Process and apparatus for inspecting microneedle arrays
Inventors
Adolf, Jeffrey P. • Floeder, Steven P. • Smith, Jason P. • DREGER, Steven R.
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Assignees
Member
Kindeva Drug DeliveryKindeva Drug Delivery is a contract development and manufacturing organization specializing in advanced drug delivery systems including pulmonary, nasal, injectable, transdermal, and intradermal therapies. Services range from formulation and analytical development to commercial-scale, Annex 1-compliant GMP manufacturing across global facilities. The company brings integrated expertise in regulatory strategy, device engineering, process and technology transfer, and quality assurance, with a focus on sustainable solutions such as low-GWP propellants and microneedle patch platforms. Kindeva supports complex, patient-centric, and environmentally optimized therapies from product conception through commercialization.
Kindeva Drug Delivery is a contract development and manufacturing organization specializing in advanced drug delivery systems including pulmonary, nasal, injectable, transdermal, and intradermal therapies. Services range from formulation and analytical development to commercial-scale, Annex 1-compliant GMP manufacturing across global facilities. The company brings integrated expertise in regulatory strategy, device engineering, process and technology transfer, and quality assurance, with a focus on sustainable solutions such as low-GWP propellants and microneedle patch platforms. Kindeva supports complex, patient-centric, and environmentally optimized therapies from product conception through commercialization.
Publication Number
US-11460411-B2
Publication Date
2022-10-04
Expiration Date
Abstract
A process of making a microneedle array comprising providing a microneedle array having a plurality of microneedles of a desired shape, illuminating at least a portion of said microneedle array that comprises at least one microneedle, capturing an observed image of said at least one microneedle using an optical device, electronically processing said observed image and determining at least one shape parameter for said at least one microneedle, accepting said microneedle array if said at least one shape parameter is within an acceptable range, thereby providing a microneedle array that comprises a known shape of the plurality of microneedles.
Core Innovation
The invention relates to a process of making a microneedle array and a process of inspecting a microneedle array using an optical, non-destructive, shadow-projection approach. The process illuminates at least a portion of a microneedle array so that at least one microneedle or at least one coated microneedle projects a shadow onto a surface of the microneedle array. The method captures an observed image of the projected shadow using an optical device and electronically processes the observed image to determine microneedle-related parameters.
For the making process, electronically processing the observed image determines at least one shape parameter for at least one microneedle based upon the processed observed image. Shape parameters include at least one of microneedle height, microneedle width, microneedle angle, microneedle spacing, microneedle base area, or combinations thereof. The microneedle array is accepted if the at least one shape parameter is within an acceptable range, thereby providing a microneedle array that comprises a known shape of the plurality of microneedles.
For the inspecting process, the method illuminates at least a portion of a microneedle array that comprises at least one coated microneedle using a directed light source, captures an observed image of shadows projected onto the surface, and electronically processes the observed image to determine an amount of a material coating on the at least one coated microneedle. The coating determination includes defining a coated region from a shadow and determining the amount of a material coating on the at least one coated microneedle.
Claims Coverage
The provided material identifies two independent claims: clm-00001 and clm-00017. Across these independent claims, the core inventive coverage is based on directed illumination, shadow-projection imaging, electronic image processing, and downstream determination of either microneedle shape parameters or coating material amount.
Shadow-projected microneedle imaging for making and acceptance based on shape parameters
providing a microneedle array having a plurality of microneedles of a desired shape; illuminating at least a portion of said microneedle array that comprises at least one microneedle; capturing an observed image using an optical device, wherein the observed image is at least one shadow projected onto a surface of the microneedle array from the at least one microneedle; electronically processing the observed image and determining at least one shape parameter for the at least one microneedle based upon the processed observed image; accepting the microneedle array if the at least one shape parameter is within an acceptable range; thereby providing a microneedle array that comprises a known shape of the plurality of microneedles.
Shadow-projected coated microneedle imaging for determining coating material amount
inspecting a microneedle array by illuminating at least a portion of said microneedle array that comprises at least one coated microneedle with a directed light source; capturing an observed image of said at least one coated microneedle using an optical device, wherein the observed image is at least one shadow projected onto a surface of the microneedle array from the at least one coated microneedle; electronically processing said observed image; and determining an amount of a material coating on said at least one coated microneedle.
Taken together, the independent claims cover a shadow-projection imaging process that electronically determines microneedle shape parameters and accepts an array when within an acceptable range, and a shadow-projection imaging inspection process for coated microneedles that electronically determines the amount of a material coating.
Stated Advantages
Non-destructive.
Provides a microneedle array that comprises a known shape of the plurality of microneedles.
Documented Applications
Making a microneedle array.
Inspecting a microneedle array.
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