Enhanced BioMedical Manufacturing

Precision Sealer System Case Study

The Brief

Facing significant challenges with their manual sealing process, A leading medical device manufacturer aimed to enhance their packaging operations through automation. This crucial process, while essential for maintaining product integrity, was labor-intensive and fell short in terms of efficiency and reliability, particularly at the scale required for high-volume production. In pursuit of a solution that could automate and refine their sealing operations, the manufacturer engaged with SEYMOUR Advanced Technologies. The collaboration aimed to create an autonomous, state-of-the-art sealing system to enhance production efficiency significantly. Designed to complement existing assembly and loader machinery, this innovative system proposed to automate the entirety of the packaging steps — from product placement in trays and desiccant addition to the final sealing — all within a compact operational footprint. This initiative strived for a seamless, uninterrupted workflow that adhered to the exacting standards of medical device packaging, emphasizing precision, reliability, and scalability.

“Innovation is the ability to see change as an opportunity - not a threat”
- Steve Jobs

The Challenge

Transforming the manual sealing process into a highly efficient, autonomous system presented a set of multifaceted challenges. Key among these were the integration of the new sealing system with established assembly machinery to ensure uninterrupted operations that met rigorous quality standards. Innovations in mechanical design, software integration, and operational logistics were essential to address these challenges effectively. The project's success was contingent upon navigating four primary hurdles:

Necessity for Rapid Prototyping and Cost Efficiency

A pivotal challenge in developing the sealing system was the need for rapid prototyping and the production of custom components while maintaining strict budget constraints. Traditional subtractive manufacturing methods, although reliable, are both time-consuming and costly, particularly when dealing with the variety of metals required for this project, including tool steels, mild steel, stainless steels, titanium, and copper. The high cost and extended lead times associated with these conventional methods posed a significant risk of inflating the project's budget and delaying development timelines, potentially hindering innovation and the ability to quickly iterate designs based on testing feedback.

To overcome this challenge, SEYMOUR Advanced Technologies (SAT) turned to both metal and plastic 3D printing technologies as a solution. This additive manufacturing approach allowed for the in-house rapid prototyping and production of components, significantly reducing both cost and development time. The ability to print with a wide range of materials in-house not only offered substantial cost savings—by potentially eliminating an extra zero from the project's cost if outsourced—but also increased design flexibility and reduced lead times for parts. This strategic decision enabled SAT to swiftly iterate designs within the project's budget, ensuring the sealing system's development remained on schedule and within financial parameters. By embracing 3D printing, SAT demonstrated its commitment to innovation, efficiency, and cost-effectiveness, directly addressing the challenge of rapid prototyping and manufacturing efficiency in the development of advanced automation solutions.

Achieving Consistent Tray Separation

Addressing the challenge of consistent tray separation required a focused approach to mechanical engineering and automation. The system needed to autonomously manage the separation and handling of trays from stacked configurations to the sealing process. This was a critical operation, as any inconsistency could lead to operational delays or compromises in product integrity.

The initial concept envisioned the robotic arm picking and placing trays; however, the variability in tray alignment and the potential for sticking together necessitated a more sophisticated approach. The engineering team at SEYMOUR Advanced Technologies developed an elevator mechanism designed to store multiple stacks of trays, feeding them into the system upon request.

This elevator mechanism was instrumental in consistently delivering trays to the robotic handling system. It utilized a novel separation technique that allowed for the individual dispensing of trays, ensuring that each tray was correctly oriented and ready for processing. The integration of this system with advanced robotics, specifically chosen for their precision and small footprint, enabled the precise handling and positioning of trays for the sealing process.

The technical solution incorporated several key components:

Elevator Mechanism: Allowed for the storage and sequential dispensing of trays, overcoming the challenge of manual tray separation and alignment.
Advanced Robotic Arms: Mecademic robots were selected for their compact size and high precision, enabling efficient manipulation within the system's confined space.
Levitating Conveyor System: Provided a novel approach to moving trays between process stages. This system used magnetic levitation to minimize contact and contamination, offering superior cleanliness and flexibility in tray positioning.

The design and integration of these components required close collaboration with equipment manufacturers to ensure compatibility and optimize performance. Software modifications were also necessary to coordinate the actions of the elevator, robotic arms, and conveyor system, ensuring a seamless operation from tray separation to sealing.

