MPN EU Issue 56

EUROPEAN EDITION

MEDICAL PLASTICS news WHY IS IRELAND SUCH A HOTSPOT FOR MEDTECH? WHAT EXACTLY IS INDUSTRY 4.0 AND HOW DO WE GET THERE? SUSTAINABILITY: THE NEXT FRONTIER IN THE MEDICAL DEVICE INDUSTRY

UPWARDS ONWARDS &

MEDICAL PLASTICS news Carclo Technical Plastics takes continuous improvement to new heights

ISSUE 56

September - October 2020

WWW.MEDICALPLASTICSNEWS.COM

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CONTENTS September/October 2020, Issue 56

Regulars

Features

5 Comment Laura Hughes discusses the difficulties faced by the Eudamed database since the beginning of a challenging year.

15 Global Medtech Hotspots IMR COO Maurice O’Connell on why Ireland is a hotspot for the medtech sector.

6 Digital spy 8 Therapy area focus: Respiratory 9 Digital Health 12 Cover Story Carclo shares with MPN some recent examples of its success in the field of Continuous Improvement 26 10:2020

19 Industry 4.0 Saint-Gobain Medical Components’ Charles Golub looks at the processes required to implement industry 4.0.

21 Sustainability Sancroft’s Dom de Ville explains the implications of a plastics tax for the sector.

23 Sensors Adtech Polymer Engineering MD Samantha Deverell: replacing a carbon atom with a fluorine atom changes the properties of a molecule, and creates endless possibilities.

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EUDAMED, EU MDR AND IVDR: Tackling

editor | laura hughes laura.hughes@rapidnews.com advertising | sarah livingston sarah.livingston@rapidnews.com head of media sales life sciences & plastics | lisa montgomery 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)

obstacles to implement the regulatory framework EDITOR’S COMMENT LAURA HUGHES

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y now I’m sure everyone in the medtech world is familiar with the term Eudamed - a database which will be used to monitor both the safety and performance of medical devices. It will contain various identifiers and information to help improve the transparency and co-ordination of information for medical devices on the European market – or at least that is the idea.

Previously there has been issues regarding the preparation of this database in a timely manner. The Medical Device Co-ordination Group recently published a paper confirming the launch of the first module of the Eudamed database at the start of December this year.

This means there will be almost 18 months between the introduction of the first module and the full Eudamed launch which is planned for May 2022.

The first announcement regarding delaying the launch of Eudamed was in October last year. Companies were told of the benefits of this delay, including additional time to finish the necessary Eudamed modules, and to prepare the relevant systems and databases.

Richard Houilihan, CEO of Eudamed, even advised industry to “view this delay as a gift”. However, thoughts during the current situation seem to have differed from that in October 2019 when the initial delay was announced. At this time, Sophie Dupin De Saint-Cyr, press officer for internal market, industry, entrepreneurship explained how “the Commission concluded that it will only be possible to make Eudamed operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit”. This statement contradicts the current plans, where a single module will be rolled out in December this year.

she highlighted how the Eudamed database was out-of-date, and the implications of this for companies trying to prepare for the EU MDR and the In Vitro Diagnostic Regulation (IVDR) deadline. Of course, since this talk in February, the implementation of EU MDR has been postponed to May 2021 to allow medtech companies to focus on tackling the Covid-19 pandemic. The IVDR deadline is, however, not delayed despite calls by MedTech Europe to change the implementation date from 26th May 2022. The organisation said: “[The IVDR implementation date] needs to be adapted by at least 12 months, both to address today’s reality and to prevent unintended fall out in the future.” Oliver Bisazza, regulatory lead at MedTech Europe also highlighted the need to think about IVDR, commenting in a recent interview: “I would really like to stress the growing importance of IVDR for our sector because it’s often having to patiently wait for its turn while everyone focuses on MDR.” There was originally concerns around the EU MDR enforcement date, and if companies would be ready in time. However, I think the one year delay to May 2021 has been welcomed by organisations and the additional time was very much needed by the sector.

Currently, there are sixteen notified bodies designated under the EU MDR, four under EU IVDR, and organisations awaiting designation for MDR or both MDR and IVDR. Implementing Eudamed, EU MDR and IVDR was always going to be a big task, and 2020 has thrown in multiple obstacles which have only made the enforcement of the regulatory frameworks more difficult. It does, however, seem like processes are more in place now to enable companies to prepare for these regulations to be put into practice.

2020 has thrown in multiple obstacles which have only made the enforcement of regulatory frameworks more difficult

The European Commission writes how the six modules that make up Eudamed (Actors registration, UDI/devices registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and postmarket surveillance, and market surveillance) will become available on a rolling basis, with plans for the second and third module to be released by May 2021.

Earlier this year, I attended a talk by Isabelle Lang-Zwosta, a global regulatory affairs and business development director – medical (MD) from Knoell Germany at MD&M West. Here, WWW.MEDICALPLASTICSNEWS.COM

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DIGITAL SPY

DIGITAL

MATERIALS UPDATE

spy NEWS UPDATE

https://www.kraiburg-tpe.com/ http://www.nextis.fr/

KRAIBURG TPE and NEXTIS partner on USB socket protection for respiratory devices

https://www.porex.com/markets/

PFOA-free membranes offer safe, innovative material solutions www.skyrora.com

P

orex and Oxyphen’s family of track-etched and fibre-based membranes are PFOA-free.

Since July 2020, the use of persistent organic pollutants has been restricted in the EU. Therefore, POREX Virtek PTFE and Oxphen’s track-etched membranes serve as optimal solutions.

Avi Robbins, VP Global Product Development at Porex, said: “The new PFOA-free regulations emerging from the EU are the latest in a decades-long manufacturing balance between efficacy and safety. With the

POREX Virtek PTFE membrane and Oxyphen’s track-etched membranes, our customers have two innovative venting options that deliver on both fronts.”

POREX Virtek PTFE makes an ideal material solution for applications such as medical or surgical devices requiring optimised air flow and fluid control.

In laboratory applications, Oxyphen’s track-etched membranes are resistant to gamma-ray sterilisation and effective for proper ventilation of cell cultures.

NEWS UPDATE

www.medtronic.com www.companionmedical.com

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n close collaboration with KRAIBURG TPE, medical components specialist NEXTIS has developed an articulated cover designed to protect the USB port on respiratory devices.

medical components and assemblies, NEXTIS is moulding several parts for an advanced respirator from Air Liquide Medical Systems (ALMS), including a flexible protective cover for the device’s USP port.

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The part is moulded in a proven THERMOLAST compound that delivers a balance of high mechanical properties and aesthetics, ease of injection moulding, and reliable resistance against professional cleaners.

The TPE compound offers excellent mechanical properties, as well as long-term dimensional stability. The THERMOLAST range is available globally and can be easily recycled to meet the demands of enhanced sustainability in a circular plastics economy.

Sean Salmon, President of the Diabetes Group at Medtronic,

As a system supplier of

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MEDTRONIC ANNOUNCES ACQUISITION edtronic plans to acquire smart insulin pen company Companion Medical, the manufacturer of InPen. This medical device is an FDA-cleared insulin pen system which is able to pair with an integrated diabetes management app.

said: “This acquisition is an ideal strategic fit for Medtronic … We look forward to building upon the success of the InPen by combining it with our intelligent algorithms to deliver proactive dosing advice personalised to each individual.”

DIGITAL SPY

PROCESSING UPDATE

https://www.broanmainplastics.co.uk/

Compression or injection moulding Which do you need?

T

he aim to manufacture quality parts using quickly and efficiently has led to the emergence of two popular techniques: injection moulding and compression moulding. Both come with their own unique set of advantages, but which process better suits your production? Thomas Catinat, Operations Manager of Broanmain Plastics, explains.

