ENGEL iQ weight control successfully passes the validation process
ACCESSING THE UK MARKET
ULTRASONIC WELDING MEETS INDUSTRY NEEDS
REVOLUTIONISING MEDICAL DEVICES WITH PPSU
Jul/Aug/Sept 2024
Regulars
3 Comment Olivia Friett explores the importance of sustainability in the industry
4 Digital Spy
Sharing some of the latest news in the medical plastics industry
12 Cover Story
ENGEL discusses the medtech validation process
32 Q&A
Systech discusses tracking counterfeit epidemics plaguing the industry
Features
16 Regulatory Update
LFH Regulatory debates whether a company should access the UK market
18 Components & Assembly
Horizon explains how micro-AM produces next-gen precision devices
21 Extrusion
Rinco explores how ultrasonic welding meets industry needs
24 Materials
Porex highlights the importance of material choice in diagnostic tests
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ISSNNo:2047-4741(Print) 2047-475X(Digital)
Editor’s Comment
OLIVIA FRIETT
PROTECT THE PLANET
Intoday’s healthcare industry, sustainability is becoming a top priority. The challenge of balancing medical innovation with environmental responsibility is especially pressing when it comes to medical plastics. As we strive to improve healthcare while protecting our planet, it’s crucial to address sustainable practices in this area.
Medical plastics, used in everything from single-use syringes to complex prosthetics, have transformed patient care. Their versatility, durability, and cost-effectiveness are key to better medical outcomes. However, these advantages come with a significant environmental cost. The medical sector generates millions of tons of plastic waste each year.
The push for sustainable practices in medical plastics is urgent. This journey starts with innovative materials, designing products for recyclability, and strict waste management protocols. Biodegradable plastics made from renewable resources like cornstarch or sugarcane are promising alternatives. These materials can reduce environmental impact while maintaining the quality and safety standards essential for medical use.
Incorporating circular economy principles into healthcare can also drive substantial progress. This means rethinking the entire lifecycle of medical products—from design and manufacturing to use and disposal. For example, creating products with modular components can make recycling easier and cut down on waste. Programmes like takeback initiatives and advanced sterilisation technologies can enable the safe reuse of some medical devices, reducing reliance on single-use plastics.
Policy and regulation play a crucial role in this transition. Governments and regulatory bodies need to establish frameworks that encourage sustainable practices and ensure compliance with environmental standards. This involves strict regulations on medical plastic disposal and support for R&D in
sustainable materials and technologies. The European Union’s Medical Device Regulation (MDR), for instance, includes provisions aimed at reducing environmental impact through sustainable design and production practices.
Collaboration across the healthcare ecosystem is essential. Manufacturers, healthcare providers, policymakers, and environmental organisations must work together towards sustainability. For manufacturers, this means investing in R&D for eco-friendly products. Healthcare providers need to adopt best practices in waste management and educate staff on sustainability. Policymakers should create a supportive regulatory environment, while environmental organisations can provide expertise and advocacy.
As we move forward, it’s important to recognise and celebrate the pioneering efforts already happening. Many companies and institutions are leading the way with innovative solutions that reduce waste and improve recyclability.
Together, we can ensure that medical advancements and environmental sustainability go hand in hand.
DIGITAL spy
SUSTAINABILITY NEWS
Guill offers corrugated tube crossheads and dies
Guill Tool offers its patent pending extrusion tooling, Series 400. It’s adaptable to a wide variety of corrugated equipment and moulds. The Series offers a host of benefits for OEMs, as well as for medical applications.
The tooling includes the multi-port spiral flow design that provides a balanced compound distribution with no weld lines to the corrugator. The elimination of weld lines increases the finished product’s overall strength.
Models offered include 420, 423, 432 and 434. Features of the 400 Series include Spiderless Inline, fixed centre or adjustable, built in cartridge heaters, adjustable gum space, low inventory, expandable to multi-layer, heated core pin
CLEANROOM NEWS
and one-piece body/flow diverter.
Since there are no spider lines, there’s room for more air and no cold legs. Most products should be run fixed. Users can change only one component and become fully adjustable.
The cartridge heaters offer even heat for better flow and ensure there aren’t any cold spots. Benefits of the heated core pin and one-piece body/flow diverter are better temperature control and easy cleaning-quick changer, respectively.
Nordic Semiconductor has announced it has achieved an important step in its sustainability strategy, by becoming one of the first semiconductor companies to use component reels made from recycled plastic.
The switch to recycled plastic will reduce plastic waste by almost 15,000 kilograms per year.
“We’re continuously looking for ways to minimise our environmental impact,” said Ole-Fredrik Morken, executive vice president of supply chain, Nordic Semiconductor, “So, we are delighted that we, together with our trusted OSAT partners, have been able to achieve this milestone. This is especially important given that Nordic’s customers are some of the world’s largest ‘consumers’ of wireless IoT connectivity semiconductor chips, deploying hundreds of millions of devices each year with Nordic components inside.”
The majority of Nordic’s component packaging reels now use reground old plastics. To meet this milestone, Nordic was required to test its recycled plastic component reels and ensure they performed as reliably as traditional non-recycled equivalents, meeting all relevant component tapeand-reel industry standards. This means the packaging didn’t break during shipping, protected Nordic’s valuable semiconductor parts, and didn’t jam when fed into high-speed PCB placement machines.
Work is under way on a variety of different builds across The Guardtech Group’s brands.
Among a list of concurrent projects are a 40sqm ISO8 Diagnostics modular in Cambridgeshire, HVAC upgrade for the University of Cambridge, manufacture and installation of a series of separative devices for a Biopharma firm and a bespoke 8sqm ISO8 Isopod in Northumbria.
But it’s not just in the UK that the pace is creeping up – work has started on a 12sqm modular cleanroom and bespoke 8sqm Isopod for Cell & Gene Therapy in Stockholm, a 20sqm Grade D Pharmaceuticals modular in Absam, Austria and a 30sqm
ISO6 Pharmaceuticals controlled environment in Switzerland.
Commercial director, Mark Wheeler, said: “We are really beginning to see a nice spread of projects across all our brands – from large-scale Cleanroom Solutions projects in the South and North of England to a variety of more modest Guardtech Cleanrooms modular builds at home and abroad.
“The two larger-scale CleanCube construction projects are particularly exciting, as they’re the kind of groundbreaking innovations that are rare in the industry. We look forward to undertaking everything ahead of us with our usual laser focus, indomitable work ethic and resolutely high standards.”
https://RIDAT.com/
Ridat enhances medical device manufacturing with export project
Ridat has demonstrated its ability to support the international medical devices market, through a new project for 3BY, which is headquartered in Northern Galilee, Israel.
Ridat has delivered a Model 4030MM Midmatic Vacuum Forming Machine and 406RCP Roller Cutting Press to the company, which is a provider of turnkey solutions for medical device companies.
Ridat’s technology will help 3BY to further enhance its manufacturing capabilities and achieve greater production efficiency.
Ridat’s Model 4030MM Midmatic Vacuum Forming Machine is a reelfed thermoformer with a forming area of 1000mm x 750mm. Its operation is fully automatic, and this allows for uninterrupted production with minimum operator supervision. The material is indexed with a set of rollers powered by a stepper motor, and a centre pull guillotine powered by a pneumatic cylinder separates the sheets.
The model also includes standard Ridat features such as a user-friendly microprocessor system that assists with fault finding and has zone control capabilities for accurate zone temperature control.
Ridat has more than 60 years of heritage in thermoforming equipment manufacturing and in supplying allied ancillaries, and it has more than 2500 installations in over 65 countries.
GC Aesthetics implant for breast reconstruction surgery
It is estimated that around 30% of women diagnosed with breast cancer each year in the UK undergo a mastectomy, with 21% of these patients opting to have immediate breast reconstruction.
FixNip NRI: The Nipple and Areola Reconstruction Implant is a medical device that provides the answer to breast reconstruction for thousands of women around the world. It is a biocompatible smooth silicone implant specially designed for a long-lasting reconstruction of the Nipple-Areola Complex.
The product has unique characteristics that mimic a natural nipple touch and look. This can help to relieve the psychological burden and impaired quality of life for women treated with total or partial mastectomy.
Breast reconstruction is often the final stage of patient recovery, and the nipple is an essential part of restoring the shape and appearance of the breast.
Breast reconstruction typically involves the reconstruction of the breast shape and volume, and many times, it leaves out the recreation of the Nipple-Areola Complex (NAC). However, it should be considered an integral part of breast reconstructive surgery. This is because it offers an important psychological contribution to breast reconstruction and leads to greater overall well-being. The product also helps combat the psychological consequences of a breast cancer diagnosis by helping to rebuild women’s self-confidence and instil more positive body confidence.
