US-12618859-B2 - Methods and systems for automated syringe quality evaluation

US12618859B2US 12618859 B2US12618859 B2US 12618859B2US-12618859-B2

Abstract

Automatic syringe quality control systems, apparatus and methods are provided. The automatic syringe quality control systems, apparatus and methods may determine a plunger depth within a syringe that has been pre-filled with a medication. The plunger depth may be based on digital image data.

Inventors

Vikashni Padmakumar
Evan Kruchowy
Daniel Coller
Opeyemi Babatola
Oscar Rosas Andrade
Gregory Evans
Stephen Flores

Assignees

AMGEN INC.

Dates

Publication Date: 20260505
Application Date: 20220412

Claims (14)

1 . A method of rapid syringe quality verification, comprising: providing an imaging system including an imaging surface and a processor; securing a syringe in an alignment device, the alignment device comprising: (a) a syringe rack defining a syringe receptacle receiving and aligning the syringe relative to the syringe rack, the syringe receptacle comprising an open end with a perimeter against which a flange end of the syringe rests, or (b) a spring actuated mechanism retaining the syringe; aligning the syringe on the imaging surface relative to the imaging system by disposing the alignment device on the imaging surface, the syringe having a transparent or translucent syringe barrel including a distal end and a proximal end, and a plunger disposed inside of the syringe barrel and located at a plunger depth relative to the distal end of the syringe barrel; capturing an image of the syringe, including the plunger and a distal end of the syringe; measuring, via the processor, the plunger depth; and determining, via the processor, whether the plunger depth is within a predetermined tolerance.
2 . The method of rapid syringe quality verification of claim 1 , wherein: the imaging system comprises a digital optical comparator; and/or the image comprises an illuminated silhouette.
3 . The method of rapid syringe quality verification of claim 1 , wherein: (a) the flange end is disposed on a distal end of the syringe; or (b) the flange end is disposed on a distal end of the syringe; the plunger includes a distal end and a proximal end opposite the distal end; the flange end includes a distal end and a proximal end opposite the distal end; and the plunger depth is measured as a distance between the distal end of the flange and the distal end of the plunger.
4 . The method of rapid syringe quality verification of claim 1 , further including: aligning a planar portion of the syringe barrel relative to the imaging system; and/or generating syringe quality data and storing syringe quality data.
5 . A method of analyzing a plurality of syringes, comprising: providing an alignment device, carrying a plurality of syringes, each syringe including a transparent or translucent syringe barrel having a distal end and a proximal end, a flange end at the distal end, and a plunger disposed inside of the syringe barrel, the alignment device comprising: (a) a syringe rack defining a plurality of syringe receptacles receiving and aligning the plurality of syringes relative to the syringe rack, each of the plurality of syringe receptacles comprising an open end with a perimeter against which the flange end of a syringe of the plurality of syringes rests, or (b) a spring actuated mechanism retaining the plurality of syringes; providing an imaging system, including an imaging surface having at least one alignment tab; disposing the alignment device and the plurality of syringes on the imaging surface against the at least one alignment tab; capturing an image, via a camera, of the alignment device and the plurality of syringes; and measuring, via a processor, a plunger depth relative to the distal end of the syringe barrel of each plunger disposed in each of the plurality of syringes; and determining, via the processor, whether the plunger depth of each plunger is within a predetermined tolerance.
6 . The method of analyzing a plurality of syringes of claim 5 , wherein: the imaging system comprises a digital optical comparator; and/or the image comprises an illuminated silhouette of each syringe.
7 . The method of analyzing a plurality of syringes of claim 5 , wherein: (a) each plunger includes a distal end and a proximal end opposite the distal end; or (b) each plunger includes a distal end and a proximal end opposite the distal end; each flange end includes a distal end and a proximal end opposite the distal end; and each plunger depth is measured as a distance between the distal end of the respective flange end and the distal end of the respective plunger.
8 . The method of analyzing a plurality of syringes of claim 5 , further including: aligning a planar portion of each syringe barrel relative to the imaging system; and/or generating syringe quality data and storing syringe quality data.
9 . An automatic syringe measurement system, comprising: an imaging system capable of generating imaging data, including a camera, an imaging surface, and an illumination source; an alignment device for aligning at least one syringe relative to the imaging system, the alignment device comprising: (a) a syringe rack defining at least one syringe receptacle receiving and aligning the at least syringe relative to the syringe rack, the at least syringe receptacle comprising an open end with a perimeter against which a flange end of the at least one syringe rests, or (b) a spring actuated mechanism retaining the at least one syringe; and a processor configured to receive the imaging data from the imaging system to determine whether a depth of a plunger within a barrel of the at least one syringe is within a predetermined tolerance.
10 . The automatic syringe measurement system of claim 9 , further comprising an alignment tab disposed on the imaging surface and configured to align the alignment device relative to the imaging system.
11 . The automatic syringe measurement system of claim 9 , wherein: the imaging system comprises a digital optical comparator; and/or the imaging data generated by the imaging system includes illuminated silhouette image of the at least one syringe.
12 . The automatic syringe measurement system of claim 9 , wherein the imaging surface is disposed between the camera and the illumination source.
13 . The automatic syringe measurement system of claim 9 , wherein: the alignment device is configured to hold between 8 and 25 syringes.
14 . The automatic syringe measurement system of claim 9 , wherein the processor is further configured to transmit at least one of the imaging data and the plunger depth to an external memory.

