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100 mL Lab-scale Celsius® Pak (MPC/MPC/EVA/C-Flex)

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.

Item no.:  FZB129263

Availability (ex works):  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 the Celsius® production-scale (FFT, FFTp and CFT) 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 Celsius® production-scale platforms (FFT, FFTp and CFT) 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
  • 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
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
Have you ever thought about freezing?
en 380.9 kB

Publication

Evaluating Freeze-Thaw Processes in Biopharmaceutical Development
en 1.2 MB
Safe Freeze-Thaw of protein drug products: a QbD approach
en 4.3 MB
Large-Scale Freezing of Biologics - A Practitioner’s Review, Part 2: Practical Advice
en 293.8 kB

Applications

  • Application Area
    Frozen Storage & Shipping
  • Process Step
    • Cell Harvest & Downstream Processing Intermediates
    • Drug Substance Purification
    • Drug Product Formulation
    • Lab-scale Freeze & Thaw

Compliance Information

  • 100% Bag Chamber Leak Testing
    Yes
  • 100% Visual Inspection
    Yes
  • 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
  • Biocompatibility (USP Class VI)
    USP and ISO 10993-5; USP
  • Change control and business continuity
    48 months notification period on Celsius® bags and 24 months on critical fluid-contact components
  • Extractables
    Extractable data readily available
  • Quality Standards
    ISO 9001 and ISO 13485 for medical devices

Connections (Physical)

  • Connector Inlet
    MPC Male + sealing cap
  • Connector Outlet
    MPC Male + sealing cap
  • Inlet
    Sanitary or Aseptic Connection under LAF with quick coupler
  • Line Inlet
    1/4" ID 5/16" OD EVA 0.1m + 1/4" ID 3/8" OD Clear C-Flex® 0.15m
  • Line Outlet
    1/4" ID 5/16" OD EVA 0.1m + 1/4" ID 3/8" OD Clear C-Flex® 0.15m
  • Outlet
    Sanitary or Aseptic Connection under LAF with quick coupler

Features

  • Thermowell
    No

General Specifications

  • Temperature Range
    -80°C – +45°C
  • Tubing
    EVA + Clear C-Flex® 374

Materials of Construction

  • Film Material
    S71
  • Gas Barrier Layer Material
    Ethylene vinyl alcohol (EVOH)
  • Product Contact Layer Material
    EVAM®

Physicochemical Information

  • Pressure Range
    Max. 1 barg in transfer lines

Product Information

  • Primary Product Type
    2D Freezing Bags
  • Sterilization Method
    Gamma irradiation
  • System Type
    Celsius® S3 Benchtop System or Conventional Freezers

Volumes

  • Volume
    100 mL
  • Working Volume
    90 mL – 100 mL (when used with Celsius® S3 Benchtop System)

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