Increasing demand for plastic components has driven the market growth for plastic moulding technology from various industries, including medical devices. Over the

past ten years, the injection moulding segment has witnessed a significant surge. Nevertheless, for basic plastic parts made with thermoset materials, compression moulding remains popular. Although injection moulding is more widely used, both techniques are needed by specific industries.

talking

POINT

Another approach Broanmain offers is direct screw transfer (DST) moulding, where the two technologies essentially meet. Although DST has been around for decades, its flexibility is yet to be realised by many manufacturers.

https://www.sibo-group.eu/

Blaž Osterman, VP and COO, SIBO Group RECYCLING UPDATE https://www.lyondellbasell.com/en/news-events/corporate-financial-news/lyondellbasell-successfully-starts-up-new-pilotmolecular-recycling-facility/?id=28448

LyondellBasell successfully pilots molecular recycling facility

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yondellBasell has announced the successful start-up of its MoReTec molecular recycling facility in Ferrara, Italy.

The proprietary advanced recycling technology aims to return postconsumer plastic waste to its molecular form for use as a feedstock for new plastic materials with applications in food packaging and healthcare items.

collaboration proved the efficiency of the MoReTec technology at laboratory scale.

The goal is to have this completed over the next couple of years and then plan for an industrial scale unit.

In what ways does SIBO Group contribute to the medical plastics industry?

Our key products are packaging solutions, technical solutions and pharmaceutical primary packaging. We provide solutions from an idea to industrialisation and work with one of the biggest moulding productions in Slovenia.

What is your current output capacity?

In 2019 our production has made around five billion components. The majority is caps, shoulders and closures for tubes, but also primary packaging for pharmaceuticals made in a cleanroom environment, thin-wall packaging products and components for household, medical and industrial use.

How has automation helped to improve production?

In one word, much. High levels of automation are simply a must in a mass-production environment. Our machine utilisation in the packaging sector in 2020 was above 85 per cent, with a high yield as well.

How have production levels been affected during the Coronavirus pandemic?

Our production has not been affected by Coronavirus. They’re meant for use in pharma and food, so no reduction has been felt. Quite the opposite, in fact. We have had to ramp up production. If anything, we were affected in a positive sense.

In July 2018, LyondellBasell announced a collaborative effort with Germany’s Karlsruhe Institute of Technology (KIT) to advance its molecular recycling efforts. This

WWW.MEDICALPLASTICSNEWS.COM

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RESPIRATORY

Therapy FOCUS Breathing easier NEIL WRIGHT FROM GBS CLINIC EXPLAINS HOW INDUSTRY MOBILISATION PREVENTED A VENTILATOR SUPPLY CRISIS.

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n mid-March, at the start of the lockdown and amidst peak uncertainty around the virulence of the coronavirus, the British prime minister Boris Johnson hosted an emergency telephone conference with over 60 UK manufacturing companies.

The plan of action was to manufacture more ventilators - and fast.

At the time, the National Health Service (NHS) is believed to have possessed little over 8,000 ventilators and - although the infrastructure was in place to quickly double that number - even that was inadequate for the 30,000 minimum that the models from Imperial College London were projecting.

The conference was followed by a flurry of activity, in which companies of all sizes began working on making new ventilators, with the biggest collective effort coming from the VentilatorChallengeUK consortium, which encompasses BAE Systems, Ford Motor Company, and even some Formula One racing teams.

VENTILATORCHALLENGEUK The ambition of the consortium cannot be overstated. After some initial information blackouts, it was eventually revealed in late-March that the plan was to manufacture two types of ventilators.

One was a completely new prototype, based on existing technologies that can be readily assembled from parts and materials already pre-made for (and being diverted from) other manufacturing equipment.

The other ventilator already existed - and the consortium’s plan was to put considerable effort in place for additional manufacturing support, and to assemble facilities in order to ramp up and abet production.

In order to deliver on both ambitions, the consortium had to look for parts 8

that could not be disrupted from supply chains overseas. And so, the materials and parts for both ventilators were sourced from the UK. MAKING USE OF NEW SUPPORT TECHNOLOGY Some of the most contemporary tools in the history of manufacturing were being called on to deliver the huge numbers of ventilators, including Vuforia augmented-reality technology, and Microsoft’s HoloLens mixedreality headsets. The hope is that both will help to capture crucial steps and processes along the way of assembly.

OTHER INVENTIVE WAYS OF MEETING DEMAND Elsewhere, another approach has provided a testament to the will of corporations and academics, when the urge is there. Such as the collaboration between the F1 team Mercedes, University College London, and nearby hospitals.

This group reverse-engineered what is known as Continuous Positive Airway Pressure (CPAP) device that was already enjoying use in Italy and China, in order to set about manufacturing it in the UK without the need to rely on foreign supply chains susceptible to shutting down. It took less than six weeks for the device to complete clinical trials, and for a production target of 1,000 a day to get up and running.

The CPAP device makes pre-existing ventilators more powerful, reducing the need for other models, specifically more powerful, to be built on their own.

The most impressive feat, however, comes from outside the UK. In New York state, a company called PVA managed to design a completely new ventilator of their own in just a few days. The manufacturing outfit achieved this by re-orientating its multi-axis automated robotic production equipment towards the manufacturing of medical equipment. It only took a couple of days for the design team - starting completely from scratch - to come up with a viable prototype without external help.

CONCLUSION Thankfully, looking back on that long stretch since March, the pandemic never reached critical levels in the UK for such a large number of ventilators to be depended upon.

But, echoing James Dyson’s words to his colleagues following the government’s decision to suspend use of his CoVent, we can only be immeasurably thankful to the hard work and the determination of the men and women working around the clock to prevent the unthinkable.

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DIGITAL HEALTH

IS SMART PILL DISPENSING TECHNOLOGY THE NEXT REVOLUTION IN DIGITAL HEALTH? AS THE GLOBAL HEALTHCARE INDUSTRY TRANSITIONS TO DELIVERING MORE REMOTE CARE, SMART PILL DISPENSING COULD OFFER A SIMPLE, EFFECTIVE SOLUTION TO MEDICINES MANAGEMENT. DR JAMES BURNSTONE, CEO, ELUCID DIGITAL HEALTH, EXPLAINS.

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edicines management and adherence tracking remains a key issue for the healthcare industry, especially with remote medications reviews and clinical trials becoming the norm in the wake of the COVID-19 pandemic.

Medication adherence for patients with chronic conditions like hypertension, diabetes, and psychiatric diseases is just 50%, and as the prevalence of chronic conditions across the world grows, issues of poor adherence are becoming increasingly acute. Figures from the OECD (OECD Health Working Paper No.105) show that poor adherence contributes to nearly 200,000 premature deaths in Europe per year, with an estimated cost of €125bn in the EU, and $105bn in the US, in avoidable hospitalisations, emergency care, and outpatient visits.

Adherence also continues to be a key issue in clinical trials, where poor adherence can easily compromise the validity of the trial. It is well known that compliance rapidly declines over time and in studies lasting more than nine months, it can drop off a cliff. Over three years, medication adherence in clinical trials can go below 50%. To try and compensate for this, regulatory authorities demand considerable increase in trial numbers, sometime by as much as 200% at a cost of tens of thousands of dollars per patient. If the regulatory authorities can ascertain that adherence rates are much higher, this could save millions of dollars on a large study.

Healthcare professionals are in desperate need of reliable, easy-to-use technology to monitor their patients’ adherence, and smart pill dispensing may be coming of age at just the right time to offer a solution.

SIZE MATTERS Smart pill dispensing technologies have been available for some time, but large, clunky bottles have been difficult for pharmaceutical companies to fit into their production lines, and so uptake has been limited. At Elucid Digital Health, we recognised that size was going to be a key issue, and so reformulated our smart pill bottle to a patented dispenser cap which can be made to screw on to any pill bottle.

