Closed System Solutions | Bioprocess | Corning

Safe, Sterile, and Convenient Closed Systems

Safe, Sterile, and Convenient Closed Systems

Closed processing mitigates contamination and safety risks and can help reduce costs of cleanroom measures. But acquiring closed system configurations that match your specific needs can seem daunting. Corning gives you the flexibility to close your processes your way. Choose from a large selection of standardized pre-assembled solutions, or easily design your own solution with Corning Configurable Assemblies.

Our Standard and Configurable Closed Systems are Bioprocessing Ready

  • Nonpyrogenic
  • Animal-free or BSE/TSE compliant
  • Compliant with USP Class VI
  • Sterility Assurance Level (SAL) SAL 10-6

OFF-THE-SHELF SOLUTIONS

Off-the-Shelf Closed System Solutions

Off-the-Shelf Closed System Solutions

Standard offerings are described in our catalog of Closed System Bottles and Tubes and Flasks, including aseptic transfer cap accessories or vessels with pre-attached aseptic accessories. For information about specific vessels, click on the links below to browse our online catalog.

Custom Solutions

Compose your own closed system with Corning Configurable Assemblies

Compose your own closed system with Corning Configurable Assemblies

Configurable Benefits:

  • Proven Corning vessels: CellSTACK chambers, Erlenmeyer flasks, roller bottles, centrifuge tubes, and storage bottles
  • Optimized library of 100+ components for all applications
  • Robust component supply levels for reliable delivery
  • Balance of off-the-shelf speed and custom flexibility
  • Complete documentation for effortless implementation

If you desire more hands-on technical assistance designing a custom closed system, please contact your Corning representative.

Corning Configurable Assemblies FAQs

Frequently Asked Questions

  • What are Corning Configurable Assemblies?

    Corning Configurable Assemblies are customized closed system solutions designed to meet specific bioprocessing needs. They combine proven Corning vessels with a selection of pre-qualified components to create a tailored assembly that aligns precisely with requirements.

  • What are the benefits of using Corning Configurable Assemblies?

    Our Configurable Assemblies offer the reliability and performance you expect from high quality Corning vessels, designed to deliver consistent results. With an optimized component library, you have access to a wide range of carefully selected components tailored to different applications. Our high component stocking levels ensure reliable delivery to meet your operational requirements. Our pre-qualified design space provides the perfect balance between the speed of off-the-shelf solutions and the flexibility of custom solutions. Complete documentation streamlines the implementation process, making it seamless and simple. Additionally, closed processing provides significant benefits, including minimized risk of contamination, reduced cleanroom expenses, and increased operational efficiency.

  • What types of vessels can be incorporated into a configurable assembly?

    You can choose from a variety of Corning vessels, including:

    • Corning CellSTACK® Vessels: Available in 1-, 2-, 5-, 10-, and 40-chamber options with surface treatments such as Corning CellBIND® surface, TC-treated, and Ultra-Low Attachment (ULA) surface
    • Erlenmeyer Flasks: Sizes range from 125 mL to 5L, with flat and baffled bottom options
    • Roller Bottles: 850 cm², not treated
    • Centrifuge Tubes: 50 mL and 500 mL options
    • Storage Bottles: Sizes include 150 mL, 250 mL, 500 mL, and 1L
  • What components are available for creating a customized assembly?

    The component library includes over 100 pre-qualified items such as tubing, connectors, fittings, filters, and more. These components are optimized based on historical data for various applications, ensuring a configuration that suits your unique process. Corning technical experts will work with you to create a configuration perfectly suited for your unique process.

  • What is the process for designing and ordering a configurable assembly?

    The process involves several steps:

    1. Initiate the process by requesting Configurable Assembly Assistance on our website or by contacting your account manager
    2. Collaborate with a Corning Application Scientist to create your design Obtain a finalized drawing and quote
    3. Test a sample to ensure the design meets your needs
    4. Approve the design and place your order

    After completing the above steps, you can order the final product through Corning or a local distributor. Once your order is placed, Corning manufactures, sterilizes, and ships your unique product.

  • What is the estimated total timeline for this process?
    • Design and Approval: The drawing and approval process may take a few weeks depending on application scientists' availability and the complexity of your request. If you’d like a sample, it may take 2-4 weeks for the sample to be built, sterilized, and shipped. Customers must approve and sign the drawings before Corning sets up the product internally.
    • Part Setup: For Corning to set up the product internally, it typically takes 2 weeks in North America (NA) and 3 weeks elsewhere (this allows an additional week for coordination).
    • Manufacturing, Sterilization, and Shipment: Once the part is setup, you may place a purchase order. After receipt of the purchase order, the lead time for manufacturing and sterilization is typically up to 14 weeks for the product to be ready at the NA distribution center.
    • Shipment to EMEA or Elsewhere: Additional transit time to the EMEA region or elsewhere should be accounted for, depending on the destination.

    The estimated total timeline from the start of the design process to readiness for shipment is up to 16 weeks for NA and 16-17 weeks for elsewhere (including transit).

  • What are the quality standards for the Corning Configurable Assemblies?
    Claim Description Specifications
    cGMP  ISO 9001 and FDA CFR 21 Part 820  Compliance 
    Nonpyrogenic  USP <85>  ≤ 0.25 EU/mL 
    Class VI  USP <87> and/or USP <88>  Class VI Compliance 
    Sterile  ANSI/AAMI/ISO 11137  Sterility Assurance Level (SAL) of 10-6 
    BSE/TSE  EMA/410/01  Animal-free or compliance with regulation 
    Shelf Life  Claims valid for specified duration  3 years 
    Inspection  Internal visual and packaging inspection methods  Pass