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Lab-scale Celsius®-Pak

Lab-scale Celsius®-Paks are sterile, pre-assembled and ready-to-use single-use bags intended for use in the Celsius® S3 Benchtop System, a scalability tool for process development studies. These bags are commonly used for stability, compatibility and other developmental tests, or for small aliquots (e.g., ID samples). Two sizes of lab-scale Celsius®-Pak are available, 30 mL and 100 mL nominal volume.

Order Number:  FZB129261

Availability:  On Request

Celsius® Lab-scale features lab-scale Celsius®-Paks that are sterile, pre-assembled and ready-to-use single-use bags designed to support the implementation of production-scale freezing and thawing operations with the Celsius® technology. They are intended for use in the Celsius® S3 Benchtop System, a process development tool that replicates Celsius® CFT production-scale freeze & thaw kinetics on as little as 30 mL product.

Lab-scale Celsius®-Paks are made with the same S71 film and thickness as the production-scale Celsius® bags and will support all validation activities linked to freezing and thawing:

  • Process development activities
  • Freeze & thaw kinetics studies to establish the best process conditions at production-scale
  • Formulation studies and optimization
  • Sampling for QC test analysis
  • Stability Studies
  • Exploring future use of the Celsius® FT33 | 66| 100 with the Celsius® S3 Benchtop system and its pre-defined freeze and thaw recipes that match performance at 100 L production-scale

The versatile range of lab-scale Celsius®-Paks in our Pre-Designed Solutions (PDS) provide single-use freeze & thaw solutions for every process step when frozen storage and frozen shipment are required. Lab-scale Celsius®-Pak PDS are configured with the features needed to laboratory-scale validation studies, process development activities and sampling operations.

Lab-scale 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.

Lab-scale Celsius®-Pak are available in sizes of 30 mL and 100 mL nominal fill volume and feature a variety of connections and tubing materials to represent the best possible scale-down model for each of the production-scale Celsius® bags.

Thermowell

  • with thermowell for non-invasive temperature measurement during freeze and thaw kinetics studies or for stability studies to mimic 8.3 L and
  • 16.6 L Celsius®-Pak
  • without thermowell for stability studies to mimic production-scale Celsius® bags not equipped with thermowell (Celsius® FFT|FFTp, 1 L and 2 L Celsius®-Pak)

Inlet and outlet connectors

  • CPC quick couplers are used for either sanitary connection or aseptic connection under ISO5 laminar air flow to single-use systems
  • Luer connectors are used for either sanitary connection or aseptic connection under ISO5 laminar air flow to single-use systems

Tubes

Inlet and outlet lines are made with EVA, Clear C-Flex® or Dow Corning® Pharma-50 silicone tubes to reproduce the different production-scale Celsius® bags transfer lines. EVA tubing is directly sealed to the bag chamber at both inlet or outlet and allows for sterile seal disconnection with radio frequency sealer after filling and draining. Sterile seal disconnection with BioSealer® after filling and draining is also allowed for lab-scale Celsius®-Pak PDS equipped with Clear C-Flex®.

All fluid-contact components of Lab-scale 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

Flyer

Have you ever thought about freezing?
en 988.7 kB
Celsius CFT: safeguarding your drug substances in controlled-rate FT manufacturing
en 379.2 kB

Publication

Bulk Freeze-Thawing of Macromolecules in BioProcess technical
en 1.2 MB
Safe Freeze-Thaw of protein drug products: a QbD approach
en 4.3 MB
Large Freezing of Biologics - BioProcess Technical
en 419.2 kB

Product properties

  • Temperature range
    -70°C to +45°C (for use at lower temperatures contact Sartorius)
  • Volume
    100 mL
  • Working volume
    90 mL – 100 mL (when used with Celsius® S3 Benchtop System)
  • Tubing
    EVA + Silicone Dow Corning® Pharma 50
  • Thermowell
    Yes (Sealed-end 3/16" ID EVA tube)
  • Connector Outlet
    ¼" Luer Female + luer lock plug
  • Connector Inlet
    ¼" Luer Female + luer lock plug
  • Line Inlet
    1/4" ID 5/16" OD EVA 0.1m + 1/4" ID 3/8" ODDow Corning® Pharma-50 Silicone 0.15m
  • Line Outlet
    1/4" ID 5/16" OD EVA 0.1m + 1/4" ID 3/8" ODDow Corning® Pharma-50 Silicone 0.15m
  • Primary Product Type
    2D Freezing Bags
  • System Type
    Celsius® S3 Benchtop System or Conventional Freezers
  • Biocompatibility (USP Class VI)
    USP<87> and ISO 10993-5; USP<88>
  • 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)
    Weekly 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 Luer Connector
  • Outlet
    Sanitary or Aseptic Connection under LAF with Luer Connector
  • Extractables
    Extractable data readily available
  • Gas barrier layer material
    Ethylene vinyl alcohol (EVOH)
  • Product contact layer material
    EVAM®
  • 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` Lab-scale Freeze & Thaw
  • Quality standards
    ISO 9001 and ISO 13485 for medical devices