If smart dispensing is going to move into the mainstream, it needs to fit its disruptive technology in with the existing strictures and limits of the pharmaceutical industry. Only then are we going to see the widespread benefits of increased medications adherence.

A FULLY DIGITAL SOLUTION Smart dispensing technology also needs to be more than a smart pill bottle: it needs to be part of a wider digital health, remote monitoring system. A digital dashboard for healthcare professionals and clinical trials monitors, allowing them to monitor adherence in real-time, is a key element of our smart dispensing system. The detailed monitoring and reporting dashboards allow healthcare professionals and monitors to identify any adherence problems quickly, and to address them directly with the patient.

Smart pill dispensing may be coming of age at just the right time CAPPING COSTS Cost remains a key problem when implementing smart, digital solutions into healthcare systems where every budget decision must be heavily scrutinised. At Elucid, we have dedicated a great deal of time and effort to ensuring that our system is going to be available at an appropriate price point. This technology is potentially transformative for medications management and health outcomes across the world, and we want to make it available to as many people as possible.

The price point is always going to be offset by the potential savings, and in clinical trials in particular, the potential savings created by smart dispensing and better adherence are huge. If a trial doesn’t demonstrate the required efficacy due to non-adherence, then that would be disaster for the sponsor, costing tens of millions of dollars.

The high-level conversations we have had over recent months with major pharmas about implementing our technology both in clinical trial and in the community for high value medications suggest that there is significant and growing for these solutions, and we look forward to the smart dispensing revolution to come.

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REGULATORY UPDATE

OLIVER KLUGE, MARKET SEGMENT MANAGER MEDICAL APPLICATIONS AT KRAIBURG TPE, DISCUSSES THE EFFECTS OF THE MEDICAL DEVICE REGULATION ON PRODUCT MANAGERS AND MATERIAL MANUFACTURERS.

CRYSTAL CLEAR D

ue to Covid-19, the Regulation (EU) 2017/745 on medical devices (also known as Medical Device Regulation, (EU MDR)) will come into force only at the end of May 2021. A central requirement of the regulation is the intensified communication between material suppliers and the person responsible for the product or the person placing it on the market, because it insists, among other things, on material uniformity between prototype and series production. The MDR underlines that only a transparent and comprehensible communication between the supplier and a certified authority can minimise future risks, optimise responsibilities, and avoid legal consequences.

REQUIREMENTS AND CHANGES Even if the MDR involves numerous long-term changes and expenditures, these serve the general well-being as well as the protection of the individual and must be implemented by manufacturers. Probably the most prominent negative example of the compelling necessity of this new regulation is the scandal involving breast implants of inferior quality. This is a momentous decision for those affected, doctors, and health insurance companies.

Spurred on by this scandal and other events, a Europe-wide, independent approval was proposed to rule out such a scenario in the future. This endeavor was followed: The linchpin of MDR is successful risk management and risk minimisation. For the raw material supplier, as in the previous version of MDR, the material equality between certified type and series production therefore plays a decisive role. What is new is that medical devices and products without direct medical benefit are also affected as long as they have similar properties, including tinted contact lenses, but also masks in a much more precisely regulated focus.

ACTIVE DUTY TO INFORM In the context of MDR’s active duty to inform, the communication between the product manager and the raw material manufacturer must be transparent, complete, and comprehensible, including changes and complaints. This means that as soon as there is a material change in a medical device, an item of personal protective equipment or a product with similar benefits, the responsible product manager is legally obliged to carry out risk management in accordance with EN ISO 14971. Decisive and legally binding here is the written evaluation and documentation of the topic and the decision.

In return, the manufacturer must evaluate the product and the risk that arises from the change, however, possible effects on the functionality of the device or possible interactions with other components, e.g. a drug, cannot be

A policy of absolute transparency is needed in terms of communication by raw material manufacturers

evaluated at this point. Furthermore, there is no danger for the material manufacturer if they make an incorrect assessment. The responsibility for potential risks and side effects lies solely with the person responsible for the product. Such a scenario inevitably leads to a moral impasse: The responsibility does not lie with the person who makes the decision about such a change, but in the worst case with someone careless.

DEFINE RESPONSIBILITIES, MINIMISE RISKS Consistent material is the solution, but how is such a material defined? Here, too, one quickly encounters another challenge, because raw material and medical product manufacturers define them differently. The VDI Guideline 2017 for Medical Grade Plastics can provide assistance. According to this guideline, notification is mandatory as soon as little as one parameter changes. The next step is a risk analysis with a subsequent evaluation to determine further measures.

The higher the number of components in a product, the more complex the MDR is, and this is particularly relevant for compounds that consist of a wide variety of ingredients. For this reason, a Medical Grade Plastic should not be changed, if possible. However, if a change cannot be avoided, it is imperative that the raw material manufacturer informs the customer as part of a comprehensive change management process - a process that has always been standard practice at Kraiburg TPE. So, there can only be one way to clarify responsibility: The longer the list of raw materials, the stricter the change management must be. That is why a policy of absolute transparency is needed in terms of communication by raw material manufacturers.

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COVER STORY

UPWARDS ONWARDS &

CARCLO TECHNICAL PLASTICS (CTP) UNDERTAKES RIGOROUS CONTINUOUS IMPROVEMENT ACTIVITIES ACROSS A RANGE OF AREAS.

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s a contract manufacturer serving the highly regulated medical industry, and as a company keen to maintain its edge within a competitive global market, Carclo Technical Plastics (CTP) undertakes rigorous Continuous Improvement activities across a range of areas. This case study gives a brief overview of recent activities and the benefits which have accrued.

LEAN PRINCIPLES As part of a CTP-wide initiative, CTP’s Mitcham facility has led the way with adoption of Lean principles, utilising 5S and 6σ methodologies. The process has been led by senior management, including a master black belt practitioner and passed through the organisation to encourage complete employee ownership.

Following training of a majority of the facility’s workforce in 5S and 6σ white belt methodologies, CTP appointed a site-wide committee to develop this process further, training certain personnel to 6σ green and, ultimately, black belt levels. Individuals subsequently identified opportunities for process improvement and cost reduction. Several projects were identified and prioritised, led in each case by the specific instigator, and supporting methodologies such as Kaizen, Gemba and Muda have been introduced.

GEMBA In one example, inefficiencies were identified in the packaging and handling of work-in-progress (WIP) stock components between moulding and printing activities. The original procedure used disposable packaging to transfer WIP stock between manufacturing activities at CTP’s factory in Mitcham, UK. However, after a thorough appraisal of the process and product requirements, a solution was selected that utilised reusable pallet boxes. The optimisation of this activity has yielded cost savings of £4,625 (~€5,100) over eight months of implementation on one production line, with a projected annual saving of £6,939.

CTP is able to benefit from utilising these technologies by improving injection moulding process control, lowering personnel costs and optimising overall production process efficiency

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KAIZEN During a material variance green belt project at CTP Mitcham, a weakness in the packaging system of a bespoke automated production line was noticed, which led to a Kaizen project to optimise the entire automated manufacturing line. The project team used operator and technician feedback, as well as their own review of the current process to outline improvements, which were subsequently executed, monitored, and reviewed against the original process.

These improvements increased the output per machine by almost 9,000 parts per day. CTP estimates additional annual revenues of approximately £190,000 from this project alone.

PROCESS MONITORING As part of a major project to develop and scale-up manufacture of a drug delivery device in partnership with a global medical device company, CTP has invested significantly in advanced process monitoring equipment, as well as personnel training and development, aimed at improving injection moulding process control and reducing costs of Quality Assurance (QA) and waste.