The FixNip NRI is implanted with a minimally invasive procedure carried out by surgeons which takes an average of 15 minutes. The outcome has demonstrated high patient satisfaction with minimum patient downtime and an excellent safety profile.
Women who have undergone either a bilateral or unilateral breast reconstruction, are eligible to reconstruct the NippleAreola Complex with FixNip to help achieve projection and form to correctly mimic the look and feel of a real nipple.
FixNip NRI is produced from biocompatible smooth silicone with a floral-shaped nitinol frame which allows a minimal incision as its key to recover the original shape of the implant when it is folded and inserted.
The perforated silicone implant allows rapid integration and fixation to adjacent tissue, avoiding rotation or displacement.
Many women who undergo breast reconstruction report feeling “whole” again and highly recommend it to other women facing a similar decision.
Gladys who underwent breast reconstruction with FixNip NRI, said: “At first, I felt very ashamed of my body, I avoided looking at myself in the mirror or undressing in front of my own husband. Even after my breast reconstruction. The nipple implant made a difference, it was like the final step. It changed my perception. I felt myself again, I was happy to recover what cancer took away from me.”
PAUL
RUNYAN, VP
OF SALES, ACCUMOLD HIGHLIGHTS ALL YOU NEED TO KNOW ABOUT MICRO INJECTION MOULDING OF THIN WALL CANNULAS.
Poke holes in
High-volume production of small and thin-walled cannulas using traditional methods like extrusion, tipping, and gluing to a metal hub presents several limitations that hinder efficiency and quality.
Extrusion becomes challenging for extremely small dimensions due to the risk of material inconsistency, wall thickness irregularities, and potential defects. Tipping, the process of adding a plastic tip to the cannula, introduces variability in terms of bonding strength and tip alignment, impacting the precision required for medical procedures.
The gluing process poses reliability concerns as adhesives might degrade over time, leading to potential detachment of the cannula from the hub.
These methods are labour-intensive and time-consuming, making it difficult to meet the demands of high-volume production efficiently.
MICRO INJECTION MOULDING
Modern manufacturing technologies like micro injection moulding offer a more streamlined approach. Micromoulding enables the creation of intricate and consistent cannula designs with
precise wall thickness control. It eliminates the need for separate extrusion, tipping, and gluing steps by producing the entire cannula in a single mould, enhancing product reliability and reducing the risk of defects.
WHAT TO CONSIDER
Material choice is paramount when optimising outcomes in micro moulding cannulas due to its profound influence on product performance, reliability, and manufacturability. The unique challenges posed by microscale manufacturing, such as precise cavity filling and intricate geometry replication, demand materials with specific properties like low viscosity, excellent flowability, and minimal shrinkage. Material selection also impacts the durability and biocompatibility of medical devices, ensuring they can withstand the rigours of use while being safe for patient interaction.
Several critical design for manufacturability (DFM) considerations must also be addressed. Ensuring uniform wall thickness is paramount, as variations can lead to warping, cooling inconsistencies, and inadequate filling. Proper gate placement is essential, influencing material flow and minimising stress points, while suitable venting channels are crucial to prevent air traps that can result in surface defects. Incorporating appropriate draft angles facilitates seamless ejection from the mould and prevents potential damage.
Furthermore, maintaining accurate parting line alignment prevents flash and surface mismatches. Strategic placement of features like ribs and supports enhances structural integrity without compromising the overall design, while carefully considering the positioning of ejector pins prevents interference with critical features during demoulding.
Additionally, addressing assembly considerations in some instances can be vital, particularly if the cannula is part of a larger device. Ensuring mating surfaces, alignment features, and interlocking mechanisms are welldesigned enables smooth integration.
AVOIDING POTENTIAL CHALLENGES
Maintaining a balanced aspect ratio is essential to avoid challenges associated with flow dynamics, cooling, and structural integrity. An excessively high aspect ratio can lead to difficulties in material flow and cavity filling, potentially resulting in uneven thickness and defects. Conversely, an aspect ratio that is too low might hinder proper cooling and cause warping, making it vital to strike the right balance that promotes both accurate moulding and structural stability.
One other variable that has been critical is the use of proprietary micromoulding presses, developed over generations at Accumold. Cannulas were moulded on conventional presses and on Accumold’s presses, and it was discovered that conventional micromoulding presses had problems with non-fill and flash. Through the use of our fully automated in-house developed micromoulding presses and 16 cavity micromould tooling, we achieved reliable, repeatable, and high-volume production of 40 million parts a year from a single production cell.
MATTHEW BASELEY, TECHNICAL SALES EXECUTIVE, INTERTRONICS, EXPLAINS HOW AN ADHESIVE’S RHEOLOGY IMPACTS ITS PROCESSING.
There are many factors that make specifying an adhesive for medical plastics complex, one of which is rheology — the material’s flow behaviour.
In choosing an adhesive, coating or sealant, you will understandably focus first on performance — does the material adhere and do its job through the lifetime of the assembly. You may also consider mandatory regulatory specifications, like flame retardancy, or ISO 10993 biocompatibility for medical device manufacture. Often a later consideration is processability, but this can be just as important a selection factor.
One component of processability is the material rheology. Rheology is the study of how materials flow and deform under applied forces or stresses. In relation to adhesive applications in technology manufacturing, the two most important components of rheology are viscosity and thixotropy. These factors impact how an adhesive can be decanted, mixed and prepared, applied or dispensed, and how it subsequently settles and flows. Understanding this will be very valuable as you establish an accurate, repeatable bonding process.
In practice, medical device manufacturers do not generally need to become experts in adhesive science. Working with a reliable adhesives partner can help strike the balance between the technical and process considerations, with the partner advising on tried and tested techniques to build a successful process.
VISCOSITY
Colloquially referred to as a liquid’s ’thickness’, viscosity is a measure of a fluid’s resistance to flow. Liquids can be low viscosity — free flowing like water, or high viscosity — thick like toothpaste.
The units of measurement used to describe viscosity are the millipascalsecond (mPa·s), and centipoise (cP), which is numerically equivalent to mPa·s. Adhesives are available from single-digit centipoise figures, including watery-like cyanoacrylate adhesives, all the way up to thick silicone sealants with viscosities in the hundreds of thousands of mPa·s. For reference, the viscosity of water at 20°C is almost exactly 1 mPa·s, castor oil is around 1,000 mPa·s, treacle is around 20,000 mPa·s, and
peanut butter approximately 250,000 mPa·s. Because viscosity means that different fluids will flow at different rates under the same pressure, it is highly relevant to building an adhesives process. The higher the viscosity of a fluid, the harder you have to push it to move it. You want to be able to accurately control the liquid flow, apply it where you want it, and make sure it stays there — viscosity affects all these things.
THIXOTROPY
An interesting phenomenon, thixotropy means a material exhibits a reversible change in viscosity or flow behaviour under applied stress. Mayonnaise is a good example of this; you can feel it thinning as you stir with your knife in the jar. In contrast, peanut butter is not very thixotropic.
Certain (not all) high viscosity adhesives are thixotropic and become less viscous when subjected to an applied stress — many of our higher viscosity adhesives exhibit this property. It makes them much easier to dispense. A material with high viscosity that is not thixotropic can be difficult to process; back to the mayonnaise/peanut butter example.
RHEOLOGY IN PRACTICE
The rheology of your chosen adhesive is one of the important factors to consider when building an adhesives process. In some cases, the application will demand a certain rheology — a high viscosity material will be useful for a vertical application, to offer non-drip or non-sagging properties, or in applications where the material needs to stay in place during application and curing. Single part RTV silicones which are used to make FIP gaskets are high viscosity so that they retain the dispensed bead shape, and don’t slump.
A low viscosity material, on the other hand, might be useful for applications where you want the adhesive to wick into or around an assembly, such as bonding a fibre optic cable into ferrule, or bonding an injection needle into a hub. Many adhesives which are application specific, like gasketing materials, or catheter or needle bonders, have appropriate rheology built in to make application relatively straightforward. In other cases, a functional
requirement of the adhesive will result in a formulation which is complicated to process – for example, to get an adhesive which is very thermally conductive, it will be heavily loaded with fillers, resulting in a very high viscosity material and an application challenge. In extreme cases, the adhesive will be too viscous to wet out on the surface unaided, in which case the application methodology will have to include some form of spreading.
