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    Robust clarification processes are critical to safeguard biological products production since they directly affect yield, product consistency and reproducibility. Clarification of recombinant therapeutic proteins, monoclonal antibodies and vaccines requires cost-efficient processing of cell-culture fluids. By combining multiple separation technologies (such as centrifugation, TFF–MF, depth filtration and sterile filtration) clarification removes cells, cell debris, colloids, insoluble precipitants, aggregates, and other materials found in fermentation broths.

    Managing Higher Cell Densities During Clarification

    Clarification techniques are evolving to manage the more efficient bioreactors that facilitate higher cell densities. These new treatments, including feed pretreatment, flocculation, and different filtration technologies, help to increase process capacities and filtrate quality which helps reduce biomanufacturing costs. Newer clarification methods assist in reducing filtration area, time and steps necessary for filter preparation (including flushing).

    Single-Use Systems Helps Reduce Clarification Complexity

    Single-use technologies (SUT) such as mixers, integrated filtration platforms, storage containers and hardware help meet the increasingly complex fluids required in today’s clarification process while making lower costs possible. CPC single-use, aseptic connectors simplify the media transfer of fermentation broths, cell debris and other cell-culture fluids while minimizing the risk of operator error. Cleaning requirements can be reduced with single-use technologies including CPC Steam in Place (SIP) connectors.

    Clarification Systems Considerations

    • Large footprint requirements in fermentation suite including headroom to disassemble housin
    • Handling of new and used media and solutions
    • Handling waste including environmental impact
    • Design and fabrication of streaming equipment
    • Removing spent filters and containment of biologic organisms
    • Changeover requirements
    • Built-in system safety

    CPC Expertise and Experience Aid Clarification Workflow Processes

    Designing clarification operations is vital to overcome potential issues of scale-up, flexibility and installation in the production of biologic products. CPC understands the need to have an efficient clarification and capture process to overcome these issues. The expertise and experience CPC has gained over more than 40 years has resulted in connection technology that meets the increasing complexity of process fluids produced by today’s bioprocessing and cell and gene therapies. Collaborating manufacturing and process design engineers around the world, CPC has helped to design and implement clarification processes that provide a high yield, economical separation process with enhanced impurity removal.

    Seven Benefits of Single-Use CPC Aspectic Connectors

    1. Support for a wide variety of clarification technologies 
    2. Ensure closed connection and disconnection for media transfer
    3. Suited for bag and bottle assemblies used in clarification
    4. Streamlined design for ease of use
    5. Repeatable performance with no additional hardware
    6. 3-step connection process reduced operator error
    7. Sterile connections even in non-sterile environments

    Provide Workflows Clarity with CPC Aseptic Connectors

    The broad portfolio of innovative CPC aseptic connectors is engineered to provide the appropriate connection technologies to help advance clarification workflow processes. CPC aseptic connectors ensure efficient changeover and operator safety in managing clarification media as well as helping make quick changeovers due to changing fermentation broth properties.

    Versatility and Flexibility

    Flexibility is a key requirement for clarification workflows. CPC aseptic connectors provide flexibility to easily combine multiple components including process containers, tubing manifolds, single-use and metal transfer lines, bioreactors and other bioprocess equipment. When changeovers need to occur, genderless CPC aseptic connectors make it easy to connect and disconnect components and processes. Multiple termination options meet today’s mounting and flow requirements.

    Innovative Design

    The broad range of clarification techniques are met by CPC’s comprehensive portfolio of aseptic connectors with multiple sizes, configurations, termination options and materials. Innovative connection methods help eliminate contamination risk and ensure connection assurance. CPC’s biopharma design and application engineers develop innovative, high-quality products that make sterile media transfer during the clarification process safe and easy.

    Trusted Reliability

    CPC sterile connectors are engineered for upstream and downstream applications including clarification. By helping maintain aseptic transfer of media, CPC sterile connectors facilitate getting the best biologic product yields at a cost-effective price. All CPC aseptic connection solutions are rigorously tested ─ including materials testing, product testing and torture testing to failure ─ to meet product specifications. As a matter of fact, CPC offers reliable, reproducible performance and provides validation and extractable reports that support the performance attributes.

    Overall Robustness

    CPC aseptic connectors deliver optimized flowrates with excellent flow to size ratio for superior performance to manage the media transfer required during clarification. CPC purpose-built connectors are designed to be compatible with the wide variety of clarification platforms and processes. We provide a unique combination of industry expertise with the broadest portfolio of products including sterile connects, sterile disconnects, SIP connections and quick connects.

    Sterility Assurance

    Increased cell densities and complex clarification fluids mean manufacturers must design their facilities to manage shorter production runs with multiple changeovers. Single-use bags and transfer lines use CPC MPC or MPX Connections and SaniQuik Adaptor for quick changeovers. Robust and easy-to-use, single-use, aseptic connectors from CPC maintain flow path sterility and integrity while enabling biopharmaceutical manufacturers to use the necessary clarification processes and platforms to improve biologic product yields and reduce costs.

    Assurance of Supply

    CPC has a proven track record of providing products consistently under their stated specifications and quality requirements through having a strong supply assurance program. The program includes control of the manufacturing process from raw materials to final product manufacturing. Investments in extra capacity and redundant manufacturing ensure capacity before it’s too late. Biopharma customers have confidence in CPC’s ability to fulfill demand acquired by a track record of accurate lead times, identifying and communicating potential delays and, most importantly, by sound supply chain management.

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