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COVER STORY

CTP has constructed a new production cell, with 14 FANUC all-electric injection moulding machines, each equipped with six-axis robots, bespoke end-of-arm tooling (EOAT) and RJG’s e-Dart process monitoring software, allied to in-mould pressure transducers. The pressure sensors are located in each tool with corresponding hardware and software incorporated into the moulding machines. These sensors provide output data for peak cavity pressure, hold pressure, hold time and back pressure. These parameters are measured and recorded from each cavity for every injection moulding cycle. These data can then be used to plot a graphical depiction of individual cavity conditions during every moulding shot, thereby generating trend data that can be viewed as the fingerprint of the injection moulding process – because precise information about the conditions within each cavity of the tool is available.

Not only does this offer increased clarity about the quality of the moulding process for individual components manufactured, it effectively enables 100 per cent inspection to be achieved without requiring any human intervention. In contrast, to achieve 100 per cent inspection from conventional process monitoring methods is extremely laborious and costly.

CTP has made widespread use of these technologies through the process development and validation phases of this project, supported by existing metrology and statistical analysis using commonly available tools. CTP is now able to achieve an added layer of process monitoring beyond the current capabilities of the standard injection moulding process, by providing live and retrospective data, showing accurate injection moulding process parameters from individual cavities during each cycle.

CTP’s experience of using cavity pressure sensors has given the company the confidence to scale back the frequency of metrological inspection of the products manufactured in the new production cell. This has resulted in reduced production labour costs associated with quality control activities during standard manufacturing operations such as in-process inspection and the material scrappages associated with sample collection for this activity. This is a direct consequence of achieving tighter control on the quality of the parts produced. In addition, the reduced need for human intervention during routine production also significantly decreases the potential for outside contamination to occur. Most recent quality data reveal an 80 per cent reduction in overall non-conformance reports, with none attributable to part quality since the introduction of the cavity pressure sensors, across all production lines utilising this technology. CTP has also observed a notable drop in overall scrap rates from production activities in this manufacturing cell.

Other than the reduced labour costs CTP is now able to offer, the company anticipates that substantial savings will be accrued over the lifecycle of this contract, including a reduction in the cost of non-quality. If one considers an estimated average cost of each non-confirming batch of product to be between £40,000 and £100,000, the benefits are clearly significant.

Although the initial investment in the process monitoring equipment is high, the main return on this investment to CTP’s customers lies in minimising the QC and QA cost of human intervention, targeting zero defect supply of product and ultimately, cheaper product unit pricing long term. CTP is able to benefit from utilising these technologies by improving injection moulding process control, lowering personnel costs and optimising overall production process efficiency, allowing CTP to remain competitive on both the quality and pricing of the products the company delivers to its customers globally. In parallel, CTP’s commercial partner in this project, assessed several of CTP’s global manufacturing facilities as part of its own vendor management program and is highly supportive of CTP’s Continuous Improvement activities, rating CTP among its leading global vendors.

PREVENTATIVE MAINTENANCE CTP Mitcham recently purchased an i3 MicroClean dry ice blasting machine from Cold Jet. This non-abrasive tool cleaning method utilises compressed air and fine ice particles to clean gas build-up produced during the moulding process. CTP is currently able to perform in press cleaning on both the fixed and moving half of mould tools, and the cleaning process can be performed whilst the tool is still hot, with no detriment to polished surfaces of the cavity or tool. Since the introduction of the ice cleaner, CTP has been able to reduce in-press tool cleaning time on average from four hours to 45 minutes per tool, whilst also reducing preventative maintenance time in the tool room.

Consequently, CTP can now produce more parts since tool cleaning time and frequency have been significantly reduced, therefore increasing the available production ‘up-time’ for the respective tools.

CONCLUSION By definition, the process of Continuous Improvement never ends. Carclo Technical Plastics has introduced a number of initiatives, aimed at delivering Best-in-Class performance with measurable benefits to its business and customers. While progress has been acknowledged by a world-renowned customer base, the process continues.

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GLOBAL MEDTECH HOTSPOTS

MAURICE O’CONNELL, CHIEF OPERATING OFFICER, IRISH MANUFACTURING RESEARCH, DESCRIBES WHY IRELAND IS A HOTSPOT FOR THE MEDTECH SECTOR.

Why Ireland is such a hotspot for medtech

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edtech falls under a broad sector covering technology that can be used in the healthcare setting from disposables to biomaterials and connected health IT.1

The Global MD&D Market is poised to reach $560B by 2023,2 and Ireland’s medtech sector continues to grow as a collective category driven by Foreign Direct Investment (FDI). It has become a world-leading cluster for medical device manufacturing (€68bn exported in 2018).3 Ireland now employs more than 32,000 people in medtech – the highest number in Europe as a percentage of population.4 Medtech companies have the potential to drive efficiencies to reduce healthcare cost. New AI start-ups are leading the way on how new drugs are developed. New connected health technologies, such as AI (analytics) and blockchain (security) are driving innovative care models and rapidly gaining attention. This will increase exponentially given the rise in technology-driven consumers. Many have indicated a willingness to choose physicians that offer telehealth services, with 40% of millennials saying telehealth is an extremely important factor in their decisions.5 THE IRISH MEDTECH SECTOR At a headline level, 80% of the world’s cardiovascular stents, 75% of the world’s knees, 40% of the world’s contact lenses, and 25% injectable devices for diabetics are made in Ireland, establishing the country as a significant global medtech hub.

Per capita, Ireland has the highest industrial output in the medical device sector in the EU (30,000+ employed in a population of 4.5 million people6 Medtech companies are attracted by competitive corporate tax rates, the availability of skilled labour, and a strong compliance culture. The 2018 IBEC report on medtech in Ireland claims 89% of companies are involved in some level of R&D activities.7 Irish medtech has been delivering a significant CAGR over the past five years of over 8% in terms of output revenue.8 Essentially Ireland is taking 2.6% of the market with just 0.06% of the population. The Industrial Development Authority (IDA)9 and Enterprise Ireland (EI)10 have strategically targeted this sector to

References 1. https://www.lsxleaders.com/blog/what-is-medtech 2. https://www.researchandmarkets.com/reports/4852650/opportunities-in-global-medical-devices-and?utm_source=dynamic&utm_medium=GNOM&utm_code=x7j5s2&utm_campaign=1336725+-+Global+Medical+Devices+%26+Diagnostics+(MD%26D)+Market+Analysis%2c+2019-2023&utm_exec=joca220gnomd 3. https://irishmedtechspringboard.ie/wp-content/uploads/2019/02/medtech_sector-1024x678. jpg 4. https://www.idaireland.com/doing-business-here/industry-sectors/medical-technology 5. https://www.trapollo.com/8-trends-that-will-shape-connected-health-in-2020/ 6. https://www.irishmedtechassoc.ie 7. https://www.ibec.ie/ 8. https://www.ibec.ie/-/media/documents/media-press-release/ima-budget-submission-2020. pdf 9. https://www.idaireland.com/ 10. https://enterprise-ireland.com/en/ 11. https://www.irishtimes.com/business/economy/exports-jump-to-a-record-high-of-140bnfor-2018-1.3795060 12. https://ibecclg.ie/Sectors/IMDA/IMDA.nsf/vPages/About_us~about-the association/$file/ Irish+Medtech+AGM+2018.pdf

Ireland now employs more than 32,000 people in medtech, which is the highest number in Europe as a percentage of population replace more mature manufacturing employment that has experienced competition from Asia and Eastern Europe over the last two decades.

Since the early 1990s the number of medtech companies in Ireland has risen from 50 to more than 450, with nine of the world’s top ten companies based there.8 Over the past year, more than €557m in investments by FDI multinationals and funding for startups has been publicly announced in Ireland. In 2018 the total value of Irish goods export was €140.8bn, of which €68bn was pharmaceutical and medtech goods.11 LOOKING FORWARD Medtech in Ireland is at somewhat of an inflection point in terms of securing its future, and is facing evolutionary challenges with understanding, embracing, and implementing industry 4.0 technologies, such as advanced automation, digitised factories, and data analytics.

