MPN EU Issue 59 by MPN Magazine

EUROPEAN EDITION

MEDICAL PLASTICS news REMOTE MAINTENANCE DURING A CRISIS

SUCCESSFUL MEDICAL MANUFACTURING THROUGH COLLABORATION AND DFMM ISO 10993-23: MOVING FROM IN VIVO TO IN VITRO IRRITATION TESTING

An adhesives specialist explains how medical device manufacturers can use UV light curing systems to achieve a repeatable, validatable and productive bonding process

ISSUE 59

March - April 2021

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for medical devices, pharmaceutical manufacturing and digital health. Keep up to date with key developments that matter.

AVAILABLE IN PRINT, ONLINE AND DIGITAL FORMATS

ADVANCING HEALTHCARE

CONNECTING PHARMA

Advancing Medical Plastics

Intelligence for professionals involved in the design and production of Class I, II & III medical devices

Intelligence for the pharma and biopharma manufacturing supply chain – from clinical trial to mass production, regulations, and logistics and distribution

The essential information source for anyone involved in the design, manufacture and supply of plastic medical devices

www.med-technews.com @medtechonline

www.epmmagazine.com @EPM_Magazine

www.medicalplasticsnews.com @MPN_Magazine

CONTENTS March/April 2021, Issue 59

Regulars 5 Comment Corrine Lawrence considers the shape of the new normal. 6 Digital spy 12 Cover story Intertronics’ Peter Swanson explains how device manufacturers can use UV light curing systems to achieve a repeatable, validatable and productive bonding process. 26 04:2021

Features 8 Industry 4.0: Safeguarding production Christoph Lhota, vice president, ENGEL explains the key role of remote maintenance and online support.

14 Joining technologies: A quick ﬁx Didier Perret, medical business development manager, Branson Welding and Assembly at Emerson, considers medical device assembly scale-ups to meet market demands amid COVID-19. 17 Injection & micromoulding: DfMM — it’s no small matter! Accumold’s vice president of marketing and customer strategy, Aaron Johnson, explains why successful medical micromoulding depends on collaboration and design for micromoulding. 21 Recycling medical plastics: Averting the PPE waste pandemic Thomas Davison-Sebry, chief sustainability offi cer at Thermal Compaction Group, shares how their innovative device can help to resolve the global PPE waste problem. 24 Testing & Inspection: In vitro irritation Nelson Lab’s Audrey Turley on understanding ISO 10993-23 and how to navigate the transition from in vivo to in vitro irritation testing.

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You expect precision. We deliver. contract manufacturing injection moulding medical devices Our manufacturing includes cleanroom environments, automation, and assembly services, delivering total value solutions that reduce investment and improve cost.

www.carclo-ctp.co.uk +44 208 685 0500 sales@carclo-usa.com United States

• United Kingdom

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editorial content producer | corrine lawrence corrine.lawrence@rapidnews.com advertising | caroline jackson caroline.jackson@rapidnews.com

Editor’s Comment

vp sales & sales talent | julie balmforth julie.balmforth@rapidnews.com

C O R R I N E L AW R E N C E

head of studio & production | sam hamlyn graphic designer | matt clarke junior designer | ellie gaskell publisher | duncan wood Medical Plastics News Europe Print Subscription – Qualifying Criteria UK & Europe – Free US/Canada – £249 ROW – £249 Medical Plastics News NA Print Subscription – Qualifying Criteria US/Canada – Free UK & Europe – £249 ROW – £249 FREE on iOS and Android devices Subscription enquiries to subscriptions@rapidnews.com Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2021 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

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A cherry-picked normal?

ello and a warm welcome to the March/April issue of MPN Europe. No, Rob has not taken ‘lockdown hair’ to a higher and more extreme level; rather, I have the pleasure of joining the MPN community and working with you to deliver content that will inform and inspire. Before I continue, I would like to thank Rob for his work on the publication and the brand while, at the same time, looking after European Plastics Product Manufacturer. So, here we are, a quarter of the way into 2021 and how’s the industry shaping up? I wanted to write this introduction without mentioning COVID-19, but it’s unavoidable. How can something so devastating, so disruptive be brushed aside simply because, perhaps, we’re growing a little tired of the subject dominating the airwaves and column inches, and crave something new to distract us from this reality? As is evident from the news covered on the MPN website and shared through our social media (Twitter and LinkedIn) profiles, as well as the daily volume of press releases landing in my inbox, the medical plastics industry has demonstrated (and continues to do so) its resilience, agility and dedication. For the past year, whether through altruism or survival, companies across Europe have responded to the call of doing their bit to help keep people and businesses as safe as possible in the given circumstances. For many businesses, the past 12 months represents a period of discovery during which they realised they could reshape their capabilities to help meet the escalating demands for PPE and domestic supply chains.

Although the pandemic is still very much a dominant force, the mass vaccination programmes in operation across the world breathe hope into resurrecting a sense of normality. Throughout the lockdowns, many professionals have continued to work on site, manufacturing essential products; others have discovered the highs and lows of working from home. Travel restrictions put paid to service providers making client visits, and trade fairs/exhibitions became a strict ‘no’. Through necessity, however, the industry has discovered how to harness and push the potential of digital and virtual technology, whether to facilitate internal meetings, webinars, virtual site tours or even offsite maintenance and supplier audits. As we creep towards the familiarity of ‘normal’, how much of the old will we choose to reinstate? I suspect too much has changed — in some cases, for the better — for a complete return to how things were. I am interested to see which bits we decide to keep, and which we relegate to the postCOVID bin.

ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital) WWW.MEDICALPLASTICSNEWS.COM

MATERIALS UPDATE

DIGITAL

spy OUTSOURCING UPDATE

SUSTAINABILITY UPDATE

www.borealisgroup.com

www.aranbiomedical.com

Aran Biomedical expands medical device manufacturing capacity

Collaboration in Sweden set to increase supply of chemically recycled feedstock

iomaterials contract manufacturer Aran Biomedical is set to treble its manufacturing capacity by building a new purpose-built facility in Spiddal, Galway. The company says it the new 70,000-sq. ft implantable device manufacturing facility will be completed on a phaseby-phase, with full completion estimated by mid-2025. The contract manufacturer has also said that it will be creating 150 new jobs during the next 3 years. These positions will help to meet increased demand in the company’s design services and commercial manufacturing segments in the vascular, general surgery and orthopaedic fields.

he Swedish Energy Agency has awarded Borealis a grant to fund a feasibility study for a chemical recycling unit to be established at the Borealis production location in Stenungsund, Sweden, with project partner Stena Recycling. The new unit, which is looking to secure an increased supply of chemically recycled

feedstock for the production of more circular base chemicals and polyolefin-based products, is expected to commence operations in 2024. Borealis will also co-operate independently with Fortum Recycling and Waste on a project involving the sourcing of plastic waste to the chemical recycling unit.

www.medskinsuwelack.com

New MatriDerm products offer surgeons more flexibility

edSkin Solutions Dr Suwelack, a company focused on tissue regeneration and skin health has expanded its MatriDerm portfolio by launching MatriDerm Flex Dermal Matrix and MatriDerm Fenestrated Dermal Matrix. The two new products offer surgeons more flexibility in the treatment of complex wounds when it comes to one- and two-stage surgical procedures using a split-thickness skin graft. Both products have received CE-certification and will be rolled out in the second half 2021.

PRODUCTION UPDATE

www.covestro.com

Covestro opens expanded production lines in Germany Polymer company Covestro has started up additional production lines for high-quality specialty films at its Dormagen site in Germany. The new coextrusion lines are designed to meet a rising demand worldwide and will primarily produce multilayer flat films. The project is part of a global program to expand film capacity with a total investment of more than €100 million and was completed as planned despite restrictions due to the coronavirus pandemic. Approximately 30 new jobs will be created to operate the new lines. “With this expansion in capacity, we are strengthening our Dormagen site as a production and competence center for specialty films,” says Dr Klaus Schäfer, chief technology officer at Covestro. “At the same time, we are investing in future-oriented technologies and applications.” The competence center in Dormagen houses production, a technical center for film processing, as well as a showroom and research laboratories. 6

We are strengthening our Dormagen site as a production and competence centre

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DIGITAL SPY

ROBOTICS UPDATE

www.rockwellautomation.com

Simplifying robot integration for manufacturers

ockwell Automation and Comau are partnering to give businesses worldwide vital tools to maximize manufacturing efficiencies through unified robot control solutions. According to Rockwell Automation chairman and CEO Blake Moret, the collaboration will simplify programming and lifecycle management, which will accelerate time to value for customers. Engineers will now be able to program their entire machine in one environment, including Comau robot arms directly controlled through Rockwell Automation’s Logix-based controllers. Rockwell Automation’s Studio 5000 automation system design software provides relief from the timeconsuming and often difficult task

of trying to coordinate traditionally separate machine control and robot systems to work together using two different software tools.

talking

POINT

https://tekni-plex.com SOFTWARE UPDATE

www.rjginc.com

New Simulation Support app for RJG’s injection moulding networking software

JG has added a new app on its injection moulding networking software, The Hub, to provide users with the tools needed to launch a tool more effectively, saving time, money and hassle. Simulation Support allows users to import simulation files into The Hub database and automatically generate

a universal process sheet that they can convert to a machine-specific setup sheet for any capable machine. This translates as a significant time saving during a tool launch, as users can go from concept to process without cutting steel. No more rework or spending weeks establishing and testing processes.

Brenda Chamulak, President, Tekni-Plex Packaging Products When you take up the mantle of president and CEO of Tekni-Plex at the end of June, what is your immediate priority? Our first priority remains the same — to always put our people and customers first. The Tekni-Plex team are all motivated to grow and contribute to our customers’ successes. What is the company’s next phase of growth? Tekni-Plex focuses on highly engineered material solutions that protect brands, products and patients around the globe. Growth for us means understanding the needs of our markets to bring solutions proactively to our customers’ biggest challenges. How are current macro-environmental factors affecting your market? We see the increasing need for sustainable consumer products and more advanced medical technologies that extend quality of life as enduring forces that our engineered solutions approach is built to address. We also see a need to become even more innovative. How are customers shaping your products? Our customers are at the forefront of the sustainable and life-enhancing product trends. We are looking to create even closer relationships with them, so we can get involved earlier in the ideation process and contribute even more to their product design.

INDUSTRY 4.0

COVID-19 HAS GIVEN A BOOST TO THE DIGITALISATION OF PRODUCTION PROCESSES. CHRISTOPH LHOTA, VICE PRESIDENT, ENGEL MEDICAL EXPLAINS HOW DIGITAL SERVICE PRODUCTS IN PARTICULAR, SUCH AS REMOTE MAINTENANCE AND ONLINE SUPPORT, ARE SHIFTING INTO THE FOCUS BECAUSE THEY HAVE BECOME KEY TO ENSURING PRODUCTIVITY AND DELIVERY CAPABILITY, EVEN IN THE EVENT OF FUTURE CRISES.

Safeguarding production …

magine the scene: The image is a little jerky and out of focus. The injection moulded part, a labon-a-chip article, has to be held up to the camera, rotated and turned several times so that everyone taking part in the Skype chat, can see clearly the part quality. The participants are spread across three locations: Schwertberg (Austria), the headquarters of injection moulding machine manufacturer ENGEL; at Houten (the Netherlands), the headquarters of ENGEL’s Benelux subsidiary; and Tilburg (the Netherlands), where Helvoet Rubber & Plastic Technologies produces highprecision injection moulded parts for

medical technology and diagnostics. Together, the experts discuss the freshly moulded parts and the tweaks that the injection moulding machine offers for further optimisation. “Jeroen, can you zoom in on this point again please?” Jeroen Molenschot is not a cameraman, but development manager at Helvoet, a company for which this – that is, managing process optimisation virtually - is new territory and explains why the camera image is not yet ideal. ONLINE SUPPORT The travel restrictions and contact limitations due to COVID-19 coincided with Helvoet being in the critical phase (where injection moulding tests on the machine and close collaboration with ENGEL were necessary to further proceed) of what was already a time-critical optimisation project. Fortunately, their ENGEL e-mac injection moulding machine, on which they produce diagnostic products, was equipped with e-connect.24 — ENGEL’s solution for remote maintenance and online support. The screen pages of the CC300 control units on the injection moulding machines can be transferred across the internet to computers several thousand kilometres away. As the data are

