Lab-scale Celsius® Pak

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 optimal 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 for 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.

Our assurance of supply and performance for PDS is based on the fact that we retain complete control over 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 excellent 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 optimal scale-down models 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:

• Excellent quality, change control and business continuity
• Excellent delivery reliability with available stocks
• Compliance to quality standards such as USP <87> and USP <88>, TSE-BSE, REACH