The Biggest Challenge Verus + BD have Faced to Date

February 18, 2022

The Biggest Challenge Verus + BD have Faced to Date

February 18, 2022

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Constant innovation and advancing medical device designs are part of the reason Becton Dickinson helps to save the lives of patients every day. We all know the role of safety in new product development. However, testing and Validation solutions are not always as clear-cut as they may seem.

During the new product development stage of the Barricor component, BD was not alone in the challenges they faced with this clever device. From tooling and fixturing to measuring, this component presented many challenges. But consequently provided the best learning experiences the team at Verus has possibly experienced.

Glen Miller, Senior Metrology Engineer at BD Plymouth was instrumental in the project from the initial contact with Verus, sharing his years of expertise during the fixture POP stage to implementing the final installation on site. Working with the team in Franklin Lakes, including Mukund Patankar, Sr. Staff Engineer, and Mike Ross, Staff Research and Development Engineer, collaboratively found a solution to solve the challenges this component brought. 


From Concept to Completion

Verus attended a collaborative meeting with OGP in BD Plymouth to discuss a solution for the Barricore component. In attendance was Glen Miler, Senior Metrology Engineer, Jamie Tabb, Quality Engineer (Projects), and Tom Stimson who was the project lead and finally Graham Shaw from OGP.

Verus proposed a course of action to BD considering the complexity involved in this solution. Along with a proposal on capabilities and timelines, Verus proposed to initiate the project with a test unit.

The proof of principle was successful, and the team quickly got to work on the production fixture. 

The BD team placed the order for the vision machine which OGP delivered to Verus in Sligo. Upon completion of the 32-station fixture, the measurement machine arrived. This meant the team could then combine the fixture and the OGP to undertake rigorous testing.

Verus achieved a fill Gauge R&R in Ireland to prove out the fixture and the transfer system. This team could then complete programs collaboratively with OGP. The entire system, Gauge R&R and program were then shipped to BD Plymouth for an on-site install and full MSA.

An initial single station fixture was developed in Franklin Lakes achieving results of sub 30% Gauge R&R. Verus engaged from a production perspective to improve the results. We got it to 15% thanks to the collaborative process to all the team involved as well as Verus’ expertise and capabilities.

As demand ramped up, two repeat projects followed for 128-station versions of the original 32-station fixture. In BD Plymouth currently, there are two 128-station fixtures, one 32-station fixture, and a transfer system. Verus remains in constant communication with the engineers involved in this project as they overcome internal challenges with this component, looking towards the next steps. 


The Barricor Component

The component itself is very complex, intricate, and extremely unreceptive to touch given that it is produced using an exceptionally flexible rubber.

Although the Barricor is minuscule in size, the effect this component has on the process of separating blood and plasma is gigantic. The purpose of the component is to separate the plasma layer. Centrifugation causes the red blood cells to pack at the bottom of the tube with Barricor closely following and providing a barrier between the cells and plasma.

5 Critical Dimensions in 4 Different Positions.

The Barricor must rotate to 4 orientations, in a multi-position situation to access all 5 critical dimensions.


What Challenged verUS The Most?

To ensure the integrity of the measurements, given the nature of the material used, the holding solution must give access to all dimensions needed without compromising the rubber profiles.

From the rubber bung rite down to the chin strap, each profile comprises the rubber material. This proved many challenges from a fixturing perspective. The surfaces also change in geometry as they are rotated. The rubber molds down and around the component and back up.

The A datum is 4 small flat pads on the bottom of the component. Critical to the measurement the A datum stops the part pivoting through its 3 degrees of freedom. The pitch and the yaw control the Z position. It controls the part from spinning or falling. It also controls the position in the direction of the Z height. So, once we know it’s resting on that face and know where the face is, we can then control it.


Measuring The Untouchable

At Verus there is a widely held philosophy, that the fixture is there to hold the part, not to control its position. The team achieves this through innovative design and incorporating flex into the fixture to allow the part to move within reason. Therefore, the machine can then locate the part and attain its datum structure. 

However, this was certainly not the case with the Barricor. There was no physical way to hold this component to then access the datum structure. The plastic aspect of this component is the only material that can be held without compromising the geometry of the part. And yes, you guessed it, the datum structure is located in the plastic. With no alternative resolution, the fixture was used in this instance to control all the positioning of the part. That being said, the innovation incorporated into this solution knows no bounds.

Using the fixtures to control the positioning of the component does not come without its challenge when accessing all 5 critical dimensions in a total of 4 different positions. The fixture nests into the modest hollow using pins. However, once you rotate the fixture the component would fall off those pins.

