Single-Use Assemblies

Mixing and Powder Handling

DuoMixer^®: Benchtop and Floor Single-Use Mixers

We’ve combined scalability and ease of use into a complete single use mixing platform from 2L to 3000L for all upstream and downstream processing. The MiniDuoMixer^® and DuoMixer^® have a robust and intelligent design that ensures you can mix efficiently and monitor quality no matter the application. Using various powder-liquid chemistries, mixing characterization ensures excellent operation, optimization, and quality no matter the formulation.

Unmatched Performance with Mixing Characterization

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Let us help you increase production!

Liquid Storage and Transport

2D Bags for Storage and Transport

Our 2D and 3D bags are designed for convenience and ease of use for all your aseptic fluid handling steps, such as media and buffer preparation, chromatography feed and collection, and bulk drug substance storage and transport.  Combining best-in-class quality control and robustness, you can trust FlowLinX bio bags for your most critical applications. 

Learn about our product range of 2D bags, from 50mL to 100L.  Choose from pre-configured designs or customize to your needs.  All bags are provided sterile for quick and easy implementation.

• Optimized chamber design for minimal holdup
• Each lot is integrity tested prior to release
• Available with face ports or end ports

3D Bags for Storage and Transport

Learn about our product range of 3D bags, from 50L to 3000L.  Choose from pre-configured designs or customize to your needs for Media/Buffer aliquoting, TFF or Fill-Finish.  All bags are provided sterile for quick and easy implementation.

• Fits FlowLinX tanks and other industry tanks
• Each bag is integrity tested prior to release
• Available with hose barb and sanitary ports

Our Guarantee

FlowLinX bio bags are supported by a comprehensive validation package, so you can implement worry-free. 

• ULDPE contact layer, 300 µm thickness = superb physical strength and flexibility
• Well-characterized biochemical/ physiochemical testing = safe for storage of critical drug substances and drug product
• Extractables study per BPOG protocol = defined extractables profile for dependable process validation

Fill-Finish Assemblies

Single-Use Filling Solutions

Our configurable single-use technologies meet stringent requirements so you can ensure operational safety and efficiency in final filtration, final filling, and compounding.  Utilizing state-of-the-art manufacturing, our team can work with you to design a customized sterile flow path or beta bag. 

Filling and Filtration Assemblies

Single-use filling and filtration assemblies can be configured from a wide range of components and designed to meet compliance such as PUPSIT, leak integrity assurance, USP <85> endotoxin and USP <788> sub-visible particulates.  All assembly connections are assessed for engagement qualification during the design process.  Optionally, overmolded silicone can be used for assembly elements, such as dosing pump loops, sanitary ends or surge product bag connections, providing a leak-free fluid path and minimized entrapment. 2D FlowLinX surge product bags are optimized for ease of draining and maximum product recovery.  Optimize your process and fill drug product with confidence. 

FlowLinX Ported Beta Bags

FlowLinX ported beta bags are offered in standard or customized pre-sterilized and non-sterile options.  Choose from a complete range of hose barb and sanitary ports from 1/8” to 3”.   Whether you are using a DPTE® Alpha port, Biosafe® port or another port, we can provide you with a custom ready-to-use beta bag configuration that can be easily integrated into a flow path assembly.

Sampling Assemblies

Our assemblies are ideal for aseptic sampling throughout every step in your production process, such as cell culture, fermentation, chromatography, sterile bulk and transfer.  The closed system design minimizes the risk of false positives and process cross-contamination.  

Sampling assemblies are available in standard designs or can be configured based on your process requirements.  Choose from tubes, bags and bottles as well as a wide range of aseptic connectors or sampling needles for use with sanitary flange sampling holders.  Our FlowLinX manifold luer lock clips ensure luer lock connections remain integral during transport and use, while our overmolded silicone connectors provide a leak-free flow path, so you can sample with confidence. 

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Transfer Assemblies

At CCG we understand the importance of freedom of design for your fluid transfer assemblies, as these are the critical linkage between equipment and process steps.  Using our open design architecture, choose from thousands of components to build fluid transfer assemblies used for filtration, pumping, and more.  We have a comprehensive library of connectors, filters, sensors, pump heads, and fittings available from global manufacturers, including our world-class brand of FlowLinX components.

Supported by our best-in-class manufacturing and quality, each transfer assembly design is verified for engagement qualification as part of our design review process.  Leak integrity assurance, USP <85> endotoxin and USP <788> sub-visible particulates are some of the other qualifications you can choose. 

Engineering and Development

We’re Committed to Ensuring Your Success

Our knowledgeable staff has industry experience and technical expertise to help you design a solution the way you want it.  We offer services for single-use product design, development, prototyping, and testing, ensuring improved flexibility and increased speed in your bioprocessing operations.

Design

Our team works with you to understand the needs of your bioprocessing operation. 
Together, we’ll define your unique requirements to verify the single-use assembly components utilized in the design will maximize efficiency and minimize potential risks. 

Biocompatibility:
We have a deep understanding of polymeric materials, such as polypropylene, silicone and thermoplastic elastomers.  Utilizing our knowledge and vast supplier network, we’ll choose the right materials to ensure product efficacy.

Mechanical/System Integrity: 
We utilize engagement testing and qualification to meet fitness-for-use requirements of the design.  Selected components and connections are verified to be robust and leak-free under defined operating conditions to maintain product quality and prevent contamination.

Sterility: 
Product sterility is of paramount importance to maintain safety. Components are selected from our comprehensive library and new components can be adopted as required.  Our program is rigorously monitored to ensure your product is sterile to ISO 11137. 

Development

We’re driven to innovate and develop solutions that improve yield, cut costs and advance time to market.
  Using leading industry software and 3D printing, our team can work with you to build tooling, create prototypes, and validate the production of your specific product design.  

Testing

In our world-class laboratory, we can work with you to design experiments and analyze data based
on your critical single-use assembly requirements. 

Testing capabilities include:

• Pressure
• Leak Integrity
• Torque
• Tensile
• Autoclave
• Pump Life and Spallation
• Ultra Low Temperature
• Mixing Characterization
• Growth Promotion