MPN EU Issue 53 by MPN Magazine

EUROPEAN EDITION

MEDICALâ&#x20AC;&#x2C6;PLASTICS news EU MDR

PROTECTING MEDICAL DEVICES RECYCLING MEDICAL PLASTICS

CO LI

TIONS &

How BioInteractions is innovating polymer coatings to improve medical devices ISSUE 53

Mar - Apr 2020

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CONTENTS March/April 2020, Issue 53

Regulars

Features

5 Comment Laura Hughes discusses recycling medical plastics

10 The final countdown Kallik explores the issues compliance preparations have raised for manufacturers

6 Digital spy 9 News focus Medtech in India 11 Therapy area focus: Neonatology 12 Cover story How BioInteractions are innovating polymer coatings to improve medical devices 34 04:2020

14 Chain reaction Avery Dennison Medical describes the path to progress in healthcare industry sustainability 22 Where extrusion and industry 4.0 meet Teel Plastics explores the potential of industry 4.0 within the extrusion process 30 The force Emerson explains how ultrasonic plastic welding is improved through improved force control

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So clear it’s like it’s not even here: highly transparent CYROLITE® for diagnostic applications.

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We invented CYROLITE® over 40 years ago – and we’ve used the time ever since to perfect its properties. The result is highly advanced acrylic polymers that boast outstanding optical properties such as superior UV transmittance. At the same time, CYROLITE® offers excellent flow properties, thus enabling them to be molded into extremely thin-walled components. It goes without saying that CYROLITE® meets all the relevant USP Class VI, ISO 10993-1, and REACH standards. For more reasons why CYROLITE® is the clear choice, visit www.cyrolite.com.

29.01.20 11:54

editor | laura hughes laura.hughes@rapidnews.com head of content | lu rahman web content editor | ian bolland advertising | sarah livingston sarah.livingston@rapidnews.com

Editor’s Comment

head of media sales life sciences & plastics | lisa montgomery

LAURA HUGHES

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 © 2020 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.

BPA Worldwide Membership ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital)

Recycling medical plastics: Where are we now?

n February I jetted away from the cold and stormy weather in England to head to sunny Los Angeles. Despite the cancelled and rescheduled flights causing a bit of stress, I was relieved to land safely in Anaheim ahead of MD&M West – a key industry event with thousands of attendees. During the show I met with lots of companies and buzz words such as sustainability and recycling were constantly brought up in conversation. Solvay, a materials and chemicals company, explained how there was a real focus currently on replacing single use metal with plastic. However, I was informed that the plastic currently used is not recyclable. Rose Catherin, sales development manager, Solvay, explained this is because of a supply chain issue. Catherin said how there was not a system in place to collect the devices from the hospital and take them to a relevant location in order for recycling to take place. Whereas, Steve Duckworth, global head of segment medical and pharmaceutical, Clariant, said for him, “it is more about using less material, rather than making everything recyclable.” He explained how the company’s number one priority is to ensure that the device does not compromise patient safety. Duckworth also highlighted how once medical devices are recycled, these devices cannot then be re-used in the medical field. He explained there can be issues around the responsibility of these devices following recycling, if a single use medical device is reused and an incident occurs. As well as talking to exhibitors on the show floor, I was fortunate to be able to attend a panel discussion titled, ‘The power of partnership to drive competitive advantage in sustainable packaging.’ Ron Basak-Smith, co-founder and CEO, Sana Packaging, reiterated the point raised above by Rose Catherin regarding the lack of a recycling supply chain. Other key points mentioned by the panellists included how it is important not just to use recyclable material, WWW.MEDICALPLASTICSNEWS.COM

11:54

but also for manufacturers to consider the whole life cycle of packaging when discussing sustainability. Additionally, how much are manufacturers expecting others to know about their products? Education is vital to know what parts can be recycled, and where. For instance, we all know that aluminium can be recycled, but with plastics it is not always clear which plastics can be recycled, and where this takes place. An article published in The Wire explored if scientists could “do away with single-use plastics from labs in India.” In 2017, the Central Pollution Control Board announced that India generates 1.6 million tonnes of plastic waste in a year. Although the country is reportedly not the biggest plastic producer in the world, India reportedly manages plastic in the most inadequate way. Replacements such as reusable petri-dishes and cups were proposed, however, if these were implemented, the newly introduced contamination risks would need to be adequately managed. I am confident that recycling and sustainability will be on the radar of all manufacturers. There are multiple benefits associated with using reusable devices within the pharmaceutical and medical sector for conditions such as diabetes where injection devices are used often. As users and manufacturers become more environmentally aware, I’m sure there will be a significant number of changes within the medical sector for both manufacturers and the users of these medical devices.

Education is vital to know what parts can be recycled, and where. 5

DIGITAL SPY

DIGITAL

NEWS UPDATE

spy MEDTECH UPDATE

www.polyone.com

PolyOne develops alternative TPE to silicone

olyOne, a global polymer material provider, has developed an alternative ThermoPlastic Elastomer (TPE) to silicone. There was a real need for an alternative following the FDA’s reports of siloxane shortages - a key ingredient in silicone. Additionally, the news regarding the closure of ethylene oxide facilities was resulting in longer lead times and higher prices for medical tubing. In response, PolyOne launched its Versaflex HC BT218 at MD&M West earlier this year. The company claims the material is able to deliver the critical demands for biopharmaceutical tubing applications, including weldability, kink resistance and tensile strength performance to the same standard as silicone and

other TPEs. Jim Mattey, global marketing director, specialty engineered materials commented: “We’re excited to add the new Versaflex grade to our expanding set of solutions that enable customers to continue pursuing product innovation and meet market demands.” He added: “We are committed to leveraging our material science expertise to formulate alternative and customised solutions that meet regulatory demands and functional necessity for life-saving medical devices, especially in the face of market uncertainties.” The material is currently available in the United States and has been submitted for USP class VI and ISO 10993-4,5 certifications.

WWW.SKYRORA.COM

www.skyrora.com plastic POWER

kyora, a rocket launch start-up based in Edinburgh, UK, has successfully tested a 3D-printed rocket engine using power from plastic waste. “Ecosene” is the name given to this new type of fuel which the company claims is making its vehicles greener and more ecologically sound than competition. Skyora says it can create around 600kg of kerosene from 1000kg of plastic waste, whilst

REGULATORY UPDATE

ec.europa.eu

NSAI NAMED AS A NOTIFIED BODY

ational Standards Authority of Ireland (NSAI) was awarded Notified Body (NB) status under the new EU Medical Device Regulation (MDR) which comes into effect on 26th May 2020. The new regulation consists of stringent requirements around devices, clinical data and post-market surveillance. As part of its role as a NB, the NSAI is now able to inspect medical devices and other products for safety and compliance. Having a NB within Ireland means that multinationals and local businesses will be able to have their devices checked in Ireland. Currently there are only ten other NBs. This is thought to be because all NBs require approval by European officials. A delay by the European Commission has meant there are much fewer NBs at this stage

also stating that its fuel results in around 45% less greenhouse gas emissions. A key benefit of Ecosene is that it can be stored in tanks for long periods of time as it doesn’t require cryogenic freezing. Volodymyr Levykin, CEO of Skyrora said the fuel had transformative potential for the entire space sector. The company believes the results are encouraging with its first vehicles set to fly in 2022 from the UK based launch site.

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than anticipated. For example, the NSAI applied in November 2017 (over two years ago). A shortage of NBs could result in a large number of devices not being re-certified in time, and therefore possible shortages.

DIGITAL SPY

NEWS UPDATE

www.amcor.com and www.hprc.org

Company promises recyclable and reusable packaging by 2025

lobal packaging company Amcor has partnered with the Healthcare Plastics Recycling Council (HPRC) in an attempt to ensure more sustainable practices and innovation across the healthcare industry. The HPRC is a coalition of industry peers across healthcare, recycling and waste management, who are seeking to improve recyclability of plastic products within healthcare. “The healthcare industry poses a unique recycling opportunity,” according to David Clark, vice president sustainability, Amcor. “Amcor has global experience in developing more easily

recyclable packaging, and we share HPRC’s vision of improving recycling rates of healthcare plastics.” In January 2018, Amcor reportedly became the first global packaging company pledging to develop all its packaging to be recyclable or reusable by 2025. Peylina Chu, executive director of HPRC commented: “As a packaging leader, Amcor is highly focused on creating a circular economy as shown in their 2025 pledge. With their technical expertise and their commitment to developing responsible packaging in collaboration with likeminded partners, Amcor is a fantastic addition to HPRC.”