So, what is the solution? The design team at Verus incorporated a small hook to grab into the hollow. This design aspect allowed the part to pull onto the pins because the channel is plastic. This ensures that the part does not gravitate when we rotate by 90-degree increments as it stays pulled onto the pins.


Getting it off the Molding Machine and on to the Fixture

Developing an innovative fixture to hold the Barricor component is only part of the solution. But how do you get the component from the molding machine to the fixture without touching it and causing changes to the part’s geometry?


Robotics, Hydraulics, and Transfer Systems

Incorporated beside the injection molding machine is an end-of-arm robot. Originally the robot used beside the cube mold was a 32. The robot offloads 8 components at a time to one of four transfer trays inside the system. The robot replicates the process, filling the 32-stations. There are 4 red lights that look across the rail to make sure the parts are located correctly.

Once this process is complete, outside the cage is a hatch system controlled by a green button. Once pushed it allows you to reach into the robot facility and take the 4 rails. The operator can then move the rails into a base plate and onto the transfer system.

The air pressure gauge is then set at 3.5 bar on the transfer system awaiting the loaded parts.

Using the lifting positions, the robot rail is loaded onto the cross-slide. The operator can then visually check the parts to ensure they are square and located down on their nests. The operator then switches on the air and presses the yellow knobs at the top of the system. The component then visibly lifts out of its nest.

The operator then replaces the robot rail with the empty fixture while the parts float above. Repeating the process in reverse, as demonstrated in the video, until each component is located in the fixture rail. The operator can then confidently move the multi-station fixture to the OGP for measurement. All the while confirming no direct contact with the parts ensuing the component geometry remains unaffected by human intervention.


Why The BD Partnership is so Important to Verus

The long-standing partnership between Verus + Becton Dickinson is based on clarity, communication, trust, and shared expertise. What once seemed like a near-impossible task, these four pillars of our partnership were demonstrated throughout and are the reason for the successful completion of the Barricor project. 

To find out more about the Verus + BD partnership, contact our Business Development Manager Tracey Flynn on +353 (0)76 661 9000. To find out more about our turnkey metrology solutions, contact our COO Michael Nugent on +353 (0)71 91 43506 (ext. 215).

Introduction 

As 2024 unfolds, the field of metrology is witnessing transformative changes. At Verus Metrology, we recognize the importance of keeping pace with technological advancements and new trends in the science of measurement. In this rapidly evolving landscape, innovations in metrology are not just about achieving precision; they are about meeting the evolving challenges of industries like medical devices, where accuracy is critical for ensuring safety and quality. This article explores the emerging trends and technological breakthroughs shaping metrology’s future. 

As 2024 unfolds, the field of metrology is witnessing transformative changes. At Verus Metrology, we recognize the importance of keeping pace with technological advancements and new trends in the science of measurement. In this rapidly evolving landscape, innovations in metrology are not just about achieving precision; they are about meeting the evolving challenges of industries like medical devices, where accuracy is critical for ensuring safety and quality. This article explores the emerging trends and technological breakthroughs shaping metrology’s future. 

Metrology Fixture Types – What’s Available, and Which is Best?

9 February 2023

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Fixture type and use cases

Metrology fixturing technologies continue to develop at a rapid pace, offering manufacturers in the medical device industry new and innovative solutions. Those solutions don’t just meet inspection and quality process requirements, but they also deliver efficiency savings and productivity gains. How do you know what metrology fixture types are available and which is best for your application? In this blog, we’ll outline the main options, their underlying technologies, and the use cases they are best suited for. 

However, it is also important to point out that the fixture types described in this blog represent broad categories. Within those categories, there is an infinite number of ways that a fixturing solution can be developed to meet your specific needs, reduce risk, and take advantage of opportunity

While there are metrology fixture types that we can explore, every fixture solution that we develop here at Verus Metrology is completely unique. In other words, fully customised for the product or component being measured, as well as the inspection machine, quality department workflows, production processes, and any other influencing factor. 

Metrology Fixture Types 

There are six main metrology fixture types: 

  • Auto rotational 
  • Manual rotator 
  • Multi-station
  • Proof of Principle (POP) 
  • Vision system 
  • Docking station 

 

Auto-Rotational Fixtures

Isometric view of an auto rotational metrology checking fixture, the automatic part of the fixture is the turning of the rail by a motor. The fixture has white plastic components held in place using brown clips

 

At a fundamental level, the job of a metrology fixture is to hold a product or component securely in place so it can be effectively inspected and measured. However, there are situations where the inspection process requires the part to be presented at different orientations to enable all the relevant measurements to be taken. This requirement for measurement in multiple orientations is increasing as medical device products become more complex and intricate. 

