MPN NA Issue 20

NORTH AMERICAN EDITION

Medical Plastics N E W S

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I N T E R N A T I O N A L

Busting the myth Going green and nuance surrounding “single-use”

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FIGHTING PHARMA FAKERS MED-TECH INNOVATION EXPO FOR MPN READERS DELIVERY SOLUTIONS FOR VACCINES

ISSUE 20

Jan/Feb/Mar 2022

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ADVANCING MEDICAL PLASTICS

CONTENTS MPN North America | Issue 20 | Jan/Feb/Mar 2022

Regulars

Features

3 Comment Ian Bolland introduces you to the new Medical Plastics News International edition.

7 Injection molding Sumitomo (SHI) Demag explains how thin wall molding can help fight pharma fakers.

4 Digital Spy Rounding up some of the latest industry news.

15 Cleanrooms Connect 2 Cleanrooms and Optimold explain how modular cleanrooms support manufacturing process control for medical plastics.

10 Cover story Ian Bolland speaks to Solvay on pandemic challenges and the need for a more nuanced conversation around single-use devices.

26 Med-Tech Innovation Expo A brief overview as to why readers of Medical Plastics News should attend Med-Tech Innovation Expo in June.

32 Q&A Essentium’s CEO explains how a recent acquisition can bring changes to the industry.

20 Adhesives Intertronics explains the considerations when designing light curing adhesives into medical device assembly.

24 Extrusion Benvic outlines how recent acquisitions has given the company a foothold in extrusion.

30 Making drug delivery devices BD explains the company’s practices when developing drug delivery components for the COVID-19 vaccine rollout.

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editor | ian bolland ian.bolland@rapidnews.com advertising | caroline jackson caroline.jackson@rapidnews.com advertising | christine joinson christine.joinson@rapidnews.com

Editor’s Comment

advertising | victoria dunsmore victoria.dunsmore@rapidnews.com

IAN BOLLAND

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

NEW BEGINNINGS, NEW CHALLENGES

head of studio & production | sam hamlyn graphic design | matt clarke publisher | duncan wood Medical Plastics News NA Print subscription - qualifying criteria US/Canada – Free UK & Europe – £249 ROW – £249 Medical Plastics News Europe Print subscription - qualifying criteria UK & Europe – Free US/Canada – £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 © 2022 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.

ISSN No:

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ello and welcome to the first edition of the new, international version of Medical Plastics News. It’s a new magazine for 2022, with a new editor at the helm, but you have me for one issue only. I will be handing over the reins very soon to someone else to look after you and bring you the latest news and insights from the industry for what I hope will be a good while longer.

I hope that the pandemic has proved that the term ‘single-use’ shouldn’t be treated as if it’s the devil’s work in some ways. One interview which features in this issue shows that a couple of studies show your greenhouse gases output can be just as high, if not higher, in certain reusable devices – and that there is room for a more nuanced discussion around ‘single-use’.

You might have heard and read my musings on our sister title Med-Tech Innovation News and The MedTalk Podcast, so I will keep this one as brief as possible.

That shouldn’t all take away from the need to be more sustainable and look for ways to continuously improve what the medical plastics industry has to offer. But there is no need to demonise medical plastics, and the wider industry, as it looks to develop solutions that are more sustainable and have a more positive impact on the planet. There are plenty of examples of it being a force for good, and hopefully this year it is highlighted a lot more, including at this year’s Med-Tech Innovation Expo in June.

But I would like to doff my cap to all of those who have worked in the medical plastics industry throughout the pandemic. Though our publication, and the industry, to many will be regarded as niche, it’s hard to argue against it becoming that little bit more mainstream over the last couple of years.

Monitoring our vital signs, testing for an infectious disease that has taken the lives of so many and those working to deliver the therapeutics to aid us to return to some semblance of normality are all things that we have become a little more accustomed to. It’s hard to come across someone who has not interacted with medical plastics during the course of the pandemic, albeit indirectly.

As the world tries to move on, with some governments taking the approach that living with Covid means that they will try to pretend it doesn’t exist, there will be the continuous demand for the industry to play its part while dealing with the buzz word of the last few years: sustainability.

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DIGITAL

TOOLING UPDATE

spy

www.guill.com

INSPECTION UPDATE

GUILL RECIPROCATING HEAD CHANGES PROFILE

www.visioneng.com

Vision Engineering launches 4K digital microscope

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ision Engineering has launched its first 4K resolution digital microscope, Makrolite 4K. Makrolite 4K provides fine detail with greater detail shadow and highlight areas, suitable for inspection routines, including on rubber and plastic.

The console configuration provides direct HDMI connection to the monitor for live display. Connecting Makrolite 4K to a PC with Vision’s dimensioning software, ViPlus, extends its capabilities to include image capture, annotation, on-screen measurement, live

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overlays, data/image report generation and image processing tools Paul Newbatt, Vision Engineering group sales and marketing director, said: ‘’Makrolite 4K represents a step forward for Vision Engineering in terms of inspection microscope image resolution.

“It retains the core Vision Engineering values of superb image quality combined with ease of use, and also adds 4K resolution, a choice of console or PC versions, and range of five stands, to deliver a really flexible inspection solution.”

uill Tool, a global manufacturer of extrusion tooling, has released its new reciprocating head. The traditional tip and die assembly is replaced with a linear reciprocating assembly that changes the tube’s profile within a given length. This process is repeated throughout a single extrusion run without interruptions. Cutting capability, in association with the extrusion speed, cuts the finished product to length.

While cost and value stream activities are reduced, it aims to improve quality. Only one

extrusion run is needed to produce a finished product, as opposed to multiple extrusion runs with tooling changes along with a manual assembly operation to connect different tubing shapes.

Guill’s reciprocating head eliminates an assembly operation.

It also eliminates in-process inventory. Thus, there is no need for storage of various tubing shapes and connectors needed for assembly, fulfillment of orders and replenishment of finished goods.

COATINGS UPDATE

www.sparthamedical.eu

Spartha Medical receives €2.4m investment

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partha Medical, a French medtech company specialized in developing multifunctional antimicrobial, antiviral and anti-inflammatory coatings, has received €2.4 million ($2.75 million) in grants and an additional undisclosed equity financing from the European Innovation Council (EIC) Fund.

The company’s coatings for medical devices offer antimicrobial, antiviral and

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anti-inflammatory capabilities – including against SARSCoV-2.

Spartha’s innovation is a non-antibiotic-based solution, derived from natural biopolymers that make it biocompatible and applicable to all surface types.The antibacterial effect occurs by contact on the polymer coated surfaces. The coating can be used on medical devices without affecting their primary function.

Dr Nihal Engin Vrana, CEO of Spartha Medical, said: “Spartha Medical is thrilled to have the support of the EIC fund, which we will use to launch clinical trials, strengthen our infrastructure and hire new talent. We are set to achieve the necessary regulatory compliance steps, including ISO certification, as well as start researching the next generation of coatings.

These will propel us to the forefront in preventing postoperative infections and in fighting against resistant bacteria. By consolidating our current co-development programs and partnerships and the development of new

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business opportunities, our aim is to become the market leader in customized coating development services, using a platform supported by Artificial Intelligence.”

DIGITAL SPY

BIOPROCESSING UPDATE

www.dupont.com

EXTRUSION UPDATE

DuPont launches online portal for bioprocessing players

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uPont has launched a new online portal tailored to the needs of bioprocessing industry purchasers.

DuPont’s bioprocessing solutions enable sophisticated purifications and separations for therapeutics

and diagnostics, with brands such as DuPont AMBERCHROM and DuPont AMBERLITE being established in the biopharma industry. Its products are used to purify process streams during drug and diagnostic kit manufacturing.

The e-store is created in collaboration with DWS Advantage, a Xenon arc entity.

Alyssa Cunnington, COO at Xenon arc, said: “The addition of this new store to the DWS Advantage online site is an exciting development for both Xenon arc and DuPont. Adding the Life Sciences product offering to the DWS Advantage online store speaks to the quality and integrity of DuPont’s leading product portfolio and will enable us to better address the complex technical and service needs of bioprocessing customers.”

