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Medical Devices Quality Control – 3 Things to Consider When Selecting Equipment

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Ensuring that components used in medical devices are fit for purpose and comply with strict industry regulations means quality control is a critical step in the manufacturing process.  To deliver a high standard of quality control the correct equipment must be used to make these checks. This not only safeguards operator accuracy, but also allows quick, efficient checking.

In this article we look at the key points to consider when selecting equipment.

Equipment Practicality

The first thing to consider when selecting equipment for microscopic quality control is the type of work that the operator will be required to undertake.  As a starting point you need to consider if you will need to undertake non-contact measurements or whether you will be looking for surface defects.

When undertaking non-contact measurement the ability to use a digital overlay is extremely helpful when working with complex precision moulded pieces or irregular shapes.  In this instance it is simple and quick to place the component under the microscope and view the image of the component on a digital screen. You can then import a CAD drawing and use this as a digital overlay to ascertain whether the component fits within tolerance parameters. This process is ideal when working with medical implants.

Simpler more geometric shapes, such as diameters, distances, angles etc. can easily be measured using measurement software, providing that there is enough contrast under the microscope for the edges to be digitally detected.

Medical Device Components

In some cases, such as when the part is made of clear or white plastic, digital edge detection will be problematic. In this instance the higher resolution of an optical view may be required. An example of this would be when measuring the internal and external dimensions of tubing used in IV sets or the diameter of syringes.

In some situations there may be a need to conduct both non-contact measurement and surface checks. In such a situation a dual digital and optical microscope is the ideal choice. A case in point is quality control checks on stents.  There is a requirement to measure strut thickness and radii down to µm level, together with the overall stent dimensions. The stent then needs to be inspected for burrs and the overall quality of the surface finish.

Finally, practicality considerations are not only about functionality. With space being at a premium in any manufacturing area, equipment must be of a reasonable size, fitting on an average sized work bench.

Regulatory Compliance

In an industry where the failure of a device can have life-threatening consequences, a documentation procedure detailing evidence that all components are within tolerance levels is essential. However, the process should be streamlined to avoid delay in delivery time scales. Capturing of digital images for insertion into quality control documentation, together with the ability to mark-up measurements on these images is a definite advantage in this process.

And if for any reason there is a non-compliance issue, the marked-up image can quickly be shared with the production manager or supplier and the issue easily communicated for a quick resolution.

Of course, it goes without saying that any measuring equipment used should be calibrated to a relevant industry standard.

Operator Comfort

Last, but certainly not least, is the requirement for operator comfort.  An ergonomically designed system will allow operators to work for longer periods of time without experiencing eyestrain or posture related discomfort. Optimal ergonomics will ensure excellent levels of productivity and accuracy, not to mention happy staff!

The Swift PRO Duo, with its digital measurement system and optical eyepiece-less technology is the perfect solution for the quality control of medical device components.  Find out more about Swift PRO.

Vision Optics - custom optical components

New Vision Optics website launched

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Vision Optics is a new division of Vision Engineering Ltd that specialises in supplying high quality optical components: lenses, mirrors, prisms and filters, as well as optical design services, custom optics and assemblies.

Over recent years more and more customers have benefited from our optics expertise and the competitively priced optical solutions we offer.Vision Optics - custom optical components

The dedicated Vision Optics website www.voptics.com provides further information on these products and services.

As pioneers in designing and manufacturing eyepiece-less microscopes and inspection systems, we know the importance of high quality optics to the success of a product and we understand that not every organisation has optical design capabilities or in-house optical expertise.

In addition to off-the-shelf optical components, we provide a full service solution for your optical requirements. Our experienced engineers will work with you throughout the design and development life cycle, from early concept right through to final design, testing and production.

The role of optical inspection in today’s demanding electronics industry

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The role of optical inspection in today’s demanding electronics industry

Reliable automated systems for populating PCBs are a common sight on most of today’s assembly lines. With this in mind, to what extent are manual processes implemented into the production of PCBs, in today’s demanding electronics industry?

The development of automated inspection routines has been fuelled in part by the changes in electronics manufacturing processes.

Firstly the departure from through-hole components to surface mount components meant that traditional in-circuit tests no longer had the electrical connectivity to provide high levels of fault coverage. It has further been accelerated by the use of smaller and smaller geometry devices forcing the requirement for a high connection count automated solution.

PCB inspection systems come in a number of guises: automated optical inspection [AOI]; automated X-ray inspection [AXI]; automated Infra-red inspection; manual video and manual optical inspection – positioned at post paste, post place, post solder and finished goods stages.

With all of the technological developments of automated inspection solutions, there remains the fundamental reliance on human intervention to program and train the automated inspection system to achieve the level of fault coverage that is required for a particular product.

