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CHANGING THE GAME
Why Schottli believes it is increasing the efficiency of injection moulding ISSUE 50
Sept-Oct 2019
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CONTENTS September/October 2019, Issue 50
Regulars
Features
5 Comment Laura Hughes talks about the importance of changing people’s perceptions within the medical plastics field
19 The digital transformation Connect 2 Cleanrooms explains how to provide an intelligent cleanroom solution
6 Analysis How 3D printing could shape the medical wearables market
25 Breaking it down Teysha Technologies discusses how a breakthrough in bioplastics could help to reduce the amount of single-use plastic
8 Digital spy 16 Cover story Schöttli, a Husky Company explains why the organisation believes it is increasing the efficiency of injection moulding
26 A balanced approach Vancive Medical Technologies talks about how to design ostomy and wound care devices for purpose, use and manufacturability
34 How to avoid medical device adhesive failure 3M’s guide for what you need to know in order to avoid medical device adhesive failure 39 Better together Saint Gobain explains what to discuss with your vendor when creating a part that will be micromoulded utilising liquid silicone rubber
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Showing our colours – closing material cycles At ENGEL, we embrace responsibility, helping our customers achieve sustainable injection moulding production. At the heart of this are our inject 4.0 solutions for the smart factory, which also open up new opportunities for the Circular Economy. For instance, the iQ weight control software balances out process fluctuations when processing recycled material. Consistent high part quality increases the range of possible uses for the recycled material. Technologically, we are also promoting increased use of recycled material. With the new ENGEL skinmelt process, we are enabling a high proportion of recycled material even in complex component geometries. The bottom line: green is more than the colour of our machines. Come and see what it all looks like at K 2019 (Hall 15, Stand C58).
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editor | laura hughes laura.hughes@rapidnews.com
EDITOR’S
group editor | dave gray head of content | lu rahman assistant editor | ian bolland 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 © 2019 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.
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Changing people's perceptions
W
omen have been fighting to achieve equality status with the male gender since the 1900s when they fought for the right to vote. This sense of inequality was until recently, something I had been fortunate enough to never directly experience. I had heard stories in the media from women who had experienced inferior or inappropriate treatment simply because of their gender, but it had always felt like something that was far removed from me and my life. So recently when I attended a site visit, I was shocked at the treatment I experienced. Certain comments made me feel uncomfortable and left me questioning how I could be made to feel so singled out simply because of my gender. As someone who is fairly new to the world of medical plastics, I am told that this is an experience other women have had within the industry too. But why should this be an ordinary occurrence? During this year’s Med-Tech Innovation Expo, I was fortunate enough to attend the women in plastics panel which featured Artemis Stamboulis, Helena Flowers and Rebecca Smith who are a senior lecturer in biomaterials and nanomaterials, owner and managing director and a national territories manager respectively. During the discussion Stamboulis discussed the sense of injustice she felt, and how despite obtaining a degree in polymer science and
engineering specifically for a role within her family’s company, she had found that once she began working there the men had some sort of priority. Whereas Smith highlighted the advantages of diversity within a workplace, and how she believes that the more diverse an organisation is, the better it is. Therefore, in manufacturing where women only made up 29% of the workforce in the US in 2016, could more be done to increase this percentage? Well this year, for the first time in history, more female students took science A levels compared to male students. This statistic highlights the impact events such as international women in engineering day has had on the sector. The aim of this day is to inspire other women to become the engineers of the future and the figures would suggest it is proving to be effective. However, it is important that the women choosing to study science A levels also choose to work within fields such as manufacturing and engineering where there are currently fewer women.
This year for the first time in history, more female students took science A levels compared to male students.
I believe if women are not made to feel welcomed within these previously male dominated environments, or if organisations are not willing to adapt to accommodate responsibilities such as childcare that many women juggle with their careers every single day, then industries such as engineering and plastics may stay heavily male dominated.
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NEWS ANALYSIS
How 3D printing could shape the medical wearables market A LOOK INTO THE ROLE 3D PRINTING COULD PLAY WITHIN THE SECTOR.
T
he popularity of 3D printing is on the rise, probably due to the technology’s ability to customise products in order to fit a specific customer’s size requirements. Additionally, many manufacturers have invested in the research and development of 3D printing with hopes of this technology being carried out on a mass scale in the near future. A report recently published by market researchers, Future Market Insights, looks into the future of 3D printed wearables. The report predicts that 3D printing will see a decrease in costs around 2025. As currently 3D printing is not thought to be fast or cost effective enough to produce precision parts in large quantities, a drop in costs would be beneficial for those within the 3D printing field.
The healthcare wearable industry is anticipated to reach $40 billion revenue by 2022.
In terms of a long-term plan, 3D printing could therefore be seen as an investment for companies in order to gain a competitive advantage, as well as providing the opportunity to increase the life cycle of a product through the increased sustainability options the technology could offer. Despite these anticipated benefits, it is important to note however, that it is extremely unlikely that 3D printing will completely replace current manufacturing practices. The healthcare wearable industry is anticipated to reach $40 billion revenue by 2022. This is thought to be as a result of the combination of an aging population and the constantly improving quality of healthcare wearables, which are both contributing factors towards helping to increase the popularity of medical wearables.