DISTRIBUTION UPDATE

www.medovate.co.uk

The new XP Expres® - AGT rollstand for extrusion sheet and cast applications.

www.davis-standard.com

Davis-Standard introduces multi-use XP express - AGT roll stand

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MEDOVATE AND MERCURY STRIKE SAFIRA DISTRIBUTION DEAL

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edovate has entered into an agreement with Mercury Medical for exclusive distribution of the FDAcleared device SAFIRA (SAFer Injection for Regional Anesthesia) across the whole of the United States.

The agreement also includes the SAFIRA Palm Operator which has been launched in the US market to offer anesthesiologists more versatility and choice when using the SAFIRA regional anesthesia system.

clinicians in both airway solutions and anesthesia – a philosophy that aligns very well with Medovate and SAFIRA. We are excited to this partnership with them as primary distributor of our SAFIRA system in the USA and look forward to entering this next phase of our journey.”

Stuart Thomson, managing director of Medovate, said: “As our company grows, it has been our vision to centralize our USA distribution with a primary distributor to streamline processes and provide a single contact point for clinicians in the US interested in SAFIRA. Mercury Medical have positioned themselves as a US leader in providing technological advances for

avis-Standard has announced the introduction of the XP Express - AGT (Active Gravity Touch) roll stand for both sheet and cast extrusion. The AGT model features greater automation and process control for the full range of sheet (nominal 8 to 60 mil) applications.

Processors benefit from technical and bottom-line advantages of the roll stand’s inverted-down, multiroll design. This arrangement facilitates improved die nip management and handling, efficient web cooling and conditioning capabilities, precision roll drive control, and high-performance web path options.

The XP Express AGT addresses low melt strength resin delivery from die slot to nip and expands the processing of thin gauge sheet.

Steve DeAngelis, Davis-Standard’s vice president of sheet and foam, said: “The XP Express - AGT is our most versatile and operator-friendly roll stand model yet. It builds upon the sustained success of our existing product line to offer more automation and roll control along with smarter ergonomics and a space-saving footprint. This design is also engineered for both sheet and cast extrusion to give processors flexibility to support more applications, especially in rigid and flexible packaging.”

The XP Express - AGT is currently available in widths from 36 to 80 inches (900 to 2,000mm) and with process rates up to 5,500 pounds per hour.

Processors can choose among three AGT roll stand options depending on specific requirements.

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Medtech | Digital HealthTech | Medical Plastics | Manufacturing | Software | Inspection and Metrology Regulation | Design | Early-Stage | Innovation | Pharmaceutical | Manufacturing

MED-TECH INNOVATION

8-9 JUNE 2022 NEC | BIRMINGHAM | UK

Co-located Shows

Medical Device Supply Chain Intelligence

INJECTION MOLDING

SUMITOMO (SHI) DEMAG EXPLAINS HOW USING THIN WALL MOLDING TO APPLY THE LATEST INJECTION MOLDING PRECISION TECHNIQUES TO STEP UP THEIR FIGHT AGAINST PHARMA FAKERS TO MITIGATE RISKS AND SAFEGUARD BRAND INTEGRITY.

FIGHTING PHARMA FAKERS

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harmaceutical safety demands traceability. Yet, even with stringent serialization standards and covert technologies like barcodes, holograms, sealing tapes, and radio frequency identification devices to preserve the integrity of the pharmaceutical products, counterfeiting remains a multi-billion-dollar industry with bootlegging of devices and falsification of medicines and wellbeing products rife.

However, these are the visible parts that are being detected. The dark web is a whole different story with the repackaging of medicines resulting in even more complex and covert criminal channels.

The pandemic added further to these pressures. High demand for PPE, test kits, broken supply chains and fewer physical audits amplified the risks of opportunists and illicit trade networks. The impact was significant reports the OECD. Enforcement authorities reported a sharp uptick in seizures of all types of medical products.

During the height of the pandemic, the World Customs Organization supposedly seized 200 Covid-19-related products. In addition, the EU purported countless examples of substandard products, non-compliance and falsified certificates of conformity.

Packaging specialist at Sumitomo (SHI) Demag UK Ashlee Gough examines how specialist closure and thin wall molders can apply the latest injection molding precision and In Mold Labelling (IML) techniques to step up their fight against these pharma fakes to mitigate risks, safeguard consumers and protect brand integrity.

The economic cost of IPR infringement is huge and extends right across the world. In their most recent report, the European Union Intellectual Property Office (EUIPO) put the annual cost of fake medicines at €10.2 billion per annum. Equating to approximately 4.4% of sales across the sector in Europe alone.

These lost sales convert into direct employment losses. The EU calculates it at nearly 38,000 jobs. Although this doesn’t factor in imports. Nor the trade in counterfeit products via non-EU channels.

THE DARK WEB Notably, the pharma and perfumery sectors incur the highest propensity for e-commerce infringements. As testimony to the scale of the situation, Interpol’s Operation Pangea XIV in May 2021 shut down more than 100,000 online market places, with over 70% of seizure cases at EU borders relating to Internet sales.

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It’s not just brand revenue through lost sales that suffers from counterfeiting. Illicit medicines can contain lethal ingredients, such as mercury, arsenic, rat poison or cement, which can be harmful when consumed. Others can just be ineffective. Lower quality cosmetics may cause skin inflammations.

Causing consumers to lay the blame on authentic brands and diminishing brand equity.

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INJECTION MOLDING

Despite these widespread dangers, another survey of senior food and drink execs by assurance specialists The Lloyd’s Register, revealed that during the pandemic only a third vetted suppliers against a recognized GFSI standard. One in five declared that no checks were made as part of sourcing decisions.

Yet, despite these prevalent risks – 97% stated that they’d been affected by fraud in the last 12 months - few in the industry regard authenticating products as their highest priority.

REGAINING CONTROL In a concerted effort to crackdown on groups profiting from illicit pharma, wellbeing and cosmetic products, manufacturers are making labels more difficult to copy and bottles harder to refill. “One way to counteract counterfeiting and product tampering is through the innovative design of packaging that cannot be easily copied,” highlights Gough.

“Until recently, this may have involved putting shrink or foil sleeve around a pack or bottle, for example. Closure molders especially are stepping up their efforts and investing in dedicated cells to produce high quality and anti-refill closures made up of a number of complex parts.” Due to the intricacy of these closures, molding precision is paramount.

Any steps that brands can do to curb counterfeiting and protect trademarked brand integrity by making packaging harder to replicate or refill will be welcome. The ultimate goal will be to create an unbroken chain of traceability Significant investment in high quality tooling, automation, machinery, and expertise can be another major deterrent, highlights Gough. “Realistically, few counterfeit operators would make the level of investment required to replicate this level of technical precision.”

Other overt packaging methods to deter counterfeits include concealing unique identifiers, such as a QR code, holograms, or tags within the IML. Another challenge for closure molders supplying the pharmaceutical and wellbeing sectors is balancing the protection of consumers with usability.

As well as child resistance (CR) closures, pharmaceutical companies need to provide for senior friendliness. The result is a significant investment by premium packaging suppliers in sophisticated valve technology to control the dispensing of product, while also preventing containers being refilled.

“Many new and innovative CR packaging concepts utilize complex and sophisticated opening mechanisms, such tamper evident bands on custom closures that requires pressure being applied to two points,” notes Gough.

To outsmart quick-witted counterfeiters, manufacturers may consider using several tactics simultaneously to prevent brand value being diluted, including, secure closures, snap buttons, barcoded labels and batch codes, and even chemical markers.

Use of infrared and ultraviolet (UV) light, microscopic tagging, molecular markers, and biological tracers are also being deployed. These technologies can be identified by customs and enforcement agencies using laboratory equipment.

For mainstream packaging molders producing thin-walled containers, caps and closures by the millions, cost effectiveness nevertheless remains vital. Sumitomo (SHI) Demag’s El-Exis SP range typically achieves between three and five percent more productivity when benchmarked against other packaging machines on the market.

Now in its fourth generation and always aligned to evolving market trends, the EL-Exis SP series is designed to withstand the higher stresses and injection pressures that are so critical in achieving repeatability in complex closures and thin-walled packaging products, while maintaining comparable mechanical properties.

Given the overwhelming popularity of e-commerce, the risks of counterfeiting are more real than ever. “Any steps that brands can do to curb counterfeiting and protect trademarked brand integrity by making packaging harder to replicate or refill will be welcome. The ultimate goal will be to create an unbroken chain of traceability,” ends Gough.