Through innovative mechanical design and strategic integration of automation technologies, the project successfully overcame the challenge of achieving consistent tray separation. This solution not only enhanced operational efficiency but also ensured the reliability and cleanliness essential for medical device packaging processes.

Navigating Software Integration Hurdles

The project's complexity was amplified by the need to integrate software from multiple sources, each controlling a distinct part of the operation—from robotic arms and vision systems to conveyor mechanisms and thermal sealers. The initial integration efforts revealed software bugs that hindered the system's efficiency and reliability. These bugs manifested in various forms, such as incorrect part recognition, misalignment during handling, and timing discrepancies between the conveyor system and the robotic arms.

To overcome these challenges, the engineering team at SEYMOUR Advanced Technologies initiated a series of collaborative engagements with the OEMs. These efforts were aimed at identifying the root causes of the software bugs and implementing tailored solutions to resolve them. Key actions included:

Software Debugging Sessions: Intensive debugging sessions were conducted, involving both the project's engineering team and software engineers from the OEMs. These sessions facilitated a deep dive into the software's operation, allowing for the identification and rectification of bugs.
Custom Software Modifications: Where necessary, custom software modifications were developed to enhance compatibility between different components. This involved adjusting software parameters, rewriting portions of the code for better integration, and optimizing performance to meet the system's operational requirements.
Enhanced Software Libraries: In collaboration with OEMs, the project team worked on expanding the software libraries of certain components. This effort aimed to introduce new functionalities and improve existing ones, thereby broadening the system's capabilities and ensuring smoother operation.
Iterative Testing and Validation: Each software modification underwent rigorous testing and validation to ensure that it not only resolved the existing issues but also did not introduce new ones. This iterative process was critical in achieving a stable and reliable software environment for the system.

Through persistent collaborative efforts and a methodical approach to software integration, the project successfully navigated the software integration hurdles. These efforts not only resolved the immediate operational challenges but also strengthened the system's overall reliability and efficiency. The engagement with OEMs further facilitated a mutual exchange of knowledge, leading to software enhancements that benefited all parties involved.

Adhering to Compact Space Constraints

The design team encountered the complex challenge of configuring the sealing system to perform its required tasks without exceeding the spatial limitations. This constraint was critical not only for the initial installation but also for ensuring that the system could be easily maintained and possibly reconfigured in the future without significant disruption to the surrounding operations. The solution involved several key engineering and design strategies:

Modular Design Approach: The system was conceptualized with modularity in mind, allowing for components to be compactly arranged and, if necessary, reconfigured with minimal effort. This approach facilitated ease of maintenance and the potential for future upgrades without requiring additional space.
Integration of Compact, High-Precision Robotics: The selection of robotics, such as the Mecademic Meca500, was pivotal. These robots were chosen for their small size, high precision, and embedded controller, which minimized the system's overall footprint while maintaining the operational accuracy needed for medical device packaging.
Utilization of a Levitating Conveyor System: To optimize the use of space, a magnetic levitating conveyor was incorporated, providing a flexible and clean method for moving components between stages of the sealing process. This system eliminated the need for bulky mechanical conveyance, freeing up valuable space while also enhancing cleanliness—a critical consideration in medical device manufacturing.
Efficient Layout and Spatial Planning: Careful attention was given to the physical layout of the system, ensuring that every square inch was used efficiently. This involved strategic placement of components to optimize workflow and minimize unnecessary movement or space usage.
Custom Solutions for Tray Handling: Addressing the need to manage and separate trays efficiently within the compact space, the team developed a custom elevator mechanism for tray dispensing. This solution occupied minimal space while ensuring trays could be fed into the system accurately and consistently.

Through these strategies, the project successfully adhered to the compact space constraints without compromising on the system's performance, cleanliness, or scalability. This achievement underscored the team's ability to innovate within strict parameters, delivering a solution that not only met the immediate needs of the medical device manufacturer but also provided flexibility for future growth and adjustments.

Our Solution

System Overview

The sealing system was engineered as a fully automated solution to streamline the final stages of the medical device packaging process. With a primary focus on efficiency, reliability, and cleanliness, the system was designed to operate autonomously, handling and sealing trays with minimal human intervention. Central to its operation were several key components and technologies, each selected and optimized to meet the project's stringent requirements within a compact footprint.