Medical wearables are currently able to collect lots of information including the number of steps a person has walked in a day, to things such as the composition of interstitial fluids beneath skin. Research within 3D printing is currently focused on flexible materials and sensors, and their ability to be both pliable and bendy. These properties are ideal for wearables particularly with products such as smart watches and small discrete sensors becoming increasingly popular. At the moment lots of research is being done on 3D printing and its use within medical wearables. Researchers from Washington State University have been working on a wearable sensor which is able to monitor glucose in body fluids such as sweat. By using 3D printing to develop the monitor, researchers believe they were able to develop a more sensitive and stable glucose monitor than they would have been able to with traditional methods. The researchers hope their invention will lead to improved glucose monitors for millions of people who suffer from diabetes. Additionally, earlier this year multiple 3D printed garments hit the red carpet at the Met Gala in New York City. This was widely covered across multiple news platforms, and coverage at events like this will definitely help to raise the profile of 3D printing not just in the medical field, but also amongst the general public. In the future 3D printing will aim to offer faster prototyping and reduced costs, alongside a customisation process. If these goals are achieved, this would make 3D printing within the medical wearables field a more widely used technique.
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DIGITAL SPY
DIGITAL
spy
www.eden2020.eu
THE WORLD’S FIRST FLEXIBLE CATHETER INSERTION n July 5th in Lodi, Italy, engineers and researchers together claim to have made history by performing the first known live flexible needle insertion at the University Veterinary Hospital. The team responsible for this were part of the Enhanced Delivery Ecosystem for Neurosurgery (EDEN2020) project which is funded by the European Union Horizon 2020 programme. The EDEN2020 project’s aim is to translate the latest surgical robotic technologies into patientspecific neurosurgical applications, with less invasive treatment for patients. The ability to insert a flexible needle is hugely advantageous compared to the current neurosurgery method
www.intersectent.com
FDA approves first dissolvable steroidreleasing sinus implant
DEVICE UPDATE
O
DEVICE UPDATE
which involves surgeons delivering medication via cannulas which are thin, hollow needles which do not have the ability to bend. This means that the cannulas can only be inserted in a straight path, and often leads to inaccurate placement of cannulas in the brain which can be detrimental for patients. EDEN2020’s coordinator, Ferdinando Rodriguez y Baena commented: “For me personally, this has been the culmination of a 13-year-long wait, and a stark reminder of why I love my job as much today as I did when I first started: The privilege of working beyond the state of the art with some of the best scientists and clinicians available.”
M
edical device company Intersect ENT has received FDA approval for its delivery system – Propel Mini sinus stent. Physicians should implant the delivery system in to patients behind the bridge of the nose. The device will enable those patients who have had sinus surgery to maintain the opening of the sinus whilst the device dispenses the steroid, mometasone furoate. Once the steroid is released, the stent dissolves. Intersect claims that other stents within its portfolio are the first and only dissolvable steroid-releasing sinus implants approved by FDA. Propel Mini hopes to shorten procedure times and improve ease of use for physicians.
MEDTECH UPDATE
www.bedfont.com
Bedfont Scientific wins silver award for technology and innovation
T
he medtech company was presented with its first national business award at the annual Family Business Awards. Although Bedfont have specialised in the design and manufacture of breath analysis medical devices since 1976, the company only became a 2nd generation family business in 2016. Devices within the organisation’s portfolio include breath monitors for smoking cessation, emergency carbon monoxide screening and devices for the diagnosis and management of asthma. Jason Smith, managing director at Bedfont commented: “This is our first national accolade and we are over the moon to have
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been awarded the silver award for technology and innovation. At Bedfont, we take pride in being an innovative company and try to break the mould of traditional healthcare and it’s honestly amazing to have that recognised on a national scale.”
DIGITAL SPY
DEVICE UPDATE
www.emsgrivory.com
EMS-GRIVORY DEVELOP A REUSABLE POLYMER
O
ver the past two years, EMSGrivory, a manufacturer of high-performance polyamides has developed a reusable polymer. The company claim that this polymer can be sterilised more than 500 times and thus reused. Additionally, the low density of this polymer means that part weight can be reduced by up to 80%.
EMS-Grivory have already received the relevant certification to use these materials within the medical sector.
www.deepmind.com
MOBILE APP COULD OFFER FASTER DETECTION OF FATAL KIDNEY CONDITION IN HOSPITAL PATIENTS
DEVICE UPDATE www.additiveorthopaedics.com and alexanderorthopaedics.com
Man receives 3D printed finger implant n 2017 when Robert Smith was at work, his middle finger on his left hand was crushed and the bone was completely shattered. This left Smith struggling to grab, grip or clasp anything. Previously Smith would have faced the decision of either having his finger amputated or living with the broken finger – both of these options would have prevented Smith returning to work.