Description

CROSS-REFERENCE TO RELATED APPLICATION This is the United States national phase of International Patent Application No. PCT/US2022/024331, filed Apr. 12, 2022, which claims priority to U.S. Provisional Patent Application No. 63/178,339, filed Apr. 22, 2021, the entire contents of each of which are hereby incorporated by reference herein. FIELD OF DISCLOSURE The present disclosure relates to syringe manufacturing and quality control and, more particularly to methods and apparatus for automated syringe quality control imaging. BACKGROUND Numerous drug products are manufactured and stored in syringes and manufactured to the highest quality standards. Some drug products include pre-filled syringes having pre-measured doses of drugs stored within the syringe barrel. Properly manufactured pre-filled syringes have unique plunger depth requirements. The plunger depth is unique based on the drug, container, and fill volume. Thus, for a given drug, container, and fill volume, how deep the plunger is disposed in the syringe barrel is a controlled variable. Because the plunger depth is a controlled variable for all pre-filled syringe cartridges, one aspect of the quality control process is verifying the depth of plungers in manufactured syringes. Currently, the plunger depth is manually measured by lab technicians using calipers. If the plunger depth does not match the plunger depth corresponding to the unique drug product, the syringe fails this quality control process. SUMMARY An automatic syringe measurement system may include an imaging system capable of generating imaging data. The imaging system may include a camera, an imaging surface, and an illumination source. The automatic syringe measurement system may also include an alignment device for aligning at least one syringe relative the imaging system. The automatic syringe measurement system may further include a processor configured to receive the imaging data from the imaging system, and determine whether a depth of a plunger within a barrel of at least one syringe is within a predetermined tolerance. In another embodiment, syringe carrying tub assembly may include a tub configured to receive a plurality of syringes. The syringe carrying tub assembly may also include a syringe carrier plate have a plurality of apertures extending from a top surface of the syringe carrier plate to a bottom surface of the syringe carrier plate. Each of the plurality of apertures may be configured to receive one of a plurality of syringes. The syringe carrying tub assembly may further include a tub insert configured to be placed within the tub prior to the plurality of syringes being placed into the tub. The tub insert may include at least one syringe elevator aligned with at least one of the plurality of syringes. When the syringe carrier plate, the tub insert, and the plurality of syringes are placed within the tub, the at least one syringe elevator may be configured to elevate the at least one syringe configured to be received in the at least one aperture aligned with the syringe elevator relative to the remaining syringes of the plurality of syringes. In a further embodiment, a syringe removal tool may include a syringe carrier having a first end, a second end, and a plurality of syringe receptacles linearly arranged along an edge of the syringe carrier from the first end to the second end. The syringe removal tool may also include a stationary grip portion having a first end and a send end. The first end of the syringe carrier may be connected to the first end of the stationary grip portion via a first slide rod. The second end of the syringe carrier may be connected to the second end of the stationary grip portion via a second slide rod. The syringe removal tool may further include a syringe retainer portion having a first end, a second end, and a plurality of spring biased syringe retainers linearly arranged along the syringe retainer portion from the first end to the second end. Each spring biased syringe retainer may be configured to retain a respective syringe within a respective syringe receptacle independent of any other spring biased syringe retainer in the plurality of spring biased syringe retainers. The first end of the syringe retainer portion may be configured to slide along the first slide rod. The first end of the syringe retainer portion may be biased toward the first end of the syringe carrier portion via a first syringe retainer portion bias spring. The second end of the syringe retainer portion may be configured to slide along the second slide rod. The second end of the syringe retainer portion may be biased toward the second end of the syringe carrier portion via a second syringe retainer portion bias spring. In yet another embodiment, a syringe rack may include a plurality of syringe receptacles. At least one syringe receptacle may include an open end defining a syringe barrel receptacle. The syringe barrel receptacle may be configured to receive a syrin