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INDUSTRY 4.0

accessed in real time, the current state of the machine can be displayed whenever needed. As a result, the machine operators on the ground and external support staff can see the same settings and production data, and can consult and guide each other. The manufacturing cell can even be controlled remotely when necessary. In this way, Helvoet and ENGEL, were able to implement the optimisation project on schedule and safely meet the go-live date for series production. For Jeroen Molenschot and his team, this project sets a precedent for future collaboration with his machine supplier. “Without the current pandemic, we would not have agreed to this virtual process. I would have felt it was important for someone from ENGEL’s headquarters to visit us in person in Tilburg,” says Molenschot. “As developers, we have to learn to take advantage of these new technologies, which are already available to us. Even if it just means working more effectively and as a result more cost-effectively.” The time aspect for solution-oriented implementation and the resulting flexibility in finding a date for a joint online meeting, coupled with reduced travel expenses, caused Helvoet to rethink its stance on this new technology. PROCESS OPTIMISATION The combined knowledge of the processor, who has a sound understanding of their product, and ENGEL experts, who know every detail of their injection moulding machines, makes it possible to identify and leverage the minutest optimisation potentials. Frequently, it is the view from the outside that opens up new opportunities. ENGEL performance.boost — the company’s process optimisation service — starts with an in-depth analysis of the current production process by ENGEL specialists. They acquire the process settings and the pertinent efficiency and quality performance indicators to identify the existing optimisation potential. While doing so, they take into account the improvements offered, for example, by the use of smart assistance systems such as iQ weight control or iQ flow control, condition monitoring solutions or other products from ENGEL’s inject 4.0 portfolio.

Based on these results, the customer decides which optimisation steps they would like to implement with the support of ENGEL application technology. Users benefit from ENGEL’s high level of expertise in systems solutions. The automation solution, the peripheral units and the upstream and downstream processes integrated into the production process can be evaluated in the scope of process analysis and taken into account in the optimisation recommendations. DATA SECURITY A year after the first lockdown, virtual service calls, and even virtual machine acceptance, have become part of everyday life. Using remote service and online support, ENGEL, for example, has been able to provide its customers with continuous support without loss of quality and speed during the pandemic, both for ongoing projects (for example, for process optimisation) and in acute service cases. The huge importance of smart service for production availability, and, therefore, the processor’s ability to deliver, has become self-evident; even companies that have not previously worked with these systems are now addressing how they can safeguard their productivity in the event of future crises. The uptake of digital service solutions is on the up, as the benefits are obvious. Does this trend reflect a strengthened trust in digital solutions? Not necessarily. And that is a good thing. With all virtual solutions, data security must continue to be critically scrutinised. Providers of digital tools do not want anyone to access their systems without controls. Data security is, therefore, top of the agenda when developing service tools. At ENGEL, for

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example, service technicians can only start remote maintenance once the customer has authorised access for just this one machine. All data connections are encrypted, and once the customer signs off the service request, the remote maintenance link is disconnected. Establishing trust in the new solutions is important: irrespective of crises, the increasing complexity of the production units and the growing shortage of skilled workers will drive their use. After-sales is no longer just about getting a machine or production unit back up and running quickly, it’s also about giving processors the assurance that their production will run smoothly throughout.

When developing diagnostic or clinical trials kits, consideration of compliant patient sample return is critical. SpeciSafe® is a complete, convenient solution that with appropriate outer packaging meets regulatory requirements.

Contact our UN3373 experts for more information or to discuss your requirements and join our long list of satisfied customers. Web: www.UN3373.co.uk Phone: +44 (0)23 8048 3000 Email: marketing@alphalabs.co.uk

ADHESIVES

ltraviolet (UV) curing adhesives can be used to assemble medical devices such as catheters, reservoirs and housings, needles and syringes, medical electronics, tube sets and fittings, facemasks, and many more. When assembling these devices, UV light curing systems may be a good option because they help achieve process reliability, repeatability and validation. Medical device manufacturers face specialised adhesive needs: the material must bond to the parts, withstand the rigours of the product end-use, and comply with the industry’s particular regulatory needs. Medical device manufacturers want assurance that the process is verifiably and consistently in control; it must be efficient, reliable and repeatable. Adhesives may be cured by a variety of mechanisms, but UV light curing is popular for medical device applications due to speed and process control advantages. Light curing adhesives are solvent-free, offer a full cure in seconds and are sterilisable. They are designed to adhere to the typical substrates used in medical devices, for example, PEEK, PVC, PEBAX and ABS. Furthermore, they can be biocompatibility tested in accordance with ISO 10993 and/or USP Class VI (typical test results provided include ISO 10993-4 Hemolysis, ISO 10993-5 Cytotoxicity, ISO 10993-6 Implantation 14 Days, ISO 10993-10 Intracutaneous and ISO 10993-11 Systemic Toxicity), making them suitable for medical device applications where proof of non-toxicity is an industry requirement. UV curing adhesives are process friendly. Being single part, only curing on demand and with a range of viscosity choices, application is relatively straightforward, with methods ranging from simple syringe dispense under time/pressure control right up to sophisticated volumetric positive displacement pumps.

PETER SWANSON, MANAGING DIRECTOR OF ADHESIVES SPECIALIST INTERTRONICS, EXPLAINS HOW MEDICAL DEVICE MANUFACTURERS CAN USE UV LIGHT CURING SYSTEMS TO ACHIEVE A REPEATABLE, VALIDATABLE AND PRODUCTIVE BONDING PROCESS.

UV CURING EQUIPMENT It is important to select UV curing equipment that matches the adhesive of choice. UV curing lamps are primarily based on two quite different types of technology: mercury arc lamps and LED-based UV curing lamps. Traditional mercury arc lamps produce a broad spectrum of light and have been used successfully for decades. Mercury arc lamps, however, typically have less than 2,000 hours of bulb operating life, and the intensity of the lamp degrades over time, which creates a process variable that can affect output. The warm-up and cool down time associated with broad spectrum lamps often mean that manufacturers choose to leave them running all day, increasing operating costs. LED-based UV curing lamps are a more recent technology and, unlike mercury arc lamps, produce a narrow spectrum of light. They offer numerous advantages compared with traditional technology, including no output degradation over time, no bulbs to replace and cooler cures. With instant on/ off capability and no warm-up time, medical device manufacturers can turn them on as and when needed, thereby removing the need for mechanical shutters, and reducing running and energy costs. Because LED UV curing lamps offer a narrow spectrum of output, they may not optimally cure an adhesive that has been formulated to work with broad spectrum mercury arc lamp technology. It is recommended that the adhesive chosen is designed to cure with narrow spectrum UV LED lamps — as is usually the case with newer products. If this is not possible, then practical testing and verification with production parts should be undertaken to ensure that the LED lamp and the chosen chemistry provide a satisfactory result.

