Celsius® Pak - Opta® - Opta® - Midisart® BV - 8.3 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