A high quality manual inspection process is essential in the generation and stabilization of an automated inspection programs. This is particularly important where a variety of boards are assembled and tested.

Use of manual inspection in today’s industry

Optical inspection is often used by research and development engineers, especially where the prototypes of boards are inspected for accuracy and design for fit. At this point automated routines have not been programmed and with no defect history, quality procedures rely on the experience of their engineers and the accuracy of the tools allowing them to manually inspect the boards.

Often, alongside automated inspection systems there will be spot checks on production solder quality. This will usually be implemented to stringent quality procedures making sure the boards are being inspected by the automated systems consistently.

With a balance of cost and quality always in mind, new components are often sourced from competing suppliers and new suppliers are often sourced to provide new and improved components. When this occurs, it is paramount that these components are checked for quality and this can only be achieved by inspection, where often manual inspection is preferential.

Where bespoke boards are designed and manufactured, optical inspection is an ideal solution where a large investment of automated inspection is not always necessary.

Manual inspection systems come in a number of guises. Ranging from simple bench magnifiers to high resolution video cameras, the humble stereo microscope has become the mainstay of manual inspection solutions, since whilst the resolution of video systems has increased dramatically over the decade, they are only able to present 2D images to the operator.

However the design of the microscope dictates that operators must sit in an uncomfortable position, often for prolonged periods, which can result in operator fatigue, leading to a risk of error.

Ergonomics and manual optical inspection

Where manual optical inspection is required, a high level of ergonomics is essential to maximize comfort to operators, minimising associated fatigue from a strained body posture, optimizing both accuracy and productivity.

Traditionally, optical microscopes have two eyepieces, look like a microscope and act like a microscope. The resulting combination of a human operator with a microscope provides a powerful and highly flexible inspection solution for any size of electronics manufacturing operation, yet for many, the issue of operators fatigue and the resulting errors provides a real-life and everyday obstacle.

Eyepiece-less microscope technology

Vision Engineering’s patented optical technology is designed to overcome the fundamental problem of a conventional microscope – the small image that exits from the microscope eyepieces.

With ‘eyepiece’ microscopes, the size of the image exiting the eyepieces (the exit pupil) is around 3mm in diameter. This means that the operator must precisely align their eyes with the eyepieces, otherwise just a small movement of the head will result in a loss of image.

The result is an operator fixed rigid in and uncomfortable position. ‘Eyepiece-less’ technology enlarges the image exiting the microscope eyepieces.

Vision Engineering’s patented range of stereo inspection microscopes utilise a technology to optimize ergonomics is the sophisticated Dynascope™ viewing head used on the Lynx – an advanced stereo zoom microscope – as well as Vision Engineering’s range of optical measuring microscopes.

The patented Dynascope™ optical technology used in Lynx systems utilize a 148mm diameter multi-lenticular (multi-lens) disc surface comprising of over 3.5 million individual lenticules (lenses), each measuring just 70 microns in size.

The Dynascope™ disk spins at 3,400rpm to merge the millions of individual optical paths into a smooth, expanded stereo image with a generous depth of focus and a wide field of view.

In use, the multi-lenticular disc serves to expand the intrinsic pupil of the system. The resultant image is reflected through the field lenses to the operator’s eyes and the high resolution image is projected onto a large viewing area for maximum viewing comfort.

Reducing eyestrain and fatigue

As operators frequently alternate their views from the magnified object image to the actual object (especially during rework or when manipulating parts), the long distance to the apparent magnified image eliminates the need for the eyes to refocus each time.

In fact, the magnified image is almost exactly the same distance from the operator’s eyes as the actual sample is – a tangible advantage in reducing eyestrain and fatigue.

In addition, employing a viewer rather than eyepieces permits much greater positional head freedom and an upright body posture for the operator, plus allows the use of spectacles.

Operators who require reading glasses remove them for microscope viewing and must then re-focus at a different distance, which again quickly leads to eye fatigue. Operators with astigmatism fare worse: removing spectacles immediately spoils their vision.

The significant ergonomic advantages contribute to increased production rates and reduced scrap as the operator is able to work longer without experiencing eyestrain and fatigue.

Even better ergonomic viewing of PCBs

Vision Engineering Limited is launching an updated Lynx LED stereo microscope with oblique and direct viewer. Now employing LED illumination and an oblique and direct viewer, the Lynx provides a full 360° view around the PCB for 34° angled inspection of solder joints and pad alignment that can often be hard to reach by usual stereo inspection methods.

The Lynx is widely used in the electronics industry providing unrivalled ergonomic performance and optimum clarity with superb optics.

In addition, the Lynx now benefits from LED illumination, projecting brighter, whiter, long-life illumination on the PCB. Consumable costs have also been greatly reduced with costs decreasing by more than 80% and lamp life lasting up to an impressive 10,000 hours. The dimmable LEDs allow for every application to benefit from the precise intensity of illumination.