POINT
away the need to keep purchasing items which were previously disposed of after a single use.
It is hoped that this polymer could help tackle the issues surrounding singleuse plastics and medical devices, as well as reducing health costs by taking
I
talking
WHAT IS ACUTE KIDNEY INJURY (AKI)? AKI is the term for when kidneys stop working optimally. The condition is typically caused from complications linked to another illness and affects one in five people admitted to hospital.
However, thanks to Daniel Penello from orthopaedic practice, Alexander Orthopedic Associates and a team from med-tech company, Additive Orthopedics, Smith was able to receive an implant through additive manufacturing.
WHY IS IT IMPORTANT TO DETECT AKI QUICKLY? If AKI is not detected and treated, abnormal levels of waste products can build up in the body and cause a person to become seriously ill. Additionally, in some cases AKI doesn’t present with any symptoms.
The 3D printed finger implant was created to fit Smith’s left hand, and as a result Smith regained some ability and movement in his finger, which previously would never have been thought to be achievable.
HOW CAN THIS APP DETECT AKI? The app is called Streams and was developed between The Royal Free London NHS Foundation Trust and technology firm, DeepMind. The app claims to make information on blood markers such as creatinine rapidly available to specialists. HOW MUCH FASTER CAN THIS APP DETECT ANY KIDNEY ISSUES? A trial was conducted where healthcare professionals received warning signals via the mobile phone app. It took 14 minutes on average for healthcare professionals to be alerted when a patient’s blood test results may indicate AKI. Without the app, this would usually take several hours. WHAT DO HEALTHCARE PROFESSIONALS THINK OF THE APP? Mary Emerson, lead nurse specialist at the Royal Free commented: “Healthcare is mobile and real time, and this is the first device that has enabled me to see results in a mobile real-time way.” Consultant Dr Sally Hamour, a kidney specialist at the Royal Free said she thought that the project was “potentially lifesaving.” 9
EXTRUSION
Flick of a switch MARK CRAWFORD, ELDON JAMES CORPORATION, EXPLAINS WHY THERMOPLASTIC ELASTOMERS (TPES) OFFER THE PERFECT TUBING REPLACEMENT AS SILICONE SUPPLIES DWINDLE.
F
or the last few years, the silicone raw materials market has been highly turbulent. Many key components for making silicone elastomers such as siloxane are in critically short supply, leading to huge price fluctuations and frustrating supply issues which have pushed lead times on some silicone tubing products out as far as three to four months. The source for much of this market unrest is China which is one of the largest silicone component producers in the world. Although China provides nearly 45% of the global production capacity for these materials, increasing Chinese domestic consumption has left less material available to export to other countries. “A significant portion of the supply of these materials has been removed from the marketplace,” states Jonathan Kane, CEO at manufacturer, Polytek Development Corporation. “This has buyers scrambling to find supply and willing to pay whatever it takes to stay in business.” This reduction, too, would be less of an issue if other suppliers had increased their manufacturing capacity for these components over the years. “There are shortages everywhere in the market,” adds Len Rogers, supply
chain manager for silicone, metal and metal fabrication for Freudenberg-NOK Sealing Technologies. “There has been no investment, no basic plants, no basic assets added in the past decade by any of the major suppliers. I think this is coming to fruition as demand continues to grow, to the point where the manufacturers are making some hard choices in where they supply and who they supply.” Additionally, China’s Environmental Protection Administration is forcing silicone manufacturing facilities with high pollution levels to shut down for weeks or months to audit their procedures and enforce clean-up operations. Tariffs with China are also driving up silicone costs for U.S. manufacturers, and worries about the possibility of a prolonged trade war between the U.S. and China have companies concerned about both the long-term disruption to their supply chains and the increasingly higher costs they will have to reluctantly pass on to their customers. Therefore, to deal with the ongoing silicone shortage, manufacturers will continue to raise prices in the short term in order to accommodate swings in material and energy costs, knowing that supplies will remain tight and lead times almost unbearable. However, an increasing number of silicone manufacturers, material suppliers, and customers, who see the silicone shortage as a serious, costly, and longterm production problem, are choosing to be proactive by looking for costeffective substitutes for silicone - especially TPEs. THE TPE ALTERNATIVE Silicone has always been the gold standard for medical and pharma tubing until recently. Over the years plastic material manufacturers have improved alternative materials, such as TPE, which have similar properties compared to silicone but are easier to work with and less expensive. TPE is becoming a preferred material for extruded tubing and offers a wider range of beneficial properties than silicone does. Both silicones and TPEs are soft flexible elastomers with very similar physical and chemical properties at room temperature. However, because TPEs are a special class of materials that consist of copolymers of plastic and rubber, they have a greater number of beneficial surface characteristics. TPEs can be compounded to meet very specific requirements for softness or hardness, flexibility and stiffness, and stretched to moderate lengths and then returned to their original shape. They also provide better abrasion resistance than silicone (up to 95 durometer A), and can be repeatedly melt processed, which reduces material waste (compared to silicone which sets and then cannot be melted and reused again). Although silicone and TPE are extruded in a similar fashion, silicone requires more steps and a curing process which adds time and cost. TPE is also more environmentally friendly than silicone and can be recycled. Converting to TPE TPE is becoming an effective, lower-cost alternative to silicone. TPEs compete well with silicones for strength, temperature resistance and chemical resistance, and have performance advantages for characteristics such as flexibility/stiffness, abrasion resistance, softness/hardness and lighter weight. TPEs such as Eldon James’ Flexelene that are engineered for higher durometers with very low non-extractables are now approved for medical device and pharma applications. TPE provides beneficial properties compared to silicone, has fewer environmental impacts and provides a more stable market, which results in shorter, more reliable lead times and faster time to market.