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ADHESIVES

IMPROVING PRODUCTIVITY WITH LED UV CURING UV curing systems offer several productivity advantages. For example, fast curing can reduce work-in-progress (WIP) and release factory space, employees and other resources so they can be reallocated to parts of the manufacturing process that add more value. There are also UV curing products available that offer inline quality inspection to help reduce defects and waste; for example, products that change colour when fully cured. Co-optimising adhesives and equipment can also shorten cycle times, leading to reduced work in progress. Improving productivity doesn’t have to be about big leaps; it could be about increasing manufacturing output or decreasing operating costs or input by small incremental amounts. For example, LED UV curing lamps offer a consistent output compared with that of a broad-spectrum lamp, which

allows medical device manufacturers to achieve process stability and uniform results. This facilitates superior process control, increased manufacturing throughput and lower operating costs, resulting in an increase in productivity. AUTOMATING IMPROVEMENTS There is no room for inconsistency in medical device manufacturing. With a manual process, operators can introduce process variability that may lead to problems with quality; for example, if too much or not enough adhesive is applied. UV curing adhesive processes can be readily automated to improve productivity and eliminate inconsistencies — benchtop and gantry robots can be integrated with dispensing, curing or surface preparation equipment. CASE STUDY One successful customer example is Brandon Medical, a UK manufacturer and designer of technology for operating theatres. The company was experiencing production bottlenecks due to extended curing times when bonding three polycarbonate lenses together to make the large front lens of its Quasar eLite operating theatre lamp. Intertronics supplied Brandon Medical with the Dymax 3225-T-SC singlepart UV light curing adhesive and a Phoseon LED UV curing lamp with a 50 x 20-mm emitting window. The lamp’s 396 nm intensity output provided enough light energy to give Brandon Medical a fast cure, with less heat introduced compared with traditional broad-spectrum lamps. The application was automated using a benchtop robot, integrating both the dispensing and the curing process, saving time in the production process.

…LED UV curing lamps offer a consistent output compared with that of a broad-spectrum lamp, which allows medical device manufacturers to achieve process stability and uniform results

CONCLUSION With any medical device, the manufacturing process must be validatable, by establishing evidence that a process is capable of consistently delivering quality products. Each step of the manufacturing process is controlled to assure that the finished product meets all design characteristics and quality attributes including specifications. UV curing processes and equipment such as LED-based UV curing lamps reduce process variability, facilitating the establishment and maintenance of a validated production.

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JOINING TECHNOLOGIES

DIDIER PERRET, MEDICAL BUSINESS DEVELOPMENT MANAGER, BRANSON WELDING AND ASSEMBLY AT EMERSON, CONSIDERS MEDICAL DEVICE ASSEMBLY SCALE-UPS TO MEET MARKET DEMANDS AMID COVID-19.

hether for contact tracing, infection detection, controlling the spread, preventing or treating the disease, the ability to rapidly scale up manufacturing capabilities is vital in the global fight to control COVID-19. To do so, product-design and manufacturing teams must consider a variety of factors when deciding how to ensure proper scalability when choosing between adhesive or ultrasonic welding assembly methods — two popular methods for assembling thermoplastic medical devices and medical grade textile materials into safe, reliable, finished products. These considerations generally fall into two broad categories: the speed and flexibility that are needed in the assembly operations; and the materials and shape or geometry of the part.

FLEXIBILITY Of the two assembly methods considered here, adhesives often provide more flexibility in the assembly process. Adhesives can create bonds between plastic components that use a wider range of materials and shapes. They may be a good solution for assembly of products in small quantities, including prototype designs, product samples and high-product-mix production.

Safety syringes or auto disable (AD) syringes are commonly assembled using ultrasonic welding technologies or adhesives. Adhesives and ultrasonic welding technologies are also widely used to assemble in-vitro diagnostic (IVD) test kits, strips, collection swabs and biocontainment enclosures. Ultrasonic welding and adhesive tapes are quickly replacing traditional needleand-thread assembly for nonwoven textiles used for personal protective equipment (PPE) such as face masks, gowns and surgical drapes. Adhesives and ultrasonic welding are permanent joining methods. It is, therefore, important to also consider whether the assembled device will need to be disassembled to allow for maintenance, component repair or internal parts replacement. To allow for device disassembly, a product design likely needs to incorporate either mechanical fasteners or snap-fit components as opposed to permanent assembly methods such as adhesives or ultrasonic welding. 14

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JOINING TECHNOLOGIES

Adhesive processing methods do, however, come with many constraints. The first involves the optimisation and maintenance of the dispensing equipment. The applicator must be kept relatively clean, and the adhesive must be applied with consistency and care. When the number of adhesive dispensers increases (for scaling up production), ensuring process control becomes more challenging. Assembly managers must ensure that adhesives flow smoothly, and cure times are consistent and assure part strength. This often requires the periodic purging and cleaning of dispensing systems and applicators, which can lead to waste, production delays or costly equipment repairs. Data process management can also present challenges. Another constraint on adhesive methods is that adhesives are consumables. Every adhesive bond represents an incremental production cost that rises in direct proportion to output. If product sales and production ramp up rapidly or new product variations are introduced, production costs will likely escalate accordingly. PRODUCTION VOLUME CHANGE AND SCALABILITY If production volumes and expected sales increase rapidly, the benefits of ultrasonic welding become apparent. Ultrasonics offer an excellent opportunity to consider, or reconsider, adhesives versus ultrasonic assembly. Using ultrasonic welding requires some upfront investment in welder capital equipment and product-specific tooling, which is needed to precisely hold the various plastic components in place for the welding process. This onetime investment can then be effectively and rapidly scaled up using existing