Rheology will be one factory informing your choice of dispensing equipment. A low viscosity material may require a positive shut off mechanism to prevent it dripping, for example. A material that is very highly viscous or has poor thixotropic properties will be difficult to process, be that decanting, mixing, dispensing or other aspects of the material application. A highly viscous material will be difficult to dispense from a reservoir with pure air pressure, meaning you will require a more expensive option like some form of pump.
The viscosity of some adhesives changes significantly with temperature, so if you have very tight tolerances on the volume of application, you may need to consider some form of positive displacement application equipment. In most cases, the adhesives partner can use their experience to advise on an approach that works for the chosen adhesive. They will know how to handle those highly filled thermally conductive pastes or know how to work with RTV silicones which refuse to travel down feed tubes.
In rare cases, a material is almost impossible to apply in an efficient, automated way, and you may end up with a manual process. Contacting an adhesives specialist early, before the material choice is locked in, can help you avoid problems like this later down the line.
KUN WANG, BUSINESS DEVELOPMENT MANAGER, MEDICAL BRANSON WELDING AND ASSEMBLY AT EMERSON DISCUSSES THE ADVANTAGE OF JOINING TECHNOLOGIES FOR SINGLE-USE MEDICAL FLOW MANAGEMENT DEVICES.
To achieve optimal effectiveness, medical tests and treatments need to be simple and easy for healthcare professionals to administer. Patient accessibility and ease of use are also key factors. With these objectives in mind, medical manufacturers are creating innovations in medical flow management devices ranging from microfluidic “tests on a chip” to invitro home tests, enhanced oxygen therapies, and patient-friendly peritoneal dialysis equipment for home use.
Making diagnostic tests and therapies more user-friendly for nonprofessionals creates novel design and manufacturing challenges. Home-based test results must be just as reliable as those generated in a laboratory, with consistent and dependable fluid and gas flows. The tests must also be lightweight, easy to ship and affordable. To protect patients from adverse outcomes, such as peritoneal infection due to nonsterile fluid connections, they must be designed only for single use. To meet these complex demands in mass production, medical manufacturers produce flow management devices made of engineered polymers. These are typically assembled from multiple injection-moulded parts and assembled using plastic welding.
PLASTIC WELDING OPTIONS
Single-use assemblies, like automated peritoneal dialysis (APD) cassettes, can benefit from ultrasonic plastic welding. This widely used assembly technique combines vibratory motion, heat and gentle compressive force to create strong welds between plastic components. Components are secured in position and then subjected to high-frequency (10–70 kilohertz), low-amplitude (1–250 µm) mechanical vibrations, which generate friction to melt mating surfaces and create a strong molecular bond. This process suits high-volume production due to its short cycle times - often less than a second - and the ability to integrate with automated production lines. Innovations in ultrasonic welding allow precise control over downforce and weld depth, enhancing accuracy of the weld.
Ultrasonic welding, like other plastic welding methods, joins assemblies without the need for expensive consumable items such as adhesives or fasteners. However, parts must meet specific geometric and material criteria for this method.
Certain flow-management products are sometimes assembled using a different process: hot-plate welding. Here, mating components are pressed against a heated plate until the edges soften, and then they are joined under pressure as the plastic cools. This method offers a high level of control over heating and weld quality. For devices requiring smaller microfluidic channels, like single-use disks, cartridges, or cards used in diagnostic tests, the added precision of laser welding is often preferred. There are two different approaches: Simultaneous Through-Transmission Infrared (STTIr) welding and a QuasiSimultaneous method. Both employ laser energy to heat surfaces to be welded with unsurpassed precision. In these processes, two components - one made of a laser-transparent plastic and the other made of a laserabsorbing polymer - are pre-assembled and held together while a light
beam is directed through the transmissive component to the absorptive surface. Heat is generated at this interface, melting the plastic so bonding can occur.
In STTIr welding, laser energy is directed through specially shaped fibre-optic waveguides so the entire weld joint is heated simultaneously. This results in a lower power density and shorter cycle times, which are ideal for mass production. Quasi-Simultaneous welding uses moving mirrors to trace a laser beam along the weld joint. This requires higher power density and longer cycles but offers precise control over energy application.
SINGLE-USE FLUID MANAGEMENT COMPONENTS
At-home peritoneal dialysis systems, blood separation units, and “wearable kidney” devices are examples of systems that incorporate disposable fluid management components. These components, such as injection-moulded cassettes and cartridges, are assembled using different plastic welding techniques depending on the application requirements. Here are three applications, each involving the use of a different welding technology.
APD
Fluid Management
Cassettes:
The at-home peritoneal dialysis market heavily relies on single-use products, as patients must use a fresh, sterile set of fluid connections to perform dialysis regularly and prevent peritonitis. To ensure home-based patients can correctly make essential fluid connections - from their peritoneal catheter to PD fluid bags and the APD machine (cycler) - manufacturers have developed precise yet costeffective single-use plastic cassettes. These cassettes provide an easy interface to the APD cycler with external connection ports for flexible tubes. Internally, they feature various fluid paths, chambers and valves.
Typical APD cassettes are assembled by ultrasonically welding two injection-moulded halves. This assembly process is challenging because each part must be made of transparent, biocompatible plastic, and their
internal features must join cleanly and consistently to form fluid channels or circuits connected to external tubes for different fluid flows during the APD process. For these reasons, ultrasonic welding is the process of choice.
Wearable Kidney:
The “wearable kidney,” currently in clinical trials, is a portable device consisting of a small infusion machine and a special disposable adsorbing cartridge. It aims to enable continuous, tidal peritoneal dialysis using just two litres or less of dialysate solution. After the dialysate fluid is infused, small amounts of dwelling dialysate fluid are passed through the adsorbing cartridge, where thin, absorptive membranes capture and remove uremic toxins from the spent fluid. The infusion machine then reconstitutes the fluid by infusing it with minerals and glucose to desired levels, allowing it to be reinfused. This process of continuously draining, cleansing, reconstituting and reinfusing small amounts of fluid makes continuous “tidal” PD possible.
The wearable kidney relies on a laser-welded plastic assembly. Laser welding is chosen because it can hermetically seal the cassette while providing control over heat inputs.
Blood-separator Cassettes:
Cassettes from a blood separator unit are assembled by joining matching injection-moulded parts using hot-plate welding. While this disposable part is associated with a hospital-grade blood separation unit, its singleuse cassette design reflects the same design imperatives as point-of-care type products. The cassette accepts several flexible tubes that, together with the separator machine, process fluid flows to separate various blood components.
In each of these applications, the design of the specific device dictates which of the various plastic-assembly options will be chosen for use. To ensure success, developers of flowmanagement devices should work closely with the experts from their welding-equipment supplier.
ENGEL IQ WEIGHT CONTROL SUCCESSFULLY PASSES THE VALIDATION PROCESS.
B. Braun, a medical technology manufacturer, has successfully integrated the digital assistance system iQ weight control from ENGEL into their production process for roller clamp housings. This enhancement has ensured high process accuracy and stability, crucial for producing precision medical components used in the Intrafix Safeset for infusion devices.
ENHANCED MANUFACTURING PROCESS
The roller clamp housings, produced in millions annually by B. Braun, require high precision and a stable manufacturing process. Since last summer, production has been carried out using the ENGEL iQ weight control system, which compensates process fluctuations in real-time, ensuring consistent component quality. This dynamic process control has successfully passed the validation process according to EN-ISO and FDA specifications, which is a first for B. Braun.
Christian Münch, project engineer at B. Braun’s Melsungen site (Germany), explained that the roller clamp housing production is now independently regulated via inline controls within the process window. This automation eliminates manual readjustments by operators, reducing production-related rejects. The iQ weight control system, a software-based support tool, adjusts process parameters in real-time during the injection moulding cycle, ensuring consistently high quality. Deviations in injection volume and material viscosity are detected in fractions of a second, and the system automatically adjusts the switchover point, injection profile, and holding pressure shot by shot.
DIGITAL TRANSFORMATION IN MANUFACTURING
“Digitalisation is a must nowadays,” emphasises Münch. B. Braun’s investment in digital assistance systems aligns with their strategy to enhance process capability and efficiency. With around 40 injection moulding machines in their medical division, the integration of iQ weight
control into their production processes represents a significant advancement and commitment to digitalisation.
The initial contact with ENGEL occurred at a trade fair, where B. Braun expressed willingness to use iQ weight control in a validated process. The EN-ISO for Europe and FDA regulations for the USA require detailed documentation during the entire process planning and production phase. Critical production processes that cannot be verified by subsequent monitoring must be validated. Integrating the iQ weight control system into the validation process required defining process windows without altering existing parameters. The validation followed a structured approach, including Design of Experience (DOE), Operational Qualification (OQ), and Performance Qualification (PQ).