Compact, High-Precision Robotics: Central to the system's operation were the Mecademic Meca500 robotic arms, chosen for their unparalleled precision down to microns and their diminutive size. These robots efficiently executed tasks such as tray handling and component positioning, crucial for the sealing process, with a cycle time of approximately 15 seconds per tray, illustrating the system's rapid throughput.

Innovative Tray Handling Mechanism: The elevator mechanism design included several key features to ensure reliable operation and future flexibility:
- Stack Management: The mechanism was equipped to store multiple stacks of trays, utilizing vertical space efficiently. This storage capacity allowed for continuous operation over extended periods without needing to replenish the tray supply frequently.
- Automated Separation: Through precise control and innovative design, the elevator mechanism automatically separated individual trays from the stacks. This function was critical in ensuring that each tray was correctly oriented and ready for sealing, addressing a common bottleneck in traditional manual processes. AMCI (Advanced Motion Control) was our selected vendor for this process - self-contained so that we only needed to supply power. This allowed the separation of the trays to be seamlessly integrated into the solution.
- Integration with Robotic Systems: The mechanism was seamlessly integrated with the system's robotic arms. Once a tray was separated and positioned, robotic arms took over, moving the tray to the sealing station with high precision. This integration was facilitated by sophisticated software algorithms that coordinated the actions between the elevator mechanism and the robots.
- Future-Proofing for Tray Design Changes: Anticipating future changes in tray designs, the mechanism was engineered to be adaptable. The SAT team, understanding the dynamic nature of manufacturing requirements, incorporated flexibility into the system's design to accommodate different tray sizes and configurations without extensive modifications. This foresight allowed for rapid adaptation to new tray designs, ensuring the system's long-term viability and reducing the need for future capital investment.
- Consultative Expertise: The development of the tray handling mechanism highlighted SAT's consultative approach to solution development. Recognizing the importance of future-proofing in the system's design, SAT proactively included features that allowed for easy adjustments to tray designs. This capability was not an initial requirement from the customer but was identified by the SAT team as a critical value-add, demonstrating their commitment to delivering solutions that not only meet current needs but are also poised to adapt to future challenges.

Component Integration and Functionalities: The sealing system’s advanced capabilities are further augmented by the integration of IAI and Keyence technologies, ensuring precision and compliance with cleanroom standards. Specifically, the system incorporates IAI's servo motors, with five units distributed between the two machines, offering consistent movement and positioning with the cleanroom-grade reliability required for medical device manufacturing. Keyence IV3 series sensors play a critical role in sealing detection and quality control, monitoring the process to ensure each seal meets stringent quality standards. These sensors also facilitate real-time detection during the process, such as identifying tray removal, contributing to the system’s overall efficiency and reliability. For selecting a thermocontroller for the control of the heat sealing process, we chose Watlow due to their self containment and communication with Ethernet/IP.
Levitating Conveyor System: The levitating conveyor system integrates Planar Motors flyways to facilitate a contactless mechanism for transporting components within the sealing system. This feature is critical for maintaining the stringent cleanliness standards of cleanroom environments in medical device manufacturing, as it eliminates the generation of particulates from component friction. The system's design allows for isodirectional movement, providing the capability to adjust the conveyor's height (Z-axis) and orientation (theta) for precise positioning of parts before the sealing process. Enhanced through collaboration with the conveyor manufacturers, additional functionalities were developed and integrated into the software. These include autonomous recognition of part locations and a locking mechanism for securing components during critical operations. Specifically tailored for SEYMOUR Advanced Technologies, these features emphasize the system's advanced automation and precision, enabling efficient handling and accurate positioning of components, thereby reducing the need for manual intervention and enhancing overall process reliability.
Modular, Space-Efficient Design: The system's modular design facilitated a footprint that was both space-efficient and conducive to future scalability. This design approach allowed for easy maintenance and the potential for system enhancements without extensive modifications, ensuring the solution's long-term viability.

Integration of the Meca500 Robot from Mecademic

Integral to the system’s modular framework is the incorporation of the Meca500 robot. This robot is selected for its compact size and precision, aligning with the system's emphasis on spatial efficiency and operational accuracy. The Mecademic robot is particularly suited for precise tasks, such as component handling and placement.

Technical Justification for Choosing the Mecademic Robot:

Compact Footprint and Precision: The robot's design maximizes space efficiency within the system while delivering high precision in component manipulation, critical for maintaining stringent quality standards in medical device packaging.
Flexibility and Programmability: The robot offers extensive programmability and adaptability, enabling straightforward integration into the system and allowing for easy reconfiguration to accommodate future product or process adjustments.
Support for System Modularity: Its design complements the system's modular nature, facilitating seamless integration and reorientation within the system to meet varied manufacturing processes without substantial spatial reconfigurations.

