Celsius® Pak - MPC - MPC - Midisart® BV - 16.6 L

Tech Support Documents
Celsius® Pak - MPC - MPC - Midisart® BV - 16.6 L
 

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.

Connector Inlet
Connector Outlet
Vent Port Connection
Item No.: 
FZB115377
Availability: 
Pieces
6

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

Choose your Celsius® Pak

See more products

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

Applications

  • Application Area
    Frozen storage & shipping
  • Process Step
    • Cell Harvest & Downstream Processing Intermediates
    • Drug Substance Purification
    • Drug Product Formulation
    • Bulk drug substance freezing and thawing
    • Process intermediates freezing and thawing

Connections (Physical)

  • Connector Inlet
    MPC Male + sealing cap
  • Connector Outlet
    MPC Male + sealing cap
  • Connector(s)
    MPC
  • Inlet Line
    MPC Male + Sealing Cap + ‎3/8" ID Silicone (Liveo™ Pharma 50) 1.05 m (41")
  • Outlet Line
    MPC Male + Sealing Cap + ‎3/8" ID Silicone (Liveo™ Pharma 50) 2 m (80")
  • Vent Port Connection
    Midisart® BV Air Filter for sterile venting
  • Venting Lines
    Midisart® BV + 3/8" ID Silicone (Liveo™ Pharma 50) 0.15 m (6")

Features

  • Sensors
    Thermowell

General Specifications

  • Design
    bag in frames
  • Temperature Range
    -70 °C - + 45 °C (for use at lower temperatures contact Sartorius)

Materials of Construction

  • Film Material
    Film S71: Ethylene-vinyl acetate (EVA)

Product Information

  • Brand
    Celsius® Pak
  • Freezer Technology
    Vertical plate freezing
  • Pack Size
    6

Sterility/Purity

  • Delivery Condition
    Sterile

Volume

  • Volume
    16.6 L
  • Working Volume
    4.0 L – 16.6 L
  • Celsius® FT100
    Celsius® FT100
    Item no.
    Celsius_FT100

    Celsius® FT100 is a controlled-rate freeze & thaw system designed to minimize the adverse effects of the cryoconcentration in your biopharmaceutical products. This modular equipment provides flexibility for processing up to 100L of solution with single-use Celsius® Paks.

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

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

  • Celsius® Shippable Storage Module (SSM)
    Celsius® Shippable Storage Module (SSM)
    Item no.
    FTH-SM00101-0024

    The Celsius® Shippable Storage Module (SSM) allows for storage of up to 100L of frozen product in 1L, 2L, 8.3L and 16.6L Celsius® Paks. The Celsius® SSM can be directly placed inside the Celsius® SSM Shipper for reliable frozen transport to remote locations.

  • Celsius® FS16 Filling Station
    Celsius® FS16 Filling Station
    Item no.
    Celsius_FS16

    The Celsius® FS16 Filling Station is designed for filling and gas overlaying 1L, 2L, 8.3L, and 16.6 L Celsius® Paks. It is equipped with a Sartorius platform balance and a peristaltic pump managed by a controller which enables semi-automated filling and gas overlaying.

  • Celsius® Pak Single-Unit Shipper
    Celsius® Pak Single-Unit Shipper
    Item no.
    FTH-SM00102-0002

    The Celsius® Pak Single-unit Shipper is a robust, pre-qualified shipper that ensures the reliable transportation of individual frozen 8.3L or 16.6L Celsius® Paks. The Celsius® Pak Single-unit Shipper is refrigerated by dry-ice pellets and helps simplify the biopharmaceuticals supply chain

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

    The Celsius® Transfer Carts is designed to minimize the operator efforts when transferring Celsius® Pak into the Freeze-Thaw Modules. The Transfer Carts are available in two sizes: TC33 with a maximum carrying capacity of 33 L and TC100 with a maximum carrying capacity of 100 L

  • Celsius® SSM shipper
    Celsius® SSM shipper
    Item no.
    FTH-SM00101-0028

    The Celsius® SSM Shipper is a robust, pre-qualified, reusable shipping solution that ensures the reliable transportation of frozen 8.3L and 16.6L Celsius® Paks stored in Celsius® SSMs to remote locations. Refrigerated by dry-ice slabs, the shipper can transport up to 100L of product per unit.

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

    The Celsius® Transfer Carts is designed to minimize the operator efforts when transferring Celsius® Pak into the Freeze-Thaw Modules. The Transfer Carts are available in two sizes: TC33 with a maximum carrying capacity of 33 L and TC100 with a maximum carrying capacity of 100 L

  • Celsius® Pak Frame,16.6 L
    Celsius® Pak Frame,16.6 L
    Item no.
    FTH-CF00016-0009

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