2 25

MEDTECH UPDATE

www.gehealthcare.com New technology offers better protection for hospitals against cybersecurity threats

he new system launched by GE Healthcare, a manufacturer and distributor, aims to help hospitals monitor and mitigate cybersecurity threats. The technology, called Skeye, brings together medical device expertise, artificial intelligence and process management tools to enable hospitals to detect, analyse and respond to cybersecurity threats in real time. Skeye will provide customers with a complete medical device security assessment. This will include identifying potential risks and vulnerabilities, as well as

recommending action plans. Matt Silva, chief information security officer, GE Healthcare believes, “this new offering provides customers with 360˚ threat visibility and a resolution roadmap to help defend and protect against vulnerabilities.” He added: “We strongly believe that security is a shared responsibility across various stakeholders, and with this new solution, hospitals will now have access to a range of proactive and reactive cybersecurity services to support their own security programs.”

talking

POINT Chen Gu Lab, UCLA ©

www.nature.com/natbiomedeng

Could this technology revolutionise the patient experience for diabetes management? WHAT IS THE MEDICAL DEVICE? The adhesive patch is able to monitor the blood sugar level of the person and deliver insulin dosages based on this level. It is designed to be used once-a-day. HOW DOES THIS MECHANISM WORK? Within the device there are micro-needles which are less than 1mm long and made from a glucose-sensing polymer. These microneedles are pre-loaded with insulin. The amount of insulin which is released depends on the person’s blood sugar levels. WHAT ARE THE BENEFITS OF USING THE PATCH TO MONITOR BLOOD SUGAR LEVELS? Besides from the convenience of this method of insulin delivery for people, the device aims to prevent the chance of an insulin overdose. HOW WAS THE PATCH DEVELOPED? The technology was developed by researchers at the University of California Los Angeles (UCLA), the University of North Carolina School of Medicine and Massachusetts Institute of Technology. The research has been published in the journal Nature Biomedical Engineering. IS THE PATCH READY FOR USE IN THE REAL WORLD? Not quite. Following successful testing on animals, the researchers have applied for FDA approval to conduct clinical trials in humans, which they anticipate to begin within a few years.

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NEWS FOCUS

Medtech in India WHY AN ENTREPRENEUR DECIDED THE MEDTECH SECTOR WITHIN INDIA WAS THE RIGHT PLACE TO SET UP A BUSINESS.

ccording to Invest India, the country’s medical device industry has the potential to grow at 28 percent per annum to reach $50 billion by 2025. Therefore, having previously worked in the sector, Ankit Kedia knew it was the right industry to be involved in. In 2019 Kedia founded Caremont, an organisation aimed at providing quality medical equipment and devices.

Kedia began by meeting with the following two global pharma companies: Olberon and Halyard Health. He successfully convinced these companies that he could take over the distribution of their products, commenting: “Once you fix the distribution chain and understand what the market wants you can enter manufacturing.”

Prior to founding Caremont, Kedia was a promoter director and board member at Manjushree Technopack. In this role he was responsible for delivering a sales budget of over $100 million, as well as creating pharma packaging for FDA regulated markets. In 2018, Kedia was awarded the Zee TV Dare to Dream Award for Best Business Performance.

By doing his research Kedia realised that some medical products could be manufactured in India at lower costs. He commented: “Many companies export devices to India from point of origin. We want to make in India, with 50 percent manufacturing abroad and 50 percent here. This will bring costs down and we can reach many more hospitals.’’

The decision to begin the Bengalurubased medtech start-up followed a year where Kedia spent time learning and understanding regulations regarding importing medical devices. For instance, he learnt that many medical products need to be registered for import, and any company who are keen to legally register or import medical devices must comply with the rules of the Drugs and Cosmetic Act of 1940.

Following these meetings, Caremont started to distribute both Olberon and Halyard Health’s products in five cities. For Haylard this included clinical drapes, gowns, masks, gloves, knee arthroscopy preparation drapes and surgery gowns, and for Olberon, items such as ear, nose and throat diagnostic devices.

As a result, Caremont has now acquired land in Bengaluru to set up a large manufacturing facility. The organisation also has plans to set up a research and development centre which plans to use 3D printing. Caremont’s business model currently works by taking commission from distribution. However, when the company begins manufacturing products the model will then be adapted for this.

Once you fix the distribution chain and understand what the market wants you can enter manufacturing.

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EU MDR

The final countdown BOB TILLING, NEW BUSINESS DEVELOPMENT MANAGER AT ENTERPRISE LABELLING COMPANY, KALLIK, EXPLORES THE ISSUES THAT COMPLIANCE PREPARATIONS HAVE RAISED FOR MANUFACTURERS.

rom May 2020, new medical devices sold in the EU must comply with the new Medical Device Regulation (MDR) requirements. The exception is certain low-risk medical devices currently classified as class I, which are set to be moved into a higher-risk class under the MDR at a later date, since they have been granted an extended transitional period.

Incidents like the PIP breast implant scandal of 2009/2010, which generated all of the new safety measures that have recently come in, have the potential to create enormous damage. This is what MDR is designed to put an end to.

Much has been written already about the phasing in of MDR, and the in vitro device equivalent, In Vitro Diagnostic Regulation (IVDR). But what challenges remain for all classes of medical devices getting ready for MDR?

THE PERILS OF ELEVENTH HOUR PREPARATION The most significant impact MDR has had on manufacturers relates to the scale of the work involved. Many companies have radically underestimated the resource and time required. The danger, where companies have left MDR preparations until the eleventh hour, is that they are forced by time pressures to do the minimum required for compliance, compromising the internal business benefits. Worse, it’s a costly workaround that doesn’t deliver the quality control, compliance confidence or process efficiencies the manufacturer needs. This is clearly less applicable to device manufacturers in the class I bracket, since they now enter a transitional period. But experts caution this shouldn’t mean that these manufacturers should be lulled into a false sense of security and so slow their preparations to any great degree. What’s more, the class I extension has no impact on timescales for device manufacturers to include the device identifier and appropriate symbols mandated by the EU on their labels.

PLAYING CATCH UP Many medical device manufacturers have not factored in just how demanding this wholescale process change is. Preparing for MDR has involved playing catch-up to a large extent. Up to this point, and in comparison with the pharmaceutical and biotech sectors, the medical device industry has been bound by relatively relaxed controls over device identification and traceability, and product lifecycle monitoring and reporting. This, as well as the relative scale of many of the firms involved, has meant processes such as global labelling management have not been a board-level priority. THE PIVOTAL ROLE OF LABELLING In the event of a safety scare and potential product recall, it is not enough for patients and their medical consultants or pharmacy outlets to know which type of devices are affected. To limit the harm and manage the fears and hysteria, as well as cap the cost to the manufacturer and minimise the impact on their brand reputation, it is important that faulty batches of products can be accurately identified and tracked down in the market, for targeted remedial action. This in turn depends on consistentlyreliable labelling.

CONSOLIDATED CONTROL AND VISIBILITY Organisations now realise that the only way to ensure consistency and reliability is to have a single global source of labelling ‘truth’ that all marketfacing product information and materials flow from; namely, one single place to update and check everything - which any authorised team can access, anywhere in the world, supported by appropriate limits on who can do what to and with the content assets.

MORE REGULATION ON THE HORIZON Another sobering realisation has been that regulatory disruptions are not – or certainly won’t be - a one-off event. Any companies that haven’t taken the time to do things properly this time around face having to go through new upheaval the next time new international requirements are introduced. For instance, from May 2021 unique product identifier codes/ detailed product serialisation information will have to appear on all product labelling – so there is a lot to get right in the coming months and years and having a structured way of managing this will be critical. The specific requirements of MDR are just part of this bigger picture, which is about ensuring patient safety and restoring public trust in the industry and its product - so manufacturers should not be limited by them in their efforts to streamline their approach to global labelling management.

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NEONATOLOGY

Therapy FOCUS Different dimensions CHRISTELLE LETOURMY, PRINCIPAL INTERNATIONAL MARKETING MANAGER – BU OBSTETRICS NEONATOLOGY ENTERAL, FROM SPECIALIST SINGLE-USE MEDICAL DEVICES GROUP VYGON, EXPLAINS WHY NEONATOLOGY REQUIRES SPECIALISED STAFF, PROCEDURES AND DEVICES. WHO IS VYGON AND WHAT IS ITS PLACE IN NEONATOLOGY? Since 1962, Vygon has been a supplier of single-use medical devices which are dedicated to helping clinicians deliver optimal outcomes for their patients. Vygon offers a wide range of products in a number of clinical specialties, including neonatology. Just 30 years ago, it was rare for a 27- or 28-week infant to survive and dedicated medical devices didn’t really exist. This is why Vygon decided to look for solutions and adapted products within this field. Today, newborn care still lies at the heart of Vygon’s activities. Vygon is constantly looking for innovation for these vulnerable patients and developing and supplying bespoke neonatal medical devices for enteral feeding, respiratory care and vascular access. WHY DO NEONATAL PATIENTS NEED DEDICATED MEDICAL DEVICES? A neonatal patient may be a baby born during the fifth month of pregnancy with a weight as low as 500 grams. They are often hypersensitive, difficult to feed, and difficult to calm. The objective of healthcare workers is to help neonates develop outside of the womb without inducing any physical or mental damage. Medical devices must therefore be adapted to their tiny morphology and specific physiological features. PLEASE EXPLAIN AN EXAMPLE OF HOW VYGON ADDRESSED THE MORPHOLOGY CHALLENGE IN NEONATES. Preterm babies often suffer Respiratory Distress Syndrome (RDS), a breathing disorder resulting from surfactant deficiency and underdeveloped lungs. A significant part of RDS treatment is surfactant administration. However, the existing method for surfactant administration requires the insertion of an undedicated thin tube through the vocal cords with Magill forceps, a large bulky device that is difficult to manipulate in the tiny infant’s mouth and could injure the mucosa. Vygon co-invented with Dr Kribs from the University Hospital of Cologne (Uniklinik Köln, Germany) a thin and highly manoeuvrable catheter for surfactant administration. This new device, called Surfcath, avoids the use of the bulky Magill forceps and helps to speed up the surfactant procedure, thus the patient care. The device addresses the morphology constraints of the premature infants and also the clinicians’ need.

ensure accuracy and avoids any risk of misconnection with the vascular access. CONCLUSION Vygon continues to develop innovative single-use medical devices in a number of clinical specialties that protect and save lives, particularly in the field of neonatology. Its devices aim to offer healthcare professionals the best possible chance to treat and care for vulnerable neonatology patients in the most secure conditions - protecting hypersensitive babies that need help with specialist respiratory care, vascular access and enteral feeding.

