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16,6L Celsius® Pak (ID/ID/BV)

Celsius® CFT (Controlled Freeze & Thaw) is an industry-leading platform technology that controls the freezing and thawing rate to minimize cryo-concentration in biopharmaceutical products.

This robust and reliable platform ensures drug substances are well-protected from start to finish, and offers process flexibility by processing up to 100 L of solution in single-use Celsius® Paks. Qualified transfer, storage and shipping solutions are offered as part of the complete frozen logistics.

Item no.:  FZB129251

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® Product Lines - Discover our Freezing Capabilities
en 1.6 MB
Celsius® CFT - The Controlled-Rate Freeze & Thaw Platform Technology
en 2.7 MB
Celsius Pre-designed Solutions for Freeze & Thaw - Robust, Complete and Scalable Solution for Frozen Storage and Shipment
en 5.7 MB

Flyer

Celsius® CFT: Safeguarding Your Drug Substances in Controlled-rate Freeze & Thaw Manufacturing
en 617.6 kB

Poster

Frozen Transfers With Celsius® – Linking Drug Substances to Drug Product Sites Worldwide
en 2.0 MB

Publication

Article in the PDA Journal
zh 367.6 kB
Bulk Freeze-Thawing of Macromolecules published in BioProcess technical
en 966.5 kB
Large-Scale Freezing of Biologics - A Practitioner’s Review, Part 2: Practical Advice
en 293.8 kB
Scale up case study for long term storage of a process intermediate in bags
en 978.5 kB

General Specifications

  • Temperature Range
    -70°C – +45°C (for use at lower temperatures contact Sartorius)
  • Tubing
    Clear C-Flex® 374
  • Vent
    Sterile Connection with Midisart® BV

Volumes

  • Volume
    16.6 L
  • Working Volume
    4.0 L – 16.6 L

eShop Dynamic Attributes

  • Application Area
    Frozen Storage & Shipping
  • Connector Inlet
    3/8" ID Press in plug
  • Connector Outlet
    3/8" ID Press in plug
  • Film Material
    S71
  • Gas Barrier Layer Material
    Ethylene vinyl alcohol (EVOH)
  • Inlet Line
    ‎⅜" ID ⅝" OD Clear C-Flex® 1.25m
  • Outlet Line
    ‎⅜" ID ⅝" OD Clear C-Flex® 2m
  • Pressure Range
    Max. 1 barg in transfer lines
  • Process Step
    • Cell Harvest & Downstream Processing Intermediates
    • Drug Substance Purification
    • Drug Product Formulation
  • Product Contact Layer Material
    EVAM®
  • Sterilization Method
    Gamma irradiation
  • System Type
    Celsius® FT33|66|100
  • Thermowell
    Yes (Sealed-end 3/16" ID EVA tube)
  • Vent Port Connection
    Midisart® BV
  • Venting Lines
    ‎⅜" ID 5/8" OD Dow Corning® Pharma-50 Silicone 0.15m
SSM, Shippable Storage Module, Celsius®
SSM, Shippable Storage Module, Celsius®
Item no.: FTH-SM00101-0024

The Celsius® Shippable Storage Module (SSM) allows storage of up to 100 L of frozen product in 8.3L and 16.6L Celsius® Paks. The Celsius® SSM can be directly placed inside the Celsius® SSM Shipper for safe, reliable frozen transport to remote locations.

Shipper, SSM, with 2 Straps, Celsius®
Shipper, SSM, with 2 Straps, Celsius®
Item no.: FTH-SM00101-0028

The Celsius® SSM Shipper is a robust, pre-qualified, reusable shipping solution that ensures safe shipment of multiple frozen 8.3L and 16.6L Celsius® Pak stored in Celsius® SSM to remote locations. Celsius® SSM Shipper is refrigerated by dry-ice slabs which contributes to significantly simplify biopharmaceuticals supply chain through the transport of up to 100L product per unit to its destination site for thawing.

Transfer Cart, 33L
Transfer Cart, 33L
Item no.: FTH-TC00033-0001

The Transfer Carts are designed to minimize the operator efforts when transferring Celsius® Paks between the equipment and accessories of the Celsius® CFT platform.

Celsius® Pak frame 2G RTD Holder
Celsius® Pak frame 2G RTD Holder
Item no.: FTH-CF00000-0029

The Celsius® Pak Frame RTD Holder allows proper placement of the product RTD temperature probe inside to the thermowell of the 8.3L and 16.6L Celsius® Pak for non-invasive temperature monitoring at the last point to freeze.

Transfer Cart, 100L
Transfer Cart, 100L
Item no.: FTH-TC00100-0001

The Transfer Carts are designed to minimize the operator efforts when transferring Celsius® Paks between the equipment and accessories of the Celsius® CFT platform.

Frame,16.6L Celsius® Pak 2G
Frame,16.6L Celsius® Pak 2G
Item no.: FTH-CF00016-0009

16.6L Celsius® Pak Frames are reusable protective structural frames purposely engineered to fit with 16.6L Celsius® Pak. They protect the contents of 16.6L Celsius® Pak throughout its lifecycle during all processes, making the assembly robust, reliable and simple for confident handling, storage and shipping of the Celsius® Paks.

Shipper, Indl for 8.3L/16.6L.
Shipper, Indl for 8.3L/16.6L.
Item no.: FTH-SM00102-0002

The Celsius® Single-unit Shipper is a robust, pre-qualified shipper that ensures safe shipment of individual frozen 8.3L or 16.6L Celsius® Paks to remote locations. The Celsius® Single-unit Shipper is refrigerated by dry-ice pellets which contributes to significantly simplify biopharmaceuticals supply chain through one-way logistics and the transport of frozen Celsius® Paks to its destination site for thawing.

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