Ultrasonics offer an excellent opportunity to consider, or reconsider, adhesives versus ultrasonic assembly

equipment, processes and procedures. Whether a manufacturer is welding 1,000 or 1,000,000 devices, there are no incremental consumable or assembly costs. Manufacturers with production volumes ranging from tens of thousands to millions per year can often realise a clear return on investment using ultrasonic welding processes. Manufacturers planning high-volume production from the outset often choose ultrasonic welding. With ultrasonic welding, once a product design is finalised, weld tooling can be completed and highvolume production can begin. CYCLE TIME A key consideration for plastics assembly processes is the cycle time. Adhesive assembly requires curing time for each assembly. The most basic adhesive assembly process may consist of a relatively simple fixture, a handheld adhesive dispenser and a clamp or fixture to hold it steady during the curing process. Higher-volume adhesive assembly methods often involve automation, but the need to hold the assembly during adhesive dispensing and curing remains. Robotic adhesive dispensing tends to be flexible, as robots can be reprogrammed to incorporate fixture changes, respond to changes to the adhesive chemistries, or adapt to

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JOINING TECHNOLOGIES

GEOMETRY The use of adhesive joining methods allows for considerable variation in the geometry of parts.

the assembly of different parts with different geometries. All adhesive assembly methods, however, require dispensing and curing time. By contrast, ultrasonic welding provides a permanent, welded bond in typically one second or less. Once the welded part is removed from the weld fixture, the weld cycle is complete and the next manufacturing step can begin as a new part is loaded immediately to start the next cycle. Ultrasonic processes can weld some products two at a time or in groups. MATERIALS Material selection is an important variable in selecting an assembly process. In general, it is more difficult to bond dissimilar materials — rubber to plastics or plastics to metals — making mechanical fasteners, snap-fit or adhesives good considerations.

Part geometry imposes a few more challenges when it comes to ultrasonic welding, as the structure of the part itself must adequately transmit the ultrasonic vibrations from the horn or sonotrode to the weld joint. Some part geometry or shapes will inherently do this better than others. An example of an easy-to-weld shape would be a cube with walls that are rigid enough to direct energy straight to the weld joint, such as those used in some lateral flow devices for rapid IVD tests. A more difficult shape to weld would be a sphere, as one half would tend to flex under load and, therefore, not transmit the energy as efficiently. Easy-to-weld parts tend to have the following characteristics: • Relatively flat surfaces (limited contours) so that good horn contact can be achieved • Surface area on the top of the part over the weld joint area • Side walls with enough rigidity to transmit energy to the weld joint • A properly designed weld joint. Every part is unique, so the most efficient first step in the design process is to speak with a knowledgeable professional who can evaluate the design, consider assembly needs and find the right solution.

Adhesives generally offer greater options for bonding between dissimilar plastics. There are some exceptions, as some polymers may react chemically or degrade in the presence of certain solvent bond or adhesives. For ultrasonic welding, similar or identical thermoplastic polymers tend to weld better than dissimilar polymers. Some dissimilar polymers, however, may also be welded if they have similar glass transmission temperatures (Tg) and melt flow indexes (MFI). Also, amorphous polymers tend to weld better than semi-crystalline polymers, as they have more gradual melt curves and more predictable melt flows between parts, which help to create more consistent bonds. Amorphous materials that weld particularly well include acrylonitrile butadiene styrene (ABS), polystyrene and polycarbonate.

DESIGN FOR MANUFACTURING: FUTURE CONSIDERATIONS Incorporating rapid product volume scale-up capabilities into manufacturing processes can greatly improve a company’s responsiveness to challenging market demands such as those related to COVID-19. A key consideration could be to make design choices that keep assembly options open to both adhesive and ultrasonic welding methods. Perhaps the easiest way to do this is to design a simple tongue-and-groove (Figure 1) joint into the mating surfaces of the assembly. This type of joint offers an inherent alignment feature — the groove — that’s ideal for capturing adhesive and aligning the tongue of the mating surface, as well as for producing a strong ultrasonic weld. Should production needs or volumes change, it is a straightforward process to convert a tongue-and-groove part from adhesive assembly to assembly using ultrasonic welding. All that is required is the addition of an ‘energy director’ — a small bead of sacrificial weld material — to the bottom of the existing tongue. Typically, this can be done with a modest ‘steel safe’ change to the mold. Then, during the weld process, the energy director on the tongue melts neatly into the groove, resulting in a very precise, high-strength weld joint that offers good sealing properties.

Figure 1: A simple tongue-and-groove joint.

Semi-crystalline polymers are more challenging to weld because these materials tend to melt and solidify more abruptly. These characteristics can make achieving a consistent melt and melt flow more difficult, making it correspondingly more difficult to get a consistent bond. Polyethylene, polypropylene and nylon are examples of semi-crystalline materials that are more challenging to weld.

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INJECTION & MICROMOULDING

AARON JOHNSON, VICE PRESIDENT OF MARKETING AND CUSTOMER STRATEGY, ACCUMOLD, EXPLAINS WHY SUCCESSFUL MEDICAL MICROMOULDING DEPENDS ON COLLABORATION AND DESIGN FOR MICROMOULDING.

DFMM — IT’S NO SMALL MATTER!

lthough many medical device OEMs are well versed in the use of micromoulding in their product development cycles, there are a larger number who recognise the business need to produce increasingly smaller, and often more complex and innovative, products and components, but cannot see an obvious route to attain these goals. There is a general understanding throughout industry that micromoulding is not just “macromoulding but smaller”. There are a certain set of rules and understandings of the moulding process at the macro level that simply don’t work at the micro level. The flow of molten plastic, its cooling, warpage, necessary venting and gating and so on are all different when moulding at the microscale, and to a greater or lesser extent the process needs to be relearned. Most, if not all, medical device OEMs undertaking micromoulding at scale outsource their production, so the ‘way’ that micromoulding works, while relevant, should not be seen as a barrier to engagement. Your chosen micromoulding expert will remove the need for you to understand the vagaries of the characteristics of thermoplastics when moulding small. There are, however, other areas that any OEM must focus on beyond the micromoulding process itself.

THE PRODUCT DEVELOPMENT PROCESS Micromoulding is only one part of the overall product development process, and it is important for medical OEMs to appreciate that various departments involved in a micromanufacturing project must be engaged from product design inception. Reassessing the relationship between OEM and moulder in a micromoulding scenario is critical for success. Micromoulders should not be seen as a job shop, but rather a full and collaborative product development partner. The reasons for this are numerous, but begin with the understanding that just as micromoulding and the macromoulding are different processes, so too are the design for manufacture (DfM) rules. Design for Micromoulding (DfMM) is essential, and the expert in the room to offer advice and counselling is the micromoulder. Frequently, the less complete an idea is when the micromolder is engaged the better, as the earlier that the design of a microproduct can be influenced and adjusted to optimise manufacturing outcomes, the better the cost and production timeliness.