Medical devices must be adapted to their tiny morphology and specific physiological features.

PLEASE EXPLAIN AN EXAMPLE OF HOW VYGON ADDRESSED THE PHYSIOLOGY CHALLENGE IN NEONATES. Due to the physiology of the premature patients, delivering the right drug dose is critically important for the venous access as well as for the digestive tract. Underdosing can result in a lack of efficacy, and overdosing can result in adverse effects. The Children’s Hospital of Philadelphia shared data showing that more than 80 different oral medications are administrated in volumes less than 2ml and 1,250 of these doses are prepared every day, representing 48% of their daily administrated oral doses. The challenge here is to be able to propose a safe enteral feeding system that ensures a high dosage accuracy during drug administration. Vygon developed the Nutrisafe2 system in 2005, especially for neonates. This system aims to WWW.MEDICALPLASTICSNEWS.COM

COVER STORY

ARJUN LUTHRA, COMMERCIAL DIRECTOR, BIOINTERACTIONS, EXPLAINS HOW THE COMPANY IS INNOVATING POLYMER COATINGS TO IMPROVE MEDICAL DEVICES. COMPLICATIONS OF BIOMATERIAL RESPONSE Innovations in the field of medicine and surgery are in constant demand for new and improved materials to enhance the quality of the therapy. Biomaterials play a critical role in improving the biocompatibility of surfaces which improves the quality of the therapy. Biocompatibility of materials involves critical complications such as inflammation, fibrosis, infection and thrombosis. The successes of applications are dependent on a variety of biological events occurring on the surfaces and these events intensify the complications which have to be addressed during innovation. The challenges of infection and thrombosis are two significant factors which hinder long-term applications, as these biological events are potentially linked to each other and are critical to improving the performance of biomaterials. Biological responses are complex processes which are governed by a variety of factors. These factors range from surface properties which include the chemistry, topography, wettability and composition of a surface to the biological entities present at the interface. Materials used in medical devices are likely to interact with blood first, and this interaction is in itself highly complex. The contact of biomaterials and blood induce protein adsorption, platelet activation, platelet adhesion, coagulation and thrombosis. Plasma proteins adsorb onto the surface initially which leads to activation of the blood and subsequently causes additional biological responses. These responses lead to complications which impede the performance of medical devices, reduce the efficacy of therapies and

can cause harm to patients. Catheter thrombosis can be seen in the form of venous thrombosis or the formation of fibrin sheath which accounts for up to 40% of catheter failures. These challenges interrupt strict dialysis schedules, reduce the flow rates of catheters and can result in the use of costly measures. The reduction of flow rates has been a consistent complaint when delivering blood for dialysis. Central venous stenosis can be a devastating complication resulting in pain and disfiguring arm swelling and treatments can be used to temporarily relieve the issues; however viable surgical options are still required. Infection is likely to be the most significant challenge which impedes long-term applications. A variety of preventative techniques have proven not to be significantly effective. It has been seen in a randomised study of surface treatments to prevent infections that silver surface treatments have failed to reduce infection rates. It has also been seen that the use of silver-impregnated collagen cuffs may impede catheter fixation due to the killing of fibroblasts which can cause the catheter to dislodge. Furthermore, it has been recommended that any catheter which has caused bacteraemia should be immediately removed and only replaced once results of blood cultures are normalised. Although, there has been progress with this therapy as newly emerging strategies to treat these complications allow for medical treatment whilst the device remains in place. This approach has had limited success, requiring the use of antibiotics, and is still seen as a sceptical approach by many nephrologists. The interactions mentioned above are only a few of the many complications seen when biomaterials are used within the human body e.g. thrombosis, infection, reduced efficacy of the intended use of the device and insertionrelated complications. The complications and the biological responses are influenced by critical factors such as surface chemistry, surface energy and surface topography. Hence, the biological events which occur on a surface are complex and are a result of interactions between the surface, the proteins and cells which are present at the device-body interface

COVER STORY

MULTI-FACETED SOLUTIONS REDUCE CHALLENGES The complications experienced by biomaterials requires a multi-faceted approach which considers all the factors in order to provide an ideal surface which prevents the biological responses. BioInteractions innovates high-performance biocompatible coating technologies such as Astute Antithrombogenic Coating, AvertPlus Antimicrobial Coating and Assist Lubricious Coating. Through our commitment of advancing healthcare through innovation, we have a range of proprietary polymer coatings to target the specific complications of biocompatibility. Our coatings enable medical devices to perform their intended function, as well as reduce the patientsâ&#x20AC;&#x2122; complications throughout their therapy. Astute Antithrombogenic Coating prevents thrombosis formation using a multi-layered approach. We have developed the coating to use an active antithrombogenic agent heparin and combined this with additional passive components to provide a high-performance, non-leaching antithrombogenic coating. Active functionalised heparin actively prevents blood activation and hinders thrombosis. The prevention of blood activation reduces the risks of a thrombus forming downstream. The additional passive components physically prevent blood components from interacting with the surface to provide an additional level of protection. This multi-faceted approach mimics the endothelial layer to give an active antithrombogenic coating. The Astute antithrombogenic coating also prevents platelet adhesion without leaching to enhance the long-term effect. Our Astute antithrombogenic coating provides high-performance of biocompatibility whilst reducing risks and complications to the patient. AvertPlus is a non-leaching, active antimicrobial coating, which targets a comprehensive spectrum of bacteria and prevents biofilm formation. It uses a combination of active agents and passive components to provide a contact-kill mechanism which causes cell lysis and prevents bacterial colonisation. The multi-faceted approach significantly reduces the bacterial presence and stops proteins from depositing onto the service. Our non-leaching AvertPlus coating provides a prolonged antimicrobial effect without any degradation of effect over time. Our coating provides high-performance antimicrobial activity on a surface and has achieved a five-log reduction activity, without the use of leaching toxic compounds or anti-biotics. Our AvertPlus coating reduces the risk of device related infections without introducing the risks of toxic components to the patient. Assist Hydrophilic Coating reduces the friction coefficient of a surface, as well as provides complementary non-thrombogenic effects. The technology is available in both UltraViolet (UV) cured and heat cured forms. This enables us to apply our technology to a variety of surfaces and geometries. The coating is thin and flexible, which enhances the coatingâ&#x20AC;&#x2122;s stability on a device such as balloon catheters. The coating reduces friction resistance as well as preventing proteins and cells interacting with the surface to improve

Biomaterials play a critical role in improving the biocompatibility of surfaces to improve the quality of healthcare.

biocompatibility. The complementary non-thrombogenic properties provides support to the surface, enabling the coated device to remain implanted and perform for extended periods. We can achieve a high-performance lubricious coating without leaching or the use of cytotoxic and toxic components. The technology is also available in both UV and heat-cured variants, which allows us to coat a variety of devices internally and externally to improve function. The coating activates instantly through wetting, removing the need to presoak the surface and reduces the preparation time. Our expertise in coating a variety of substrates and geometries allows application of the coating technology in a range of areas. Assist Hydrophilic Coating significantly reduces the friction, and instantly activates and provides complementary benefits to improve its biocompatibility. BioInteractions innovates all its coating technologies in-house, provides optimised application processes, coating services and in-house testing services. We have combined our expertise to help our partners through the development process, and our complete coating service focuses on the main biocompatible challenges faced by the devices and the development process, resulting in the organisation providing an all-inclusive coating service.

WWW.MEDICALPLASTICSNEWS.COM

SUSTAINABILITY

DEEPAK PRAKASH, SENIOR DIRECTOR, GLOBAL MARKETING, AT AVERY DENNISON MEDICAL, DESCRIBES THE PATH TO PROGRESS IN HEALTHCARE INDUSTRY SUSTAINABILITY.

CHAIN REACTION

nvironmental sustainability is one of the most important priorities for the healthcare industry and for medical plastics and device manufacturers. The challenge ahead demands that supply chain partners focus on sustainability within their own organisations and across their extended supply chains.

ECO-FRIENDLY MANUFACTURING PROCESSES Sustainability advocates often refer to creating circular economies. The Ellen MacArthur Foundation defines a circular economy as one “based on the principles of designing out waste and pollution, keeping products and materials in use, and regenerating natural systems.” This is as opposed to a linear economy, which runs on a “take-make-waste system,” according to the foundation. One example of a circular economic practice is responsible collection, recycling and reuse of chemicals from the medical plastics manufacturing process.

Healthcare sustainability initiatives are gaining momentum. The Healthcare Plastics Recycling Council’s (HPRC) membership has grown to include some of the industry’s largest device makers. Health Care Without Harm is working globally to promote sustainable procurement practices, green hospitals and healthcare waste reduction. Through its “For a greener NHS” campaign, the U.K. National Health Service is tackling climate change on multiple fronts, from reducing hospital emissions to investing in telemedicine.

