Celsius® FFTp Bag with Safecore™ Technology - Opta® - Opta® - 12 L

With its innovative bag-in-plate design, the Safecore™ Technology provides exceptional protection to Celsius^® FFT|FFTp in a proven design format that is scalable from small to large-size single-use container. Celsius^® FFT|FFTp along with its purpose-designed shippers (Celsius^® FFT|FFTp Box and Celsius^® FFT Bulk Shipper) offers enhanced process capabilities to create a versatile approach to to protect your product in conventional manufacturing.

Safecore™, bag-in-plate (cassette) design

• Plates protect the bag and lines by adding impact resistance, suppressing wrinkles and restricting degrees of freedom
• Excellent bag-to-plate contact provides high robustness and more uniform freeze/thaw, plates compress the bag to reduce ice bulging formation
• Container assembly is tool-free and intuitive for minimum risk during production assembly

Maximum Robustness down to -80°C

• Material selection based on characterization of physical and thermal properties across wide temperature range to ensure suitable use for the intended application
• Handling and shipping qualifications built on deep understanding of mechanical stresses occurring during lifecycle for reliable performance in real-world environments
• Storage and shipping operations down to -80°C, multiple freeze-thaw cycles, shipping qualification according to ASTM D4169 at Assurance Level 1 method

Simplified Operation

• Plates are transparent with bag chamber fully visible for product inspection
• Configurable with various connector/disconnector technologies, easy wipe down
• Sample bag compartment to store/ship sample bag, label adhered to the shell for full product traceability, label placard for end-user labelling

Bulk Processing

• Bulk Shipper minimizes storage and shipping density and reduces associated risks during handling with multiple frozen containers per pallet
• Compatible for truck and ocean transportation in refrigerated environment as is, compatible with any type of thermal insulated shipper for air transportation
• 2 shipping solutions: Box and Bulk Shippers, qualified according to stringent regulations for shipping containers

Celsius^® FFT|FFTp with Safecore™ Technology provides single-use freeze & thaw solutions for every process step when frozen storage and frozen shipment are required. Celsius^® FFT|FFTp with Safecore™ Technology are configured with the features needed to decouple downstream process steps and securely transport drug substances to drug product sites.

Celsius^® FFT|FFTp with Safecore™ Technology is qualified against extensive biological, chemical, physical, extractable and functional testing.

Our assurance of supply and performance for Celsius^® FFT with Safecore™ Technology 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 exceptional delivery reliability.

Celsius^® FFT|FFTp with Safecore™ Technology is available in 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
• MPC quick couplers are used for either sanitary connection or aseptic connection under ISO5 laminar air flow to single-use systems

Tubes

• Clear C-Flex^® tubing allows for sterile weld connection with Biowelder^® TC and sterile seal disconnection with Biosealer^® TC

All fluid-contact components of Celsius^® FFT|FFTp with Safecore™ Technology are secured by supply contracts and quality agreements to provide:

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