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COVER STORY

IAN BOLLAND SPOKE TO ANNA-MARIA BERTASA, GLOBAL MARKET MANAGER – HEALTHCARE, SOLVAY, ABOUT NAVIGATING THE PANDEMIC AND THE FOCUS ON SUSTAINABILITY IN THE MEDICAL PLASTICS SECTOR.

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ith a company that is exposed to so many different markets, it’s fair to say that Solvay has had something of an up-and-down period during the pandemic.

“At the beginning of the emergency there were lots of projects we had been working on at a very fast speed, like trying to help with the emergency.

We provided transparent films for the production of face shields and other protective equipment, and we had to face an exponential surge of the demand for a product that is utilized in the production of ventilators, as a lot of customers had to produce, very quickly, a huge number of these devices.”

Many different parts of the economy in several countries suffered as the pandemic took hold and everyone’s habits had to change because of Covid-19.

Solvay’s role in ventilation production involved supplying specific polymers, Radel PPSU and Udel PSU, to customers that expanded the production of their already approved devices so they could get to the front-line more urgently.

Companies who develop materials, components and devices for the healthcare setting naturally experienced a spike in demand of certain products at the start of the pandemic, as Anna-Maria Bertasa explains.

Though many would feel that the pandemic would mean a huge spike in demand for healthcare applications, Bertasa mentioned there was a significant decline of consumption in the orthopedic space, as non-lifethreatening procedures were postponed or canceled to tackle the health emergency, which is being slowly recovered.

After the first emergency wave, another significant trend that Solvay experienced was the 40-60% growth of the biopharma sector linked

Busting the myth Going green and nuance surrounding “single-use”

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COVER STORY

I see huge potential for us to be a leader in the future as well in sustainability, helping in partnership with customers in the value chain to improve that aspect as well

to the production and development of vaccines and therapeutics for facing the pandemic challenges. The company currently supplies high performance materials that are used to produce single-use components for biopharmaceutical processing.

Reflecting on the years prior to the pandemic, Bertasa highlights the role and features that thermoplastics have had in medical devices, and the properties that make it stand-out from other materials.

“Since Solvay started supplying polymers into the healthcare market segment, we’ve seen high performance thermoplastics stepping forward from previous materials like metal and glass thanks to a combination of features that enables technology innovations in healthcare.

“Compared to metal, they are lightweight first of all, so an instrument can be much more light and easier to handle for helping the work of healthcare professionals. They have more flexibility in the design, while offering comparable strength and stiffness with metal. On top, they offer features like transparency and colorability that are not possible with metal.

“They still provide the safety that you need in terms of biocompatibility and sterilization. All in all we could actually see a lot of examples where certain devices have been innovated because of thermoplastics.

“Elasso Surgical Instruments developed a device for tonsil and adenoid removal. The device used to be made with metal, but that company was able to make a complete innovation step to include new features in the device thanks to thermoplastics. For instance, in the past the device was only cutting tissues now the device can also cauterize the tissues with an electrical connection that can burn the tissues at the same time. The blue color of one part of the device helps to quickly identify where the electrical connection is located. In addition, it’s lightweight for the doctor and the ergonomic shape of the device itself are additional features that enhance the overall user experience and satisfaction.”

While cost is also a factor, enabling more medical devices to be made cheaply, the properties of certain thermoplastics can also mean they are as robust as metal devices. Solvay highlighted an example with the Zillion Black surgical instruments in 2019 with the use of its Ixef PARA material.

With sustainability, recycling, and better practices all goals that companies are trying to strive for, plastics have probably been targeted for their singleuse devices. While the name might suggest this is an area that provides more waste for the planet, it is in fact more nuanced – especially when you factor in all the aspects that contribute to the overall sustainability assessment of a technology or a device: the type of device that is being used, transportation costs and the amount of energy that is used in the sterilization of reusable devices are all factors that have to be taken WWW.MEDICALPLASTICSNEWS.COM

into account, on top of safety considerations about the infection control and flexibility of scheduling last-minute surgeries that are allowed by single-use instruments.

Bertasa explains that studies have been performed and results published show that specific examples of single-use surgical devices and single-use components of biopharma processing are more sustainable than their respective reusable equipment and sweeping statements about single-use devices can be unhelpful.

As an example, a study by Solvay with Medacta in 2016 indicated a lower carbon footprint for a surgical instrument kit for knee replacements compared to the reusable kits.

“What I can say is for instruments we did that example, and it’s been published and clearly demonstrates it’s not granted that reusable is more sustainable than single-use.

“Every time you have to deal with sterilization, every time you save cleaning procedures, sterilization, re-packaging and transportation between the surgery room and the sterilization unit you actually save a lot of energy and water.”

Sustainability, says Bertasa, is a key part of Solvay’s strategy in the healthcare segment going forward.

“In healthcare it’s probably a little bit behind compared to other segments we are exposed to like consumer goods or construction but definitely I see huge potential for us to be a leader in the future as well in sustainability, helping in partnership with customers in the value chain to improve that aspect as well.”

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CLEANROOMS

AFTER RESTRUCTURING ITS BUSINESS GUARDTECH CLEANROOMS EXPLAINS HOW IT IS SET UP SO ALL OF ITS CLIENTS’ CONTROLLED ENVIRONMENT NEEDS ARE CATERED FOR.

5IVE WAYS to meet the needs of a

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diverse medtech market

t’s about growth, it’s about opportunity and it’s about delivering the best possible service to all our different types of clients in the diverse range of industries we cover. Five distinct divisions all delivering a five-star service.”

Commercial director Mark Wheeler has seen a lot of change over the past few years in the cleanroom design & build sector.

Even during a devastating pandemic, his team and the business have found a way to grow and develop, and the industry has found a way to continue to thrive.

With that, Mr Wheeler and his firm, Guardtech Cleanrooms, have launched the Guardtech Group, which will now act as the umbrella company for five businesses, each

contributing to an extensive portfolio of cleanroom-related products and services.

Guardtech Cleanrooms will now cater specifically for the modular cleanroom market, while CleanCube Mobile Cleanrooms will continue to provide portable solutions for businesses all over the world.

Isopod Rapid Cleanrooms will offer a quicker, more flexible and costeffective alternative – including the option for ‘flat-pack’ delivery and selfassembly installation.

There will be a new addition at some point in 2022, with Isoblok Pre-Fab Cleanrooms focusing on pre-configured ‘plug and play’ cleanroom units and pods constructed off-site.

The company has acquired controlled environment design & build firm Cleanroom Solutions, which will continue to specialize in larger turnkey construction projects under the new Guardtech Group banner.

Wheeler said: “They’d been a ‘friendly competitor’ of ours for many years and we always respected their core values – culturally the two businesses really fit. The relationship started out as us working together, but the idea of an acquisition seemed to make sense as we’re so closely aligned – it strengthens both brands.”

Mr Wheeler explains how Guardtech has grown “organically” over the past 20 years – and in that time product development and innovation had become core tenets of the firm’s philosophy.

“Those innovations have taken on a life of their own,” he adds, “developing in a way that they’ve become big enough to support their own divisions.

We felt that this restructure was the clearest route to show our customers that there is a distinct outline in the way each element of the Group is run, yet with some central themes. These derive from our ‘GUARD Charter’ – the overall ethos of the Group – which focus our minds to Guide, Adapt, Understand, Respond and Deliver the best possible service for our clients.”

What does this mean for medtech?

These developments are set to have a huge impact in how the Guardtech Group, and its subsidiary companies, will serve the medtech market over the coming years.

Guardtech Cleanrooms has served clients in the sector over the past 20 years, including the likes of Zimmer Biomet, SFM and Contamac.

Wheeler believes that by restructuring the different elements of the Guardtech Group into more defined, customer-specific entities, it will give

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CLEANROOMS

“Across all the divisions, our approach is consistent,” says Mr Wheeler.

“Client-focused problem-solving. With any of the business, we’re always looking to deliver all of the values that the GUARD charter embodies.

This is the same for medtech as it is for any industry we might serve.

“We’re tackling different types of construction using the same quality standpoint and intellectual property.

We wanted to compete with what was out there in the market without giving up the quality mark that’s a key component of our heritage modular builds.

them the best opportunity to serve their diverse client base more effectively than ever before.

