Micron-Scale Inspection via Precision Vision & Motion

Medical validation company achieved micron-scale visual quality inspection using Cyth's vision and motion solution built on NI sbRIO and Cyth CircaFlex.

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Project Summary

Medical validation company enhanced quality assurance capabilities with a micrometer-scale syringe lubrication inspection system built by Cyth using the NI sbRIO-9651 and Cyth CircaFlex-315.

System Features & Components

• Micrometer-scale positioning accuracy for consistent syringe rotation and imaging alignment

• Automated inspection workflow integration with existing production systems

Outcomes

• Achieved micrometer-scale precision in lubrication coverage measurement, eliminating variability of validation accuracy.

• Dramatically reduced inspection time per syringe while improving consistency across production runs

• Enabled expanded pharmaceutical contracts through enhanced quality assurance capabilities

Technology at-a-glance

• NI sbRIO-9651 System on Module

• Cyth CircaFlex-315

• Applied Motion stepper motors with encoders and integrated drives

• 20 Megapixel CMOS global shutter camera

• Custom LED array with RC Series LED strobe controller

• Telecentric illuminator

• NI LabVIEW image processing algorithms

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Emergency Drug Delivery

Life-saving medical devices like EpiPens® rely on a silicon lubricant coating in the inner bore of the syringe to ensure precise and reliable delivery of emergency medications during allergic reactions such as anaphylaxis. Even microscopic variations in syringe lubrication coating can affect delivery accuracy and patient outcomes.

The coverage, consistency, and distribution profiles of the silicon-based lubricant coating inside every auto-injector must meet exacting standards and comply with federal regulations.

Manual Process, Aging Technology

A medical validation company specializing in auto-injector quality control faced critical limitations with their existing syringe lubrication inspection system. Manual processes and limited inspection tools presented risks to existing client relationships due to lack of scalability and aging technology.

• Inconsistent Performance: Lighting intensity decreased over time, causing measurement variations across production runs.

• Limited Capability: The system couldn't capture high-resolution images necessary for detecting microscopic lubrication defects.

• Scalability Constraints: Manual inspection processes couldn't meet increasing production volumes and faster client turnaround requirements.

Expanding Throughput Capacity

To scalably grow their business by maintaining and steadily expand their customer base, the validation company required a higher throughput, higher performance system that would also help simplify their regulatory compliance activites.

• Market Expansion: Advanced and scalable validation capabilities would enable the pursuit of larger pharmaceutical contracts previously beyond their capacity.

• Regulatory Compliance: FDA and international standards demand rigorous inspection processes with documented precision and repeatability to ensure patient safety.

They required a technical solution capable of:

• Precise Inspection: High-resolution 2D imaging with consistent lighting, micrometer-levels of precision, and seamless integration with existing workflows.

• Automated Measurements and Datalogging: Overall reduction in manual processes to mitigate human error, optimize repeatability and increase mean validation rate

Synchronized Motion & Image Acquisition

Cyth built the validation solution using the NI sbRIO-9651 and Cyth CircaFlex-315 control hardware with Applied Motion stepper motors to deliver micrometer-scale positioning accuracy to ensure consistent, high-quality imaging.

Why Choose NI Embedded Systems?

For the validation company, the technical differentiation of the inspection solution was critical to attaining their throughput and quality goals. They required a highly synchronized and precise validation solution to be able to pursue larger customers and

Synchronized Precision:  Micrometer-scale accuracy and consistent imaging achieved through tight synchronization between stepper motors, dynamic lighting sources, and camera through the real-time capabilities of the NI sbRIO-9651. Cyth's CircaFlex platform enabled direct connectivity to stepper motor control I/O to minimize system jitter and ensure tight coordination of all system components.

• LabVIEW Real-Time software, running on Linux Real-Time Operating System (RTOS) enabled precise process synchronization between motor rotation, auto-injector illumination and image acquisition

• Cyth's CircaFlex platform provided all control signals directly to the motors' drives.

• Stepper motors were programmed to make predefined movements with accuracy on the micrometer scale.

Learn more about stepper motor control

Advanced Lighting Control: Custom LED strobing algorithm eliminated lighting degradation issues while extending lifespan through optimized pulse-width modulation control. The programmable logic controller integration with CircaFlex enabled synchronization between LED strobing sequences and camera acquisition cycles to ensure consistent illumination profiles and eliminate exposure timing variability.

• Custom strobing algorithm with optimized pulse-width modulation to ensure consistent syringe illumination and extended LED lifespan through controlled duty cycles and thermal management.

• CircaFlex provided built-in signal conditioning and hardwired connection to FPGA I/O on the sbRIO-9651 necessary to smoothly and precisely coordinate the system with millisecond-levels of precision

• Programmable Logic Controller (PLC) configured to strobe LEDs in tandem with camera capture sequences to ensure well-illuminated, detailed images.

Automated Image Processing: Real-time image processing algorithms stitched together multiple captures together to create a 2D image that comprehensively represents the profile of the lubrication coating of the auto-injector.

• 20-Megapixel CMOS global shutter camera with telecentric illuminator for detailed interior imaging

Machine Vision Capabilities

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Hardware, camera, stepper motor, and programmable controls

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The final solution was contained in a compact, custom enclosure. The overall syringe lubrication inspection process included:

1. Syringe oriented vertically then rotated at a predefined rate using a stepper motor with a built-in drive

2. Illumination of syringe using a strobing array of LEDs

3. Reflected light captured with high-resolution camera to create 2D images of interior lubricant coating

4. High-definition composite images of interior syringe coating stitched together automatically

5. Images analyzed automatically with pass/fail results and data for regulatory compliance needs

The resulting high-defintion images enabled the validation company to accurately quantify the quality of syringe lubricant coating. The automated and precise nature of the vision inspection system streamlined regulatory compliance and augmented throughput capacity.

Full Compliance, Market Expansion

The upgraded system positioned the medical validation company as a leader in auto-injector lubrication inspection technology. The system exceeded their performance expectations and helped accelerate their growth.

• Precision Measurement: Delivered micrometer-scale lubrication coating measurements, eliminating variability that previously compromised validation results.

• Improved Compliance: Facilitated quantification of images, data storage and reporting to streamline regulatory compliance activities.

• Enhanced Throughput Capacity: Process automation dramatically reduced average cycle time per syringe, improving consistency across production runs.

• Business Growth: Pharmaceutical clients reported significantly improved confidence in validation results, leading to expanded contract opportunities and full regulatory compliance .

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