Anticipated as a key strategy to ensure competitiveness and relevancy,12 industry 4.0 and technological innovation are leading to growth in several medtech areas. In most (if not all) cases, the evolution is driven by advances in sensors, capability, edge of cloud computing and data analytics combined with advances in medical process and product technology. The challenge for players is to excel at their current business while participating in technological developments to ensure relevancy and competitiveness.

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TESTING AND INSPECTION

A SOLID FOUNDATION MARK CUNNINGHAM, SENIOR DIRECTOR OF SCIENCE AND TECHNOLOGY, TECHNICAL SERVICES, AT WUXI APPTEC MEDICAL DEVICE TESTING, EXPLAINS HOW TO PREEMPTIVELY REDUCE REGULATORY REVIEWER REQUESTS.

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edical device manufacturers are facing the brunt of impacts from the global pandemic, working hard to keep critical devices on the market while responding to evolving regulatory guidance documents. Staying up to date with regulatory expectations is challenging enough, and effectively implementing them is a battle of its own – occasionally resulting in regulatory reviewer requests following submission.

For many, there is no capacity to risk regulatory reviewer requests. Such requests are challenging to predict, especially with new processes under the EU Medical Device Regulation (MDR). If manufacturers hope to keep their projects on track, they must mitigate the possibility of delays and associated costs whenever possible.

A vital component of any medical device submission is biocompatibility data, yet the perspectives of major regulatory bodies on the acceptable approaches to this testing varies.

While exact methodologies for biocompatibility testing differ based on submission plans, regulators find increasing value in customised testing strategies to address device-specific risks rather than taking a checklist approach.

Providing background about submission plans is essential to tailor testing designs. This information builds a foundation for a well-rounded testing plan that addresses product specific endpoints.

CREATING A SOLID FOUNDATION FOR TESTING Sample preparation is one area that is commonly subject to reviewer requests across biocompatibility methodologies. Medical device evaluation is a collaborative effort, and there are a few areas where

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Regulatory success at the end of the submission process comes down to a transparent, engaged collaboration from the start manufacturers and labs must be on the same page to avoid any assumptions in the test design.

1. Regulatory pathway. Without this information, labs might be unclear on establishing the correct testing parameters. For example, the categorisation of contact duration varies between FDA standards and MDR standards. If a testing lab assumed limited contact instead of long-term for the use of a specific device, it could garner incomplete results.

2. Surface area. Surface area calculations impact design parameters, such as establishing the necessary ratios of test material to the volume of solvent during extractable and leachable analyses. The best way to avoid challenges is to consider sharing scaled drawings of the device with your testing lab contact from the start.

3. Materials. Many factors in the production process are often neglected. A reviewer’s interest sparks when a previously characterised material is used in a different device or classification and can prompt further questioning. Call out any obscure materials or uses to ensure they receive proper investigation.

4. Particulates. Manufacturers are the experts of their device, and testing labs do not have an equal background in a specific device intended use scenario.

When the size of a device in its standard form hinders testing, fragmenting a cross-section of the device to adequately represent the sample is difficult.

The device cross-section sample can release particulates that will receive considerable attention during regulatory review. Testing strategies need to address what the potential source of the particulates are.

5. Justifications. Any areas in submissions that do not follow the defined standards “to a T” may draw a reviewer’s attention and lead to follow-up questions. Testing labs should defend and describe the reasoning behind the calculations and choices, so the manufacturer can provide the details to legitimise the results. Companies should keep these justifications on hand and thoroughly review before final submission.

Sample preparation is a seemingly small part of the testing process, but it can make or break the resulting data for submissions. Labs need a well-rounded description of the device. Disclose design, composition and end goals from the beginning to keep the path to compliance clear. For a productive partnership between lab and manufacturer, regulatory success at the end of the submission process comes down to a transparent, engaged collaboration from the start.

W W W. M E D I C A L P L A S T I C S N E W S . C O M

TESTING AND INSPECTION

Put to the test ALAN THOMAS FROM ZWICKROELL GROUP, A GLOBAL SUPPLIER OF MATERIALS AND COMPONENT TESTING SYSTEMS, DISCUSSES THE IMPORTANCE OF TESTING THIN PLASTIC SHEETS AND PLASTIC FILMS.

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he medical and pharmaceutical sectors are heavily regulated by laws and regulations. That is why safety requirements are even more stringent than in most other industries because these products, from pen injectors and implants to sterile packaging, directly impact humans.

Quality control that fulfills stipulated requirements comprises not only development, production and packaging of medical and pharmaceutical products in compliance with the legal framework and applicable standards, but must also minimise risk to patients and users.

Manufacturers of medical grade plastics are called upon to meet high levels of quality due to regulations governing the medical industry

Manufacturers of medical grade plastics are called upon to meet high levels of quality due to regulations governing the medical industry. As OEMs seek suppliers capable of consistently delivering to high quality standards, compounders must ensure that proper characterisation of raw materials and components is undertaken.

Plastic films have become an integral part of daily life. Film packaging is common in the medical industry and often saves lives. We use them to package food, carry our groceries home from the store, and protect vegetables grown in greenhouses and fields. A wide variety of films are also used in the construction sector.

Films today are high-tech products that have a wide variety of characteristics.

Mass production uses cost-effective plastics, such as high and low density PE, PP, PVC, and PS. In cases where special characteristics such as toughness, permeability, or light resistance are required, high-quality polymers such as various polyesters, PTFE, or ETFE are used. Films such as EPDM and EVA are used to waterproof roofs. Multilayer films have various characteristics such as strength, impermeability in regards to gas and bacteria, and suitability for contact with food.

Thin plastic sheeting with a thickness of up to 1 mm is a constituent material for many hollow bodies in packaging technology, which are formed by means of processes such as thermoforming or compression moulding.

Due to the broad scope of film manufacture and its downstream processing, requirements of the applicable test method vary greatly. The objectives of the tests can be very different in nature.

In an incoming goods inspection, the first step involves testing raw material.

This step determines the melt index, meaning the melt mass-flow rate of plastic granulate.

In the second step, the plastic films are tested after the extrusion or blow moulding process. In addition to testing film thickness, a variety of other mechanical characteristics are important. These are strength, strain, yield point, and the tensile modulus in the longitudinal and transverse directions of the film. Toughness is also important, which is determined during impact tests. In the case of multilayer films, adhesion between the layers is crucial.

Yet the focus lies on other characteristics during and after processing, including adhesive strength, weldability, and strength of adhesives and joints. If sharp objects are packaged, the puncture resistance of the film is measured.

Understanding the coefficient of friction is interesting for packing machines or in film printing. Changes in light and moisture is also important when evaluating thin sheeting and plastic films.

Testing systems are specifically designed for these requirements and address a wide range of mechanical tests. For example: • Extrusion plastometers characterise the materials of incoming goods.

• Universal testing machines provide accurate, reliable measurement of values for stress-strain characteristics, adhesion forces between two layers, coefficients of friction, penetration resistance and flexure characteristics.

• Creep test benches measure the creep behaviour at room temperature.

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Polymers for Healthcare Applications

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Microspec Corporation

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

INDUSTRY 4.0

CHARLES GOLUB, MARKET DEVELOPMENT MANAGER, SAINT-GOBAIN MEDICAL COMPONENTS, LOOKS AT THE PROCESSES REQUIRED TO IMPLEMENT INDUSTRY 4.0, AS WELL AS THE ASSOCIATED CHALLENGES.

What exactly is industry 4.0 and how do we get there?

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here is a buzz around industry 4.0 with many people talking about the Internet of Things (IoT), Machine-ToMachine (MTM) communication, and automation.