DfMM ensures the end product will be fit-forpurpose and optimised for the production processes that will be used

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INJECTION & MICROMOULDING

Essentially, DfMM ensures the end product will be fit-for-purpose and optimised for the production processes that will be used which, in this case, is micromoulding and automated assembly. The micromoulding team that medical device customers work with must be able to advise on such issues as material choice, draft angles and undercuts, part lines, ejector pin locations, gate locations, the likely flow of material in the mould, and wall thicknesses. MICROTOOLING AND ASSEMBLY Perhaps the key enabling technology when micromoulding is microtooling. Tooling in any manufacturing scenario is always the most expensive and time-consuming part of the product development process, but when looking at micromoulding, the tolerances and complexity that are often required in micromoulds make it critical, and often very expensive. For medical device OEMs it is vital to work with micromoulders that can design, build, and maintain moulds in house, and have the expertise and experience to optimise tool fabrication. One size does not fit all when looking at microtooling, and it is important that OEMs engage with micromoulders that can work alongside them to drill down into the specifics of a particular application, understand the effects of a certain material, cycle time expectations, part criteria, and expected volumes before beginning to cut steel. In-house tool fabrication — in fact vertical integration in general, ensuring that design, moulding, metrology and validation, and automated microassembly are all undertaken in the same facility with departments working collaboratively — is vital in micromanufacturing, where tolerances are so tight. The probability of successful outcomes increases exponentially when the responsibility for project and production, timeline, and execution are controlled within a single entity. Unsurprisingly, a micromoulder should be expert in micromoulding. Engaging with a company that has the right technology and forming a collaborative relationship that allows total transparency at this stage of the product development process is essential for success. Every stage of the product development process in micromanufacturing is driven by a total focus on micron and sub-micron tolerances. It is key that OEMs engage and work alongside a micromoulder that has the necessary business acumen and experience, an expert team of engineers, an understanding of the correct manufacturing methodologies, and the tooling and processing expertise to ensure optimised outcomes. Finally, when dealing with miniaturised plastic parts and components, the assembly part of the product development process must be discussed and considered early in the design cycle. When dealing with micro-scale parts and components, the cost of manual assembly is prohibitive, and often requires levels of precision when dealing with sub-micron tolerances that are impossible to achieve. Automated assembly is therefore a must in most micromoulding scenarios, requiring that medical device OEMs select a micromoulding partner that is able to understand the methodology of micro assembly, and achieve the extreme positional accuracy required. PARTNERSHIP AND COLLABORATION Collaboration and transparency are not just required between the micromoulder and the medical OEM customer, but also between the teams

within the micromoulding facility, which is why working with a vertically integrated company is essential. Although project success depends to a great extent on the expertise of the micromolder, customers still own the projects, and it is they who should remain central to all conversations and reviews that occur during product development. There is little value in producing a microproduct or component that is fit-for-purpose, easy and inexpensive to mould and assemble, yet bears no resemblance to the OEM customer’s vision. Transparency, therefore, is vital in ensuring the OEM customer understands the decision-making process and works with the micromoulder to problem solve and optimise outcomes, while maintaining control. Internally, all teams involved in the product development process must also work with clarity and transparency and collaboratively. Producing a plastic product with micron or submicron features, repeatably, economically, and on time means abandoning the ‘over the wall’ approach. A true inter-disciplinary approach will result in an optimized product made to specification repeatably. Product development teams working collaboratively from project inception allow for a singular focus on quality assurance, which begins with design for manufacturability reviews to ensure the project starts on the right foot, and extends through to the development of control plans to assess critical part features, failure mode and effects analysis (FMEA) results, high-resolution in-line vision systems, and high magnification microscopic measurements to verify tool and finished part dimensions.

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RECYCLING MEDICAL PLASTICS

THE AMOUNT OF SINGLE-USE PPE WASTE GENERATED BY THE CORONAVIRUS PANDEMIC IS SLOWLY BECOMING ANOTHER GLOBAL CRISIS. THOMAS DAVISON-SEBRY, CHIEF SUSTAINABILITY OFFICER AT THERMAL COMPACTION GROUP, SHARES HOW THEIR INNOVATIVE DEVICE CAN HELP TO RESOLVE THE GLOBAL PPE WASTE PROBLEM.

AVERTING THE PPE WASTE PANDEMIC

ore than 12 months after the World Health Organization (WHO) declared COVID-19 a global pandemic, the world remains dependent on the now ubiquitous blue ‘paper’ mask. Globally, more than 129 billion of these single-use masks are worn and disposed of every month — that’s 3 million a minute, or 50,000 per second.1 So while medics across the globe battle one pandemic, another is bubbling away — the mountains of personal protective equipment (PPE) waste that will hang around in our natural environment for centuries because, of course, those masks aren’t just made of paper. They’re also made of polypropylene (PP), the same plastic used for drinking straws and takeaway cartons. As the world grapples with the impact of single-use plastic in our soil, drinking water and oceans, we’re now faced with trillions of discarded masks and the resulting impact on our planet. A recent WWF report estimated that even if only 1% of masks are disposed of incorrectly, 10 million will end up in the natural environment.2 We live in a world where so much is disposable, from surgical masks to shampoo bottles. Our ecosystems can no longer cope with this “take, make, waste” model. This linear supply chain model, whereby natural resources are

extracted, turned into products, sold to consumers and used until they are discarded, is long past its sell-by date. It is expensive, represents a gross waste of resources and is hugely damaging to our planet. To preserve our precious natural resources and reduce the amount of waste our economy must become circular. The circular model is based on three core principles: designing out waste and pollution; keeping products and materials in use for as long as possible; and regenerating natural systems. The circular method reimagines how products are designed, manufactured, distributed, repaired, re-used, and recycled. The goal is to minimise our dependence on natural resources, prolong and extend

