CFT features Celsius^® Paks that are sterile, pre-assembled and ready to use single-use bags purposely engineered to fit into reusable structural frames. Celsius^® CFT defeats 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 the frozen drug substances around the world.

Maximum Product Security:

• Extensive functional qualification in real process conditions
• Optimized logistics from fill through drain
• Defeat cryoconcentration 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
• Facilitate any process transfer
• Reduce process time with fast freeze and thaw processes

Scalable:

• In performances: Benchtop (30mL) to production (100L)
• In capacity: Flexible production platform (33L with Celsius^® FT33, 66L with Celsius^® FT66 or 100L with Celsius^® FT100)
• In contact material: Same film for all Celsius^® products for easy scale-up

The versatile range of Celsius^® Pak Pre-Designed Solutions (PDS) provide single-use freeze & thaw solutions for every process step when frozen storage and frozen shipment are required. Celsius^® Pak PDS are configured with the features needed to decouple downstream process steps and securely transport drug substances to drug product sites.

Celsius^® Pak PDS are qualified against extensive biological, chemical,physical, extractable and functional testing. You can use our intuitive digital brochure to select your Celsius^® Pak 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 of PDS are based on the complete control of our manufacturing process for the resins, the film, the bags, the filters and the assemblies. 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.

Celsius^® Pak are available in sizes of 1 L, 2 L, 8.3 L and 16.6 L nominal fill volume 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^® Pak are equipped with a thermowell, a sealed-end EVA tube with a luer connector to monitore 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:

• Best quality, change control and business continuity with at least 24 months change notification
• Best delivery reliability with available stocks
• Compliance to quality standards such as USP <87> and USP <88>, TSE-BSE, REACH