The decision to integrate the Mecademic robot within the modular design framework exemplifies the system’s technical strategy to balance efficiency, precision, and adaptability. This approach ensures that the sealing system not only meets current manufacturing requirements but is also equipped to adjust to future technological advancements and operational needs.

Reporting and Quality Control in the Sealing System

An integral component of the sealing system's design is its comprehensive reporting capabilities, reflecting SEYMOUR Advanced Technologies' commitment to detail-oriented solutions and robust quality control. The system's architecture incorporates advanced monitoring and data analysis tools to provide real-time insights into operational performance and product quality, enabling proactive management and continuous improvement.

Technical Overview of Reporting Capabilities:

The sealing system utilizes a multi-layered approach to data collection and reporting, capturing detailed metrics at each stage of the manufacturing process. This data is instrumental in ensuring adherence to quality standards and identifying areas for optimization. Key aspects of the reporting functionality include:

Real-Time Monitoring: Equipped with sensors and vision systems, the sealing system continuously monitors the operational parameters and product quality. This includes the precise detection of tray placement, seal integrity, and component positioning, ensuring each packaged product meets predefined quality criteria.
Data Aggregation and Analysis: Data collected during the manufacturing process is aggregated and analyzed to provide comprehensive reports on production performance. This includes metrics such as cycle times, throughput rates, and downtime incidents, offering actionable insights into system efficiency.
Quality Control Integration: Quality control is strategically embedded within the system's operational framework. The use of Keyence IV3 series sensors for post-seal quality checks exemplifies this integration, automating the verification process to ensure each product's integrity before final packaging.
Batch-Level Reporting: The system generates detailed reports for each production batch, documenting key performance indicators and quality metrics. This capability supports traceability and compliance requirements, providing a documented record of manufacturing conditions and outcomes for each batch of products processed.
Future-Proof Reporting: SEYMOUR Advanced Technologies’ approach to reporting is designed to be adaptable, accommodating future enhancements in data analytics and reporting standards. The system's software architecture allows for updates and integrations with emerging technologies, ensuring the reporting capabilities remain cutting-edge.

Significance of Reporting to SAT's Quality Assurance Strategy

At SEYMOUR Advanced Technologies, we prioritize the integration of comprehensive reporting and quality control mechanisms within our systems. This approach stems from our commitment to precision and accountability in all our engineering solutions. Far from being simply add-ons, these features are fundamental to the design and function of our systems. They provide essential transparency and enable a level of control that ensures the output meets the high-quality standards we set, and more importantly, that our clients expect.

Our focus on developing an advanced reporting infrastructure is driven by the technical challenges inherent in meeting and exceeding current quality standards. We recognize the importance of data in driving operational improvements and enhancing product quality. Therefore, we've embedded sensors and analytics capabilities within our systems to offer real-time monitoring and post-operation analysis. This not only aids in immediate quality assurance but also in the long-term adaptation to industry changes and standards evolution.

The detailed metrics and analytics we gather serve a dual purpose. They offer a granular view of the manufacturing process, enabling pinpoint identification of areas for improvement, and they ensure each product’s journey through the system is fully documented for quality verification and compliance purposes.

In designing the reporting and quality control features of our sealing system, we aim to embody our dedication to technical accuracy and strategic quality management. By investing in sophisticated data collection and analysis, we don’t just meet the immediate needs of our clients; we also contribute to advancing the standards for operational transparency and quality assurance across the automated manufacturing landscape.

In Summary

Through engineering solutions like automated tray handling mechanisms, software integration across diverse components, and the design for a reduced physical footprint, the project underscores the critical role of technical innovation in enhancing manufacturing processes. Essential to the system's design was the integration of advanced reporting and quality control, ensuring operational parameters and product quality were continuously monitored and analyzed for adherence to stringent standards. This methodology not only facilitated immediate improvements in efficiency and quality but also established a framework for ongoing operational optimization. The deployment of this system illustrates a practical application of combining modular design with precision robotics and data-driven insights to meet high-quality manufacturing requirements. We encourage dialogue with professionals seeking to leverage such technologies for improving manufacturing outcomes.