Auto-rotational fixtures enable the inspection of products and components in multiple orientations with minimal operator intervention. An auto-rotational fixture can be a single-station set-up, but they more commonly come in multi-station designs to minimise the time it takes to achieve your required sample rate. 

The most important feature of an auto-rotational fixture is that you can measure multiple components in multiple orientations in a single setup. 

Manual Rotator Fixtures

Manual Rotator Metrology Fixtures by Verus Metrology

Manual rotator fixtures offer similar benefits to auto-rotational fixtures. The obvious main difference is that operators manually rotate components once they are loaded into the fixture. 

Manual rotator fixtures can be multi-station. They are also designed so that all measurements in all orientations can be taken in one set-up. So, while the operator will need to manually control the rotation mechanism, there is no requirement to touch or adjust the components as the fixture holds them securely in place during rotation. 

The benefits of manual rotator fixtures include: 

  • Significantly reduced operator intervention 
  • Improved measurement accuracy 
  • Elimination of errors 
  • Faster and more efficient metrology processes 

Furthermore, we can design your manual rotator fixture so it can be loaded with components away from your CMM. This improves CMM availability as the machine doesn’t have to sit idle while components are being loaded onto the fixture. 

Multi-Station Fixtures 

multi station rotator

According to FDA regulations and ISO 13485, it is essential that you can statistically justify sampling rates in your quality procedures using a risk-based approach. The operational part of this requirement isn’t covered in the guidelines, but it is an important business consideration. How do you efficiently, accurately, and cost-effectively inspect the number of products or components that are required to hit your sampling rate target? 

Multi-station fixtures are a common solution. We can design multi-station fixtures in any configuration. This could be a large cavity multi-station fixture, a fixture to inspect very small and complex medical devices, or solutions for products or components of any size, geometry, or characteristic. 

The benefits of multi-station fixtures include: 

  • Operator intervention is greatly reduced 
  • Fixtures only need to be loaded once before full inspection routines can take place on multiple products at the same time 
  • Reduce human error 
  • Speed up inspection processes while achieving your sampling rate target 
  • Reducing the cost of inspections 

 

Proof of Principle Multi-station Prototype Fixtures 

proof of principle

 

In many product development and process change situations, it is beneficial to have a POP fixture that can be used for verification and validation purposes. The approach we typically take at Verus Metrology is to design a multi-station fixture to deliver on your requirements. 

However, before this multi-station fixture design goes into manufacturing, we design and produce a single-station POP prototype fixture. This POP prototype can be manufactured quickly in our advanced manufacturing facility. We’ll then put it through a gage R&R study to give you confidence in its repeatability and reproducibility, before sending it to you for evaluation and testing. 

POP prototype fixtures offer a range of benefits: 

  • Facilitates design for inspection during the product development process 
  • Minimises delays in process verification 
  • Enhances and speeds up the design transfer process 
  • Reduces time to market in line with regulatory requirements 

 

Vision System Solutions

We also design and manufacture fixturing solutions for vision systems in addition to the fixtures we design for use on CMMs. Fixturing solutions that are optimised for vision systems have a number of specific and differentiating features, including ensuring there is a clean and clear view of the part. 

Vision system solutions can also allow for backlighting where necessary. Furthermore, a single set-up is all that is required for the full inspection routine to take place, with parts securely held with as little force as possible. 

 

Docking Systems 

Docking System Verus Metrolody

Docking systems enhance the efficiency of quality departments that use multiple fixtures and/or have high sampling rates. Docking systems are securely fixed to CMMs to make it quick and easy for technicians to load fixtures that are fully set up with components ready for inspection. Once the inspection routine for a fixture is complete, it can be quickly and easily removed from the docking system ready for the next fixture to be loaded. 

With a custom-designed docking system, you can have confidence that each changeover results in precisely secured fixtures for repeatable and reproduceable inspections. 

Choosing the Right Fixture for Your Requirements

There are many factors to consider when choosing the best type of metrology fixture for your requirements. Your budget is an important consideration, as are your ROI goals, quality processes, quality resources, and future requirements. 

The best approach is to speak to a fixture design expert to explore the options and get an understanding of what is possible. Contact us today to find out more. 

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About Verus Metrology Partners

Verus is committed to the enhancement of our client’s metrology laboratories, machine efficiencies, and inspection processes. Since our beginning, our expert metrology engineering team has partnered with some of the world’s largest MedTech multinationals.

 

We specialize in high quantity, difficult to measure, yet critically important, medical device parts. As well as working in the MedTech, Pharmaceutical and Personal Care industry, we also work with metrology departments in the FMCG and Aerospace industry.