Fill & Finish Fluid
Management
Signata CT-5®
Flexible and closed fluid management system
The Signata platform allows users to incorporate aspects of automation early without eliminating critical flexibility during process development. The Signata CT-5 brings multiple processes traditionally performed by manual techniques under a higher level of control to protect your products from loss or contamination.
Set up user protocols for GMP manufacturing or use manual control of all pumps and control valves for simple fluid transfer. The Signata CT-5 is a closed fluid management system designed with cell culture processes in mind.
- Flow rates
- Pump 1: 44 mL/min maximum
- Pump 2: 528 mL/min maximum
- System dimensions
- Base CT-5 system: 44.6 cm W x 59.3 cm H x 34.7 cm D
- Base height dimension does not include removable bag holder mount.
- Shelf (removable): 23.5 cm W x 15.2 cm H x 35.6 cm D
- Signata Formulation Module: 35.6 cm W x 36.4 cm H x 24.1 cm D
- Mains voltage and current requirements
- 100 – 240 VAC, 50 – 60 Hz
- Remote tablet: 110/120 ~V or 220/240 ~v, 50/60 Hz
- Cleaning
- Cabinet: 70% Isopropanol in water
- Weight
- Base CT-5 System: 33.6 kg (74 lbs)
- Signata Formulation Module: 14.5 kg (32 lbs)
- Operating conditions:
- 10-40 °C, 35%-95% R.H., up to 2000 m above sea level
- Software is validated for use with a Wi-Fi wireless connection
- Noise levels
- Maximum of approximately 65 dBA
- Fluid handling platform for closed system bioprocessing.
- Semi-automated operation.
- Operating time depends on number of outputs, total fill volumes, and operating flow rates. A typical weld and fill cycle for 5 outputs takes. approximately 5 min
- Maximum source or fill volumes are specified by the user and not limited by system performance.
- Minimum recommended fill volume is 1 mL in vials. Typical maximum fill volumes depend on the output container used within 2% of specified volume (up to 200 mL per output bag in BioLife consumables).
- Accuracy may vary more widely at small fill volumes (<1-2 mL).
- For BioLife consumables, typical residual volumes should be minimal. Actual values may depend on various factors such as consumable configuration, purge flow rate, and overall length of tubing used.
- Electronic batch records with Part 11 and Annex 11 compliance package available.
Please download Signata CT-5 resources here:
User defined
flexibility
Inherent in the design of the Signata platform is true flexibility for your processes. The Signata allows use of off-the-shelf single use consumables like CellSeal vials or cryobags, as well as the ability to use output containers of your choosing. Fill rates of up to 500 mL/min allow small or large volume fill without limitation. Weldable connections close one of the most critical points in the cell therapy manufacturing process.
A universal cell
management system
Use the Signata platform for final fill, media formulation, and bioreactor fill and wash. As a fluid transfer system, the Signata CT-5 allows reversible flow direction from up to 11 input/output points and three-way control valves allowing closed movement between multiple points.
Closed processing
of simple tasks
Most cell therapy automation systems are designed for specific and highly complicated unit operations. The Signata platform is intended to bring closed-automation to the most basic functions of laboratory biology. Reduce contamination risks, capture batch records, and control processes with the first truly flexible system designed specifically with your staff in mind.