VALIDATION PROCESS
The validation process involved four steps. During the DOE, limits were tested in a statistical plan, forming worst-case combinations within permissible tolerance ranges. These were stored as parameters for defined process limits in the CC300 control system of the e-mac injection moulding machine. The IQ (installation qualification) step was omitted since it was already completed at the start of production. OQ focused on testing the predefined process
FEELING VALIDATED
ABOVE: Compact design: The ENGEL e-mac injection moulding machine requires only a small footprint in production.
RIGHT: The orange-coloured roller clamp housing as part of the Intrafix Safeset for infusion devices for pressure and gravity infusions.
In conclusion, B. Braun’s successful implementation of the iQ weight control system from ENGEL highlights the importance of digitalisation and advanced process control in medical manufacturing. This achievement sets a new standard for precision and efficiency in the industry, ensuring consistent high-quality production while addressing cost pressures and increasing output.
B. BRAUN
limits in trials, confirming that the worst-case settings could still produce parts meeting specifications. The final step, PQ, tested the results over 24-hour periods, ensuring stable process sequences and valid production environments.
Münch highlights the importance of stable processes during this phase. The validation process in injection moulding technology follows an established pattern internally at B. Braun, which handles various processes, including extrusion, injection moulding, assembly, and packaging. Millions of roller clamp housings leave the factory in Melsungen annually, fully assembled and packaged.
HIGH-VOLUME PRODUCTION
Production runs on an ENGEL e-mac 1065/160 injection moulding machine, utilising three moulds with 48 cavities each, producing polystyrene housings with a total shot weight of 170 grams. These moulds, including a recently acquired twin of the existing ones, are used on various ENGEL injection moulding machines. Preliminary tests by ENGEL confirmed the advantages of iQ weight control in maintaining constant component weight. Significant improvements were achieved in the measured deviation with the assistance system compared to production without it.
The medical technology sector faces cost pressures, and iQ weight control helps maintain high production quality while reducing reject rates. Increasing the number of cavities to boost output is a trend in the industry, and ENGEL supports this with machines offering higher clamping forces for cleanroom production. Rising energy prices, material costs, and cleanroom space expenses drive the need for efficient production. B. Braun currently operates six days a week in three shifts, and increasing the number of cavities is seen as an effective way to handle volume increases. The compact design and high plasticising performance of the e-mac series were key factors in choosing this model.
FUTURE APPLICATIONS
B. Braun plans to extend the use of ENGEL’s assistance systems to other products in their extensive portfolio. The engineering team sees all of ENGEL’s assistance systems as advantageous, and they will be considered in future contract award discussions.
As a medical technology company, B. Braun sells over 5,000 products worldwide. For over 180 years, the family-owned company has made a name for itself in the healthcare sector with innovations and investments. This innovative strength is still the driving force behind B. Braun’s success today, combined with the declared aim of improving clinical results, care costs and patient benefits.
Over 66,000 people in 64 countries and more than 300 subsidiaries create and produce intelligent solutions for a wide range of therapies. By networking products, services and consulting, the company improves treatment processes and provides concepts to increase efficiency. In 2021, the B. Braun Group generated sales of €7.9 billion.
Demanding production: “The trend towards digitalisation in the plastics processing industry is actually no longer a trend, but rather a necessity nowadays.”
JOAQUÍN CASTÁN, ENGINEERING RESEARCHER, AIMPLAS, EXPLORES ELECTROCHEMICAL SENSORS FOR THE EARLY DETECTION AND PREVENTION OF NOSOCOMIAL INFECTIONS IN THE HOSPITAL ENVIRONMENT.
Healthcare-associated infections (HAIs) are infections that are contracted by patients while receiving care in a health centre and were not present at the time they were admitted. These infections, which are caused by pathogens in the environment, lead to longer hospital stays and therefore imply additional costs to the health system.
Staphylococcus Aureus is one of the most active pathogens responsible for nosocomial infections and accounts for 10.97% of cases. For that reason, health centres require solutions for the early detection and elimination of this bacterium.
In addition, the bacterium
Staphylococcus Aureus is highly resistant, which means that conventional antibiotics are less likely to be effective.
ANTIMICROBIAL RESISTANCE
The use of broad-spectrum antibiotics to treat bacterial infections without a specific diagnosis has contributed to AMR (antimicrobial resistance). This trend currently shows no signs of reversing, so most investments are focused on the development of new drugs to treat infections, while solutions based on the detection and eradication of these pathogens are being put on the back burner.
However, according to the World Health Organization (WHO), the
prevention of nosocomial infections represents a priority and requires an integrated system to detect infectious agents and limit their transmission.
PREVENTING INFECTION
Diagnostic and action protocols currently used in hospitals for the prevention of nosocomial infections involve a combination of two techniques: firstly, ATP testing, which detects the presence but not the nature of pathogens; and, secondly, cell culture microscopy to identify pathogens, which takes an average of four to five days when performed monthly.
In light of this situation and given the need for an early detection system that is lightweight, flexible and easy to use for healthcare professionals,
electrochemical sensor-based solutions are increasingly being employed in devices to convert chemical signals produced in biochemical reactions into easily measured electronic signals. This ensures greater responsiveness and precision in the detection and diagnosis process.
AIMPLAS has been working intensively on the development of printed, flexible electronic devices since 2015 and is currently working on the development of flexible electrochemical sensors.
It has successfully produced a flexible electrochemical sensor that has the capacity to specifically detect Staphylococcus Aureus and also obtains quantitative concentration data with detection ranges of 104 CFU/mL. These sensors therefore combine the capabilities of current detection protocols to quickly identify and quantify the target bacteria in a single step.
Although the concentrations detected are relevant to the hospital environment, there is a need for a complete solution to detect lower concentrations, with a complementary disinfection system that health professionals can use quickly and easily.
INTRODUCING NOSOSENS
Based on this line of research, AIMPLAS is coordinating the project NOSOSENS: Development of a System for the Early Detection and Prevention of Nosocomial Infections in the Hospital Environment in collaboration with the Fundación Investigación Hospital General Universitario Valencia (FIHGUV) and the companies Assesoria De Gestió I Comunicacions S.L., Quimica Deambla S.L. and José Crespo Ballester S.A.
The main goal of the NOSOSENS project is to design and implement a flexible, portable biosensor platform for the rapid and selective detection of pathogens in the S. Aureus family through the integration of printed electrochemical sensors. It will be tested in a hospital environment and will encompass full visibility, monitoring and alert management with rapid, reliable results. The project also involves researching and synthesising new nanomaterials to optimise its detection capacity and thus increase its sensitivity to detection levels close to 102 CFU/mL.
In addition, the project team is researching and formulating a new bio-based disinfectant aimed at eliminating pathogens in the hospital environment with
a view to offering a comprehensive solution. Its synergy with the sensor platform will help optimise disinfection processes to enhance safety against healthcareassociated infections.
HOW IS THIS THE SOLUTION?
This would give rise to a system for the detection of these families of pathogens in a rapid, sensitive and selective manner, thus providing a much-needed solution that would have a major impact in terms of reducing HAIs.
Flexible sensors have clear advantages in the healthcare and wellness sector, since their flexibility means they can be adapted to various fields and the different parts of the body where sensors are needed.
Thus, the knowledge generated will fill a key niche in the market, and AIMPLAS is planning new research and the development of sensors such as sweat-based glucose or lactic acid sensors, which constitute non-invasive, convenient solutions for use on the skin due to their flexibility.
The NOSOSENS research is being carried out as part of a threeyear project that is due to end in 2026, with a consortium made up of AIMPLAS Plastics Technology Centre, Fundación Investigación Hospital General Universitario de Valencia (FIHGUV) and the companies Assesoria de Gestió i Comunicacions S.L., Quimica Deambla S.L. and José Crespo Ballester S.A., with funding from the Valencian Innovation Agency and an overall budget of €700,112.63.
LAURA FRIEDL-HIRST, PRINCIPAL CONSULTANT
DIRECTOR, LFH REGULATORY
AND MANAGING
LOOKS INTO ACCESSING THE UK MARKET FROM A REGULATORY PERSPECTIVE AND IF IT’S WORTH IT.
As a manufacturer have you thought about accessing the United Kingdom (UK) market but then decided against it? Understandably so, there have been complexities thrown into the mix with Brexit after the UK left the European Union (EU).
The medtech industry is one of Europe’s most diverse and innovative sectors. But it also operates within one of the most tightly regulated environments worldwide. Driven both by complex regulatory changes and the quest for innovation, the medical device industry landscape is changing fast.
UK MARKET
SHARE
Is it worth trying to access the UK market? Let’s start with the statistics.