The LED illumination can now be used in conjunction with the impressive oblique and direct viewer.

Coupled with the switchable direct view and the benefits of stereo viewing offered by the Lynx, surface features can be easily inspected in three dimensions without moving the workpiece. It is ideal for inspecting device leads, PCB via holes, connectors, solder joints, solder bumps on SMT, TAB and ball-grid array devices, and precision wafer bumping characteristics.

It is this technology that is used in parallel to automated processes, maximizing the quality of PCBs. Manual inspection plays an important role alongside automated systems or where automated systems are not a cost-effective option and since technology is constantly changing and components are evolving, optical inspection provides a magnified view for engineers so they apply their expertise and knowledge to individual case by case scenarios and imperfections.

Now celebrating their 50th anniversary, Vision Engineering’s patented optical technology brings the stereo microscope into the 21st century, breaking the mould of the traditional, uncomfortable microscope.

The latest evolution of Vision Engineering’s patented ‘eyepiece-less’ technology not only removes the need for the restrictive eyepieces of a conventional microscope, but provides the user with the ability to see high detail, in complete comfort.

Vision’s continuing research and development program is set to produce more award-winning, innovative products.

Vision Engineering brings optical and manufacturing services capabilities to Photonics West Show

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Vision Engineering is showcasing its tailor-made optical components and manufacturing capabilities at the 2017 Photonics West Show in San Francisco.

The expo is being held between 31st January and 2nd February 2017 at the Moscone Center, California, USA. Vision Engineering Ltd can be found at booth #4051.

At the show Vision Engineering optical engineers will ensure you get the best specifications offering advice and interpreting optical demands to ‘production ready’ drawings. They can also streamline optical integration into assembly and manufacturing processes. Our team can simplify your procurement of spherical lenses, prisms, mirrors, beam splitters, optical filters optical windows and stage glass.

custom_optics_banner-550px

Year by year, the company is increasing their optical components product portfolio by connecting new ideas with the consumer demands.

“Our primary goal is to help our partners to grow their business by delivering high quality optical components and tailor-made services.”

– says Chris Milborrow, Vision Engineering Manufacturing and Optical Services Division Manager.

Vision Engineering Manufacturing and Optical Services (VEMOS) division specialises in supplying a highly competitive alternative to standard off-the-shelf optical components including specialist coatings and able to provide all aspects of technical design, prototyping, production to quality assurance and logistics.

Since 1958, Vision Engineering has got a worldwide recognition for its pioneer and cutting-edge stereo microscopes and high quality non-contact visual inspection systems. Their experience helps to understand how fundamentally important are high quality optics to business success and often links to enhanced productivity and cost reductions.

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Finish solderability, shorts and opens tops PCB most common issues – according to the Vision Engineering survey

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The recent surveys performed during the latest Vision Engineering Electronic Webinars, presented by Bob Willis, have found that over half of respondents (55%) are still having some sort of PCB solderability issues.

According to the “What is the most common PCB problem?” survey, 29% of all respondents indicated to have problems with solderability finishes and more than one quarter (26%) were having shorts and opens related issues. The above findings could be possibly linked to the Class 1 PCBs – the most common type on the market where the quality of solder joints or component positions is not a top priority and expected not to last very long, but this would need further research.

Only a small part of the survey participants (5%) indicated delamination as a common issue. This could mean that the structure of the PCB and the quality of adhesion on multilayer PCBs have vastly improved for the past few years. Cosmetic faults scored a substantial 25% of all issues, but this type of defect has only visual impact on the PCB and doesn’t affect its functionality or connectivity.

Survey results showing most common PCB problems

The “What PCB surface finish do you most commonly use?” poll revealed that almost half (43%) of the Printed Circuit Board had gold (hard, soft and flash type) finish now, one quarter (24%) had tin finish followed closely by solder levelled types (22%). Silver and copper finishes corresponded to only 11% of all manufactured PCBs.

Survey results showing most commonly used PCB surface finish

The “When specifying PCBs to IPC what Class do you require?” survey showed that the most common type of PCB is Class 2 (66%), typically requested for non-critical electronic assemblies where longer term reliability is desirable, rather than essential. According to the same survey, one quarter (25%) of attendees had manufacturing requirements for Class 3 PCB types – the highest IPC standard, and aim at more critical PCB assemblies, and Class 1 only related to 14% of all PCBs.

Survey results showing class required when specifying PCBs to IPC

The Vision Engineering Electronic Webinar Academy takes an in-depth look at the most common issues affecting PCB/SMT assembly and the challenges of achieving Zero Defect Manufacturing. The webinars provide expert tips on how to identify quality issues and understand the common manufacturing problems within electronic industry.