Within their operations, best practices for medical plastics companies and their suppliers include greenhouse gas emission reduction, energy conservation, landfill waste reduction and recycling programmes for all types of scrap and waste. Sustainable raw materials sourcing is also a priority. Medical plastics material suppliers are identifying and testing alternatives to traditional chemicals and inputs. For example, PolyVinyl Chloride (PVC) has been successfully replaced in some medical foams, and materials producers are exploring alternatives to animal-based gelatine.

The medical plastics industry has opportunities to advance sustainability from design inception through product end-of-life for both disposable and durable devices and equipment. RECYCLING MEDICAL PLASTICS The HPRC said in a recent interview that each year Europe generates about 1 million tonnes of non-infected medical plastic waste which could be recycled. The council offers a HospiCycle toolkit to help healthcare institutions set up programmes to recycle more of this “clean” plastic waste.

Additionally, supply chain transparency is essential. Customers expect suppliers to have visibility and accountability for processes they directly control and those they do not. HUMAN RIGHTS, DIVERSITY AND INCLUSION Another important aspect of medical industry sustainability is the human side. Every organisation should take responsibility for human rights and workplace safety within its own operations and those of its supply chain partners, monitoring sites with regular audits. Diversity, inclusion, wellness and corporate giving programmes also support sustainability objectives. After all, without a healthy balance within human individuals, teams and organisations, how can we begin to sustain the natural world that supports us? CONCLUSION In conclusion, the path to sustainability progress requires every link within the supply chain to be engaged and accountable. Medical device developers, their customers and suppliers must challenge one another to be more sustainable and collaborate with each other to make it happen.

There is also growing interest in biobased and recycled films, and in some cases, multi-laminate packaging films which can pose recycling challenges, may be replaced with films that are readily recyclable.

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HEALTHCARE COMPOUND SOLUTIONS

PLASTICS FOR DEMANDING APPLICATIONS No matter what special feature you are looking for, we provide high-performance polymers for all kinds of applications. As a leader in distribution and compounding, we are strong in innovation and product development. You can rely on our comprehensive technical support and uncompromising service all over the world. Together we can overcome every challenge.

ALBIS (UK) Ltd. Parkgate Industrial Estate, Knutsford GB-Cheshire WA 16 8XW Phone: +44 (0) 1565 755777 Fax: +44 (0) 1565 755196 albisuk@albis.com

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Itâ&#x20AC;&#x2122;s an Interplas year This September the UKâ&#x20AC;&#x2122;s largest plastics industry exhibition is back; with over 500 exhibitors demonstrating their latest machinery, equipment, products and services for visitors to view, test and experience LIVE at the show. As a visitor you will be able to see the entire spectrum of plastic moulding and forming machines in action, as well as find materials, automation, contract manufacturing and supporting technologies including software, testing, inspection, surface treatments and much more. No other UK plastics show in 2020 offers you the chance to meet and source new suppliers, products and

services, find solutions to challenges, keep up to date with the latest technology and to network with your peers in a friendly and open environment.

CONFERENCE PROGRAMMES

The conference programmes at Interplas have been carefully tailored to deliver insight, knowledge and information on the current challenges facing the UK plastics industry from a range of expert speakers. Visiting Interplas will give you the opportunity to ask questions, engage in panel discussions and meet new contacts on all three stages, which include the Advancing UK Plastics Main Stage,

NEC BIRMINGHAM, UK | 29 SEPT - 01 OCT 2020

#InterplasUK

The Extrusion Stage and The Sustainability Stage.

SPECIALIST FEATURES

Specialist features add value to a visit to Interplas - with key areas and events that enable attendees to understand the issues they face, as well as finding solutions for them. Key features in 2020 include the return of Knowledge Pavilion, where a bank of highly experienced industry personnel will be on hand to answer questions and resolve queries, as well as a dedicated one-on-one meetings programme linking you directly to the right suppliers for your business needs.

INJECTION MOULDING

WITH LIMITED TIME LEFT BEFORE EU MEDICAL DEVICE REGULATIONS (MDR) COME INTO FORCE, NIGEL FLOWERS, MANAGING DIRECTOR AT INJECTION MOULDING MACHINERY SUPPLIER, SUMITOMO (SHI) DEMAG UK, ANSWERS SOME COMMON QUESTIONS TO HELP PUT MINDS AT REST.

EU MDR

E MDR.

A last minute checklist

U MDR is due to go live on 26th May 2020, and many medical device moulders, particularly Small and Medium Enterprises (SMEs) with limited in-house resources, are still getting to grips with the impact of the EU

Designed to make products more easily traceable by patients and the care supply chain, many perceive the labelling upgrade investment to be a challenging and costly undertaking. The regulations apply to all medical device products sold in the EU, even if it is made outside of the EU, and failure to comply could result in products removed from sale after the EU MDR deadline. WHAT IS NEEDED TO ACHIEVE TRACEABILITY? With EU MDR, every class III (e.g. implants and pacemakers) and class IIa/b devices (e.g. surgical clamps and trachotomy tubes) or its packaging must be issued with a Unique Device Identification (UDI). Given that healthcare is a high liability market, it requires a fingerprint style approach to traceability. A UDI label must be directly attached to a medical device or to its packaging. Additionally, labels in the future will need to include two identifiers: A Device Identifier (DI) that identifies the labeller and the specific version or model of a device, plus a production identifier. This variable portion of the UDI needs to include the given lot or batch number, serial number, date of manufacture, expiry date, etc.

WHAT TECHNOLOGY DOES A MOULDER NEED? In mould decorating is an automated way to issue mass-produced medical devices with globally-compliant UDIs. It is like issuing each moulded medical device component with its unique birth certificate, with all processing data held securely by a Manufacturing Executive System (MES). It means that any potential quality defect, which might not be picked up for several months, or even years, can be tracked back to the very day and cycle it was manufactured to achieve item-level traceability and conduct root cause analyses on parts and components. Connectivity to a MES is vital. IS REAL-TIME TRACEABILITY IMPORTANT? Yes, having an auditable supply chain traceability system is not purely about compliance and providing mandatory information. Due to globalised production platforms, itâ&#x20AC;&#x2122;s becoming increasingly imperative to limit operational risk exposures with targeted rather than mass recalls. For high value components or when the margin for error is zero and patient safety could be at risk, real-time traceability provides the means to limit recall exposure by improving end-toend process transparency. Real-time traceability also enables you to call up data and verify the exact settings used on the exact injection moulding machine, when that individual plastic part was made. This can enhance process monitoring and enables moulders to keep a closer watch on risk management, mitigation and containment.

EU MDR is due to go live on 26th May.

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INJECTION MOULDING

The EU MDR replaces the current Medical Device Directive (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/ EEC). Effective 26th May 2020, class III (e.g. implants and pacemakers) and class IIa/b devices (e.g. surgical clamps and tracheotomy tubes) will need to record, index and register each UDI on the European Database for Medical Devices (EUDAMED). Manufacturers of lower risk class I products, for example stethoscopes, will also be required to collect and save product data and share with regulators on request.

Traceability in injection moulding is often quite advanced with smart data capture integrated into the machine.

Using robotics is central to the in-line manufacturing process, as even a single instance of applying an incorrect code can be a major liability. DO I NEED TO MAKE MODIFICATIONS TO MY EXISTING MACHINERY? It will depend upon the age of your machinery, but the latest generations of injection moulding machines are often quite advanced with smart data capture integrated. UK customers will also be able to benefit soon from the digital MyConnect software, which can monitor machine availability, productivity, traceability and processing decisions taken. A launchpad for data-driven efficiency improvements, as well as troubleshooting tools, traceability features like myLifeCycleLog stores a full archive of past service requests and actions taken. ARE THERE SPECIFIC USER PARAMETERS I NEED TO IMPLEMENT? The key areas that might impact a stable process include changes in pressure, temperature, flow rate and cooling rates. To ensure these processes are not compromised, the latest generation medical packages we offer limit the processing ranges that operatives can adjust. For example, the IntElect S 180tonne machine unveiled at K 2019 adheres to the explicit ISO 13485 medical device quality management and validation standards and introduces new user parameters. This helps to ensure that processes are kept within specified ranges and operators cannot make adjustments unless they have been granted authorisation. HOW DOES AUTOMATION FACILITATE TRACEABILITY? Using robotics is central to the in-line manufacturing process, as even a single instance of applying an incorrect code can be a major liability. Modern medical cells typically integrate all of the elements needed in a turnkey cleanroom cell, including plastic injection processing, in mould decoration, robotics and data capture and management. The automation solution deployed will vary depending on the moulding application. For larger medical components it might be a 6-axis robot, which holds the part while codes are etched or bonded onto the component. These are generated by the MES holding system, which reconciles the machine processing data and generates a code or data matrix. In addition to the exact production date and time, process data thatâ&#x20AC;&#x2122;s recorded includes the injection and dosing time, melt cushion, injection pressure and temperature. For smaller micro-medical parts, such as pipettes, a side entry robot may be used. At K 2019, Sumitomo (SHI) Demagâ&#x20AC;&#x2122;s medical showcase featured a complete turnkey medical moulding cell with a Hekuma side entry robot with advanced batch tracking and contact-free camera inspection. Programmed to demould and rapidly place components individually in their corresponding cavity assigned racks, the Hekutip process ensures that if an issue with a specific cavity arises, the rack containing all corresponding cavity parts can be isolated and the rack recalled. This gripper system concept is capable of removing 64 pipettes in less than 0.6 seconds. After each rack is filled with 96 pipettes, a camera visually inspects the components from multiple angles ensuring there are no holes or burrs present.