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EXTRUSION
AN ENGINEER'S GUIDE
TO DESIGNING AND SPECIFYING CUSTOM TUBING ROBERT LADUCA, C.E.O., DUKE EMPIRICAL, EXPLAINS WHAT ENGINEERS NEED TO KNOW ABOUT THE EXTRUSION PROCESS WHEN DESIGNING AND SPECIFYING CUSTOM TUBING.
WHAT ARE THE KEY THINGS FOR ENGINEERS TO CONSIDER WITHIN THE EXTRUSION PROCESS? The importance of the relationship between draw down ratio and tubing mechanical properties is a factor that can greatly affect the mechanical properties of the tubing. The same exact dimensions and materials can produce dramatically different performance results depending on this important processing factor. In general, a higher draw down will impart more molecular chain alignment within the polymer producing a higher tensile modulus product in the axial direction with greater ultimate tensile strength than a tubing produced with a lower draw down ratio. Products which have higher degrees of molecular alignment axially due to higher draw down ratios will also have a greater degree of resultant stress in the tubing wall which may require annealing to relieve in order to avoid dimensional changes from occurring, not only during additional thermal processing steps such as bonding and reflow lamination, but also during transit where elevated temperatures can occur. Another important factor is the effect of die temperature on the surface finish. A colder die temperature can impart a ‘frosted’ finish on the surfaces of the tubing which reduces the tackiness at the cost of reduced clarity and imparted surface texture. Similarly, a hot die temperature can improve the clarity of the material and will have
an impact on subsequent thermal bonding and lamination operations. When performing extrusion process validations, the range of parameters should be wide enough to understand the impact on subsequent processes as well as the impact that variation in the molecular weight of the raw material coming into the extrusion process can cause in both the extrusion process and also the downstream processes. HOW TO CHOOSE THE RIGHT POLYMER SYSTEM FOR MEDICAL TUBING APPLICATIONS A wide variety of materials are extruded into tubing products, therefore it’s important to know what to consider when it comes to specifying materials for extrusion in order to ensure a material is a suitable choice for a specific application. The starting point is to fully define the user needs and proceed iteratively to a qualified specification. Following ISO compliant design controls, once the design outputs are measured and meet the design inputs, the verified design is then validated using objective evidence to demonstrate the design works for the user as intended. The product designer is responsible for identifying a complete set of user needs for the product’s duration of intended use, as well as ensuring the manufacturing process required to produce the design is suitable. For medical applications Foster Corporation launched its HLS brand of Heat, light stabilizer package that can be added to a wide variety of resins such as nylons, polyurethanes, polyethylenes etc. If the product is to be coated with a hydrophilic coating solution which has a UV
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EXTRUSION
cure, then adding a UV stabilizer will help prevent degradation of the polymer during subsequent processing. Similarly, if the extruded tubing is to undergo a subsequent lamination reflow process using removable heat shrink to add reinforcements into the wall of the tubing such as braids or coils, the use of heat stabilizer in the additive package can reduce processing variations encountered during extrusion and post process reflow steps. This allows for greater precision in the final product and translates into tighter tolerances, improved manufacturability, and even enables new catheter technologies when new designs require pushing existing limits. Other physical properties will change with the addition of radiopaque additives to provide visibility during use under fluoroscopy or ultrasound imaging. These changes include increased surface hardness, decreased tensile strength and burst pressure, and less surface tackiness. This is particularly the case with softer materials such as 40A Chronoprene by AdvanSource Biomaterials, soft urethanes such as PolyOne’s NEUsoft UR842A, and low durometer SEBS such as Kraton’s SEBS G1642. The loading percentage will vary depending upon the degree of visibility required as well as the wall thickness where a thicker wall can use less radiopacifier. Typical loading for wall thicknesses of .005” through .050” may be 20-25% barium sulfate by weight whereas glass microspheres may be added in loading percentages of 50% or higher by weight to improve the echogenicity of polymers. Since barium sulfate is whitish in colour, additional pigments such as TiO2 can be added to bring the colour to a bright white or alterative colours can be matched to Pantone colors. It should be noted that fillers have a distribution of particle sizes leading to the potential for defects in the tubing as agglomerates can create surface roughness on the ID or OD, create drag marks, pinholes, lumps, necks, and dents. Therefore, if specifying constituent materials at the compounding phase, it is important to identify the wall thickness of the tubing to be extruded so that it can be compared with the particle size distribution of the filler. This allows a fine enough powder to be selected which would avoid or reduce the prevalence of these types of defects. Nonetheless and independent of the effect additives may have on the quality of the tubing produced, gels may be present in natural grades of materials such as those which are found in amides, HDPE and urethanes. When specifying tubing made from materials where gels are unacceptable such as balloon tubing, specifications may include the requirement for the processor to use a candle filter at the single screw extruder output which will help break down gels into smaller sizes and reduce the number of gels that end up in the tubing. This inline single screw filtering is preferred to running a separate melt process on a twin screw compounding line with an inline candle filter as the additional heat history and mechanical shearing of the additional pass will reduce molecular polymer chain length and the resultant tubing will have degraded performance in tensile and burst strength which are critical in balloon catheter applications.