“In terms of the medtech market specifically, this move gives us the platform to cater for any size client with any type of application,” he continues. “With CleanCube, our mobile cleanroom solution, units are being used by medical device manufacturers all over the world who didn’t have the space in their existing site to continue their operation – some are literally in car parks, offering users a cleanroom or laboratory on a site where they simply weren’t able to build something more substantial.

“Our Isopod Rapid Cleanrooms are being deployed by a number of R&D applications and companies looking for proof of concept, as well as smallscale manufacturing, testing and niche product batches.”

The acquisition of Cleanroom Solutions allows the Guardtech Group to expand its more complex turnkey construction projects for medtech companies, with the company’s previous clients including the likes of ApaTech, ClearLab, Leica, Lombard Medical, Oclaro Technology, Stanmore Implants and Sterimedix.

But the Group’s biggest and most fruitful area of business, in regard to medtech specifically, has been modular cleanroom construction, with a list of clients including UltraVision, NCC, NES, Wesley Coe and, recently, the likes of BioPharma Dynamics and GA Health in Ireland, where they worked with NSP Expert Lab Solutions.

Building for the future Despite the restructure, the key elements of a Guardtech project will always remain the same.

The medical device industry is growing at a rapid pace domestically and abroad, and we’re keen to apply our design philosophies to deliver a product that can be built by our own teams in the UK WWW.MEDICALPLASTICSNEWS.COM

“It was vital to us that Isopod and CleanCube enhanced the brand and did nothing to compromise it.

The focus is on quality – we simply aren’t prepared to risk what we’ve established over 20 years of building quality cleanrooms.”

In the near future, Guardtech will turn some of its focus to developing its latest product group – Isoblok PreFab Cleanrooms.

Mr Wheeler says the guiding principle of this move is to provide a quality product for use in territories outside the UK which bear the same hallmarks of quality for those being used for applications in the British Isles.

“The medical device industry is growing at a rapid pace domestically and abroad, and we’re keen to apply our design philosophies to deliver a product that can be built by our own teams in the UK and shipped worldwide,” he adds. “The idea is to offer a high-quality product in territories where suppliers and providers are sparse – we can help improve the quality of applications in other territories, benefiting them and us. As part of this exercise, we recently donated a CleanCube mobile laboratory to the Ugandan Army (the Uganda People’s Defence Force) to help with the vaccine rollout there.”

With a pandemic that continues to cause chaos and many other tests and difficulties on the horizon, it won’t be plain sailing for the cleanroom industry and beyond, but the Guardtech Group feels it can deliver a five-star service, whatever new challenges come its way.

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CLEANROOMS

JENI THOMAS, CONTENT AND COMMUNICATIONS LEADER AT CONNECT 2 CLEANROOMS (C2C), AND ALISDAIR WATSON, MD AT OPTIMOLD LIMITED, EXPLAIN HOW MODULAR CLEANROOMS SUPPORT MANUFACTURING PROCESS CONTROL FOR MEDICAL PLASTICS.

Modular cleanrooms supporting PROCESS CONTROL FOR MEDICAL PLASTICS

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here are certain challenges that plastics manufacturers face when producing molded parts for medical devices. Controlling air quality with a modular cleanroom protects the production of medical plastics.

The injection molding process—in particular the material conveying equipment—naturally creates a degree of particulate contamination.

When molded parts are removed from the tool, the type of polymer and the process can also generate static, even with the use of an antistatic device. When combined, the particulate and static can cause problems for manufacturers who have tight AQL (Acceptable Quality Limit) sampling requirements. This is why the manufacture of medical devices must be performed within ISO 14644-1:2015 Class 5 to Class 8 cleanrooms.

CLEANROOMS AND PROCESSES ALIGNED TO CONTROL CONTAMINATION The way that the governing ISO standard looks at compliance is by minimizing the introduction, generation, and retention of particles. This can only be achieved through a partnership of cleanrooms and processes.

Cleanrooms stop the introduction of contamination through HEPA filtration.

Controlling the generation of contamination is then down to organizations’ SOPs, protocols, and process controls. The responsibility of controlling the retention of particles comes back to cleanrooms again as they effectively

flush that facility of contamination with appropriate air change rates.

Optimold Limited, the sister company to mold manufacturer Microsystems (UK) Limited, is a contract manufacturer producing injection molded components for medical devices, such as autoinjectors, asthma inhalers, drug delivery and blood diagnostics for both hospital and laboratory use.

Over the past decade, C2C has supported Optimold with modular cleanrooms to facilitate growth in the medical device market.

STARTING CLEAN PRODUCTION To stay competitive, companies need to be able to incrementally grow their cleanroom offering in line with the growth of the company.

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CLEANROOMS

When Optimold won its first contract for medical device parts back in 2011, one machine out of the five they had at the time needed to be enclosed in an ISO Class 8 cleanroom. Converting the entire room which housed these machines into a cleanroom and encapsulating the whole area into a single level of control would have required a huge investment. The higher overheads would inevitably have driven up the cost of the parts that didn’t require cleanroom production.

The solution was simple. C2C installed a localized cleanroom to house an individual machine. As contracts grow or new work is won, machines can be upgraded with a cleanroom accordingly and, as freestanding units, they can easily be retrofitted to molding machines.

Optimold now has 13 injection molding machines, of which seven are enclosed in modular cleanrooms. The modular cleanrooms create a clean environment to prevent contamination issues and, when combined with the controls put in place, they manage contamination well within the requirements of customers’ AQL criteria.

ENERGY EFFICIENCY Modular cleanrooms give flexibility within the production environment, whilst still providing the customer with a quality product.

Energy consumption in the manufacturing sector represents a huge proportion of overall consumption by industry and manufacturers need to do what they can to control usage. With the rising costs of energy, reducing energy consumption supports not only the environment but has a significant impact on overhead costs.

The primary cause of energy consumption within a cleanroom is the operation of the HVAC system to deliver the level of compliance. Using a localized approach to create clean environments, there is no overprocessing of air. Only the zone that needs to be controlled has the high air change rates required to deliver the particulate concentration limits according to its ISO class.

MOBILE CLEANROOMS OFFERING PART COVERAGE Part coverage of an injection molding machine means only the mold area and clamp end are covered by a cleanroom, leaving material conveying equipment external to the controlled environment.

The material conveying equipment can create a degree of particulate so separating it from the clean area makes a big difference to the overall cleanliness of the environment. In turn, a reduction in contamination generated within the cleanroom reduces the number of air changes that are required to keep within its classification. If machines were fully enclosed, a different method of conveying would have to be utilized.

Having the cleanrooms on castors means they can easily be wheeled away from the machine to give access to change tooling easily.

TEMPERATURE AND HUMIDITY CONTROLS Temperature variation can cause inconsistencies so certain products will run better when the process is kept at a consistent temperature. As Optimold have several injection molding machines in the same white room area, the external room is temperature-controlled. Each cleanroom features a ceiling-mounted HEPA fan filter unit that intakes air from the controlled surrounding environment. This keeps the temperature at acceptable limits within the cleanrooms.

Additional heat gains from operatives will affect this ambient temperature. For the most part, operators only need to enter the cleanrooms periodically to package parts or take samples for inspection, so this approach to HVAC delivers the appropriate parameters.

There is one unit, however, where a small amount of secondary work on components is performed within the cleanroom by an operator. Here comfort cooling is supplied to the cleanroom by a localized air conditioning unit. This unit supplies the cooled air to the fan filter unit, to provide terminal HEPA filtration and ISO compliance.

WHEN TO INVEST The build of a new cleanroom can generally be delivered within the lead times of a new mold, so modular cleanrooms are fully scalable without the need to speculate to accumulate.

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CLEANROOMS

MIKE RUST, GLOBAL DEVELOPMENT MANAGER – T-FIT INSULATION AT ZOTEFOAMS, CONSIDERS THE ISSUES AND DESCRIBES A TEST PROTOCOL DEVELOPED TO MEASURE THE PARTICULATE CONTRIBUTION OF THREE DIFFERENT TYPES OF INSULATION DURING TYPICAL CUTTING AND FITTING OPERATIONS WITHIN A CLEANROOM.