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• NEW CONCEPTS • SINGLE LUMEN TUBING • MULTI-LUMEN TUBING

Years

• BUMP TUBING • RIBBON EXTRUSIONS • CO-EXTRUSIONS

redefining the limits of extrusion technology...

1989–2019

• MICRO-EXTRUSIONS • PROFILE EXTRUSIONS • COATED WIRE • TRI-EXTRUSIONS • MULTI-LAYERED EXTRUSIONS • FULLY ENCAPSULATED STRIPES • OVER-EXTRUSIONS • BALLOON TUBING • INTERMITTENT/MULTI-DUROMETER EXTRUSIONS

For 30 years, Microspec has specialized in advanced medical extrusion services world wide, extruding most thermoplastic elastomers, including fluoropolymers, 1989–2019 engineering resins, and custom compounds. The precision medical parts we extrude are among the smallest and most complex in the industry, with some of the tightest tolerances. Contact Microspec with your extrusion challenge – we’ll turn it into reality. Microspec Corporation

327 Jaffrey Rd. • Peterborough, NH 03458 USA • +1.603.924.4300 www.microspecorporation.com info@microspecorporation.com

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CYBERSECURITY

The REVOLUTION WEB CONTENT EDITOR, IAN BOLLAND, CAUGHT UP WITH NATALI TSHUVA, CO-FOUNDER AND CEO OF STERNUM, AN ISRAELI-BASED COMPANY WHICH OFFERS CYBERSECURITY PROTECTIONS FOR MEDICAL DEVICES.

shuva explained Sternum aims to provide its solutions to device manufacturers so they can embed security on the device itself during the manufacturing process. This embedding of protection means that the company focuses on exploitation rather than device vulnerabilities. Explaining more about the company’s focus, Tshuva said: “Our main focus is IoT, high value devices which are part of a managed network. A good example for that is homecare medical devices like pacemakers and insulin pumps which don’t have security as part of their hospital network because the patient goes home with them. This is a good example of where Sternum’s technology can be embedded inside the device itself to keep it safe during the lead time, institution and operation of the device. “Every operation on the device itself is being filtered and monitored by our technology. You can describe it as ‘on-device firewall’ because it’s basically checking and monitoring every operation and allowing all the legitimate operations to happen on the device. “Our solution is integrated at the research and development stage. Once installed, the device manufacturer has the ability to build new firmware, with our protection already embedded. Once this protected firmware is created, all devices – including postmarket devices – can receive relevant updates with the enhanced firmware.

“This process is automatic so when new code and functionality is added, it will also be protected by our EIV solution. Our solution works with pre-market and post-market devices, and fits all existing operating systems, hardware, and resources. The same code is implemented to all devices within a managed, or unmanaged network.” The company contains personnel from a background of cybersecurity, defence and understanding how attackers work – with some receiving training from an Israeli intelligence unit – but with a shared desire of having an effect on the medical industry in some form. “When we started studying medical devices and the medical industry in general, we discovered this need to secure this connected healthcare. This is what drew us to find the company.” While cyberattacks on medical devices are becoming more prominent, Tshuva believes there is an increased effort from manufacturers to guard against such threats – and feels that a rise in cyberattacks is a knock-on effect of devices becoming more connected –comparing it to a time when the internet started to become more mainstream where similar issues developed. “In order to deal with such scale of events and more sophisticated attacks, medical device manufacturers need some advanced solutions – probably not developed in-house to handle this advanced security threat on devices. “The connected healthcare revolution is happening and we’re seeing more medical devices being connected to enable remote care and remote monitoring of patients. Once devices get connected, they automatically become more vulnerable and more attractive to hackers – whether it’s for stealing sensitive information or to perform ransomware attacks on manufacturers or hospitals. “There are devices that are under or within the hospital perimeter and there we can see fusion pumps and MRI machines and ECG machines – some of them are IoT devices and they’re vulnerable at the same level as remote medical devices like pacemakers and insulin pumps. “The difference is that hospitals have their own defence mechanisms like a firewall or other security solutions to secure the hospital network itself. When we talk about distributed medical devices like pacemakers and insulin pumps, they are both vulnerable and lack the network security solution to help secure them. I think that you can think of them as the more vulnerable devices.”

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EXTRUSION

WHERE EXTRUSION AND INDUSTRY 4.0 MEET CHRISTIAN HERRILD, DIRECTOR OF GROWTH STRATEGIES FOR MANUFACTURER TEEL PLASTICS, EXPLAINS THE POTENTIAL OF INDUSTRY 4.0 WITHIN THE EXTRUSION PROCESS.

t’s no surprise that the advent of interconnected devices and advanced computing are affecting common manufacturing processes like extrusion. This shift has been going on in extrusion for longer than most people realise, driven by the demanding medical device market. Automatic online gauges with limited feedback loops have been common for more than twenty years, however, most of these devices still required significant operator interaction and were only capable of simple adjustments to correct for one variable. This is no longer the case. New extruders typically have Human Machine Interface (HMI) control units in addition to Programmable Logic Controllers (PLCs) that are able to digitally control multiple variables on the machine simultaneously. They are generally capable of network connectivity and can send and receive data with proper IT integration. The same is true for the other pieces of equipment typically on an extrusion line. With a sufficiently skilled IT department, it is possible to log this data, analyse it, and transmit instructions both back to the equipment it originated from and to other equipment on the same line the critical step to take an automatic feedback line and transform into an industry 4.0 capable line. There is still no standardised language from PLCs, which creates the need for an integration program that

can talk the language of each piece of equipment on the line. This data then needs to be translated into a format that is capable of analysis by both software and recognition by the HMIs human beings use to control the system. Once the data is translated and aggregated, software needs to be able to analyse and direct the data. This information can be further mined with proper analytics to go from reaction to prediction. However, moving from reaction to prediction requires significantly more computing power and a better understanding of the process. Unfortunately, there is no off-the-shelf solution for this type of data analysis and integration which leads to further issues in validation of software controls and tracking as updates are released. Taking a sample case from our factory, we have a line with online OD and ID measurement and a fully network capable extruder, blender, puller, and cutter. The line is capable of tracking material usage and automatically issuing material as it is consumed. It is also capable of varying the screw speed or the puller, depending on the product, to maintain the target for the OD and wall. This same measurement information can then be sent electronically to populate a Certificate of Analysis for the product, showing the customer the product meets quality requirements without the need for secondary measurement by operators or technicians. This level of interconnection allows an extrusion process to run with very little operator interaction – but even with this level of sophistication, there is more that can be done. Additional sensors added to lines can control and predict things beyond the ordinary running conditions. The sensors can translate data into a targeted preventative maintenance system instead of using run hours or calendar days to approximate when failure is likely to occur. They can also send a signal to alert an operator when more material is needed as part of a scheduled delivery, instead of just turning on a light. It is important to understand that industry 4.0 is more of a journey than a check-the-box upgrade or option package for equipment. You can’t buy an industry 4.0 line off-the-shelf because of the amount of integration needed both between difference pieces of equipment and with things not on the extrusion line. The future is integrated, and it will be full of information that will make parts both less expensive and more reliable. That is where extrusion and industry 4.0 meet.

EXTRUSION

Extrusion with high consistency rubber silicone:

What to consider

JOHN FREEDMAN, BUSINESS UNIT DIRECTOR, BIOMATERIALS, AND ALEX SANTAYANA, APPLICATION ENGINEER, BOTH FROM NUSIL – PART OF AVANTOR, EXPLAINS IMPORTANT FACTORS TO CONSIDER WHEN USING HIGH CONSISTENCY RUBBER (HCR) SILICONE IN MEDICAL DEVICE EXTRUSION PROCESSES.