Medtech Europe published data showing market share globally for 2022 and it is no surprise that the United States (US) had the biggest market share at 46.6%.
The EU holds approximately 26.4% of the market share and UK holds approximately 10.1% of that shareholding.
It appears relatively low, however, today the UK proudly boasts the third largest medical device market in Europe, and the sixth largest worldwide with an annual turnover of approximately $33 billion (over £26 billion). The sector continues to experience rapid growth, which is thanks to its single-provider and single-payer system, meaning the UK remains a hugely desirable market for medical device companies. With this in mind, it makes the UK an attractive market to enter but what are the regulatory requirements?
UK REGULATORY LANDSCAPE
Since January 2021, the requirements for introducing
medical devices to the market in Great Britain (England, Wales and Scotland) (GB) has undergone significant changes; notably, a new route to market and UKCA marking has been introduced for manufacturers seeking to bring medical devices to the GB market.
The UK Medical Devices Regulations 2002 (UK MDR) has been a crucial requirement within the UK’s regulatory framework since before Brexit. It closely aligns with and currently mirrors the requirements set forth in the following EU Directives;
1. Medical Device Directive 93/42/EEC (MDD)
2. Active Implantable Medical Device Directive 90/385/EEC (AIMDD)
3. In Vitro Diagnostic Directive 98/97/EC (IVDD)
Since Brexit, Northern Ireland and GB have separated in terms of their regulatory requirements. Northern Ireland is now required to follow the current EU regulatory framework of the EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostics Regulation (IVDR) 2017/746, although it is governed by the same competent authority as Great Britain, the Medicines and Healthcare Product Regulatory Agency (MHRA).
UTILISING CE MARKING FOR UK MARKET ENTRY
For already CE marked devices, it is worth noting there are transitional timeframes for manufacturers to transition to UKCA marking, enabling utilisation of their CE accreditation. Figures 1 & 2 on page 17, outline the transitional timelines for accessing the GB market with CE marked medical devices and IVD’s;
2: Timelines for placing IVD’s on the GB market
Class I/General IVD’s will not be accepted by the UK if their certification still falls under the EU Directives and are not required to be up classified under the EU MDR or IVDR to a higher risk device. In these cases, compliance with the EU MDR or IVDR will need to be claimed.
Taking advantage of these transitional timeframes with CE marked devices can help manufacturers enter the market with more ease until the UK framework is understood and ready to be implemented.
UKCA MARKING
It is well known that some devices have been up classified under the EU MDR/IVDR with the biggest impact on manufactures of class I being up revised to a higher classification and having to go through a review/ accreditation process. If the device does not presently hold a CE mark, there are benefits of applying for UKCA accreditation even though the regulatory requirements are uncertain and are discussed below.
CLASS I/GENERAL (LOW RISK)
Class I medical devices and general IVDs under the UK MDR are classified as low risk and are self-declared products that do not require assessment or approval prior to being put on the market.
As the UK is currently following UK MDR, products being up classified under the EU MDR/IVDR will not apply, hence there will be no review costs from Approved Bodies. The benefits are cost savings and time efficiency for market access giving an advantage for manufacturers who want quick market shares.
Although these devices are self-declared, manufacturers are required to make sure they are compliant to the UK MDR before release.
ALL OTHER CLASS DEVICES
Class I sterile or measuring, IIa, IIb and III devices will be required to comply with the UK MDR. These device types will need to be reviewed by an Approved Body prior to market access and certified for the purposes of UKCA marking.
As of July 2024, there are nine UK Approved Bodies certified for UKCA accreditation for whom all vary under their certification capabilities. Approved Bodies are currently certified under the current UK MDR framework as the new UK regulatory requirements are pending further changes.
For current CE marked devices it is more efficient to access the UK market with this certification under the transitional timeframes posed under Figures 1 & 2 provided by the MHRA. Keeping closely up to date with the UK requirements to understand any updates or changes is a must and it is recommended to have a robust regulatory intelligence process.
Regardless of class, all device types must be registered with the MHRA prior to products being available on the market.
UK Responsible Person (UKRP)
The UK now requires any non-UK based manufacturers to appoint a sole UK Responsible Person (UKRP) to register all devices to access the GB market on the competent authority’s database prior to release. If entering GB with a UKCA mark, there will be a need to affix the UKRP details onto the labelling, which is essential for importing devices onto the GB market.
CONCLUSION
As health systems search for innovative solutions to tackle disease and medical conditions, the industry is currently undergoing dynamic change and growth.
The UK’s medical device industry presents a valuable yet challenging landscape for manufacturers, characterised by opportunities for growth and success. Although there could be deemed to have complexities and uncertainty for accessing the UK market, the statistics certainly demonstrate a strong market as well as a thirst for innovation demonstrating.
Figure 1: Timelines for placing medical devices on the GB market
Figure
ANDREAS FRÖLICH, CEO, HORIZON MICROTECHNOLOGIES EXPLAINS HOW MICRO-AM PRODUCES NEXT-GENERATION PRECISION MEDICAL DEVICES.
Recent advances in the precision and accuracy of the micro-additive manufacturing (micro-AM) technology have opened up the use of 3D printing in application areas where its relative lack of precision and repeatability until today had formerly made its use redundant. The technology today is also much speedier, making its use viable in commercial applications. However, micro-AM is somewhat restricted due to the fact that most parts produced on it are made from plastics. This article will review how this limitation can be overcome, and what this means for the use of microAM in medical applications, and more specifically in the manufacture of microfluidic devices, microneedle arrays, and miniaturised medical tools.
WHY MICRO-AM?
Micro-AM offers several significant advantages in medical applications
due to its unparalleled precision and versatility. One of the primary benefits is its ability to produce highly intricate and complex geometries at a microscale, which is essential for creating devices with the fine details required for some medical applications. Micro-AM enables the production of detailed structures with high accuracy, which would be challenging to achieve with traditional manufacturing techniques.
In addition, micro-AM is advantageous due to the fact that in more recent times, materials have become available for use on micro-AM machines that have passed the relevant tests for skin irritation and sensitisation, toxicity, cytotoxicity, pyrogenicity, and in vitro haemolysis. They are also sterilisable and are permissible for non-implantable medical applications. Micro-AM also facilitates the customisation of devices to fit specific patient needs, leading to more personalised and effective treatments. The ability to rapidly prototype and iterate designs also speeds up the development process, allowing for faster innovation and time-to-market for new medical technologies.
Micro-AM plays a crucial role in the consolidation of part production by enabling the integration of multiple components into a single build, thus eliminating the need for complex assembly processes. This capability is particularly beneficial in medical applications, where the precision and reliability of devices are paramount, and it not only enhances the structural integrity and performance of devices but also reduces the risk of leaks or failures that might occur at assembly junctions. This consolidation of parts streamlines manufacturing processes, reduces production costs, and accelerates the time-to-market for innovative medical devices.
APPLICATIONS & ENHANCED FUNCTIONALITY
Horizon Microtechnologies integrates the design and development of 3D microparts with a complete microfabrication production process under the same roof. The company combines its micro-AM expertise with proprietary coating technologies like non-metallic conductive (HMT-Conductive), environmentally resistant (HMT-Protect), and metallic (HMT-Metal).
These coatings enhance the functionality of microstructures, including plastics and ceramics, driving innovation in applications such as microfluidics, microneedles, and miniaturised surgical tools.
MICROFLUIDICS
The traditional fabrication of microfluidic devices is often cumbersome due to the need for multiple complex and precise processes such as photolithography, etching, injection moulding, imprinting, and bonding of different materials, which are not only time-consuming but also prone to errors and misalignments, and in the case of bonding an inability to withstand high pressure. These conventional methods require cleanroom environments and sophisticated equipment to achieve the necessary microscale features, making the production costly and less accessible.
COMPONENTS AND ASSEMBLY
MINIATURISED SURGICAL DEVICES
Horizon offers a streamlined solution using micro-AM, integrating the entire fabrication process into a single step followed by coating. This approach enables the design and precise printing of intricate microfluidic structures in a single build, reducing production time and complexity. It supports rapid prototyping and customization of designs, enhancing efficiency and innovation in microfluidic device development.
Additionally, micro-AM facilitates the prototyping of short-run injection moulding inserts, reducing product development timelines and accelerating time to market.
Furthermore, Horizon’s HMT protect coating can produce a closed layer on microfluidic channel surfaces, whether they are 3D printed, machined, or injection moulded. This separation between the liquid in the channel and the substrate material is advantageous, particularly in enhancing fluid flow for samples ranging from micro-litres to femto-litres. It effectively prevents cross-contamination, crucial for maintaining the integrity and accuracy of results in microfluidic applications where capillary forces or surface tension drive liquid movement.