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hile standards and specifications abound when it comes to the design features, apparel, and operator protocols necessary to minimize particulates as a contaminant in cleanrooms, there is little consideration of the part played by materials such as those used for insulation.

Wherever cleanroom manufacturing happens, the environment must be designed to ensure the safety and quality of products. Cleanroom design minimizes the introduction and circulation of potential contaminants, with control of particulate emissions essential to maintaining a secure, clean environment.

The construction of the cleanroom shell is subject to exacting engineering standards and specifications to maintain air quality in terms of particulate release. In 2016, ISO 14644, the recognized standard for cleanrooms, was expanded specifically to include the “assessment of suitability for use of equipment by airborne particle concentration” — although it did not extend to such important matters as the selection, testing or ease of cleaning of selected materials.

as it is removed to facilitate pipeline maintenance and repair. And it is during removal that traditional thermal insulation products can pose the most danger in terms of emitting potentially hazardous particulates into the cleanroom environment.

Absence of independent testing So far as we can ascertain, there are no recognized independent tests that compare the particulate-emission performance of different insulation materials commonly used in a cleanroom — a situation that is no help to those charged with specifying appropriate insulation solutions.

Thermal insulation — important but overlooked Amid all the attention paid to preventing, monitoring, and controlling particulates, one important aspect is often overlooked: the impact on particulate levels of the thermal insulation that controls the surface temperatures of process pipework and HVAC equipment in and around cleanrooms while conserving energy and providing personal protection for operators.

With all the above in mind Zotefoams commissioned Occhnet, an occupational hygiene consultancy based in the UK, to design and conduct an independent test of T-FIT Clean foam insulation, produced from Zotefoams’ ZOTEK F highperformance PVDF closed cell foam. T-FIT Clean’s performance was tested against two traditional insulation products, manufactured respectively from foil-backed stone wool and flexible open cell melamine with a PVC jacket. The

Whatever type of insulation is selected, during installation it will have to be cut to size and very likely manipulated to fit complex pipework runs in tightly confined spaces — all happening in situ. Post-installation, thermal insulation is not simply ‘fit and forget’: it is typically checked regularly

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CLEANROOMS

testing measured the indicative concentrations of particulates released into the air during cutting of the material. The testing replicated the worst-case scenario — that of operators slicing and/or cutting the insulation within the cleanroom —simulating cutting-to-size operations during installation and replacement maintenance.

Each sample insulation material was placed into a sealed glovebox containing a particle counter. This ensured that, once the test samples and testing equipment were inside, no further particulate could be introduced. The glovebox did not contain an air exchange or filtering system.

To allow for the stabilization of the background particulate reading, the procedure started with a two-minute static period where there was no movement within the glovebox. Once that static period was completed, each test piece was subjected to three cuts at 90o and three at 45o. Cutting lasted one minute in duration, followed by a further two-minute static period.

To measure any increases in background particles within the glovebox, differential µg/m3 readings were taken at particulate sizes of 0.5, 1.0, 3.0, 5.0 and 10.0 µm, at a flow rate of 2.83 l/m.

The results Measurement and comparison between the three materials produced results worthy of consideration by those charged with cleanroom design and operation.

T-FIT Clean: As Figure 2 (above) shows, the particle count fell steadily through the first two minutes of the static period. During cutting and manipulation and in the final two-minute static period there is a continued gradual decrease in particle count, indicating that T-FIT Clean does not emit particles within the measured particle size (0.3 to 10 micron). Occhnet concluded that “there was no detectable release of particulate during the cutting period.”

Flexible open cell melamine: When this typical melamine product, often installed in cleanrooms, was cut and manipulated, there was a significant increase in background particulates, indicating the materials added large amounts of particulates into the environment even before it is cut. Occhnet observed that a clean cut was difficult to achieve without compressing the material, which released air from the open-cell construction, coinciding with the rise in particulate count.

Foil-backed stone wool material: The particle count was stable during the static period but as soon as cutting commenced the particle count rose significantly, and particularly for larger particles. According to Occhnet, while a clean cut was possible without compressing the sample, “the material appeared friable and the rise in count was indicated to be associated with the cutting of the material.”

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It should be noted that this material incorporates a glue binding the fibers together, which is likely to deteriorate when the material is used in hightemperature applications, raising the prospect of particulate emissions increasing over time.

A different manufacturing process T-FIT Clean’s control of particulate emission lies in its three-stage foam manufacturing process that uses pure nitrogen as a foaming agent and produces materials with a consistent, fine closed cell structure.

In Stage 1, pure PVDF polymer is extruded into a solid slab, then irradiated to create chemical bonds that join the polymer chains (crosslinking). This results in excellent thermal stability, high strength and toughness compared to non-crosslinked materials, and crosslinking via irradiation also prevents the shrinkage that is often associated with thermoplastic materials. Stage 2 applies extremely high pressures and temperatures to dissolve the nitrogen gas into the slabs. In Stage 3, the nitrogensaturated slabs are put through a second, high-temperature, lowerpressure cycle where the pressure is gradually released to allow the free expansion of the material into sheets of foam.

The result is a fine, completely closed cell structure that demonstrates exceptional performance across the board, not just in limiting particulate emissions but on all measures of cleanroom insulation efficiency.

T-FIT Clean is also highly resistant to bacteria and mold growth and its ASTM G21-tested performance on zero fungal growth brings long-term protection against the risk of product contamination. Compared to open cell materials, T-FIT more effectively limits moisture and gas penetration because there is no continuous network through which substances can travel.

A wide temperature operating range — from -80oC to +160oC — combined with the durability of the material ensures thermal performance remains unimpaired in the long term, even where repeated cycling between chilled process temperatures and high cleaning temperatures (clean in place, sterilize in place) is involved.

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ADHESIVES

PETER SWANSON, MANAGING DIRECTOR OF ADHESIVES SPECIALIST INTERTRONICS, EXPLAINS THE CONSIDERATIONS WHEN DESIGNING LIGHT CURING ADHESIVES INTO A MEDICAL DEVICE ASSEMBLY.

Designing in light curing adhesives: A holistic approach to adhesives in medical device assembly

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aking a holistic view of designing in adhesives during the early stages of a project will result in a better production process. This involves considering the bonding method and materials at the design stage, including everything from substrates to joint design, surface preparation, quality control, application, and cure.

Considering options in any one of these can help optimize the final build process — a small variation can open the door to a different adhesive technology and a large process gain.

Generically, UV curing adhesives are resilient and tough — with high tensile, shear, and peel strength, and a cured hardness range of shore A80 to D80.

Medical device manufacturers can consider them as a structural bonding agent for multiple substrates, from glass, to metal, to many types of plastic, including those used in certain medical device assemblies like PEEBAX or PEEK. These adhesives are tested to ISO 10993 and USP Class VI and are compatible with typical sterilization methods.

Light curing adhesives are extensively used in medical device manufacturing due to their process advantages, finding applications in products like catheters, syringes and needles, anesthesia masks, reservoirs, tube sets, and medical electronics assembly. One key benefit is that they cure in seconds, “on demand”, on exposure to the correct wavelength of UV light. They reduce the need for jigs and tooling, reduce work in progress freeing up factory space, and are single part which means no mixing and reduced waste.

Fastening options for medical devices include heat sealing, welding, solvent bonding, mechanical interlocks, and adhesives. The advantages of adhesives compared with alternative methods include the distribution of load or stress, the elimination of joint fatigue, improved impact resistance, and good aesthetics.

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DESIGN CONSIDERATIONS A recommended approach when designing a device which needs bonding is to consider both a) the functional nature of the bond (strength and robustness), and b) processability. Make sure that the adhesive application and cure is achievable within the constraints of the product geometry and production time. The highest possible strength adhesive bond will be useless if the bonding process turns out to be too expensive or takes too long.

To design in a UV light curing material, start with selecting bondable substrates.

This typically means avoiding very low surface energy materials like PTFE or polyolefins, although if these are desirable for functionality you can consider

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Most UV curing materials have poor adhesion to rubbers and silicones, although the latest hybrid cyanoacrylate/UV adhesives can be considered for these substrates surface treatment to improve wettability. Most UV curing materials have poor adhesion to rubbers and silicones, although the latest hybrid cyanoacrylate/UV adhesives can be considered for these substrates.

