CTS™ Compleo™ Fill and Finish System

Automated, flexible formulation and fill system designed for cell therapy manufacturing

The Gibco™ CTS™ Compleo™ Fill and Finish System is a functionally closed, automated system that reduces variability to help better control formulation and filling as compared to manual processing. It enables solutions to help overcome common challenges that arise during the manual workflow, streamlining the process from process development to commercial manufacturing.

Key Features and Benefits

• Functionally Closed Automation: Reduces formulation and fill process variability while maintaining aseptic integrity through closed-system processing.

• Intelligent Formulation Software: A proprietary algorithm automates complex calculations, reducing manual errors and optimizing cell usage to minimize unnecessary cell waste.

• High Dosing Accuracy: Delivers a volumetric accuracy of ±10% even at ultra-low fill volumes as small as 0.5 mL.

• Modular Integration: Designed to work in harmony with the CTS™ Rotea™ system, allowing the output bag to be placed directly onto the Compleo™ system.

• System-Agnostic Flexibility: Can be implemented with other cell processing platforms to enhance formulation and filling efficiency across diverse workflows.

• Operational Speed: Automates air removal and processing, reducing formulation and filling time from an average of 45 minutes to approximately 15 minutes.

• GMP-Ready Compliance: Supports 21 CFR Part 11 compliance via an optional SAE software solution and an OPC-UA interface for seamless integration with DCS/MES systems.

• Real-Time Flexibility: The user-friendly Protocol Builder software handles variable batch sizes in real time without requiring manual protocol modification or requalification.

Technical Specifications

Input Capacity: Up to 4 inputs depending on in-process sample allocation Input Volume: 10 mL (minimum), 750 mL (maximum) Flow Rate: 5–50 mL/min Number of Outputs: 1–10 depending on number of input bags and orientation Output Volume Range: 0.5 mL to 750 mL per individual dose Output Volume Accuracy: ±10% across the full range (0.5 mL to 750 mL) Volume Verification: Independent volume checking mechanism; bubble sensors measure the volume transferred based on the volume of fluid pumped Output Container Compatibility: Compatible with most cryobags and vials; supports connection via luer lock fittings or direct sterile weld to the bag inlet line In-process Sampling: Can dispense multiple samples with as little as 0.2 mL per sample Air Removal (Burping): Automatic (pre- and/or post-fill) and manual Connectivity: OPC-UA interface Operating Noise Level: 65 dBA (typical) to 70 dBA (maximum) Dimensions (H x W x D): 31.5 x 11.4 x 18.0 in (80 x 29 x 46 cm) Weight: 55.0 lb (25.0 kg)