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RECYCLING MEDICAL PLASTICS

the life of raw materials, and ultimately reduce waste. At Thermal Compaction Group (TCG), our business is driven by finding innovative ways to support the transition to a circular economy, to benefit society and the environment. We specialise in sustainable waste recycling systems that provide cost-effective solutions to common waste management problems. We have developed a range of products that contribute to the circular economy by reducing waste volume and allowing it to be re-used or recycled. These products mainly focus on processing single-use plastics, thus reducing the amount ending in landfill or at sea. When the pandemic hit, healthcare providers were faced with an immediate problem. Estimates suggest that hospital trusts across the UK have been using a combined 10 million PPE items a day, most of which are singleuse plastic.3 How could they safely recycle the tonnes of PPE they need to keep medical staff and patients safe? TCG set to work to design a solution. Just a few months later, we created a device that recycles disposable plastic PPE at the source. Hopefully, our Sterimelt system — which thermally compacts polypropylene (PP) and re-engineers it so that it is suitable to make new products — will help tackle the global challenge of what to do with used PPE. Initially developed to recycle PP surgical tray wraps and drapes in hospitals, we adapted the machine

Each Sterimelt unit can re-engineer an average of 24 tonnes of PP waste each year

to also recycle medical-grade surgical face masks and other PPE. The device works by heating PP plastic up to 350 °C in 20 kg batches and then thermally compacting it into rectangular blocks that can be converted into pellets to make new plastic products. Each Sterimelt unit can re-engineer an average of 24 tonnes of PP waste each year. As well as reducing waste, the system also helps reduce carbon emissions associated with transporting waste by an average of 65%. The system also results in significant savings on waste collection; clinical waste disposal is very expensive, costing approximately £295–£1600 per tonne depending on waste type, location and the collection service used. Seven hospital trusts across the UK currently use the device. We have also established a joint venture with Dutch sustainability specialist Greencycl, which will see Sterimelt technology showcased to hospitals across the Netherlands and Europe. Sustainability is an increasingly important priority for the health service in the Netherlands, with 8% of all CO2 emissions in the Netherlands produced by hospitals and each patient resulting in seven bags of waste on average. Many PPE items also include materials other than paper and PP. TCG, therefore, is working closely with PPE suppliers to help them redesign products to make them suitable for processing in a Sterimelt unit. For example, we are collaborating with Hardshell, one of the UK’s first FFP3-grade maskmaking facilities, to test the product’s efficiency. We are currently trialling Hardshell’s disposable face coverings through the machine, using defective masks that would otherwise end up in landfill along with other used PPE. The collaboration is helping to reduce waste even during the product’s development stage. We are also working with them to redesign elements of the mask, replacing the elastic ear loops with non-woven PP and the metal nose piece with a plastic one. Collaboration across the supply chain is the best way to achieve a rapid transition to a truly circular economy. The COVID-19 pandemic has highlighted how poorly equipped we are, as a planet, to deal with our growing single-use plastic waste problem. As we navigate our way through this pandemic, healthcare organisations now have the opportunity to transform the way they manage their PPE waste. By adopting technology that contributes to the circular economy, healthcare providers can lead the way in the responsible disposal and recycling of medical waste. In doing so, they can set an example for many other sectors to follow.

REFERENCES 1 https://www.sciencedaily.com/releases/2021/03/210310122431.htm 2 https://www.roadrunnerwm.com/blog/impact-of-ppe-waste 3 https://www.healthtechdigital.com/welsh-company-unmasks-solution-to-global-ppe-waste-problem/

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TESTING & INSPECTION

IN VITRO IRRITATION AUDREY TURLEY, SENIOR BIOCOMPATIBILITY EXPERT AT NELSON LABS, EXPLAINS THE VALUE FOR MEDICAL DEVICE MANUFACTURERS TO UNDERSTAND ISO 10993-23 AND HOW TO NAVIGATE THE TRANSITION FROM IN VIVO IRRITATION TESTING TO IN VITRO TESTING.

very medical device on the market must be evaluated for its potential to cause irritation, from a knee brace to an artificial cardiac pacemaker, regardless of whether it has a short-term or long-term exposure to the user/patient. This is a requirement set forth in International Organization for Standardization (ISO) 10993-1:2018: Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. This standard requests manufacturers to evaluate the safety of a medical device to ensure it is manufactured using materials and processes that will not cause an adverse response (that is, for example, irritation, allergy, fever, inadvertent weight loss) when used in a clinical setting. Currently, the requirements for assessing irritation for medical devices are covered in two different ISO 10993-series standards: ISO 10993-10:2010 and the newly released ISO 10993-23:2021 Tests for irritation. This situation prompts the questions: Which standard should be referenced in internal documentation and used in laboratory testing? and Which standard is accepted by the regulatory authorities? The ultimate questions, however, are Which standard guidance or testing approach should the device manufacturers use now? and How will this be handled for regulatory submissions in the meantime?

The results demonstrated that the in vitro method accurately identified the irritation potential of several materials commonly used in the manufacturing of medical devices PHOTOS: DANIEL OLSEN

WHY ASSESS IRRITATION? First, it is important to understand why irritation is assessed and what has driven a change in the standard. Irritation is defined in ISO 10993-23 as, “a localized, non-specific inflammatory response to single, repeated, or continuous application of a substance/material”. The standard also specifies that, “It is a reversible reaction and is mainly characterized by local erythema (redness) and oedema (swelling) of the skin.” Many people have experienced an irritation response, typically after using a particular detergent, with itching and possibly a rash. Then, once the detergent was no longer used, the rash disappeared. A similar reaction can also be seen with medical devices such as bandages. Although irritation is not typically a life-threatening response on its own, if left unattended over a long period of time, it can lead to more problematic health issues. To predict an irritation response to medical devices, the most commonly performed irritation test is (and has been) the intracutaneous reactivity test. This test is performed by injecting extracts of a medical device into the subcutaneous tissue of rabbits and observing the local tissue response for redness and swelling over several days. During the test, a final score from 0–4 is given for each injection site based on the noted reactivity level (that is, redness or swelling), providing a conclusion on the irritation potential of the device. THE NEED FOR AN ALTERNATIVE Considering that that majority of medical devices available on the market are tested for irritation, and that ISO 10993-10 only outlines several in vivo testing approaches, it was urgent to find an alternative in vitro approach, in line with the principle of the 3Rs (replace, reduce, refine) of ISO 10993-2:2006: Animal welfare requirements. The international community involved with the ISO standards has, therefore, been working for the last several years to demonstrate that an adapted OECD method used to assess irritation for chemicals and cosmetics (OECD 439) in vitro can accurately predict irritation responses for medical devices. This involved several global collaborations to develop the protocol adjustments