Another important consideration is bondline design. The adhesive needs some space of its own, so friction fit joints aren’t usually suitable – the adhesive will not work if it is squeezed out of the joint. Consider an optimal bondline gap of around 0.125 mm. However, UV curing adhesives are available in a wide viscosity range, from wicking and self-levelling grades to thixotropic pastes, and can cope with bondline variations and the need to gap fill if necessary.

Light of the correct wavelength must reach the entire bondline for the adhesive to cure — so in most cases, one of the substrates will need to be clear so that the bondline is visible. If this is not possible, there are products on the market that are dual cure, like Born2Bond Light Lock, which offers a cyanoacrylate surface cure as well as UV light curing, meaning the material will cure interfacially in opaque areas.

Many polymers contain UV blocking agents to prevent yellowing and embrittlement from ambient UV light. Adhesives which use a synergistic combination of UV and visible light to cure can be specified to ensure cure speed and depth for bonding these plastics.

IMPLEMENTATION UV curing adhesives are easy to implement due to their “on demand” fast cure, solvent-free single component formulation, and viscosity choice. They can be applied using a wide variety of dispensing techniques with repeatable precision and are readily automatable.

There are two main types of UV curing lamp, broad spectrum, and narrow spectrum (LED). LED lamps offer lower energy consumption, stable output intensity and instant on off, so are growing in popularity and have become the default choice.

Modern UV curing adhesives have been formulated to cure with the narrow spectrum of LED UV curing lamps, and many are wavelength specific. For example, Dymax MD 1405M-T-UR-SC needle bonding adhesive is optimized to be LED curable at 405 nm wavelength light. Adhesive choice needs to be considered in line with substrate transmission characteristics.

Yields are typically high because the process is very controllable and repeatable. Because cure happens rapidly, you can implement quality assurance procedures immediately after assembly, or even in-line.

Because there are few variables, locking down and validating the process is readily achieved.

Medical device manufacturers can gain both functional and process benefits from using light curing adhesives. To make the most of these benefits, consider how to implement them at the design stage, by specifying substrates and bondline design to facilitate their use.

Bonding with UV light curing adhesives is usually a robust, reliable, and validatable process, offering high quality and productivity.

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EXTRUSION

BENVIC OUTLINES HOW RECENT ACQUISITIONS HAS GIVEN THE COMPANY A FOOTHOLD IN EXTRUSION.

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BROADENING THE RANGE

envic, a PVC, technical, bio-based compounds, and medical fluid systems solutions provider, is enjoying increased penetration of the world’s medical and healthcare markets thanks to the extrusion expertise supplied by its Northern Italian subsidiary Modenplast.

Modenplast was a key component of Benvic’s showing at Medica/ Compamed 2021 exhibition in Dusseldorf, November 15-18, 2021.

PVC, naturally, has been our main ingredient for tubing, and Modenplast is now eyeing the prospects for TPE based medical products and manufacturing specific medical tubing solutions - one of the key value propositions that is now emphasised within Benvic Medical.

Modenplast is also providing ranges of medical polymer compounds, making the company a solution provider for medical tubing.

This was the first Compamed configuration for these two Italian companies together and under the Benvic Medical umbrella with Modenplast adding its extrusion and materials know-how to the injection molding forte of Luc & Bel.

Michele Brambilla, Modenplast managing director, stresses longevity and technical expertise as the key to Modenplast success.

Now fully integrated inside the Benvic Group, Modenplast is developing

“The manufacturing versatility of our company means that near enough any kind of medical tubing can be custom made for the needs of the client – from material specification, additives to issues of dimension, production and special application. PVC, naturally, has been our main ingredient for tubing, and Modenplast is now eyeing the prospects for TPE based medical products.”

Brambilla points out that Modenplast is “the producer of the compound, the tubing and is also able to provide certain components. With Benvic guidance and resourcing, this is an ideal strategy to build the best synergies and valueadded for our medical customers.”

Modenplast also specializes in the production of PVC and lay-flat tubing for the manufacturing of medical bags.

The extrusion process takes place in a cleanroom ISO Class VIII (EN ISO 146441) and uses automatic laser calibrators for continuous control of diameters. The equipment is connected to a printer for graphic displays of the measurements obtained.

The visual and dimensional inspection of the finished product is performed by the company’s Quality Control Dept. (according to ISO 2859-1) by using high precision digital calibre, calibrated plugs, and high precision profile projectors.

Brambilla said: “We can provide our customers, as in the past, with complete lines even for the coextrusion and for the production of tubing in PE. We are also able to manufacture tubing and formulate particular compounds according to customers specific requirements.”

Benvic’s acquisitions of Italian medical plastics processors, Modenplast (2019) Luc & Bell (2020) and Chemres (2021) have now turned the company into an integrated polymer company, meaning that Benvic Medical can supply extruded and injection molded medical products and devices as well as medical grades of polymer for the production of same.

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MED-TECH INNOVATION EXPO

IAN BOLLAND OFFERS SOME INSIGHT AS TO WHAT MEDICAL PLASTICS NEWS READERS CAN LOOK FORWARD TO AT THE MED-TECH INNOVATION EXPO IN JUNE.

Putting on a show A tour through a medical plastics eye

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fter a successful return following a Covid-19 enforced hiatus in September 2021, Med-Tech Innovation Expo will be returning on 8-9 June at the NEC, Birmingham, UK as part of Manufacturing Week – and there will be plenty on offer for those in the medical plastics industry.

Whether that’s specialist medical plastics companies, those who can help you connect with other markets, cleanrooms, injection molding specialists, distributors, or more; here we throw the spotlight on one or two aspects that readers of Medical Plastics News might be interested in.

INFECTION CONTROL Readers of the previous iteration of Medical Plastics News, and listeners to the MedTalk Podcast, will be familiar with Biointeractions.

Its commercial director Arjun Luthra has explained that it is trying to get a multi-action biocompatible coating adopted by the UK government, saying it can consistently protect medical devices for 100 days. He will also be delivering a seminar on infection prevention measures on Day 2 of the Expo. Given the events of the

last two-and-a-half years, this is a pretty timely topic that is sure to generate a lot of interest.

AN INTERNATIONAL FLAVOR It’s Med-Tech Innovation Expo’s third visit to the NEC which, given its location next to an international airport, makes the show that bit more connected to the wider world.

Bringing that international flavor to the trade show floor are the likes of Hessen Trade & Investment, an international hub for innovative businesses.

On Day 2 you can find out more about the opportunities offered in Hessen when Dr. Hendrik Pollmann, project manager, life sciences & biobased economy, delivers his seminar on the HealthTech/Introducing Stage.

There is also the opportunity to connect with the Economic Development Board of Mauritius, while companies from Germany, Switzerland, the Netherlands, and Hong Kong are just a flavor of the worldwide appeal of MedTech Innovation Expo.

CLEANROOMS, INJECTION MOLDERS, DISTRIBUTORS Guardtech Group is one of the cleanroom specialists on show and is returning this year with a new look having restructured its group following its expansion to five divisions, and marketing manager Joe Shackley told us that we can expect a new look from the firm from its appearance in 2021.

“It will be much easier for potential clients to visualize how our products and services relate to their needs going forward – whether it’s a comprehensive cleanroom build, modular cleanroom, controlled environment pre-fab pod, rapid cleanroom or portable cleanroom that they require, the Guardtech Group divisions make it super simple for customers to get what they need without any confusion.”

PACKAGING An important, albeit final part of the process, is the packaging part and there is no shortage of those specializing in this area this year’s show.

One such company is Shawpak, a company that is increasing its presence at this year’s event after a successful visit in 2021.

Lucie Markgraf, sales administrator at Shawpak, said: “Visitors can expect to see some of our range of thermoforming packaging machinery, we have three different size machines and a brand new four Side Seal Pouch machine.

Our machinery is compact and flexible, and this is so important to medical device manufacturers when cleanroom space is so expensive.”

TAKE TO THE STAGE Across two conference stages, Med-Tech Innovation Expo will be covering several topics and issues that are pertinent to the life sciences sector, including medical plastics.

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MED-TECH INNOVATION EXPO

Companies from Mauritius, Germany, Switzerland, the Netherlands, and Hong Kong are just a flavor of the worldwide appeal of Med-Tech Innovation Expo In a similar vein, the aforementioned panel session on Day One will analyze the common pitfalls that have led to recalls of medical devices relating to design, software, and materials.