CR silicone is a versatile material with a long history of use in medical devices and other industries. Used to fabricate various articles, such as tubing, balloons, sheeting and moulded parts, HCRs consist of a high-molecular-weight polymer combined with silica to produce a silicone that has a clay-like consistency in its uncured form. Medical device manufacturers often choose HCR because of its demonstrated biocompatibility, various processing techniques and excellent physical properties. When compared to other silicones, one of the most unique properties of HCRs is ‘green strength.’ Uncured HCRs can be shaped into a given dimension or form and will hold that shape until cured. In addition, due to their relatively low overall cost, HCRs provide an excellent material for low-volume devices or parts production, using different fabrication methods, such as calendaring, compression or transfer moulding and extrusion. HCRS IN EXTRUSION PROCESSES: KEY CONSIDERATIONS Tubing for catheters and other medical devices are the most common products produced via HCR extrusion, although extrusion can also be used to produce forms, such as ribbon and rod. HCR silicone parts produced through extrusion can have wall thicknesses ranging from less than 0.01 inches up to three inches. Extruded HCR offers a wide range of elastomeric performance, with most having a durometer in the range of 30 to 80 type A.

catalysed curing systems. They can be supplied either catalysed, where the catalyst is included, or uncatalysed, where the catalyst is sold separately and requires combining prior to extrusion. A key advantage of peroxide-catalysed systems is that their curing mechanism is not initiated until the HCR is exposed to heat. This translates into a very long work time which is beneficial for moulding or extrusion. It should be noted that peroxide-catalysed systems often require a post-curing process to remove residual byproducts. Platinum-catalysed systems typically consist of two components: One contains the platinum catalyst, and the other contains hydride functional crosslinkers and cure inhibitors. When combined, the HCR retains its pre-cure consistency for one to two hours and no undesirable byproducts are produced in the curing process. A key advantage of platinum-catalysed HCRs is the ability to heataccelerate the cure for increased throughput. Before extrusion, HCRs need to be processed with a two-roll mill to soften the material and to blend two-part systems. This also modifies its consistency so it can flow more easily through the die. This processing step, as well as extrusion itself, generates heat; if too much heat is generated, the HCR can begin to cure, so it is common for this equipment and processing area to be cooled to prevent curing prior to or during extrusion. Once the HCR has been milled, it is fed into the extruder. Extrusion is a steadystate process designed to continually produce a high volume of finished parts with the exact same dimensions and properties. Many extrusion systems use a screw mechanism to force the HCR through the die since this provides a highly controllable feed system. This is important to ensure uniform production of the finished extrusion and to control factors like wall thickness. After extrusion, the HCR parts need to be vulcanised or heat cured. WORKING WITH HCR SUPPLIERS Since no two medical devices or extrusion processes are exactly the same, silicone providers will have solutions that provide greater flexibility for the manufacturing process. Suppliers with robust-quality systems and ISO 9001 certification, deep knowledge of ISO 13485 quality requirements for medical systems and experience with the U.S. Food and Drug Administration (FDA) MAster File submissions (MAFs) can help ensure that the medical devices you produce using HCRs can be more easily and readily supplied to the marketplace.

There are several factors to consider when extruding medical device components using HCRs. The first has to do with curing the HCR - the process by which the gum-like, rubbery material is formed and hardened into a final shape. Obviously, the material needs to remain soft enough to be extruded through a die, so curing occurs after extrusion.

High consistency rubber silicone is a versatile material with a long history of use in medical devices and other industries.

Most HCRs are supplied using either peroxide-catalysed or platinum-

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ADHESIVES

A RACE AGAINST THE CLOCK

PETER SWANSON, MANAGING DIRECTOR OF ADHESIVES SPECIALIST INTERTRONICS, EXPLAINS TIME-BASED CONSIDERATIONS WHEN WORKING WITH ADHESIVES IN MEDICAL DEVICE APPLICATIONS.

here are numerous considerations when specifying an adhesive for medical devices. In a demanding industry, manufacturers are looking for an adhesive that is compliant (often satisfying biocompatibility requirements evidenced by ISO 10993), bonds well to the substrates, and meets other functional requirements of the application. However, there are also time-based considerations at play. SHELF LIFE The shelf life of an adhesive is the length of time from the date of manufacture during which the material is under warranty to behave according to the technical data sheet, assuming the storage conditions have been met. It often appears on the label as the expiry date - referring to the date that the shelf life ends - or as a manufactured date. If the data sheet lists a manufactured date, you can find the shelf life and calculate the expiry date.

in performance. Changes in the adhesive may include longer cure time, failure to cure, gelling in the package, changes in viscosity, syneresis/separation or a decrease in performance. After the shelf life, the risk is entirely up to the user. Past the expiry date, a quick test (if only an indicator) would be to check cure speed under your exact process/cure conditions and compare it with your original process evaluation test records. A more rigorous way would be to do as many functional tests on the expired products as you can to see if it still meets the needs of your medical device. A guide would be the testing you did initially to validate the adhesive in the application - the ultimate arbiter of suitability of the adhesive for your application. The conditions the adhesive is stored in can affect the shelf life. For best results, store your adhesives according to the manufacturerâ&#x20AC;&#x2122;s recommendations. Choosing an adhesive with a limited shelf life will mean working with a supplier with an appreciation of the inevitable supply chain challenges. WORKING LIFE AND POT LIFE While pot life and working life are often taken to mean the same thing, there are distinctions between the two. Both, however, refer to the period of time after mixing or preparing an adhesive for use during which the material remains suitable for application.

An adhesive that remains unused in the original packaging and has been stored under recommended conditions, may still begin to see negative effects beyond the shelf life. Medical device manufacturers should be aware that the effects can be nearly immediate or be part of a slow decay

Adhesives based on chemistries like epoxy, polyurethane and methacrylate are often two-part systems; once mixed, the clock starts ticking, cure commences and the material starts to thicken, meaning viscosity increases. In this case, pot life is a data point liked by chemists, as it is defined as the amount of time it takes for an initial mixed viscosity to double and it is something they can measure. There are variations on this theme - the test is affected by the mass of the material mixed and the temperature, so these factors should either be standardised or detailed (e.g. 100 grams mixed at 25ÂşC) if you want to make comparisons. Many thermoset materials will generate heat (exotherm) and increase the temperature during cure. Since this exotherm is related to the mixed mass, the more you mix, the shorter the pot life. UV curing adhesives, which are typically single part and require no mixing, might be said to have an indefinite pot life. Working life on the other hand, is the amount of time a mixed material remains low enough in viscosity so that it can still be readily applied to a part or substrate in your application, with the appropriate accuracy and tolerance - it is application dependent. Size and shape of bondline, geometry, orientation, and even dispensing/dosing methodology will all come into it. Pot life can act as a guide in figuring out your working life, but some practical experimentation will be useful. Working life is generally shorter than pot life. There are risks in using a material beyond its stated pot life, even if it is still thin enough to apply, because if the cross linking has gone too far, then adhesion and other physical characteristics may be compromised. Not all manufacturers quote pot life or working life in the same way, so be careful of making data sheet comparisons and use the figures as a guideline. Always test the material in your application and talk to an authoritative supplier. If, for performance reasons, you must use a material with a shorter pot life than ideal for your process, then one likely ramification is increased material wastage from frequent mixing nozzle replacement or auto-purge functions on metering, mixing and dispensing machines.

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ADHESIVES

CURE TIME Cure time can vary from almost “instant” (cyanoacrylate adhesives), seconds (UV curing adhesives) to hours or even days (two part ambient temperature epoxy or single part silicone RTV adhesive sealant). There is a distinction to be made between “handling time” or “fixture time”, and cure time. The former terms refer to the time it takes for the adhesive to cure enough so that the parts can be moved with moderate care - perhaps to a holding area for full cure to occur, or to the next stage of the manufacturing process. In an ideal world, adhesive cure time would fit in with the production line speed as determined by the takt time. Adhesive specification is about compromises, however, so other selection factors may have trumped the ideal cure time factor. This may mean production bottlenecks, off-line curing, increased WIP, and the resultant required resources (space, time, energy). If assembly jigs or fixtures are required, then longer adhesive handling times invariably mean more jigs, with the associated costs. If circumstances allow, then fast curing adhesives like cyanoacrylate adhesives or UV light curing adhesives can offer production efficiency. Applications such as bonding surgical instruments and crutches may require a two-part structural adhesive based on epoxy or methacrylate chemistry. In this situation, there is often a balance to be drawn between working life and cure time. Medical device manufacturers require their processes to be highly efficient and repeatable. However, fast cure time after mixing also implies a short working life, and this may present a number of processing challenges. Higher volumes of continuous production can cope with this, but smaller volumes of inconsistent production will require careful planning in order to reduce material waste. Some of these two-part structural adhesives have cures readily accelerated by heat, although this may need to be done off-line in batch ovens unless volumes allow costly in-line ovens, or for example, by induction heating. Faster is not always better as it is possible for an adhesive to cure too quickly. For example, if you are working on a very large laminating job, where it takes 10 minutes to apply and spread the adhesive before applying and positioning the laminate, you will need an adhesive with a working life longer than 10 minutes.

CONCLUSION Shelf life, working life and cure speed are selection factors to consider when specifying an adhesive for your medical device. It is worth noting that the cost of processing the adhesive is often more than the cost of purchasing the adhesive, so using these features to gain production efficiency will save both time and money, reduce material wastage and enhance productivity while meeting the industry’s regulatory requirements.

WHEN SPECIFYING AN ADHESIVE FOR A MEDICAL ASSEMBLY APPLICATION, SHELF LIFE, WORKING LIFE AND CURE SPEED ARE SELECTION FACTORS TO CONSIDER. A GOOD UNDERSTANDING OF THESE FACTORS CAN HELP MEDICAL DEVICE MANUFACTURERS TO IMPROVE PRODUCTIVITY AND REDUCE WASTE WHEN BONDING, COATING OR MASKING CATHETERS, TUBE SETS, PROSTHETIC JOINTS, BLOOD FILTERS AND MORE.