to visual criteria requirements. A similar defect can be observed when extruding thin walled material of less than .005” where streaks of colour can be seen next to clearer areas where the colourant was not well dispersed by the shearing of the material in the screw and barrel. These issues can be avoided with the use of precompounded coloured material produced in masterbatches. A related issue is the specification of packaging so that the tubing product is not rendered unusable by shipping and handling. This is particularly important with regards to soft tacky materials which may have the tendency to weld to itself when compressed during shipping. To avoid loss due to damage, soft tubing may be supplied inflated to prevent the ID from collapse. The use of specialised packaging configurations such as individual chambers can also prevent the tubing from being in contact with other tubing. Alternative packaging designs include providing the tubing on a mandrel to allow subsequent operations to be performed without needing to insert a reflow mandrel into tacky tight-fitting lumens which can be problematic and time consuming. CONCLUSION In conclusion, these are a few of the important aspects that design engineers should be aware of when specifying materials and processes to optimise product development outcomes. Working closely with extrusion processing experts who are collaborative in their approach to providing application specific customer solutions can be highly beneficial towards achieving design goals in the development of new medical tubing applications.
Besides the aesthetic aspects, the addition of pigments can also help improve the tackiness of very soft materials and can make the difference in being able to perform subsequent assembly steps such as insertion of mandrels used in catheter construction. One potential pitfall to be aware of is the possibility of incomplete colour constituent breakdown during the single screw extrusion process. This is typically seen when using colour concentrates which are blended with natural grade pellets at the feed throat of the extruder. These unbroken-down colour concentrates can appear to be embedded foreign matter and can cause non-conformances
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COVER STORY
STEFAN SCHNEIDMADEL, DEVELOPMENT ENGINEER FROM SCHÖTTLI, A HUSKY COMPANY, EXPLAINS WHY SCHÖTTLI BELIEVES IT IS INCREASING THE EFFICIENCY OF INJECTION MOULDING.
MARKET REQUIREMENTS The medical product industry represents an exciting and challenging market for manufacturers. This is because many products will be in direct contact with human organs, and therefore requirements set by regulating authorities place high demands on the productivity and quality of the plastic parts. These requirements have led to the use of specialised multi-cavity moulds within the medical sector, in order to ensure consistent component quality at the lowest cost of ownership across millions of injection moulding cycles. In addition to the legal requirements, manufacturers also face challenges at the production level. The majority of the product range is made up of thin-walled products with a long flow path and a shot weight of just a few grams. Long flow paths generate higher injection pressure, which results
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in a higher force to keep the mould closed during injection. This creates the requirement for injection moulding machines with a higher tonnage. At the same time the injection units of bigger tonnage machines are often larger than necessary, which results in increased residence time of the melt within the injection unit. This can lead to production problems when using heat-sensitive plastics. Figure 1 shows the typical clamping force and injection volume based on the tool clamping surface. According to the graph, multi-cavity moulds lie outside of the machine manufacturer’s standard product portfolio as they require a higher clamping force with a lower shot volume. The customer must therefore use larger injection moulding machines for this type of mould. Schöttli has recently developed an advanced 8-cavity side injection nozzle, aimed at offering its customers a competitive advantage. This nozzle works by increasing the number of mould cavities with approximately the same tool dimensions, thereby improving the productivity of the tool and making more effective use of existing installation space. DESIGN OF THE HOT RUNNER SYSTEM A test tool was produced as part of the development project. The liquid melt is injected into the hot runner block from the injection moulding machine through the injection unit. The side injection nozzle is an open system, which means that the system is fully relieved after the holding pressure time. From the heated hot runner block, the melt is injected into the pre-chamber via the nozzle holder and the nozzle channels, before it is then injected into the mould cavity. Previously, the projected surface of the pre-chamber contributed significantly to the lifting force, whereby the existing clamping force of the machine was crucial for the number of usable cavities in the mould.