The panel will feature experts who specialize in quality management and quality control checks with medical devices, and how to recall devices quickly – with the help of technology – should one slip through the net.

One exhibitor returning to Med-Tech Innovation is Zener Engineering Services (ZES), which specializes in engineering validation services.

Its director, Dave Easton, explains more and why the company is returning to the show.

The Med-Tech Innovation Conference will cover important issues relating to the sector, including new developments in manufacturing, health inequalities, sustainability, and the effects of medtech on the NHS in the UK. The HealthTech/Introducing stage will involve an array of new technologies, speakers from the show floor and a session dedicated to start-ups showing off their new innovations and developments.

Two panel sessions to look out for on this stage of particular relevance across the medical device and medical plastics sector include a live MedTalk Podcast episode on the challenges of regulation in the medical device sector, and how to avoid recalls relating to software, materials, and devices.

COMPLIANCE As the medical device sector has seen a lot of regulatory development, particularly with changes to European legislation and the UK’s withdrawal from the European Union, a panel of regulatory specialists on the HealthTech/ Introducing Stage will take you through some of the current key challenges likely to face companies, and how you can go about addressing them.

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“Medical Device Software Validation is a regulatory requirement, which is a specialist area of concern, in which ZES is very experienced. ZES can also manage large projects and provide leading experts in the field to ensure that medical devices and their manufacturing processes comply with regulatory requirements and are safe for patients.

“Visitors can expect to meet our experts and chat about medical device compliance and any concerns and issues they may have.

“The 2021 show was organised to an extremely high standard during the Covid pandemic, with our particular needs being taken into account every step of the way. ZES didn’t feel like just another exhibitor!”

For more information about exhibiting or visiting Med-Tech Innovation Expo, visit www.med-techexpo.com.

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MD&M WEST

MD&M WEST MAKES ITS RETURN TO THE ANAHEIM CONVENTION CENTER THIS APRIL IN THE FIRST IN-PERSON RUNNING SINCE THE COVID-19 OUTBREAK.

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ME West, the advanced design and manufacturing event that brings together established trade event brands Medical Design & Manufacturing (MD&M) West, WestPack, Automation Technology Expo (ATX) West, Design & Manufacturing (D&M) West, Plastec West, and CannPack West, will return to the Anaheim Convention Center from April 12-14, 2022, reconnecting the advanced design and manufacturing communities across multiple verticals and industries.

With the smart manufacturing sector poised to reach nearly $590 billion by 2028 as automation and advanced technology propel the marketplace, the industry is ready to meet face-to-face at IME West.

The annual trade show serves as a springboard for innovation, networking, deal-making, education, and new this year, is a Smart Event, which gives exhibitors and attendees additional digital opportunities before, during, and after the live event. The Smart Event allows registered attendees to research exhibitors and products, access exclusive on-demand content, engage in live discussions and schedule meetings. The online platform will open on March 14 and is accessible to all registered visitors.

Industry Support Event organizers, Informa Markets – Engineering, are anticipating a strong turnout of buyers, C-suite executives, and engineers with decision-making power and have already locked in prominent industry partners, including: • California Cannabis Association • California Life Sciences • Flexible Packaging Association (FPA) • MedExecWomen • Society of Plastics Engineers (SPE) The industry is throwing its full support behind it, providing the valuable and business-critical opportunity for in-person discovery, demos, deal-making, and expertled education. Among the suppliers already confirmed across trade

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DREAMIN

MD&M WEST RETURNS TO ANAHEIM event brands include 3M, ATS Automation, Beckhoff Automation, Bosch Rexroth, Canon Virginia, Caplugs, Capmatic, Coherent, Denso Robotics, Engel, FANUC, Formlabs, GF Machining Solutions, Husky Injection Molding, Igus, Maruka USA, Multivac, Packline USA, Promach, Protolabs, Qosina, Reiser, Sumitomo Demag, Teleflex Medical OEM, Zeus Industrial Products Inc., among many others.

New Offerings “IME West serves a broad range of applications within the advanced design and manufacturing sectors, serving as the industry’s most important event fueling advancement – we are so excited to announce registration is live and provide the industry a valuable platform to grow their business,” said Adrienne Zepeda, group event director, IME West, Informa Markets. “As our industry learns from past challenges and introduces new technologies to keep up with growing demand, it’s important for us to cater our education and show floor offerings to mirror the unique needs of our community. That’s why, this year, we’re thrilled to bring several new experiential elements including keynote speakers, an opening reception, enhanced smart manufacturing and additive manufacturing education, and more.”

The introduction of keynotes speakers, which are free to attend for all event participants, supports the industry’s need for high-level education and forward-looking insights addressing timely topics such as collaborative robotics in the workforce and supply chain challenges. Informa Markets – Engineering will announce the speaker lineup in the coming weeks.

Health and Safety At this time, organizers are adhering to California Department of Public Health (CDPH) guidelines for large events. They have implemented a mask mandate and will require proof of vaccination OR negative Covid-19 test for all participants of IME West. Additional measures will be in place to ensure the confidence of event participants, including increased medical staff, additional hand sanitization stations, increased convention cleaning, and much more.

“We are eager to reconvene the industry for much-needed connection following a few challenging years safely and productively per local and statemandated health protocols,” Zepeda added. “The safety of our community is of utmost importance to ensure a constructive live event that advances the dynamic advanced design and manufacturing sectors that rely on IME West for new business partnerships and continued education.”

To register for and learn more about IME West and its established trade event brands, visit the websites of: Medical Design & Manufacturing (MD&M) West, WestPack, Automation Technology Expo (ATX) West, Design & Manufacturing (D&M) West, Plastec West, and CannPack West.

WWW.MEDICALPLASTICSNEWS.COM

Engineering

NORTH AMERICA EVENT CALENDAR

DESIGNCON

BIOMEDevice

WHERE THE CHIP MEETS THE BOARD

Apr 5-7, 2022 | Santa Clara, CA

Apr 25-27, 2023 | Rosemont, IL

DesignCon

International Powder & Bulk Solids Conference & Exhibition

Santa Clara Convention Center

Apr 12-14, 2022 | Anaheim, CA Anaheim Convention Center

MD&M West, WestPack, ATX West, D&M West, Plastec West, CannPack West

Jun 14-16, 2022 | Charlotte, NC Charlotte Convention Center

MD&M South, SouthPack, ATX South, D&M South, Plastec South, Powder & Bulk Solids South

Sep 13-15, 2022 | Novi, MI Suburban Collection Showplace

The Battery Show North America, Electric & Hybrid Vehicle Technology Expo North America

Sep 28-29, 2022| Boston, MA

Donald E. Stephens Convention Center

Jun 13-15, 2023 | New York, NY Jacob K. Javits Convention Center

MD&M East, EastPack, ATX East, D&M East, Plastec East, Quality Expo East, CannPack East

INTERNATIONAL EVENTS Nov 9-10, 2022 | Montréal, QC, Canada Palais Des Congrès De Montréal

Advanced Design & Manufacturing (ADM) Expo featuring PackEx Montréal, Expoplast, D&M Montréal, ATX Montréal, Montréal Powder & Bulk Solids

Jun 28-30, 2022 | Stuttgart, Germany Messe Stuttgart

BIOMEDevice Boston

The Battery Show Europe, Electric & Hybrid Vehicle Technology Expo Europe

Nov 2-3, 2022 | Minneapolis, MN

May 9-11, 2023 | Toronto, ON, Canada

MD&M Minneapolis, MinnPack, ATX Minneapolis, D&M Minneapolis, Plastec Minneapolis

Advanced Design & Manufacturing (ADM) Expo featuring PACK EX Toronto, PLAST-EX, D&M Canada, ATX Canada, Toronto Powder

Boston Convention & Exhibition Center

Minneapolis Convention Center

Toronto Congress Centre

Nov 29-30, 2022 | Santa Clara, CA Santa Clara Convention Center BIOMEDevice Silicon Valley

Feb 7-9, 2023 | Anaheim, CA Anaheim Convention Center

MD&M West, WestPack, ATX West, D&M West, Plastec West, CannPack West

Find out more about our live & virtual events and see the industries we serve.