For pressure driven microfluidics bonded devices are often inappropriate due to their inability to withstand high pressure as mentioned above, making micro-AM a preferred production technology.
MICRO-NEEDLES
The traditional method of fabricating microneedles, e.g. for transdermal drug delivery, typically involves complex, labour-intensive processes such as lithography (which also requires costly capital equipment), etching, moulding, micro-machining, and laser drilling all of which can be timeconsuming, costly, and difficult to scale. These methods also often lack the precision needed to create microneedles with optimal geometries for consistent drug delivery, leading to variability in performance and effectiveness.
Through the utilisation of micro-AM technology, Horizon provides a solution characterised by precision, scalability, and cost-effectiveness. This technology enables the direct fabrication of microneedles featuring intricate designs and precise dimensions, ensuring consistent quality and performance. Horizon has achieved successful printing of microneedles with internal channels as small as 100 µm. Additionally, the technology allows for the introduction of precise, miniature holes in the needle’s side walls.
Furthermore, Horizon offers coatings such as HMT-Conductive for applications requiring electrical conductivity sensing, and HMT-Protect to optimise fluid flow and prevent cross-contamination between the liquid and the plastic substrate. These enhancements are crucial for maintaining the integrity and accuracy of fluid handling in microfluidic and sensing applications.
Horizon has found the use of micro-AM for creating miniaturised surgical instruments crucial due to its ability to consolidate parts and reduce assembly efforts. Traditional manufacturing methods often involve the production and assembly of numerous small, intricate components, which can be labour-intensive and prone to errors. Micro-AM allows for the production of complex, integrated instruments in a single step, minimising the need for assembly and thereby reducing the risk of misalignment or mechanical failure. This integration not only streamlines the production process but also enhances the reliability of the instruments.
Micro-AM excels in creating geometries that are unachievable with conventional machining techniques, and it enables the creation of intricate structures and fine details necessary for advanced surgical tools. These unique geometries can include internal channels and complex surface textures essential for the functionality of some instruments used in minimally invasive procedures. This capability is particularly beneficial for devices attached to the end of endoscopes or catheters, where space is limited, and precision is paramount.
In applications where instruments are used inside a patient during operations, the benefits of micro-AM are profound. The ability to produce highly specialised, patient-specific tools enhances surgical outcomes by improving precision and reducing the risk of complications. Instruments such as micro-graspers, forceps, or cutting tools can be custom-designed to fit the anatomical and procedural requirements, ensuring greater efficacy and safety. Additionally, the reduced size and increased functionality of these instruments facilitate less invasive procedures, leading to quicker patient recovery times and reduced healthcare costs.
A micro-needle fabricated by Horizon Microtechnologies, and designed by Dr. Jufan Zhang from the University College Dublin, Ireland.
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BILL AURAND, NATIONAL SALES MANAGER, RINCO ULTRASONICS, SHARES HOW ULTRASONIC WELDING MEETS THE EVOLVING NEEDS OF THE MEDICAL INDUSTRY.
Ultrasonic plastic welding has enjoyed widespread use as a joining technology in a wide range of end-use applications including the medical industry. It has evolved since its adoption in the early 1960s and today the process is considered fairly mature. However, the technology has witnessed breakthrough advancements over the years which have dramatically improved the performance and reliability of ultrasonics, ultimately enhancing the productivity, quality, and efficiency of the manufacturing process.
The ability to measure and control the part collapse during the weld was introduced in the 1980s and gave the technology a boost in reliability and consistency. The recent introduction of servo- driven ultrasonic actuators has also given the technology another quantum leap forward. Due to modern servo technology, the precision and flexibility of ultrasonic welding has been further enhanced to a level where meaningful weld parameter changes can be made during even the shortest of cycle times.
All of these technical advancements have delivered major improvements for the manufacturing of goods for multiple industries. One of the major benefactors of the unique capabilities of ultrasonic welding has been the medical field. Ultrasonic welding has adapted well to the medical industry’s need for high precision and cleanliness. As a result, this reliable bonding method has been used extensively to manufacture medical devices and components such as surgical instruments, liquid delivery components, hygiene products, and pharmaceutical delivery systems to name a few.
PROCESS FEEDBACK AND TRACEABILITY
The ability to create hermetic seals with most thermoplastics without using adhesives or fasteners aligns well with the requirements of the medical industry. Of particular interest in the medical sector is the capability of an ultrasonic welding system to provide feedback on the weld process. Competitive assembly methods such as adhesives and thermal bonding are blind and offer no measurable proof that a quality seal has been created. The data available from ultrasonic welding systems, however, provides feedback throughout the weld process. This data is often closely monitored, with upper and lower limits set to flag suspect or bad welds.
Among the growing industry trends in medical device manufacturing is the ability to provide complete traceability of all process settings during the manufacturing of any specific part. The firm belief is that confirmation of process settings from start to finish of the various manufacturing processes will help to identify the root cause of any given product failure. Since detailed process data is available from most ultrasonic welders, this should be an easy task. Unfortunately, this hasn’t been the case. Most ultrasonic welding systems have historically allowed for the weld parameter settings to be deleted. So, the settings utilised on any given day of manufacturing can’t be confirmed.
THE RINCO EFFECT
Rinco is meeting the call of the medical market for traceability capability. The company recently released two new ultrasonic welders that are fully calibratable and offer permanent audit trails so
“Ultrasonic welding has adapted well to the medical industry’s need for high precision and cleanliness.”
users can track all system errors and adjustments.
The eMotion 2.0 (servo driven) and Standard 2.0 (pneumatic driven) are both ISO 13485 certified. For process traceability, the two welders offer an audit trail screen. On this screen is every process error, equipment fault, or process parameter adjustment that has ever occurred. Further, the information in the audit trail is non-volatile and cannot be deleted. This means that any
process tampering that might occur, on third shift for example, can’t be denied. And because the password protection can be customised for each individual accessing the machine, precise identification of the source of the change is also available. This feature helps to remove any guesswork on determining whether an ultrasonic welder’s settings were responsible for a product failure.
The advantages and adaptability of ultrasonics in the medical sector is clearly illustrated in the latest applications. Two US-based medical OEMs are employing ultrasonics to improve quality and enhance productivity. A manufacturer of vacuum devices that remove fluids from the body in hospitals originally glued the parts together. Production was slow and gave no proof of a good assembly. The company has employed Rinco’s Standard machines and is now mass producing the devices at a rate approximately 10 times faster with “superior” quality results.
Another manufacturer of reagent carriers for blood analysis systems originally tried to make the cartridges with a competitor’s machine but had very poor results. Rinco’s machines, which are designed to have high precision and extreme system rigidity, made an impact on the quality of the parts. The company has since purchased dozens of machines from Rinco.
Ultrasonic welding offers many advantages for bonding thermoplastic materials. The process continues to evolve as technology advances and manufacturing requirements shift. New advanced features like audit trail capability makes the already precise and reliable process of ultrasonic welding an even better fit for use in demanding applications for the medical device market.
MEDICAL PLASTICS NEWS TALKS TO SABIC AFTER THE INTRODUCTION OF THE NEW MEDICAL GRADE PBT RESIN.
1. You have recently introduced a new medical grade polybutylene terephthalate (PBT) resin, could you tell us more about it please? VALOX HX325HP resin is an unreinforced polybutylene terephthalate (PBT), with added mould release for optimum processing. This resin is specially designed to deliver optimum performance in components with features requiring high precision injection moulding.
2. What can this be used for?
POREX,
SHARES THE IMPORTANCE OF CHOOSING THE RIGHT MATERIAL FOR YOUR DIAGNOSTIC TEST.
In the world of diagnostics, the materials used in tests are not just important—they are critical. They influence everything from the accuracy of results to the speed and reliability of testing. At Porex, we understand that the choice of materials can be the difference between a correct diagnosis and a costly error. Our journey in diagnostics started with the introduction of midstream urine wicks for pregnancy tests and has expanded to include a wide range of materials that are now integral to many diagnostic tests.
Why should you care about the materials in your diagnostic tests? Because the right materials ensure precise and dependable results, which are essential for patient care and medical decision-making. Poor material choices can lead to inaccurate results, delayed diagnoses, and increased healthcare costs. At Porex, we have seen firsthand how high-quality materials enhance the performance of diagnostic tests, from delivering samples at optimal speeds to ensuring they are free from contaminants. This focus on quality and reliability is what sets us apart and drives our commitment to excellence in diagnostics.
