Celsius® Pak - Opta® - Press in plug - Midisart® BV

Tech Support Documents
Celsius® Pak - Opta® - Press in plug - Midisart® BV
 

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.

Item No.: 
Celsius-Pak-Opta-Press-in-plug-Midisart-BV
Availability: 

*Custom/bulk order quotes are provided within 72 hours of request.

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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