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COVER STORY
With the new 8-cavity side injection nozzle with pre-chamber relief, the prechamber no longer contributes to the lifting force and the mould can therefore have a higher number of cavities with reduced clamping force. MECHANICAL DESIGN OF THE COMPONENTS In order to meet the customer’s requirements regarding consistency, a complex measuring system was installed that records the melt pressures at different positions within the system. The purpose of the measurement is to obtain an accurate indication of the prevailing pressure at the machine nozzle, in the melt pre-chamber, and in the mould cavity. The measured values are used in the mechanical simulation to ensure that the design of the mould components is suitable for the durability as well as to detect any deformation of the mould inserts. This means that when designing new moulds, Schöttli has a reliable data set that includes not only process parameters such as melt temperature and injection speed, but also the effects of the injection moulding material. For new developments, the design of the mould components can thus be made more efficient in terms of production time and economic costs. TEMPERATURE EQUILIBRIUM IN THE PRE-CHAMBER The design of the pre-chamber poses a particular challenge when designing the hot runner nozzle. Here, the manufacturer is faced with the task of finding the optimum thermal equilibrium for the mould. The pre-chamber surface and the distance between the nozzle and the nozzle tip determine the thickness of the insulation layers. High demands are also placed on the gating area. Although one advantage of thick insulation is a high nozzle temperature with a low output on the heater band, there may be problems when the mould part is torn off the melt. The nozzle tip also has a significant impact on the tear-off behavior. If the nozzle tip is positioned too far inside in relation to the gating area, the injection
Schöttli has recently developed an advanced 8-cavity side injection nozzle, aimed at offering its customers a competitive advantage. point will be shut off. If the nozzle tip is positioned too far from the gating area, this can result in unacceptable gate quality on the plastic part. For the design of the pre-chamber geometry, Schöttli uses thermal simulations that reflect the temperature behavior of the pre-chamber and hot runner nozzle during heating and over several injection moulding cycles. This ensures that the hot runner nozzle is in the optimum position, and that the thermal aspects of the pre-chamber geometry are suitable. TYPICAL MEDICAL APPLICATIONS Injection moulding tests were carried out using various standard thermoplastics from the medical industry. Schöttli can now offer its new star-shaped nozzle for polypropylene, polyethylene and polystyrene as well as acrylonitrilebutadiene-styrene. Typical mould parts include pipettes, needle holders for insulin pens, and conventional needle holder applications. Other materials such as methacrylate-butadiene-styrene have also been successfully tested. Depending on the customer’s requirements, the prevailing pressures can be documented during injection moulding tests in order to ensure the new mould is designed in the most reliable way. Due to interchangeable inserts it is also possible to create specific parts for pre-series according to customer requirements with short lead times. The findings from the tests are then incorporated into the development of the production mould, which mitigates risk and ensures a faster time to market.
Figure 1: Injection moulding machines and mould sizes. Schottli, a Husky Company ©
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CONCLUSION A multiple cavity side-injection nozzle allows customers to make efficient use of existing installation space, whilst a greater number of cavities with the same mould size ensures economical production processes with higher productivity.
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Medical Grade Plastics with
a Human Touch Visit us at COMPAMED with our distributor Velox at Hall 8b, Booth M01
Rigid & soft-touch plastics for medical applications For nearly three decades, Trinseo has supported the medical
Application Areas:
devices market with outstanding quality rigid plastics. Since
• Single and multiple use devices • Equipment housings • Drug delivery systems • Medical wearables
acquiring Italian manufacturer API in 2017, we offer a portfolio of thermoplastic elastomers (TPEs). This addresses a need for applications requiring soft-touch materials for ergonomics, functionality, safety, and aesthetics.
Materials. Powering Ideas.
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CLEANROOMS
THE DIGITAL TRANSFORMATION CLEANROOM DESIGN AND MANUFACTURE SPECIALISTS, CONNECT 2 CLEANROOMS (C2C), TALKS ABOUT ITS EXPERIENCES WITH HIGH-TECH PLASTIC PARTS AND COMPONENTS MANUFACTURER, PROMOLDING, TO PROVIDE AN INTELLIGENT CLEANROOM SOLUTION. C2C were approached by Promolding to provide an intelligent cleanroom solution in order to protect a medical device manufacturing contract that runs until 2032.
critical environment and raising alarms if any of these parameters vary beyond a user specified threshold.
The overall objective was to provide particulate protection throughout the whole process from product mould tool face to assembly and packaging to ISO class 7 14644-1:2015, whilst accommodating tool changes to the machines by two (with the ability to increase to four, to facilitate future contract growth and project profitability) in a continuous protected environment. Thus, Promolding required environmental particulate protection to the injection moulding machines.
All relevant control parameters for each three zones are graphically displayed on a human machine interface allowing users full control and the ability to run diagnostics and locate faults. All system performance data is logged and is downloadable, for audit purposes and traceability.