The term ‘industry 4.0’ originated in 2011 from a German hightech strategy government project, to promote the computerisation of manufacturing, and was later publicly introduced at the Hannover Fair. The phrase ‘fourth industrial revolution’ was introduced by Klaus Schwab, the executive chairman of the World Economic Forum, in an article published in 2015, which emphasised advances in communication and connectivity, the removal of our dependence on animal power and brought forth the digital sphere. This revolution “is characterised by a range of new technologies that are fusing the physical, digital and biological worlds, impacting all disciplines, economies and industries…”

‘Big data’ is the term used for gathering data and analytics to predict consumer behaviours. Industry 4.0 is an extension of this - looking at internal processes, gathering data, and using that to predict how processes behave. Consistent remote monitoring of machines and processes is the path for the modern factory, and this may become a critical component of quality systems throughout the medical device manufacturing industry. One of the often overlooked steps during implementing such data gathering is ensuring the required infrastructure and procedures are in place to recall the data needed, efficiently. You generally won’t need the data until there is a problem, which you don’t want to be compounded by the data not being accessible in a timely manner.

To accomplish industry 4.0, you must have access to the proper connectivity for all this data to be transmitted and stored. Many manufacturing operations are not accustomed to requiring complex IT infrastructures, so setting up secure access points and hotspots throughout facilities can be a challenge. External experts are often hired to implement IT solutions, but what happens when something goes wrong? The result is often downtime or lost revenue. Companies need to start thinking about IT infrastructure similar to how they view their traditional operations and include SOPs, regular trainings, preventative maintenance, and end of useful life for the IT infrastructure. There may be a technical gap between your current workforce and the required skills needed to operate or troubleshoot the systems being put in place. Often, the skills required are both hardware and software based: Understanding the physical system that is in place, as well as understanding basic troubleshooting of the software used to gather, store, and recall critical data. As a result, training is critical to ensure your workforce has the skills required.

The process of establishing constant machine monitoring is similar to establishing modern machine processes, just with a technological twist.

You still set up and run a Design of Experiment (DoE) looking for Key Performance Indicators (KPIs) to monitor throughout the process. You really become a smart factory once you begin the real-time communication of this

This ability to pull information real-time from anywhere is the leap into industry 4.0 monitoring from the process control monitoring software to the Materials and Resource Planning (MRP) system.

This ability to pull information realtime from anywhere is the leap into industry 4.0. There are many approaches towards this integration into operations. Some companies may choose to bolt on systems through the MRP system, some may take a logistics approach, while others may work from a Quality Management System (QMS). To achieve the smart factory, all of these functions need to be working together and communicating real time.

At Saint-Gobain we’ve taken the QMS based entrance to the smart factory. Saint-Gobain works closely with our customers to ensure we have the systems in place to generate the data our customers need, when they need it. This way, if data is required for a specific process or campaign, our systems and expertise help to ease customer concerns.

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SUSTAINABILITY

Sustainability:

the next frontier in the medical device industry GEORGE I’ONS, HEAD OF PRODUCT STRATEGY AND INSIGHTS, OWEN MUMFORD PHARMACEUTICAL SERVICES, DISCUSSES THE BALANCE BETWEEN SUSTAINABILITY, SAFETY AND COMMERCIAL VIABILITY.

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nvironmental protection and the achievement of more sustainable processes are increasingly moving to the top of agendas across many industries, and the medical device sector is no exception. Various stakeholders – regulators, hospital systems and governments – are urging the industry to work towards the reduction of disposable waste and to adopt environmentally sound manufacturing processes. Currently, 90 per cent of medical device waste is made up of disposable items. There is an urgent need for sustainability targets to reduce waste and energy consumption generated by the healthcare sector, which is among the worst offenders. The transition towards sustainable device design and manufacturing, however, brings multiple challenges, including the need to strike a balance between product sustainability, patient safety standards and commercial viability.

Leading healthcare firms have already started putting sustainable initiatives into practice. In a survey of almost 200 pharmaceutical executives involved in drug delivery devices, nearly a quarter (23 per cent) of respondents said they are in the process of exploring alternatives to plastic disposable devices. Apart from environmental support, costsavings, new technology, market shift and reduced waste were among the major reasons underlying this initiative.

EXPLORING ALTERNATIVES Device re-use may seem a viable alternative to incineration, which has been a traditional means to reduce waste volumes and destroy biohazardous material. However, when considering medical device re-use, one

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must take into consideration that many manufacturers’ commercial models rely on revenue from the sale of single-use products and components. There are also safety concerns linked to device re-use as patients and healthcare workers must be protected from infection and needlestick injuries, in compliance with strict regulations. Another route, sterilisation, often turns out to be unsustainable from an environmental standpoint due to the energy input required. Moreover, a reprocessed device must meet the same stringent regulatory requirements as a brand-new product, as laid down in the European Medical Device Regulation.

TURNING TO THE REPROCESSING OF MATERIALS The recycling and reprocessing of materials, however, offers a valid alternative to device re-use. Considering that one million tonnes of clean, non-infectious plastic waste are generated every year in healthcare facilities in the US alone, much can be achieved through closed loop recycling schemes. Materials such as PVC, for instance, can be recycled several times without losing their properties. Pharmaceutical companies are already making progress in this area: 37 per cent of survey respondents said they are now using recyclable materials in their packaging materials and design.

37 per cent also said they have reduced the amount of materials used, which can be achieved by cutting down on components in the overall package.

A third (33 per cent) have reduced plastic content, while some are also exploring the use of faster degrading plastic.

INCORPORATING SUSTAINABILITY INTO THE DESIGN STAGE At the design stage of a new product, manufacturers take into account a range of factors regarding the product lifecycle, from initial design to endof-life disposal. As part of sustainable best practice, manufacturers should adjust their mindset and factor in sustainability considerations right from initial design. Simplifying device design and assessing logistics requirements can contribute to reducing waste and transport impact. Moreover, a product that is easy and safe to disassemble will facilitate the recycling process and lower costs.

ACHIEVING SUSTAINABILITY Manufacturing processes can be made more sustainable through reduced water use, optimised logistics and reduced use of polluting chemicals. These sustainability measures are likely to produce immediate cost savings, as well as increased energy efficiency. Additionally, new generation technology which improves productivity often has sustainability benefits. For instance, ‘digital twin’ production software uses inline sensors to create a virtual mirror of the production environment, allowing manufacturers to test product refinements without interruptions to actual production. This means the optimum product can be achieved at a faster pace.

Read Owen Mumford Pharmaceutical Services’ report – ‘Sustaining the Pace: Three perspectives on how sustainability is being achieved in the medical device market’.

W W W. M E D I C A L P L A S T I C S N E W S . C O M

SUSTAINABILITY

A TICKING TIME-BOMB DOM DE VILLE, SENIOR CONSULTANT AT SANCROFT, AN INTERNATIONAL SUSTAINABILITY CONSULTANCY, EXPLAINS THE IMPLICATIONS OF THE PLASTICS TAX FOR THE SECTOR.

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ow to manage the high proportion of non-recyclable medical waste, not least the amount of Personal Protective Equipment (PPE) which we are now seeing discarded in our streets and parks following the move to full adoption by the general public, is one of the biggest challenges facing the medical industry.

But whilst PPE is an increasingly visible waste issue – as we have seen with plastics bottles, as a comparison, these are too easily discarded by people on the move – the requirement to cut single-use plastics and only use recyclable materials in packaging runs much deeper.

Any medical supplier that is not aware of new and forthcoming changes needs to know they are important, and that they need to act now.

The plastics tax, coming into force in 2022, will see businesses whose products have less than 30% recyclable material being charged £200 per tonne. The Extended Producer Responsibility (EPR), even with the delay to the consultation until at least early 2021, will force producers and users of packaging to pay the full net cost of collecting, reprocessing and recycling packaging to local authorities. Also, on the rise are Packaging Recovery Note (PRN) charges - the fees that companies must pay towards the collection and disposal of plastic packaging waste they put on the market.