The importance of materials in diagnostic tests Materials in diagnostic tests must meet high standards. They need to deliver samples at the right speed, ensure accuracy, and be free from contaminants. Porex has been a part of this journey from the early days of home pregnancy tests to the current demand for traditional laboratory and point-of-care (POC) testing. The right materials can make a big difference in how tests perform. For instance, our CERTIFIED PURE POREX materials are designed to be free from interfering substances, ensuring the highest purity and accuracy.
Effective sample delivery and improved accuracy
One of the key factors in diagnostic testing is sample delivery. Porex wicks are engineered to deliver samples at the optimal speed. Our fibre technology provides an ideal capillary structure, which controls the delivery of the sample. This is particularly important in tests like pregnancy tests, where the speed and accuracy of sample delivery can affect the results.
Our materials also improve test result accuracy. For example, in lateral flow tests, the capillary flow rate is a critical performance parameter. The system is dynamic, and the formation of immunocomplexes at the test and control lines depends on the finite time period during which the components are close enough to bind. The capillary flow rate determines this time period, ensuring accurate results.
Meeting increased demands in point-of-care testing
The trend towards POC testing has increased the demands on material performance. Traditional testing methods often involve multiple steps,
but POC testing consolidates these steps into a single device. This means there is reduced sample handling, decreased sample size, and increased speed—all of which put more demands on the materials used.
At Porex, we have developed materials that meet these demands. Our materials are used in various applications, from vents in diagnostic cartridges to absorbents for samples and reagents. Each material is designed to meet specific needs, ensuring the best performance for each test.
The role of materials in sample filtration and contaminant control
Sample filtration is another critical area where materials play a key role. Contaminants in samples can impact the accuracy of test results. Porex materials are designed to filter out these contaminants, ensuring that the samples are clean and ready for testing. For example, our materials can be used in saliva sample filtration, providing different levels of filtration to meet specific needs.
In addition to filtering samples, materials also need to prevent contaminants from entering the test devices. For instance, our PTFE venting materials allow airflow while blocking liquids and contaminants. This ensures that the samples remain uncontaminated, providing accurate and reliable test results.
Consistent performance and reproducible results
Consistency is key in diagnostic testing. The materials used must perform reliably across different batches and lots. At Porex, we ensure batch-to-batch reproducibility, providing consistent sample volumes and flow rates. This consistency is crucial for maintaining the accuracy and reliability of diagnostic tests.
One example of this is our midstream urine collection pads. By measuring the water absorption and wicking speed, we ensure that each pad performs consistently, providing reliable results every time. This level of consistency is essential for both at-home and POC testing, where quick and accurate results are critical.
The importance of choosing the right supplier
Selecting the right supplier for diagnostic materials is as important as choosing the right materials. A reliable supplier can ensure that the
materials meet the necessary standards and are delivered on time. At Porex, we work closely with our clients to provide customised solutions that meet their specific needs. Our expertise in material science and our commitment to quality make us a trusted partner in the diagnostics industry.
Choosing the wrong supplier can lead to significant issues, such as product recalls and increased costs. For example, a supplier that provides materials with hydrophobic characteristics when the collection swab is intended to be hydrophilic can cause false negative results in diagnostic tests due to challenges with sample collection. This highlights the importance of working with a supplier who understands the unique needs of the diagnostics industry and can provide materials that meet those needs.
Final thoughts
Materials play a crucial role in the performance of diagnostic tests. The right materials can make a significant difference from sample delivery and accuracy to filtration and sustainability. At Porex, we are committed to providing high-quality materials that meet the needs of the diagnostics industry. Our material science and engineering design expertise make us a trusted partner for diagnostic material solutions.
1,000+
POLYMER prescriptions
TYAHTANHOYA MORENO, MARCOM SPECIALIST, CONSUMER GOODS & HEALTHCARE, SYENSQO, DISCUSSES REVOLUTIONISING MEDICAL DEVICES WITH THE USE OF PPSU, WHICH COMBINES PERFORMANCE WITH VISUAL APPEAL.
he field of medical device manufacturing has witnessed significant advancements over the past few decades, largely driven by the evolution of materials used in production. A notable milestone in this evolution was the introduction of Radel PPSU (polyphenylsulfone) over 30 years ago. This advanced polymer has gradually replaced traditional materials like metals, offering a blend of durability, reliability, and aesthetic appeal.
STERILISATION RESISTANCE
The Radel family of grades, particularly Radel PPSU, has shown remarkable longevity and resilience, outperforming traditional materials in crucial aspects. Accelerated ageing studies on Radel PPSU indicate that it remains stable under typical product storage conditions, ensuring a long product life. Additionally, Radel PPSU’s compatibility with various sterilisation methodsincluding gamma radiation, steam, and ethylene oxide (ETO) - enables it to maintain its mechanical, thermal, and chemical integrity through repeated cycles. This makes Radel PPSU an ideal choice for medical devices requiring frequent sterilisation, thereby enhancing patient safety and device reliability.
BIOCOMPATIBILITY AND RELIABILITY
Biocompatibility is a critical requirement for materials used in medical applications. Radel PPSU meets the stringent ISO 10993:5 and 10993:18 standards for cytotoxicity and physicochemical properties. These certifications confirm its suitability for applications involving direct contact with bodily tissues and fluids for periods of less than 24 hours, ensuring its reliability and efficacy in clinical settings.
MECHANICAL PROPERTIES AND COLOUR STABILITY
Radel PPSU stands out for its ability to retain strength and toughness, even when exposed to harsh sterilisation environments. Tests have shown minimal changes in its tensile strength and elongation, demonstrating its
robustness under stress. Moreover, steam sterilisation, a common method for Radel PPSU, does not affect the product’s colour even after 1,000 cycles. Consistent colour fidelity is crucial for devices that rely on colour coding to enhance functionality and reduce errors, thereby improving both usability and procedural efficiency.
IMPACT ON MEDICAL DEVICE MANUFACTURING
The incorporation of Radel PPSU into medical device manufacturing has enabled the design of lighter, more ergonomic medical instruments, reducing fatigue and enhancing procedural efficiency. Its availability in various transparent and opaque colours has facilitated the development of colour-coded surgical instruments, which improve operational efficiency and reduce the risk of errors in fastpaced surgical environments.
CONCLUSION
Radel PPSU represents an advancement in materials science, driving innovation in medical device manufacturing. Its durability, compliance with biocompatibility standards, and adaptability to rigorous sterilisation processes set new benchmarks for performance and reliability in healthcare applications. As the medical industry continues to evolve, Radel PPSU is poised to play a pivotal role in the development of innovative and efficient medical devices that meet the complex demands of modern medicine.
TPE COMPOUND AND CUSTOMISED SOLUTIONS FOR THE MEDICAL WORLD
MARFRAN s.r.l. has been producing TPS (SBC-based TPEs) for the medical and pharmaceutical packaging industry since the early years of the new millennium. Much progress has been made and in 2015 MARFRAN inaugurated the new plant dedicated to medical materials. The production plant is located in an ISO class 8 clean room that houses the entire production process: from the preparation of the compounds, through the compounding stage to the packaging of the finished product, the entire process is carried out in a controlled environment and with an ISO 13485 certified management system.
Over the last years, MARFRAN s.r.l. has developed a wide range of medical TPE compounds under the brand name MARFRAN.MED mostly based on both saturated and unsaturated styrenic block copolymers for the most diverse and well-established applications in the medical device and pharmaceutical packaging industries.
MARFRAN s.r.l. does not want to be just “a supplier” of medical TPE, but wants to offer innovative and customised solutions. An example of such approach are the new specific compounds intended for the manufacture of catheter balloons both by extrusion and by dipping, characterised by extremely low hardnesses and high mechanical properties in relation to hardness.
MARFRAN.MED MD 0070, available in hardnesses between 15 and 25 Shore A, offers a valuable solution for making balloons by extrusion, while MARFRAN MR 1679, available in hardnesses between 5 and 20 Shore A, enables the making of balloons by dipping due to its specific physical form that facilitates dissolution in solvent.
MARFRAN s.r.l. is therefore the ideal, flexible and fast partner to develop innovative and customised projects by offering its expertise in the service of the customer.
ADAM
HOWARD, DIRECTOR, SEALS DIRECT, EXPLAINS THE DIFFERENCE BETWEEN SILICONE AND MEDICAL GRADE SILICONE, AND PROVIDES EXAMPLES OF HOW IT IS USED WITHIN THE MEDICAL INDUSTRY.
Medical grade silicone rubber is a specialised type of silicone that meets the biocompatibility and safety standards set by regulatory bodies like the FDA and ISO. It is formulated for use in medical applications where contact with human tissue, blood and other bodily fluids may occur. This material is known for its purity, flexibility, durability and resistance to extreme temperatures.
