Development & manufacture of biosensor components

  • Project requirements
    Project requirements
    Project requirements
    1. Design components for biosensor to channel blood through very thin capillary channels, to simultaneously supply four wells from one drop of blood.
    2. The channels had to be very thin so as not to lose too much of the sample transported to the wells and to reduce the amount of blood required from the patient.
    3. Fluids must not escape
    4. Oxygen is required for the test
    5. The gas from the reaction needs to escape
    6. Must be manufactured in a controlled environment
    7. Must be manufactured to ISO 13485
    8. An automated assembly process is required due to the required speed and accuracy of assembly.
    Our solution
    Our solution
    1. In conjunction with the customer, Parafix were heavily involved in the design and development of the part and material selection, providing a number of designs and prototypes to trial, for example experimenting with many channel designs to find the perfect performing design.
    2. We designed five components for the biosensor part, assembled with our AccuPlace automated placement equipment.
    3. Component one was the flow cell, made with an inert diagnostic spacer tape. The thin capillary channels and wells required laser cutting as they were just 200um wide. We developed our own laser system to cut the channels and small holes in volume.
    4. Component two was a lid for the flow cell, made with a hydrophilic film.
    5. Component three was a microporous mesh placed underneath the flow cell, which provided a barrier to fluids, whilst allowing oxygen in for the test to work, and the gas from the reaction to escape.
    6. Component four was a black double coated tape to allow inspection and provide a contrast in the part for recognition by the vision systems of our AccuPlace automated placement equipment.
    7. Component five was a thick, white PET backing to provide stiffness and to improve the aesthetics of the part.
    8. All components were manufactured and assembled in our ISO 14001 class 7 clean room and we are accredited with ISO 13485.
    9. The assembly process was developed and we supplied the fully automatic assembly equipment to accurately assemble all components to a target speed.
    Key benefits
    Key benefits
    Key benefits
    1. Using our knowledge and access to a wide range of medical grade materials, the optimum products were specified for the diagnostic device.
    2. The thoroughly tested component was supplied in a presentation suitable for the automated assembly system.
    3. The assembly process was tried and tested during the design and prototyping stage and Parafix supplied a complete automated assembly system and components, installed and ready to operate at the customer’s manufacturing facility.
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