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INDUSTRY 4.0

The GREEN light

MARTIN GADSBY, DIRECTOR AT OPTIMAL INDUSTRIAL TECHNOLOGIES, LOOKS AT HOW PROCESS ANALYTICAL TECHNOLOGY (PAT) CAN SLASH THE ENVIRONMENTAL IMPACT OF MEDICAL PLASTIC MANUFACTURING ACTIVITIES WHILST CREATING VALUABLE OPPORTUNITIES FOR PROCESS IMPROVEMENT.

rowing ecological awareness and stricter environmental regulations are driving positive changes towards greener, more sustainable practices when it comes to manufacturing with plastics. PAT offers a key tool to keep up with these trends and realise even the most ambitious green manufacturing initiatives, especially with plastic which has recently come under scrutiny due to its environmental impact. PAT can improve the efficiency of raw material production, manufacturing and recycling processes whilst increasing the quality of the final products. This is a system for designing, analysing, and controlling Critical Process Parameters (CPPs) in manufacturing through timely measurements of Critical Quality Attributes (CQAs) defining Quality Target Product Profiles (QTPP). Ultimately, by using MultiVariate Analysis (MVA) and chemometric models to link CQAs and CPPs, PAT aims to optimise industrial processes by offering an indepth understanding of the manufacturing processes involved. This PAT process knowledge is presented in an easily accessible manner to plant operators via software platforms, such as Optimal’s synTQ knowledge management suite, allowing on-the-fly adjustments of CPPs to meet CQA targets. The result can be greener manufacturing with lower energy usage, and less waste. SOLVENT USE Key targets of PAT-led process improvement include reducing energy consumption, waste generation and substandard material production. These goals are some of the main objectives of green chemistry, a movement founded in the 1990s. In addition to the general resources being used in the manufacturing of medical plastic, there are other resources whose use, and waste treatment can be heavily reduced by PAT-led production, such as hazardous chemicals

PAT offers a key tool for medical plastic manufacturers interested in reducing the environmental impact of their activities.

and solvents. Consequently, by using lower amounts of these chemicals, manufacturing facilities can minimise the environmental impact of their processes. GREENER PROCESSES PAT acts as the ideal gateway to continuous processing. This is inherently more sustainable than batch manufacturing due to lower energy expenditure. Advanced PAT knowledge management platforms, such as synTQ, also offer ‘digital twin’ functions. These further reduce the volume of resources used, waste generated, and energy consumed, by allowing medical plastic manufacturers to develop, run and test a process data flow before an actual, physical process is started up. GREENER QUALITY TESTING PATs contribution to developing a cleaner industrial environment does not solely influence the medical plastic manufacturing process, but also encourages the development and implementation of eco-friendly analytical practices in quality control. The in-line testing procedures at the core of PAT greatly simplify the testing workflow. By doing so, test sample packaging, transport, storage and preservation activities are no longer taking place, as analysis is performed in-line. As a consequence, waste production and energy usage resulting from these tasks are completely eliminated. A GREEN WAY AHEAD It is clear how medical plastic manufacturers that have not yet implemented a PAT strategy are missing out not only on an opportunity to improve the environmental profile of their production processes and quality testing, but also the associated economic benefits resulting from resource and waste minimisation or avoidance.

References 1 Original “manifesto”: Anastas PT, Warner JC. Green Chemistry: Theory and Practice. New York: Oxford University Press; 1998 2 Hosam El-Din Mostafa Saleh and M. Koller (February 28th, 2018). Introductory Chapter: Principles of Green Chemistry, Green Chemistry, Hosam El-Din M. Saleh and Martin Koller, IntechOpen, DOI: 10.5772/intechopen.71191. Available from: https://www.intechopen.com/books/green-chemistry/introductory-chapter-principles-of-green-chemistry

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INDUSTRY 4.0

One step ahead PAUL MULVILLE, FOUNDER OF TOOLING PULSE, EXPLAINS WHY CAPTURING DATA DIRECTLY FROM THE TOOL ENSURES MEDICAL MANUFACTURERS CAN MAKE PREDICTIVE AND PROACTIVE ACTIONS.

edical device manufacturers are at the forefront of driving industry 4.0, demanding end-to-end control of every aspect of manufacturing visibility and performance and, whether you know it or not, that starts with tooling. For the purposes of this article, tooling is defined as the moulds, dies/jigs and fixtures that facilitate the conversion of raw materials into finished goods. Why is it important? There exists an assumption on the corporate side that as long as the tooling is maintained, it will last indefinitely. However, tool life cycle has come to the surface as a significant factor that directly affects profit and loss, and there is no industry standard, and no quantitative measure for tool life cycle. The corporate executive has visibility into product life cycle. After all, it’s the corporate side where orders are placed and where the finances are managed. Meanwhile, the operations side is charged with managing an open-ended tooling life cycle, with the added complication of trying to find steadily increasing repair funds for ageing tooling that no longer has an asset value. Over a period of time and usage, once the tooling has some “mileage” on it, it’s not hard to imagine that something so critical - yet which is not visible to the stake-holders - can become the catalyst for numerous problems including, but not limited to, tooling asset management, transfer tooling, constant break-downs, spiralling maintenance costs, supply-chain issues, recurring part quality problems etc. The highest specification for mould tooling is class 101, which is guaranteed to last 1M shots/cycles. Many well-maintained tools can last upwards of 10M shots, but once over 1M shots there is a grey area where it is near impossible to predict longevity. How can you bridge the gap between corporate management and manufacturing operations management, and create global visibility of these high value assets? Tooling Pulse, a US-based start-up, has developed a reliable method to quantify tool life cycle, and bridge the gap between corporate management and manufacturing operations by delivering real-time tooling metrics right to the fingertips of all corporate stakeholders. Founder Paul Mulville explains: “Until now, no-one has been able to accurately define a point in the future that says:

“That’s where the tool will fail”, or “that’s when the tool needs to be replaced or phased out”. He added: “We are a real-time global tooling audit and predictive analytics platform that lets you know: What you have, where it is, what condition it’s in and whether it’s sustainable - essentially by quantifying risk using a sophisticated formula of fixed, variable and dynamic inputs to generate tangible outputs that will enable mitigation decisions to be made.” What makes Tooling Pulse different? According to Mulville: “It’s the only product in the space that proactively delivers data (key performance indicators) that allow you to see issues on the horizon, before they become a problem”. In an ideal world we would like to see every area of manufacturing as a module, however, one might argue that tooling is neither a consumable or a tangible and is most often managed by off-site suppliers. Ironically these same off-site suppliers have difficulty communicating the current condition of tooling to non-technical purchasing agents, and the issue becomes almost perpetual. Tooling Pulse aids both the original equipment manufacturer and the supplier with transparent data that allows proactive decisions to be made. In summary, industry 4.0 is as relentless as the tide, and it’s simply unacceptable in 2020 for manufacturing leadership to be driven by failures, fallout, anomalies and breakdowns when predictive analytic technology exists to prevent these issues. Tooling Pulse’s method of capturing data directly from the tool provides the missing link in the chain of manufacturing control and accountability, thereby enabling strategic planning decisions.

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JOINING TECHNOLOGIES

TOM HOOVER, SENIOR MEDICAL BUSINESS DEVELOPMENT MANAGER – AMERICAS, ASSEMBLY TECHNOLOGIES, AT GLOBAL TECHNOLOGY AND MANUFACTURING COMPANY, EMERSON, EXPLAINS HOW ULTRASONIC PLASTIC WELDING IS IMPROVED THROUGH IMPROVED FORCE CONTROL.

he latest advances in ultrasonic welding for medical devices are driven by the need to assemble plastic parts that tend to be smaller and lighter in weight, thinner-walled, and often more contoured than in the past. A growing number of these parts also contain embedded electronics and sensors that require special care in the ultrasonic welding process. Meeting the medical device industry’s demand for repeatable, strong and consistent welds in these smaller and more delicate components has required the development of improved ultrasonic welding technology. Perhaps the most important recent improvement has been the development of new, more precise methods of force control. This has required a series of changes to the ultrasonic welding actuator and its microprocessor controls. To achieve the greater and more precise levels of force control required, the developers of Branson ultrasonic welding technology considered not only the capabilities of pneumatic actuators— which remain an industry standard—but also the rapidly advancing capabilities of servo control and technology. Their solution was a new electromechanical actuation system, recently introduced in Branson GSX welders from Emerson. A key attribute of this new welding platform and its advanced actuation system is substantially more precise and responsive force control through the entire weld process. Downforce is necessary to maintain horn/part contact and ensure the smooth, efficient transmission of ultrasonic energy into the mating parts. Managing downforce more rapidly and precisely has important implications for weld quality. THE ROLE OF WELD FORCE CONTROL For a given set of weld parameters, variations in force control that result in applying too little force reduce

compression of the mating surfaces, reduce the heat generation needed for plastic melt, and result in cold or weaker welds. Similarly, force variations that result in applying too much force can cause part joints or energy directors to deform, deflect or break and may not provide enough time for proper melt flow and polymer entanglement to occur. Applying just the right amount of force at just the right time results in quality welds with highly consistent characteristics and strength. Ideal force control requires rapid, dynamic changes in the clamp force/downspeed applied by the actuator following the melt of the plastic. This adjustment, called ‘dynamic follow through,’ enables each weld cycle to adapt to part-to-part variances and other factors such as the type of plastic, joint style, and part geometry. As the speed and precision of force control and dynamic follow-through increase, the strength, quality and consistency of plastic welds follow. For example, the strongest ‘pull force’ for a part weld results from a controlled force profile that allows for complete and random polymer chain entanglement that makes the weld as strong as the parent material (As shown in figure 1). As seen in the right-most illustration in Figure 1, ideal force control adjusts downforce milliseconds after the melt, allowing polymer chains to extend vertically across the part interface and entangle with each other across the bond line as melt and compression occur before cooling. By contrast, weaker welds, characterised by partial or no polymer chain entanglement, show polymer chains that reassemble parallel to the bond line without entangling across the part interface. The centre weld shows the impact of inadequate force control, while the ‘cold’ weld at left could be caused by too little or too much downforce in too short a weld time. More consistent and complete polymer chain entanglement and stronger welds are a direct result of technical improvements in force control. By evening out even small force variations very quickly, the process control and actuator in the GSX welder maintain more consistent contact.

