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Celsius®-Pak

Production-scale Celsius®-Paks are sterile, pre-assembled and ready to use single-use bags specifically designed to be used in the Celsius® FT33 | 66 | 100 equipment manufactured by Sartorius Stedim Biotech. The combination of a structural protective frame with a sterile container provides protection to the contents during all processes, making the assembly robust and reliable during handling. Four sizes of Celsius®-Pak are available, 1 L, 2 L, 8.3 L and 16.6 L nominal fill volume, and varying connector options.

Order Number:  FZB129252

Availability:  On Request

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

  • Dow Corning® 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

Brochure

Celsius CFT The controlled-rate F&T Platform Technology
en 2.5 MB
Discover our freezeing capabilities Celsius product lines
en 1.2 MB

Flyer

Celsius CFT: safeguarding your drug substances in controlled-rate FT manufacturing
en 379.2 kB

Publication

Article in the PDA Journal
en 367.6 kB
Bulk Freeze-Thawing of Macromolecules published in BioProcess technical
en 966.5 kB
Large Freezing of Biologics - BioProcess Technical
en 419.2 kB
Scale up case study for long term storage of a process intermediate in bags
en 978.5 kB

Product properties

  • Temperature range
    -70°C to +45°C (for use at lower temperatures contact Sartorius)
  • Volume
    8.3 L
  • Working volume
    4.2 L – 8.3 L
  • Tubing
    Silicone Dow Corning® Pharma 50
  • Thermowell
    Yes (Sealed-end 3/16" ID EVA tube)
  • Connector Outlet
    ‎⅜" OPTA® SFT Male
  • Connector Inlet
    MPC Male + sealing cap
  • Line Inlet
    ‎⅜" ID ⅝" OD Dow Corning® Pharma-50 Silicone 1.05m
  • Line Outlet
    ‎⅜" ID ⅝" OD Dow Corning® Pharma-50 Silicone 1.82m
  • Vent Port Connection
    Midisart® BV
  • Venting Lines
    ‎⅜" ID 5/8" OD Dow Corning® Pharma-50 Silicone 0.15m
  • Primary Product Type
    2D Freezing Bags
  • System Type
    Celsius® FT33|66|100
  • Biocompatibility (USP Class VI)
    USP<87> and ISO 10993-5; USP<88>
  • Physico-chemical compatibility
    USP<661> and EP 3.1.7
  • TSE-BSE Status
    EMA/410/01 and EP 5.2.8
  • Bioburden (ISO11737), Endotoxin (USP 85 and EP 2.6.14), Sub-visible particulates (USP 788 and EP 2.9.19)
    Lot release testing on representative finished product
  • Change control and business continuity
    48 months notification period on Celsius® bags and 24 months on critical fluid-contact components
  • 100% Bag Chamber Leak testing
    Yes
  • 100% Visual Inspection
    Yes
  • Sterility
    Gamma irradiated

Technical attributes

  • Inlet
    Sanitary or Aseptic Connection under LAF with quick coupler
  • Outlet
    Sterile Connection with OPTA® SFT
  • Extractables
    Extractable data readily available
  • Gas barrier layer material
    Ethylene vinyl alcohol (EVOH)
  • Product contact layer material
    EVAM®
  • Vent
    Sterile Connection with Midisart® BV
  • Film Material
    S71
  • Pressure range
    Max. 1 barg in transfer lines
  • Area of application
    Frozen Storage & Shipping
  • Process Step
    Cell Harvest & Downstream Processing Intermediates` Drug Substance Purification` Drug Product Formulation
  • Quality standards
    ISO 9001 and ISO 13485 for medical devices

No accessories & consumables found