How does silicone rubber differ to medical grade silicone rubber?
Medical grade silicone often differs from commercial silicone in several significant ways. These differences are primarily related to the compounds purity, biocompatibility, regulatory approval and sterilisation capabilities. Medical grade silicone is often purer than other grades of silicone and is manufactured under stricter controls to ensure the elimination of contaminants that could potentially cause adverse reactions when in contact with human tissue. This high level of purity is essential to ensure suitability in sensitive medical applications.
Another key difference lies in the compounds biocompatibility. Medical grade silicone rubber undergoes rigorous testing to ensure it is compatible with human tissues and fluids. This testing guarantees that the material does not cause irritation, toxicity or allergic reactions to confirm it safe for use in direct contact with the human body. This compares to other silicone rubber compounds that may not meet these biocompatibility standards and are therefore unsuitable for many medical applications such as contact with human tissue.
Regulatory approval is another factor that distinguishes medical grade silicone rubber from other grades. It must comply with the regulations set by health authorities such as the FDA and ISO to ensure that it meets the highest standards of safety and efficacy for medical use. Standard silicone rubber, while widely used in other industries, does not always meet these specific regulatory requirements.
Medical grade silicone is also designed to withstand various methods of sterilisation, including autoclaving, gamma irradiation and ethylene oxide sterilisation, without degrading. This property is important for maintaining the materials integrity whilst ensuring it remains safe for repeated medical use. Other silicone compounds may not possess the same level of resistance to these sterilisation processes which could limit their suitability for medical applications where sterilisation is essential.
How does the medical industry use silicone rubber?
The medical industry uses medical grade silicone rubber in a wide array of applications due to its versatility and biocompatibility. One of the primary uses of this material is in implants, including pacemakers, hydrocephalus shunts and breast implants. Its biocompatibility and durability make it ideal for long-term implantation in the human body. Silicone rubber is also extensively used in the production of catheters and tubing which are essential components in various medical procedures for fluid transfer and drainage.
Additionally, surgical instruments and tools often feature silicone rubber in their handles and grips. This material can provide ergonomic benefits that
enhance the comfort and precision of surgical procedures.
Medical grade silicone rubber also plays an important role in drug delivery systems. This material is used in controlled release drug delivery mechanisms, such as transdermal patches and implantable devices, where its stability and biocompatibility ensure effective and safe medication administration. Silicone rubber also has gentle adhesion properties and non-irritating nature so is beneficial in wound care products. These features make it an ideal material for use on sensitive or compromised skin to promote healing whilst minimising discomfort.
Advantages of medical grade silicone rubber
This material offers several advantages which make it a preferred material in the healthcare industry. Although medical grade silicone offers a number of unique properties for medical applications, some of these benefits are shared with most silicone compounds which exhibit similar physical characteristics.
The main advantage of medical grade silicone is its compliance and accreditation from various regulatory bodies.
Medical silicone also offers biocompatibility. This means that it is highly compatible with human tissues and fluids and can reduce the risk of adverse reactions such as irritation, toxicity or allergic responses. This property is important for medical applications that involve direct contact with the human body, such as implants, catheters and wound care products.
Another advantage of most silicone compounds is its durability. Silicone rubber exhibits a resistance to wear and tear and extreme temperatures, which ensures its long-lasting performance in various medical applications. Whether used in an implant or a prosthetic device, silicone rubber maintains its integrity and functionality over extended periods to provide reliable and consistent results.
Flexibility is another physical benefit of most silicone compounds. It retains its flexibility and elasticity over a wide range of temperatures, so it is suitable for dynamic applications that require the material to bend, stretch and move without breaking. This flexibility is particularly valuable in applications such as tubing, catheters, and surgical instruments, where adaptability is essential for both functionality and patient comfort.
Most silicone compounds can be manufactured in a wide variety of colours. This also includes transparent compounds which can be an advantage in specific applications, such as in tubing and certain implants. This transparency allows for visual monitoring of fluid flow and other internal processes to provide an additional layer of functionality that enhances patient care and treatment outcomes.
Disadvantages of medical grade silicone rubber
Despite its many advantages, medical grade silicone rubber also has some limitations that should be considered when choosing the best compound for your application.
“The main advantage of medical grade silicone is its accreditation from various regulatory bodies.”
One of the primary disadvantages is its cost. The stringent manufacturing processes, additional testing and regulatory compliance required for medical grade silicone significantly increases its production costs compared to standard silicone rubber. This higher cost can be a limiting factor, especially in applications where budget constraints are a concern.
Another limitation is related to its mechanical properties. While medical grade silicone rubber is durable and flexible, it may not have the same mechanical strength as some other materials such as EPDM or Neoprene. This can restrict its use in applications that require high tensile strength and resistance to heavy loads or high-impact forces. In such cases, alternative materials that offer superior mechanical properties might be preferred.
The permeability of silicone rubber to certain gases and liquids is another potential drawback. This permeability can make it unsuitable for some medical applications where a completely impermeable barrier is required. For instance, in certain drug delivery systems or implants, the permeation of external substances could affect the efficacy and safety of the device.
Additionally, the processing and moulding of medical grade silicone rubber can be more complex than other materials. Specialised equipment and expertise are often required to work with silicone, which can increase production time and costs. This complexity can be a barrier for some manufacturers such as those without the necessary infrastructure or experience in handling medical grade materials.
Trusted to protect
MEDICAL PLASTICS NEWS TALKS TO SREEDHAR PATNALA, GENERAL MANAGER, SYSTECH ABOUT TRACKING COUNTERFEIT EPIDEMICS PLAGUING THE MEDICAL INDUSTRY.
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1. HOW CAN WE PREVENT COUNTERFEITING?
Counterfeiting is a global issue that affects virtually every industry, with no organisation unsusceptible to the damage it can cause. The international trade in counterfeit and pirated goods accounted for an estimated 2.5% of world trade in 2019, while fake products made up 5.8% of all European Union imports.
tracking and monitoring, making it challenging for diverted products to go unnoticed. Serialisation allows you to provide a unique way of identifying individual products.
Secondly, with our track and trace capabilities, manufacturers can monitor the movement of their products throughout the supply chain, helping users to identify and address fake products. Traceability offers greater visibility into the product journey—from manufacturer to consumer—and assists with product recalls.
To overcome the counterfeit challenges currently plaguing several industries, including the medical sector, organisations should utilise track-and-trace technology. It enables firms to follow a product’s journey throughout the supply chain.
Companies ought to consider using next-generation solutions powered by the latest technological advancements to thwart counterfeit goods - namely smart vision systems, digital fingerprinting and artificial intelligence (AI).
2. HOW ARE SYSTECH TRYING TO COMBAT THIS?
At Systech, we provide digital traceability and serialisation solutions that establish essential product data, ensure digital connectivity and enable real-time insights - on the packaging line and throughout the supply chain. Firstly, our serialisation solutions enable brands to assign unique identifiers to each product. This approach allows for real-time
Finally, we provide non-replicable, non-additive, covert digital product authentication solutions through our brand protection portfolio via digital e-Fingerprint and AI-based technologies. These work with existing 1D and 2D barcodes and packaging to deliver immediate counterfeit detection. With an easy-to-use smartphone app, brands and their trading partners can instantly verify product authenticity—anywhere in the supply chain.
We recommend a programmatic approach to tackling counterfeiting rather than solely relying on a single solution. A blend of individuals, procedures, technology and time can ensure consumer safety and loyalty and safeguard brands and revenues.
3. HOW HAS E-COMMERCE LED TO AN UPTICK IN COUNTERFEIT GOODS?
The uptick in e-commerce has powered the counterfeiting surge. In the pharmaceutical industry, doing business with online pharmacies can lead to fraudulent activity. For example, a customer in the UK buying online from what appears to be a pharmacy may, in reality, be receiving a counterfeit, mislabelled, or expired product from a completely different region.
With people’s willingness to buy goods online having increased exponentially, an ever-growing number are open to taking more risks to secure a good deal for themselves.
5. WHAT ADVICE WOULD YOU GIVE TO COMPANIES IN ORDER TO AVOID COUNTERFEIT PRODUCTS?
It is critical for companies to adopt a multifaceted approach rather than rely on a single solution to address the problem of counterfeit and diverted products. This requires applying different tools. For instance, serialising products for tracking purposes is imperative to ensure each product stays within legitimate channels throughout the supply chain.
Equally important is for firms to implement a proactive approach. Companies must work together to address the extensive counterfeit issue and accurately highlight, track, trace and authenticate the genuine products.
