Amgen Inc.

Thomas Clark Pearson

Graham Frank Milne

Dmitry Fradkin

Erwin Freund

Neelima Chavali

Ryan Michael Agard

Wael Mismar

Sudeshna Dutta Ray

Jerome Olivas

Matthew Wayne Janke

Chuck Z Li

Justin Harris

Owen Ryan

Brandon Zachary Sarich

Alexis Dechelette

Michael R Berke

Joseph Peter Bernacki

Michael Gammelager

Bonchull Chris Koo

Mads Hansen

Clive Smith

Valerio Mazzon

Graham F Milne

In a method for replicating performance of an automated visual inspection (AVI) station, a mimic AVI station that performs one or more AVI functions of the AVI station is constructed. One or more container images are captured by an imaging system of the AVI station while a container is illuminated by an illumination system of the AVI station, and one or more additional container images are captured by a mimic imaging system of the mimic AVI station. The method also includes identifying, by one or more processors, one or more differences between the one or more additional container images and the one or more container images, generating, by the one or more processors, a visual indication of the difference(s) and/or one or more suggestions for modifying the mimic AVI station, and modifying the mimic AVI station based on the visual indication.

Offline troubleshooting and development for automated visual inspection stations

A robotic inspection platform comprises a robotic arm, an imager, and a controller. The controller causes the robotic arm to retrieve, using its end effector, a container, and to manipulate the container such that the container is sequentially placed in a plurality of orientations while in view of the imager. The controller also causes the imager to capture images, with each of the images being captured while the container is in a respective one of the orientations. The controller also determines one or more attributes of the container, and/or a sample within the container, by analyzing the images using a pattern recognition model and, based on the attribute(s), determines whether the container and/or sample satisfies one or more criteria. If the container and/or sample fails to satisfy the criteria, the controller causes the robotic arm to place the container in an area (e.g., bin) reserved for rejected containers and/or samples.

Robotic system for performing pattern recognition-based inspection of pharmaceutical containers

Fill-finish assemblies facilitating the manufacture of a drug delivery device are disclosed. The fill-finish assembly may include a container, an insertion mechanism, a fluid pathway connection assembly disposed between the container and the insertion mechanism, and a carrier. The insertion mechanism may include a delivery member and an insertion mechanism housing. The insertion mechanism may be configured to move the delivery member from a retracted position inside the insertion mechanism housing to a deployed position outside the insertion mechanism housing. The fluid pathway connection assembly may be selectively activatable to establish fluid communication between the container and the delivery member. The carrier may have a hollow interior containing at least a portion of each of the container, the insertion mechanism, and the fluid pathway connection assembly. The carrier may be configured to hold the container, the insertion mechanism, and the fluid pathway connection assembly in alignment with each other.

Fill-finish assemblies and related methods

A method for 3D imaging of a sample, in a vessel having a longitudinal axis orthogonal to a horizontal plane, includes capturing, by at least three cameras located at different positions around the vessel, respective 2D images of the sample. Each image comprises pixels having associated pixel values. The optical axis of a first camera is inclined or declined at a first angle relative to the horizontal plane, with the first angle being greater than or equal to zero degrees. The optical axis of a second camera is inclined or declined at a second, larger angle relative to the horizontal plane. The method also includes generating a 3D image of the sample based on the pixel values associated with the 2D image pixels, and one or more look-up tables that collectively indicate, for pixels in each image, expected paths for light traversing the vessel and the sample.

3D particle imaging in pharmaceutical containers

In a method for imaging a container holding a sample, the container is illuminated with a laser sheet of a first color, and one or more images of the container are capturing by a first imager configured to filter out colors other than the first color. Simultaneously with illuminating the container with the laser sheet of the first color, the container is illuminated with light of a second color different than the first color, wherein the light of the second color illuminates at least a majority of an entire volume of the container. One or more additional imagers of the container are captured by a second imager configured to filter out colors other than the second color. The one or more images and the one or more additional images are analyzed to detect particles within, and/or on an exterior surface of, the container.

Sheet lighting for particle detection in drug product containers

Methods and systems of performing an assay. A system for performing an assay includes an enclosure defining a temperature-controlled space. An imaging system, an actuator and a dispenser are disposed within the space. The actuator receives a well plate having wells. The actuator is to move the well plate relative to the imaging system to enable the imaging system to obtain image data of one of the wells. The dispenser includes a pump, an outlet and a reservoir holder to receive a reservoir containing a compound. The pump is to be fluidly coupled to the reservoir and an outlet. The pump is to pump the compound from the reservoir through the outlet into one of the wells. The system also includes a controller. The controller is to cause the dispenser to dispense the compound into the first one of the wells while the imaging system obtains the image data.

Methods and systems of performing an assay

In a method for imaging a container holding a sample, the container is illuminated with a laser sheet that impinges upon the container in a first direction corresponding to a first axis. A plane of the laser sheet is defined by the first axis and a second axis orthogonal to the first axis. The method also includes capturing, by a camera having an imaging axis that is substantially orthogonal to at least the first axis, an image of the container. The method further includes analyzing, by one or more processors, the image of the container to detect particles within, and/or on an exterior surface of, the container.

An inspection system for a drug container is provided to identify foreign matter, such as particles or fibers, within the drug container prior to filling with a drug. The system includes a camera device aligned with an axis of the drug container and captures a series of images of an interior surface of a sidewall of the drug container while the robot causes relative movement between the drug container and the camera device along a linear path. Atypical lighting, which improves contrast between particles and the background in images is employed to aid detection. A control circuit then processes the series of images to identify foreign matter within the drug container.

Camera-based drug container inspection

A system is described to facilitate the characterization of particles within a fluid contained in a vessel using an illumination system that directs source light through each vessel. One or more optical elements may be implemented to refract the source light and to illuminate the entire volume of the vessel. As the refracted source light passes through the vessel and interacts with particles suspended in the fluid, scattered light is produced and directed to an imager, while the refracted source light is diverted away from the imager to prevent the source light from drowning out the scattered light. The system can therefore advantageously utilize an imager with a large depth of field to accurately image the entire volume of fluid at the same time, facilitating the determination of the number and size of particles suspended in the fluid.

Imaging system for counting and sizing particles in fluid-filled vessels

An automated visual inspection (AVI) system is described to measure the depth of plungers positioned within vessels. The AVI system implements various types of image processing as well as other techniques to identify, for a vessel, a reference point and the uppermost edge of the plunger. Because different inconsistencies and/or artifacts may be introduced within the vessel image, different processing techniques may be executed on the region containing the reference point versus the plunger region. In doing so, the AVI system provides a robust means to accurately measure plunger depth that is highly resilient to the aforementioned artifacts and consistently measures plunger depth for a wide variety and types of vessels.

Image processing techniques for plunger depth measurement

A method includes, during an agitation period of an agitation profile, applying a motion to a transparent vessel containing a fluid, and while applying the motion; acquiring a sequence of original images of a portion of the transparent vessel; generating a background image from the sequence of original images; generating a resultant image from the background image and an original image in the sequence of original images; and identifying from the resultant image a particle in the fluid.

Growing community of inventors

Newbury Park, CA, United States of America

Thomas Clark Pearson