C2C developed a reliable and intelligent cleanroom solution which connects with Promolding’s Engel machines and robots through Industry 4.0 design. Design features have been optimised to ensure cleanroom performance is maintained for years to come. THE PROCESS 1. One shot injection moulding machine (80 tonne) produces one plastics component 2. Two shot injection moulding machine (300 tonne) produces the second component, made up of two plastics (injected, rotated then injected again) 3. Robots pick up moulded parts, drop them onto the motorised conveyor and transport them into the main environment 4. The two parts are then assembled and welded, then they progress to packaging THE SOLUTION Each moulding machine has two High Efficiency Particulate Air (HEPA) filtered, overhead canopies - one fixed and one actuated.They are driven by a linear actuator that is operated by programmable logic controller controls to drive the filter system to an open or closed position. HEPA-lite claims to be economical, adaptable and efficient. It attempts to effectively maintain the quality of air at points where the product is exposed, and thus negates the need for the entire production line to be fully enclosed within a cleanroom. The canopies feature effective safety mechanisms and are able to send infra-red signals across the actuators. If the signals are interrupted, for instance by the robot or by an operative’s hands, the canopy will deactivate movement, preventing any accidents.
The intelligent moulding machine is able to recognise faults with a product and drop the affected products into stainless steel drop drawers for inspection. The personnel door is interlocked with the moulding machine during manufacture. The sample drawers are accessible from outside the HEPA-lite, meaning the faulty parts or samples can be safely removed without interrupting manufacture. There are plans to have all of the processes within the main cleanroom area fully automated in the future. CHALLENGES AND SUCCESSES The main cleanroom area was installed under a mezzanine, so the ceiling was suspended from the walkway above. This secured the roof and ensured an open plan layout. There was an effective collaboration with injection moulding machine manufacturer Engel allowing C2C to integrate HEPA-lite with injection moulding machines so floor supports weren’t necessary.
INDUSTRY 4.0 Industry 4.0 is the fourth industrial revolution - the digital transformation. In this example, C2C applied Industry 4.0 techniques and designed a cleanroom with automated canopies to work in cooperation with Promolding’s robotics. The robotics aim to reduce the risk of human error and improve the quality and consistency of the end product. The cleanroom also features an intelligent digital system, in the form of C2C’s ECO control system. The system is designed to ensure that the cleanroom operates at optimum effectiveness by constantly monitoring the operating conditions in real time within the
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starlim is a world leader in the processing of liquid silicone. Originating from Marchtrenk, our parts reach the whole world and are widely used in medical technology, industrial applications and in the automotive industry. As a fullservice provider, we take care of the entire production chain – from the initial idea to the finished product. This way, we save valuable time and resources.
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CLEANROOMS
Q&A
THE
facts:
ISO 14644-1:2015 class 7
MEDICAL PLASTICS NEWS EDITOR LAURA HUGHES CAUGHT UP WITH C2C’S NEWLY APPOINTED MANAGING DIRECTOR (MD), MICHAEL WRIGHT.
WHAT DO YOU THINK ARE THE LATEST TRENDS WITHIN CLEANROOMS? The principles of Industry 4.0 and the relentless progression of the digital age will continue to change our entire perception about how we interact with facilities and systems. I think the development of fully integrated data assurance and reporting integrity will have an increasingly large influence, well beyond the current impact and expectations for critical sterile environments. Additionally, our comprehensive digital site surveys coupled with utilising material requirements planning systems ensure that we minimise the amount of construction and material conversion processes that take place on a client’s site. This minimises disruption and enables us to configure cleanrooms from a huge library of known components and controlled interfaces. I anticipate that there will be continued development in this area within the industry over the coming years. HOW DO YOU SEE THE COMPANY GROWING OVER THE NEXT FEW YEARS? The company is at a really exciting point in its development. We have supported a significant number of new companies to become cleanroom users as well as partnering with some of the most experienced and impressive industry leaders in their respective fields. I think the cleanroom market is a fascinating and exciting place to exist but provides certain challenges to solutions providers like C2C. Our customers are very varied in the structure and support they require so we need to be able to present the right sector language and alignment to fulfil the individual needs of a range of industries whilst also maintaining our own unique identity. Our intention is for customers to see us more as an integrated service provider, that adds value to their processes rather than just a product provider.
Overall footprint: 279.42m² (19.27m x 14.5m x 2.825m). Internal clearance of 2.5m
Internal change area: 13.86m² (6.860m x 2.02m) 99 no. air changes per hour at an air speed of 0.45m/s in the main area
Variable speed controlled HEPA ceiling fan filters delivering decentralised air handling Roller door for goods in/out Light emitting diode (LED) lighting
ECO control system with automated HEPA-lite canopies
WHAT DO YOU BELIEVE ARE THE MAIN CHALLENGES FOR THE MANUFACTURERS OF PLASTICS FOR MEDICAL DEVICES WITHIN CLEANROOMS? While manufacturers need to remain competitive and efficient, they also need to ensure that they can provide clear auditable evidence of effective process control and this expectation will only grow. I would also anticipate that the increased development of digitised and patient-specific devices targeted to individuals rather than batch manufactured devices will place entirely different pressures on the approaches taken by manufacturers. Finally, another challenge we come across in cleanrooms within plastics manufacturing is the harmonious pairing of process automation and meeting the required particulate control specification. This requires close collaboration between cleanroom designer and equipment manufacturer. Wright was previously head of operations within C2C and succeeds founding director Joe Govier who has now moved in to a CEO role. HEPA-lite is a registered trade mark of Connect2Cleanrooms.