The European Union’s announcement that it is to introduce a €800 a tonne levy on plastic waste from January 2021 as part of the bloc’s €750 billion coronavirus recovery fund agreement is a sure-fire sign of what is to come here in the UK. All this will increase demands for the removal of unnecessary material and an insistence on the necessity of recycling, what action should the medical plastics industry take to turn this potential disruption into an opportunity?

1. Understand the risks to your business today Evaluate the impact of current and future changes to packaging on your business. This requires establishing the implications of the evolving packaging landscape. You will need accurate data on all the packaging you currently use – including types of materials, quantities, recyclability and recycled content – which should be mapped against the current PRN system and proposed legislative changes so you can understand your exposure to risk.

2. Join up your packaging and business strategies Packaging and business strategy are now intertwined. Understanding this link and how it applies to your business opens up vital opportunities to reduce costs and add value. For many organisations this requires changing the way they think about packaging. Instead of focusing on cost management and compliance, organisations need to think about how product use, disposal and production methods can be adapted for lower costs and reduced consumption.

3. Lead from the top and take a company-wide approach Done the right way, efforts to reduce plastics and packaging require change

across the business and extend to relevant suppliers and partners.

Identifying and prioritising these changes needs top-down support. It will also require people in different functions, including operations, finance and marketing, to work together. Do not leave an individual department or functional team to drive these changes on their own. It will fail without the support of others.

4. Avoid knee-jerk reactions As plastics activism has grabbed the headlines so too have the number of businesses going for ‘quick fixes’ around packaging, typically swapping plastic for another material perceived to be more eco-friendly. The risk here is a failure to reduce overall environmental impact. If the goal is to make sustainable changes to the business then it is imperative to research alternative packaging suppliers, and understand the limitations and opportunities offered.

5. Don’t try to do it on your own A key facet of the packaging revolution is the need for organisations to communicate and collaborate within supply chains and across sectors as the entire system changes. As such, this is not something that should be navigated or tackled by a business working alone. Business leaders should be outward-looking and open-minded, absolutely ready to forge new relationships with industry peers and partners, and to cooperate on areas of shared challenge.

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SENSORS

The sky is the limit SAMANTHA DEVERELL, MANAGING DIRECTOR AT ADTECH POLYMER ENGINEERING, DEMONSTRATES HOW REPLACING A CARBON ATOM WITH A FLUORINE ATOM CHANGES THE PROPERTIES OF A MOLECULE AND CREATES ENDLESS POSSIBILITIES.

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hanks to their unique properties, fluoroplastic coatings can meet severe environmental conditions and allow for sensors to work in hostile environments. As such, fluoroplastics are ideal for protecting sensors in medical applications, from centrifugal evaporators to microwave treatments and steam generators.

WHY FLUOROPLASTICS ARE IDEAL FOR MEDICAL APPLICATIONS Also known as fluoropolymers, fluoroplastics are high-performance plastics with unique properties. The most common materials are PTFE, FEP, PFA, ETFE, E-CTFE, and PVDF. While a plastic molecule contains a carbon chain with hydrogen atoms attached, in a fluoroplastic molecule, the hydrogen atoms are replaced with fluorine atoms. This dramatically changes their properties and transforms them into high-performance materials with limitless possibilities.

Fluoropolymers enjoy exceptional medical properties. Not only are these materials inert and non-stick, fluoroplastics are also pure, non-toxic, biocompatible and can be sterilised. Additionally, PTFE, FEP, and PFA benefit from other unique properties, including: • Very high temperature resistance • Total resistance to chemicals, acids and solvents • Low friction characteristics and tensile strength • Resistance to weather, UV light and corrosion The maximum working temperature for an FEP coating is 200°C, and for applications that require a higher temperature, PTFE and PFA covers withstand 260°C. As such, fluoroplastics can meet severe environmental conditions and are ideal for protecting sensors in medical applications.

THE BENEFITS OF FLUOROPOLYMER SENSOR COATINGS Thanks to their unique properties, fluoroplastic coatings offer medical sensors the following benefits: • Protection against high temperatures and chemicals • Protection against excessive pressure, material velocity and corrosion • Increased lifespan • Reduced risk of contamination • Non-stick characteristic All in all, fluoropolymers allow medical sensors to work in hostile conditions.

PTFE, FEP and PFA are relatively difficult materials to process, but by using a combination of moulding, heat shrinking, welding, and spraying techniques, coatings can be applied without damaging delicate sensor elements inside.

Medical sensor covers can be produced using FDA-compliant and USP class VI compliant raw polymers. In addition, custom covers can be produced to fit specific design requirements.

THE USE OF FLUOROPLASTIC COATED SENSORS IN MEDICAL APPLICATIONS Fluoropolymer coated sensors find use in medical treatment, health monitoring, and medical research, and can measure temperature, pressure, liquid level, oxygen, radiation and more.

For example, fluoroplastic coated sensors are useful for monitoring temperature in centrifugal evaporators and sample concentrators. In this particular application, the sensor is encapsulated in FEP heat shrink. A weight is usually added at the tip to ensure the component stays in the vial when the centrifuge is spinning.

Additionally, the covers can include a strip of colour for identification purposes.

Fluoropolymers are ideal to cover sensors suitable for microwave treatment for patients. For this application, the coatings are designed to feature a hemispherical-domed tip with a consistent wall thickness at the sealed tip in order to control each dose of microwave treatment. The sensor is completely encapsulated and is suitable for immersion into liquids without fear of ingress.

PTFE also finds use in water level detection sensors for steam generators. Known as plugged PTFE probe covers, heavy wall PTFE tubes are usually plugged and welded to ensure the component is completed sealed and there is no chance of ingress. In this particular application, the coatings are thicker to protect against the high pressure in the steam vessel.

WWW.MEDICALPLASTICSNEWS.COM

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EXTRUSION

Screw and barrel wear –

it’s not just increased energy consumption MIKE BECKER OF UK-BASED MAGOG INDUSTRIES LTD. CONSIDERS THE PROS AND CONS OF REPAIRING OR REPLACING EXTRUSION EQUIPMENT.

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etting back to normality is happening, but to bring machines back into production after several months can be a challenge. If the equipment shows problems during start-up, the last thing one needs is added expense – but this can be a good opportunity to check screws and barrels.

These presses work best when running and at optimum settings.

However, all processes use the Archimedes screw principle wherein the helical flight arrangement pushes the material into the mould cavity or die head. Forcing the material in this way is extremely efficient – the basic design remains today.

Analogue gauges can do the job, but electronic bore gauges can provide measurement readouts directly to a computer. However, it is always wise to consult your OEM or specialist screw and barrel manufacturer.

REPLACE OR REPAIR? It’s not always easy to tell when to replace and when to repair. The best approach is to have screw and barrel specialists inspect and advise accordingly. Refurbishment and/or repair is a cost-effective method, depending on the condition. It is possible to rebuild flights, grind and polish a screw three to four times but not recommended beyond that.

However, when a screw is worn beyond a certain point, problems in production become apparent. Material is wasted but the need to increase pressure increases power consumption and efficiency.

For most materials, nitride-hardened surfaces work extremely well, but even this does not necessarily stop surface scoring, uneven wear, or cracks occurring. While surface wear does indeed occur within the highpressure areas, the barrel should also be checked.

Injection barrels are thicker-walled to cope with on/off clamp forces and can be re-bored and re-sleeved. Extruder barrels being far longer but thinnerwalled pose a different problem in that re-sleeving is likely to be along the full length – an expensive option. Hence, a new barrel is the cost-effective option.

Additional factors (e.g. high pressure, viscosity, screw speed and screw and barrel alignment) all contribute to accelerated wear. Polymer lubrication can have an effect, but where plugging occurs with build-up of solid uncompressed material, high uneven pressure on the screw causes deflection and metal-on-metal contact.

Over time, as the gap between the screw and barrel increases, the meltfilm can form, thicken and get hotter – leading to loss of melt quality. For a continuous process such as extrusion, this will be particularly apparent not least because the melt is likely to move backward across the screw flights instead of forward.

