Defect Test Sets

  • Various Containers.

    We work with many container types, including vials, syringes, ampoules, cartridges and more.

  • Particulate.

    We work with sites to define what particulate can be found in there containers based on upstream processes and materials that are used during that process. We then create our defect sets to tailor the site needs.

  • Cosmetic Defects.

    The integrity of the container is just as important as what is inside the container. We are able to produce various cosmetic defects depending on the container. Some defects we can produce are container cracks, scratches, chips, burns, crimp defects, flange defects and more.

  • Unique Coding.

    When we are performing training, qualifying inspectors, or executing Knapp studies, we want to ensure that users are not aware of a pattern or obvious differences between accepts or rejects. That is why we can label each defect with a unique data matrix, QR code, UV marking, or any other site approved method.

  • Compliance and Documentation.

    YB has developed a defect set program that aligns with all of the guidance in USP 1790.

    During our process of making particulate defects, we document the image of the defect under a camera based microscope along with information including size and material. We then ensure the particle is freely moving in the solution during a high speed inspection test stand.

  • Training / Qualifying.

    We are pleased to offer training to inspectors and qualifying them using manual visual inspection methods.