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JOINING TECHNOLOGIES

The most important recent improvement has been the development of new, more precise methods of force control.

Cold Weld

No entanglement

Weak Weld Partial parallel entanglement

Strong Weld Complete entanglement

RESULTS OF IMPROVED FORCE CONTROL In a series of laboratory tests and and customer trials, the advanced process controls and electromechanical actuator in the GSX-E1 welder reportedly consistently outperformed pneumatically actuated welders, enabling the latest ultrasonic welding platform to: • P roduce welded parts with more consistent and repeatable levels of strength. In a head-to-head comparison of welding performance on identical parts, the GSX-E1 was matched against an excellent pneumatically actuated legacy welder. Results showed that while both welders produced strong welds, the GSX-E1 was able to produce parts with an even higher average pull strength and more consistent and repeatable levels of break force (e.g., lower standard deviation in results), as well as physical characteristics that more closely matched those of parent material. • Change downforce on a weld within milliseconds as part-to-part melt occurred, resulting in more precise closed loop control over heat generation and dissipation, weld-collapse depth, and weld quality. In another example, a customer evaluated the performance of the GSX-E1 welder when its legacy welder, a pneumatically actuated welder, was unable to change weld downforce quickly enough to avoid bubble formation in the weld zone between two polycarbonate parts. The result was an unacceptable level of scrap parts. The customer found that the more rapid, precise action of the electromechanical actuator and control on the Branson GSX-E1 eliminated the bubbles, producing consistently high-quality welds. • GSX-E1 repeatability across multiple welders. A customer with a low weld clamp force (~40N) application required a torque test specification on their welded parts maintaining a tight torque value test range of between 0.2Nm and 0.65Nm across multiple welders. Their trial with GSX-E1 welders exceeded the requirement, holding torque values to within a nominal range of approximately 0.2 Nm over a run of 50 production-quality welds—a feat impossible with the customer’s pneumatically actuated ultrasonic welder. • Complete challenging part welds with exceptional consistency. The force control capabilities of the GSX-E1 were also proven in applications involving long, delicate, and thin-walled parts. In one application, a customer using a competitive, servo-actuated ultrasonic welder struggled to consistently produce welds with high break-push

Polymer Chains

Bond Line

Figure 1: Polymer chains in cold, weak, and strong welds strength (>80 lbs) on parts with a very thin (~0.5 mm) plastic shear joint. An extended production trial with the GSX-E1, working at 500 parts per hour, delivered 3,000 parts with an average break force of 152 lbs (nearly double the customer requirement). In addition, the GSX-E1 produced 100% good parts. In another example, this time involving far-field welds of a long, thin (0.070” wall thickness) tube with a shear joint into a moulded base, a customer was able to produce strong welds with its legacy welder, but sometimes had quality problems including part marking and inconsistent weld depth, resulting in flashing. A weld trial set up in less than fifteen minutes with the new intuitive Branson GSX quickly resolved the problems. Its responsive process control and electromechanical actuator delivered weld amplitude consistently and smoothly, resulting in parts free of markings and flash with higher average pull strength. The improved force control capabilities built into the new GSX ultrasonic welding platform from Emerson typically enable GSX welders to produce these and similar results while reducing weld cycle time, peak power input, and total weld energy consumption compared to welders with less-responsive and precise actuators.

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TESTING AND INSPECTION

UP TO SCRATCH STEPHEN SANDERSON, GROUP INSPECTION PRODUCT MANAGER AND GUVEN TUREMEN, GROUP METROLOGY PRODUCT MANAGER, BOTH FROM MANUFACTURER VISION ENGINEERING, DISCUSSES HOW MANUFACTURERS CAN ENSURE THE QUALITY OF PLASTIC COMPONENTS.

hether you are manufacturing parts for use in class III medical devices or class II products, such as syringes or catheters, it is necessary to have a quality management process in place to ensure your products meet industry standards, customer specifications and your own quality benchmarks.

be measured for compliance. These criteria need to be considered carefully when planning an efficient quality control procedure.

A quality control process must be reliable and easily documentable to provide proof of compliance. The detail of the quality management system will be dictated by the customerâ&#x20AC;&#x2122;s product specification which, in turn, will guide the choice of inspection and measurement systems used within the quality infrastructure.

The need to measure a variety of components can make the process more complicated. To maintain accuracy and efficiency a variety of measurement types may need to be incorporated into the quality protocol. The solution may be to combine an optical measurement system with a video measuring system. Video measurement offers speed of measurement, making it ideal for components where edges are clearly visible.

VISUAL INSPECTION Visual inspection checks are undertaken to ensure parts meet specific requirements in terms of colour and surface finish. It also makes sure that there are no residual material fragments left over from the manufacturing process.

An instant Field of View (FOV) measuring system can be used in cases where 2D measurements are acceptable. In addition, multiple small components can be placed within the FOV and accurately measured within moments - ideal for small medical devices. The use of a telecentric lens will further improve accuracy through the elimination of any distortion in the FOV due to curvature of the lens.

Where parts are more complex or have difficult to view features, the intricacies are better seen with the aid of an optical system. This is particularly useful in cases where the plastic is black or transparent. This ability to switch seamlessly from a video to an optical view maintains accuracy whilst offering time saving benefits. Measurement procedures for complex parts may also require measurements in three axes or measurement of 3D forms, where a mixture of non-contact and contact (touch-probe) measurement methods can be combined. With such a system, features that can be displayed clearly via the digital camera are measured using the non-contact method and others with poor edge definition or concealed features can be measured with a touch-probe.

In many instances, due to the size of the components, a microscope will be required to conduct the inspection.

Switching between probe and non-contact measurement will reduce measurement time, maintaining accuracy without compromising speed of checks. Inclusion of a motorised zoom lens further optimises the process offering the ability to incorporate magnification changes into the assessment process.

Visual inspection checks alone are not always sufficient to assess product compliance. In instances where there are tight-tolerance standards, a series of measurements may be included in the quality management process. MEASURING COMPONENTS There are varying degrees of accuracy when it comes to measuring components, from basic comparison against a reticule to measuring distance in terms of micrometres.

SELECTING THE APPROPRIATE EQUIPMENT A successful quality control process is reliant on utilising the appropriate equipment to ensure not only accuracy but efficiency. The simplest way to select the best system for your business is to share your requirements with the experts. They will then be able to advise you, and tailor the inspection and measurement system in order to deliver the ideal solution for you.

When creating the protocol for a quality management system, the degree of accuracy will need to be taken into consideration. Quality managers will also need to review the measurement range which will dictate whether a two or three axis measurement system should be used. High value, safety critical devices will often be made up on a number of components, all of which will need to

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Report predicts the use of plastics in packaging to rise 1

The report was published by global market intelligence company, Fact.MR.

Research predicts the use of plastics in packaging will multiply by two times during 2019-2029.

However, to overcome limitations more recycling initiatives are needed e.g. in-store recycling.

A key reason is the adoption of sub-segments such as PP in sustainable packaging practices.

The Fact.MR analyst concluded: “Sustainability is key to growth in the pharmaceutical packaging market.”

04:2020 NEW BIOPLASTIC ANNOUNCED

ioplastic offers an alternative to traditional plastic as it is made from renewable biomass sources. A team of researchers at the University of Oulu, Finland, has developed a new synthetic bioplastic which claims to be more airtight than standard PolyEthylene Terephthalate (PET) plastic as well as able to protect against the sun’s ultraviolet radiation. Despite these properties, the bioplastic is able to be fairly transparent, as well as being completely biodegradable and compostable.

This bioplastic was made by substituting chemicals for biomass. The material is made up of two raw materials, HydroxyMethylFurfural (HMF) and furfural, which are derived from cellulose and hemicellulose. These two materials are chemically linked in order to form copolymer parts with both bisfuran and furan-like structures. The team have filed a patent application for this method, and the results of this research are published in a journal by the American Chemical Society.

A LESS PAINFUL WAY TO TREAT DIABETES

reatment for diabetes often requires multiple, painful injections for a patient via a needle. Therefore, materials giant Covestro’s Makrolon material has been used by QS Medical Technology in an attempt to develop a patientfriendly delivery method. A biocompatible plastic like Makrolon was needed

as the drug is injected at a high pressure under the skin surface. Additional desirable properties of this material include its resistance to cracking when in contact with lipids, its ability to be sterilised with high-energy radiation, and how Makrolon retains dimensions in different application environments.

CHECK OUT... HAVE YOU LISTENED TO OUR PODCAST YET? The MedTalk Podcast brings together the editor of Medical Plastics News alongside the editors of our sister titles Med-Tech Innovation and European Pharmaceutical Manufacturer. Episodes aim to provide a light-hearted take on the latest news in the medical technology, digital health and pharma industries.

You can listen to the latest episode on Soundcloud, iTunes and Spotify. 34

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MPN EU Issue 53

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04:2020

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