Monitoring screw and barrel wear in-house should be part of regular maintenance. Any issues or early signs can be picked up and scheduled in by the maintenance team.

Measuring instruments can be fitted

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with extension rods to enable measurement along the interior of the barrel, and screw flights can be measured by digital micrometres with accuracy up to 0.001, but a visual check can reveal much – although it is advisable to clean both screw and barrel whilst hot.

If a throughput test on an extruder shows a capacity reduction of 15% or more, the screw and barrel will have significant wear and will need attention.

Be sure to obtain the manufacturer’s data regarding maximum throughput for your machine.

TO CONCLUDE Regular monitoring and visual checks of screws and barrels makes sense, but within a busy production environment this is not always possible. “If it ain’t broke, don’t fix it” as the saying goes. That said, screws and barrels do wear over time and for the most part, repair and/or refurbishment offers a cheaper, faster alternative.

New screws and barrels from specialists such as Magog Industries are good value, made to OEM-standard, and come with a focus on screw and barrel engineering.

For all sectors, but especially in medical plastics, it is important to keep machine screws and barrels high on the maintenance and quality agenda to ensure consistent output, less waste, and less stress on other machine parts.

If a throughput test on an extruder shows a capacity reduction of 15% or more, the screw and barrel will have significant wear and will need attention

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ELASTOMERICS

Difficult decisions ALEXANDER SANTAYANA, APPLICATION ENGINEER, AND JOHN FREEDMAN, BUSINESS UNIT DIRECTOR, BIOMATERIALS, NUSIL – A BRAND OF AVANTOR, DESCRIBES HOW TO CHOOSE THE RIGHT HIGH CONSISTENCY RUBBER FOR YOUR MEDICAL DEVICE.

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igh-Consistency silicone Rubber (HCR) is a versatile material with a long history of use in a wide variety of medical devices, such as tubing, balloons and a range of moulded parts.

Medical device manufacturers value HCRs because they are adaptable to being processed using different fabrication methods, such as extrusion, calendering and compression or transfer moulding. One key benefit of using an HCR is its ”green strength”: Uncured HCRs have a clay-like consistency that can be shaped into a given dimension or form and holds that shape until it is cured. Green strength is an important quality for manufacturers that use fabrication methods such as moulding or calendering, where the ability to handle the material is a critical factor for pre-processing or post-processing.

With extrusion, it is imperative that the material maintain its profile after extrusion, prior to vulcanisation. When compression or transfer moulding, HCRs are an excellent material for low-volume parts production due to the relatively low tooling cost.

Medical device manufacturers consider a number of factors when selecting the right HCR to use for their application. However, there are three key decision factors that help select the right HCR for their needs.

1. Intended use: Is the device intended for long-term (greater than 29 days) implantation, for short-term implantation (less than 29 days) or for use on or outside the body, such as medical tubing? Medical-grade HCRs should be specifically designed, manufactured and purified to meet the strictest requirements of the healthcare industry. This includes being manufactured in a facility that is indirectly or directly regulated by the U.S. FDA and aligned with applicable cGMP standards. In addition, it is important to understand the level of regulatory documentation and compliance support they provide, including maintaining Master Files with the US FDA for the material.

Most HCRs are offered in either platinum catalyzed or peroxide catalyzed systems: • In peroxide-catalyzed systems, curing is only initiated when the HCR is heated to the required temperature. This translates into a very long table life, or work time, which is beneficial for moulding, extrusion, or calendering operations.

• Platinum-catalyzed HCRs typically yield higher physical properties than traditional peroxide-catalyzed HCRs and do not produce byproducts.

A peroxide catalyzed HCR is the best option to use in these types of processes.

3. Adjustable cure profile: Some two and three-part HCR systems offer the flexibility of an adjustable cure profile.

These are typically platinum catalyzed systems with the base, inhibitor and catalyst as separate parts. The multipart systems provide the tools to be able to manipulate the cure profile through varying the levels of catalyst and/or inhibitor.

These materials can be useful if a manufacturer is extruding similar tubing with different wall thicknesses one thick walled and one thin walled.

In this case, the manufacturer may want to utilise the same base material for these two products but adjust the cure profile accordingly by varying the amount of catalyst or inhibitor.

Working with silicone experts Application, table life, and adjustable cure profiles are key factors to consider when selecting the right HCR but there are many other critical variables to define before a final choice is made. Working with a silicone manufacturer with deep experience in this selection process can help save time and ensure that the right material is selected — right from the start.

The next two HCR decision points include table life and adjustable cure profiles.

2. Table life: This is the amount of time, after catalyzation, to work with a material before crosslinking occurs to the point where the material is unable to be successfully processed further. With platinum catalyzed HCRs, it is best to only mix the amount of material that will be consumed prior to reaching the end of its table life. This can be challenging in both small and large batch processes. Understanding the specific material’s table life is critical to the success of fabricating with HCRs. Some production processes may call for an extended table life. For example, a manufacturer may calender a long sheet of HCR, use some of it initially and store the remainder for incremental production purposes at a later time.

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ENGEL named among most sustainable companies 1

Continuously optimising processes with the aim of economic resource use and strengthening recycling.

2

Supports customers with innovative machine concepts and reducing carbon footprints in the production stages.

3

Advancing digitalisation opening opportunities for establishing a circular economy.

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The only plastics machinery manufacturer to be included in the list

10:2020 Masterbatch specialist Americhem announces Controlled Polymers acquisition

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ontrolled Polymers is based in Ribe, Denmark, and supplies sustainable polymeric solutions to some of the largest healthcare OEMs in the world.

This acquisition expands Americhem’s global reach with increased product offerings, extended service capabilities, and broadened technical expertise. In particular, Controlled Polymers has built deep subject expertise in medical compounds

and masterbatch through strategic customer partnerships.

CEO of Controlled Polymers, Mogens Larsen, said: “We are delighted to join the Americhem family and specifically Americhem Engineered Compounds. Our companies’ customers will continue to experience the same dedicated quality and service as always, but with an expanded global reach.”

PROTOLABS LAUNCHES PODCAST SERIES

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he manufacturer has announced a new podcast series which aims to help listeners master digital manufacturing. The series titled, ‘Insight Podcast’ will provide guidance on how to design better parts, how to choose the right 3D printing

© Controlled Polymers

CHILD-PROOF PACKAGING FOR MEDICAL CANNABIS Pharmaceutical packaging specialist Sanner GmbH has developed a new patented 26

tablet dispenser manufactured on a CX 160 injection moulding machine from KraussMaffei.

The PP container is manufactured with its lid in a small-series mould. The thin arms of the lid, which end in the two child-proofing press buttons, are especially tricky to manufacture. They must be charged with extreme precision

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material, optimising design for CNC machining, and surface finishes for moulded parts.

Episodes are currently available to listen to on demand on the company’s website.

in order to achieve the desired press resistance for opening.

Hubert Mathes, Head of Technical Operations at Sanner, said: “KraussMaffei has been our reliable partner in the field of injection moulding machines for many years.

Above all, we appreciate the competent support with process engineering design and the commissioning of machines.”

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

IDEAL FOR INTEGRATION INTO ROBOTIC CELLS AN OPTIMUM SINGLE-PIECE FLOW SYSTEM BLISTER PACKAGING FOR MEDICAL DEVICES SEE US AT

SEE US AT

COMPAMED Messe Dusseldorf, Hall 8a, Stand K38.

16-19 Nov 2020

MED-TECH INNOVATION Hall 1, Stand F9 29-30 June 2021

shawpak Riverside Medical Packaging, Newmarket Drive, Derby. DE24 8SW. T +44 (0) 1332 755622 | F +44 (0) 1332 757722 W www.shawpak.co.uk | E sales@shawpak.co.uk