CALL

844-826-7469

VISIT

findmanufacturingbuyers.com

Engineering

MAKING DRUG DELIVERY DEVICES

TONY KIRK, COUNTRY BUSINESS LEADER, MEDICAL DELIVERY SOLUTIONS, BD, EXPLAINS THE COMPANY’S PRACTICES WHEN DEVELOPING DRUG DELIVERY COMPONENTS FOR THE COVID-19 VACCINE ROLLOUT SAFELY, SUSTAINABLY, AND EFFICIENTLY.

DEVELOPING MEDICATION DELIVERY SOLUTIONS FOR THE VACCINE ROLLOUT

T

he pandemic was a global call to action for key players across the healthcare ecosystem – pharmaceutical companies, medtech organizations and governments – each playing their part to ensure the successful and safe delivery of services at each stage of the vaccine campaign. Supply chains and operations were put under pressure like never before, with regulatory boards having to accelerate approvals, and manufacturers providing medical devices at a rapid rate and unexpected scale.

The ability to deliver a vaccination campaign of this nature could not have happened without effective collaboration between global governments, healthcare systems and industry. This united effort aided these bodies to overcome significant access and infrastructure challenges to support the sustainable delivery of healthcare.

A NEW WAY OF OPERATING A great example of this extraordinary global collaborative effort is the COVID-19 vaccine delivery, which required a much more agile way of operating. The manufacturing, packaging and transport of needles and syringes are a vital aspect of vaccine delivery. Products developed must meet strict safety specifications.

Individual plastic syringe and needle parts are sterilized before being distributed across supply chains and designated for government or non-government organization distribution centers. Having to navigate supply chain disruptions, as well as consistently deliver high-quality products in a timely manner presented a challenge for medtech manufacturers. However, by establishing clear lines of communication, medtech, pharma, health services and governments were able to effectively collaborate and ensure a smooth mass vaccination roll-out.

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LEVERAGING INNOVATIONS TO INCREASE EFFICIENCY The syringe has come a long way since the development of polypropylene in late 1950s. A series of evolutions in design, and manufacturing over 60 years improved sterilization processes, increased production of devices, has made them easier and more intuitive to use. Convenience trays were introduced to help pharmacists to save time when batch preparing syringes. Another innovation in the development of syringes is minimizing dose wastage. For example, BD’s Flu+ syringes contain an integrated needle and are designed to minimize waste, when used with vials that contain multiple doses. This practical, plastic disposable syringe aids patients and healthcare workers throughout vaccine delivery.

Further efficiency improvements led to the creation of pre-filled syringes. Many European countries receive annual vaccines in the ready-to-deliver form of prefilled syringes. However, to make the Covid-19 vaccine available as soon as possible, they came in vials instead of pre-filled syringes, meaning that global governments needed to ensure a separate and steady stock of needles and syringes to be able to inoculate the population. With continued innovations being made to medication delivery devices, there is great potential for future Covid-19 vaccines to come in pre-filled syringes.

MAINTAINING SUSTAINABLE OPERATIONS The development of single-use disposable plastic syringe was necessary for the healthcare industry in terms of sterilization and safety. However, the world has continued to learn of the impact of single-use plastics on the environment. From reducing the overall volume of plastic used, introducing renewable electricity in production facilities, adopting more environmentally friendly packaging, to non-toxic materials, it is important that manufacturers are developing and implementing more sustainable business practices for waste reduction – both in terms of medical and material waste - whilst ensuring the safe delivery of vaccinations for patients.

While changes were made across manufacturing, logistics and healthcare delivery systems throughout the vaccine campaign, it is vital to continue to build on improvements to aid access to vaccines and ensure efficient and timely delivery of care. Clear channels of communication and future-proofed supply chains are important aspects in strengthening partnerships across industry and key decision makers and keeping up with demands of healthcare systems.

Driving research and development to advance vaccine delivery, as well as expanding training for healthcare professionals to ensure the safe administration of vaccines must also be prioritized to help build resilient healthcare systems.

WWW.MEDICALPLASTICSNEWS.COM

ALBIS offers the medical industry an unparalleled choice of standard, technical and high-performance polymers from renowned producers. This offering is complemented by customized polymer compound solutions tailored to customer’s needs and made by ALBIS’ sister company, MOCOM.

Medical diagnostic equipment & biotech applications

Our products comply with the requirements of the VDI 2017 Medical Grade Plastics Directive. We support numerous projects in the medical sector, pharmaceutical packaging and diagnostic equipment and biotechnology, putting technical and regulatory requirements at the heart of our work, so that we can define the most appropriate material for each application. Our regional experts draw on in-depth knowledge of the medical and pharmaceutical industry to provide you with a powerful service offering that integrates technical support, product safety and risk management. Contact us to learn more about our solutions and assortment of medical polymers and compounds: healthcare@albis.com

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Q&A

SHORTLY AFTER IT WAS ANNOUNCED THAT ESSENTIUM WOULD ACQUIRE ATLANTIC COASTAL, MEDICAL PLASTICS NEWS CAUGHT UP WITH BLAKE TEIPEL, PH.D., CEO OF ESSENTIUM TO FIND OUT MORE ABOUT WHAT IT MEANS FOR THE COMPANY, AND HOW HE THINKS IT CAN BRING CHANGES TO THE INDUSTRY.

Transforming the future landscape OF SUPPLY CHAINS?

face masks and other personal protective equipment were in short supply, we quickly produced 26,000 mask frames [the equivalent of 4 million masks using disposable filters], helping to keep police, firefighters, and other front-line workers safer from the virus.

After announcing your takeover of Atlantic Coastal, you said Essentium was transforming the future landscape of supply chains… how?

Essentium’s supply chain solution deploys regional, distributed production capabilities to enable supply chain transparency and flexible inventory management at a highly competitive TCO while reducing waste and supporting a limited carbon footprint through on-site printing.

In 2022, many companies in the biomedical sector will realize that producing parts themselves without relying on global suppliers puts them in a stronger position to get their products to market.

Outdated cost disparities underpinning the optimization for global trans-pacific supply chain structures stood up over the past 20 years, simply no longer support the macroeconomic disruptions and geopolitical uncertainties comprizing the nature of the commercial battlespace in 2022 and beyond.

The bottom line is this: additive manufacturing is demonstrating its sterling relevance to traditional manufacturing. 3D printing is ready for prime time.

The biomedical industry will save costs while building stronger businesses that can withstand even a once-in-a-century crisis like the Covid-19 pandemic.

This transaction will help us scale to meet these needs in a longterm, sustainable manner.

Essentium is uniquely positioned to capitalize on the needs of the additive manufacturing and supply chain sectors. With more than 150 proprietary patents to date and the ability to address full-scale production runs by producing parts that can match the strength of injection molding at an extremely low total cost of ownership,

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With an increasing focus on sustainability and net zero, how is Essentium meeting environmental goals?

Additive manufacturing has an incredible ESG profile. From a sustainability aspect, there is on average 70% lower waste and 70% lower energy consumed in producing a part that is 3D printed or additively manufactured versus the classic subtractive machining-based approach.

In addition to this inherent value, our technology limits the carbon footprint of supply chains by pushing inventories to the cloud, reducing the total size of production runs because you do not need to overproduce to anticipate end-of-life service parts.

Essentium is advancing sustainable solutions to additive manufacturing applications for industries including biomedical.

Those service parts can be additively manufactured at the end of life, resulting in further environmental improvements, a greater sustainability profile for the technology, and cost savings for the users of the technology itself.

How will this “revolution” of supply chains affect the medical plastics and medical device sector?

During the Covid-19 pandemic, the additive manufacturing industry proved it could step in to make quantities of supplies at scale to keep assembly lines moving.

Early in the health crisis, when

What future plans are you able to tell us about?

We recently announced the Essentium HSE 240 HT Dual Extruder 3D Printer designed for small and medium-sized factory spaces and university labs. We also introduced the Essentium HSE 280i HT 3D Printer, the first true independent dual extrusion system (IDEX) designed and developed for the demands of the factory floor.

Essentium’s new 3D printing platforms help manufacturers accelerate into the digital age by enabling AM applications that significantly improve productivity and growth.

WWW.MEDICALPLASTICSNEWS.COM

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