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TESTING & INSPECTION

needed to assess medical devices, which resulted in a massive round robin study involving 18 labs in nine countries. The results demonstrated that the in vitro method accurately identified the irritation potential of several materials commonly used in the manufacturing of medical devices, and that the method would result in reproducible data among the different labs.1 A SEPARATE STANDARD: ISO 10993-23 It is this global success that has led to a change in the ISO irritation standard, which is now covered in its own separate standard, ISO 10993-23, apart from skin sensitisation (which remains in ISO 10993-10). The in vitro irritation method uses a reconstructed human epidermis (RhE) model with normal human-derived epidermal keratinocytes which have been cultured to form a multilayered, differentiated model of the human epidermis. The devices are extracted in the same manner as in the in vivo assay. After the extraction period, the extract is applied directly to the RhE tissues and then incubated for 18–24 hours. The in vitro method uses MTT (3-(4,5-dimethylthiazolyl-2)-2, 5-diphenyltetrazolium bromide) to determine cell viability. This is a commonly used dye with a reactivity that is based on cellular reduction of MTT from yellow to purple by viable cells. This colour change is then quantified on a spectrophotometer and compared to the negative control. It is important to note that although MTT is more commonly associated with cytotoxicity assays, it is not the dye that makes the assay, but rather the complexity of the test system to which it is applied. Thus, while we are examining cell viability, it is of complex tissue rather than a typical cytotoxicity experiment, which consists of a monolayer of cells. With ISO 10993-23, the in vitro method is now identified as the preferred test method for initial consideration. Yet, the most common question asked now is, “Which regulatory agencies/countries accept the in vitro method?” The general input from around the globe is that the in vitro method is preferred and will be accepted widely, even while the standard is being translated for official international inclusion and acceptance. Japan was ahead of the mark and has included the in vitro test in their guidance document already. The US FDA has yet to officially recognise the new standard, but there have been direct discussions with FDA to facilitate a speedy acceptance of this method. Technically, it is true that irritation testing is covered in two standards, ISO 10993-10:2010: Tests for irritation and skin sensitization and ISO 1099323:2021 Tests for irritation, yet the most updated and current standard, ISO 10993-23 is considered state of the art and includes the information applicable to assess irritation from ISO 10993-10 (meaning all of the in vivo testing options from ISO 10993-10 are also included in ISO 10993-23). It is, therefore, appropriate to comply with ISO 10993-23. Besides, it is anticipated

that ISO 10993-10 will soon be updated (Summer 2021) to remove all references to the irritation endpoint. MAKING THE TRANSITION There are a couple of points to consider when navigating this transition to ISO 10993-23. First, the new standard indicates a preference for the in vitro test. This is also in line with ISO 10993-1:2018, which quotes from ISO 10993-2 Animal welfare requirements: “In vitro test methods, which are appropriately validated, reasonably and practically available, reliable and reproducible, shall be considered for use in preference to in vivo tests.” As such, device manufacturers should consider transitioning their biocompatibility test plans to include the in vitro method, which may include a discussion with the regulatory body that is being used, to ensure that the method will be accepted for the subject device(s). Second, test labs will transition to the ISO 10993-23 standard according to their own internal procedures, so you will want to verify that the standard referenced in the test protocols matches your internal documentation. This move from in vivo to in vitro irritation testing in the medical device industry is no small feat; experts around the world have collaborated for almost a decade to bring this about. It is valuable for medical device manufacturers to understand the new test method, the current and anticipated state of the two relevant standards (ISO 10993-10 and ISO 10993-23), and how to navigate the transition from in vivo irritation testing to in vitro testing. A DOUBLE WIN The ultimate goal in assessing irritation is to protect patient safety, which has been proven by showing comparability between the two main testing options. It is also worth noting that as a side goal, this approach is targeted to preserving animal lives. To help understand the impact on animal lives used in medical device testing, in 2018 the US FDA had 1,608 510(k) submissions just in the first quarter. For each device, let’s assume that irritation testing was probably performed, which consumes three animals. With that in mind, moving to the in vitro option would effectively save 4,824 animals in the first quarter or almost 20,000 in one year, which is an underestimate as it only considers the US submissions, and one type of device submission.

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EOS introduces a holistic sustainability approach to responsible manufacturing...

It will represent the 3D printing industry as part of the 50 Sustainability and Climate Leaders initiative.

EOS is aiming for bio-based and biodegradable materials, enabling the vision of zero waste.

It is developing applications leading to less material consumption, and less over-production.

EOS is making internal improvements to reduce energy consumption and increase operational

04:2021 Wound care specialist reaches Spanish market though partnership

actiguard has expanded its business in the wound care market by partnering with the Spanish company Farmaban SA. The partnership enables Bactiguard to reach the Spanish market with its full range of products. By combining Bactiguard’s wound care portfolio with a wide range of bandages, dressings,

and post-operative products, Farmaban will be offering a complete wound management solution. Last year, Bactiguard entered a partnership with Libera Medica for distribution in Spain of Bactiguard’s infection prevention portfolio, with coated products for urinary tract, blood stream and respiratory tract.

FUTURE-PROOF AMBER MASTERBATCHES

vient Corporation, a provider of specialised and sustainable material solutions and services, has launched a new pelletised amber colourant masterbatch formulated for PET vials, bottles, and other pharmaceutical packaging applications. These MEVOPUR concentrates use pre-tested ingredients and prescribed manufacturing practices to help

ARBURG GAINS CATEGORY ‘B’ CDP SCORE

he company has received official confirmation that it performs better than average with regard to climate protection, ecology and CO2 emissions compared with other industry players. The classification as part of the Carbon Disclosure Project (CDP) was based on the company’s answers to a detailed list of quantitative and qualitative

questions on minimising emissions. With a ‘B’ score, Arburg is at “Management” level, meaning that coordinated measures are being taken on climate issues and the company’s own strategies in this regard are being further developed. Bertram Stern, sustainability manager at Arburg, said the company is “more than satisfied with the result”.

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customers achieve compliance with pharmaceutical packaging regulations, including those that do not come into force until 2025. The company claims their new additives block wavelengths from 290 to 450 nm and, at the same time, still provide good transparency. Avient can design these concentrates in a range of amber tones from light to dark, and with more or less red or

The shawpak is a revolutionary machine offering a thermoforming solution to your medical packaging needs that is totally unique

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shawpak USA Inc. Lusk II, Suite D108, 6440 Lusk Boulevard, San Diego, California 92121, USA T +1 201-961-4740 | F +1 201-891-1412 W www.shawpak.co.uk | E sales@shawpak.co.uk