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    Bioprocessing Component Testing: The Benefits of Reliability

    How Bioprocessing Component Testing Benefits Your SUS Assembly

    Failure isn’t an option in the competitive bioprocessing space when expectations are high and reliability is essential.. That’s why thorough testing is necessary for any bioprocessing component — especially the critical points of connection that bring the entire assembly together.

    SUS components need to undergo a battery of tests to ensure that they meet application expectations. They must be:

    • Biologically and chemically compatible with liquids used in and around bioprocessing
    • Able to handle temperature and flow rate requirements
    • Capable of standing up to unique application tests when necessary, including freeze/thaw resistance tests and bubble leak testing

    While a bioprocessing manufacturer may believe that every SUS component on the market undergoes a similar degree of rigor in its testing, the types and precision of these tests can vary widely between suppliers. For these manufacturers, determining the best products to incorporate into their systems should include seeing validated results and examples of appropriate bioprocessing component testing.

    Vetting suppliers for their testing facilities, procedures, and documentation practices helps bioprocessing manufacturers evaluate SUS components and whether they could be the right fit for their application. Bioprocessing manufacturers should expect component suppliers to, at a minimum, validate performance and readily provide the validation package to support end-user adoption.

    Bioprocessing Component Validation Testing Examples

    Because of the wide range of potential applications, single-use aseptic connectors used in SUS come in a variety of configurations – from 1/8” microconnectors to 1” large volume connectors, from male/female to genderless, from standard to custom. These components must be optimized to maintain the integrity of the overarching manufacturing process. To achieve this, suppliers should engage in variety of connector performance testing that both simulates and exceeds manufacturing conditions, including a comprehensive validation model.

    Reliability starts with building the test plan. Colder Products Company’s (CPC) product development teams work with integrators and end-users to understand the expected life cycle for their SUS components. By creating this framework, the teams are able to develop a connector performance testing plan that mirrors predicted sterilization exposures, temperature induced stresses, and physical load induced stresses. From manufacturing to shipping, assembly to sterilization, and storage to usage the wear and tear that a component can conceivably experience can be staggering.

    Bacterial ingress testing is one of the most important foundational tests for a single-use component. Other examples of bioprocessing component testing include bioburden and endotoxin particulate tests, which are designed to validate that components are free of a range of living organisms (bioburden) and gram-negative bacteria (endotoxins) that could compromise a system.

    CPC also performs accelerated aging, shipping and vibration, flow and burst, and biocompatibility testing to assess product durability and integrity. The testing profiles of its various components are available to biopharmaceutical manufacturers so they can easily evaluate components for integration in their manufacturing applications.

    See for yourself CPC's test capabilities

    CPC’s Value Proposition for Biopharma

    CPC’s testing facilities are best-in class among component suppliers. Its engineers leverage advanced modeling capabilities and prototyping equipment to evaluate the performance of every design, and are equipped to develop and test custom components based on individual customer needs. Additionally, CPC can offer verification testing of customers’ own bespoke component designs, streamlining the approval process and facilitating faster market acceptance.

    CPC’s commitment to holistic product validation is evidenced by its qualification plan for new components. These plans combine a range of rigorous evaluation metrics, like:

    • Functional testing
    • Verification and validation testing
    • Risk assessment

    End users are responsible for evaluating the functionality and performance characteristics of a connector or component before integrating it into a bioprocessing application. CPC, a global leader in single-use connection technology, has pioneered testing processes that offer users a comprehensive understanding of its products.

    Contact a CPC expert to learn more about testing today

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