Celsius® FFT Platform for Large Volumes of Frozen Bulk Drug Substances
End-to-end solution to handle large volumes of frozen BDS
Biopharmaceutical manufacturers need high-performing solutions to process and ship high-value bulk drug substances (BDS) in a safe and easy way. The Celsius® FFT Platform is a scalable and flexible end-to-end solution for handling large volumes of frozen BDS using robust single-use Celsius® FFT containers, including a newly designed 75 L container. The platform consists of a blast freezer, a fill and drain station, a lift, a mixer plus a shipping solution for safely handling palletized frozen containers.
Fully integrated solution for frozen BDS management, from filling and freezing to final thawing and mixing.
Celsius® FFT Platform is designed for safer and easier handling of palletized containers.
The FFT platform can manage up to 300 L at once with container sizes from 2 L up to 75 L.
Single-use containers with Safecore™ Technology, validated to -80°C and qualified to ASTM D4169 standards.
A Fully Integrated Platform as Flexible End-to-End Solution
The Celsius® FFT Platform is an extension of the established Celsius® FFT portfolio to manage larger volumes for high throughput GMP Processes. The platform is an integrated system offering a scalable approach with a competitive advantage on robustness, flexibility and ease of use. Designed as an End-to-End-Platform it consists of various components ranging from single-use containers, over to specialized equipment for handling of palletized containers such as a freezer, lift, mixer and a fill & drain station.
Celsius® FFT Container 75 L
The heart of the Celsius® FFT platform are the single-use Celsius® FFT 75 L containers with Safecore™ Technology for maximum bag and tubing protection. The freezing containers are qualified for temperatures down to -80°C and are stackable to fit Celsius® FFT Pallet with 4 containers, resulting in a volume of 300 L per pallet. All other volumes of Celsius® FFT are compatible with the platform equipment, so that the volumes of single-use containers range from 6 L to 75 L.
- Proven performance down to -80°C
- Tested and validated to ISTA and ASTM standards
- Safecore™ Technology for maximum bag and tubing protection
- Palletized approach for minimizing handling and simplifying logistics
- Easy disassembly for recyclability
Celsius® FFT Freezer
The Celsius® FFT Freezer is designed for freezing and thawing of palletized Celsius® FFT containers of all volumes ranging from 2 L to 75 L allowing up to 300 L drug substance processing per run. This blast freezer offers consistent freezing and thawing performances optimized for palletized containers by controlled airflow and an integrated agitation system to reduce thawing time.
- Freezing down to -70°C
- Designed to freeze and thaw palletized Celsius® FFT container (75 L, 12 L, 6 L)
- Blast freezing with controlled air flow for consistent freezing/thawing performances amongst containers
- Integrated agitation system to reduce thawing time
AliquoT Fill & Drain Station
The AliquoT | Pallet is designed for easier filling and draining of palletized Celsius® FFT containers of all volumes ranging from 2 L to 75 L. It allows for batch handling up to 2,400 L by multi pallet sequential processing. Offering integrated sampling and filtration capabilities during filling and draining phase, AliquoT helps to manage your bulk drug substances.
- Easily fill / drain palletized Celsius® FFT container (75 L, 12 L, 6 L)
- Multi pallet sequential processing allowing batches up to 2,400 L
- Designed for superior accuracy and optimal product recovery
- Integrated sampling and filtration capabilities
Celsius® FFT Lift
The Celsius® FFT Lift allows for safer and easier handling of palletized Celsius® FFT containers of all volumes ranging from 2 L to 75 L for loading and unloading Celsius® FFT Platform equipment. With its semi-automated functionalities, this electric lift is cleanroom compliant and offers autonomy to ensure operation continuity over one shift.
- To load and unload Celsius® FFT Platform equipment by using semi-automated functionalities
- Allow safe and easy handling of palletized Celsius® FFT container (75 L, 12 L, 6 L)
- Cleanroom compliant
Celsius® FFT Mixer
The Celsius® FFT Mixer is designed for homogenizing content of palletized Celsius® FFT containers of all volumes ranging from 2 L to 75 L post thawing. By mixing palletized containers there is no need for fluid transfer to another equipment to perform the mixing. This simplifies partial draining or re-freezing.
- To homogenise palletized Celsius® FFT container (75 L, 12 L, 6 L) content post thawing
- No need for fluid transfer to another container type for mixing purpose
- Ease of use on partial draining, re-freezing thanks to flexible container management
Celsius® FFT Pallet
The Celsius® FFT Pallet is designed for safe and easy handling with the Celsius® FFT Lift for optimized transition of palletized Celsius® FFT containers between the different equipment’s for filling, freezing, thawing, mixing and draining. Compatible with any transportation mode, the pallet fits any type of thermal insulated shipper with suitable dimensions for air transportation.
- To stack up to 4 Celsius® FFT 75 L (total 300 L per pallet)
- Fit for refrigerated truck shipping and air shipping into refrigerated shippers compliant with lower deck passenger aircraft
- To be handled by Celsius® FFT Lift for safe and easy transition between equipment for container filling | freezing | thawing | mixing and draining
- Qualified according to regulations for shipping containers: ASTM D4169 and ISTA 7D extreme summer | winter temperature profiles