Pendant stations control each automated HEPA-lite on the injection moulding machines. Each have manual overrides for safety reasons Proximity switches to the side of the HEPA-lite have LED lights to give a visual indication when the canopies are in situ. The canopies also feature a safety mechanism which deactivates actuators if the canopy is obstructed
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What are your tubing system needs? Tighter tolerances? Higher line speeds? Complex parts? Material issues? Whatever it might be, Davis-Standard will work with you to engineer and supply the precise extrusion system for all of your medical needs. Incorporating the latest extrusion, controls, tooling and screw technology, our sophisticated lab lines can support your medical tubing applications and product development such as microbore catheter tubing, multilumen tubing, bump tubing, and much more.
davis-standard.com
CLEANROOMS
KEEPING CLEAN
ASHLEY PHILIPP, MARKETING DIRECTOR, INJECTECH EXPLAINS THE BENEFITS CLEANROOMS CAN OFFER MANUFACTURERS.
“I
n the medical industry, you have to do it, it’s a no brainer.” This was the response received when a production manager with 20 years of experience moulding plastic components for medical devices was asked about cleanroom manufacturing. A cleanroom environment provides stability, reliability and control over moulded fittings, and these attributes are then translated to medical devices which are used in patient care and surgical procedures. One of the top factors impacting the decision whether to outsource manufacturing, and if so, which company to outsource to, is whether or not components are cleanroom manufactured. Both fitting and medical device manufacturers will be able to recognise the positive impact they can have on their processes, procedures, and outcomes by understanding the benefits of cleanrooms. Cleanrooms are regulated and classified by the International Organisation for Standardisation (ISO) in the United States and Canada by ISO 14644-1. This regulation includes cleanroom classes from one to nine, with one having the highest degree of cleanliness and nine being the least clean. The most common classes of cleanroom environments are ISO class 7 and ISO class 8. A cleanroom class is determined by the cleanliness of the space in compliance with the quantity and size of the particles per volume of air allowed. Air purity is achieved through High Efficiency Particulate Air (HEPA) filters. A cleanroom serves to ensure small particles don’t affect the manufacturing process through control of humidity, temperature and pressure within the environment. Medical devices and the parts used in tandem with them fall under intense scrutiny for cleanliness and sterility by governing bodies such as ISO and the Food and Drug Administration (FDA). Cleanroom manufacturing offers reassurance to medical device manufacturers that the fittings they have chosen to incorporate into their device will comply with their regulatory requirements. By manufacturing, assembling, inspecting, and bagging the plastic components inside a cleanroom the ability to meet sterility and regulatory compliance is easily achievable. Cleanroom environments must comply with their own set of standards, and therefore set the ground work for compliance with medical device standards. Cleanroom environments provide increased reliability for the manufacturer as everyday contaminants, dust and other particles are eliminated so as to not affect the processes or the fittings. Component manufacturers want to instil the same trust in their fittings as medical device manufacturers want to instil in the hospitals using their devices.
It is very important that the company offering cleanroom manufacturing is visited because companies may claim to have cleanroom manufacturing, however it could only be one machine within a cleanroom. This can then result in conflicts or issues such as delays if the production schedule for this machine is busy or if the machine breaks down. Another item which is important to review is the actual testing of the cleanroom. It is important to make sure the room has been tested in a ‘running’ state along with an ‘at-rest’ state. The ‘at-rest’ test provides a better cleanliness report as there are no people or moving machines, whereas the ‘running’ state will show exactly how clean the room is during manufacturing. Manufacturing in a cleanroom demands a high level of training and competency of the personnel inside to maintain the environment standards and overall cleanliness. The individuals chosen to assemble, inspect, and bag fittings in the cleanroom have undergone extensive training that reflects the needs of the ISO requirements. The required competency and heightened attention to processes by individuals performing the procedures provides greater accountability from those inside and outside of the cleanroom. A cleanroom provides an elevated amount of control over the operations and functionality that can assure medical device manufacturers that the parts they are receiving will be reliable. With the benefits of efficiency, competency, accountability and ability to comply with sterility and regulatory standards, cleanroom manufacturing truly is a ‘no-brainer.’
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compounds
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BIOPLASTICS
BREAKING IT DOWN ASHLEE JAHNKE, DIRECTOR OF RESEARCH AT PLASTIC SUBSTITUTE SPECIALIST TEYSHA TECHNOLOGIES, EXPLAINS HOW A BREAKTHROUGH IN BIOPLASTICS COULD HELP TO REDUCE THE AMOUNT OF SINGLE-USE PLASTIC.
W
hile the professional healthcare industry has existed in some form for the last 200 years, manmade plastic was only invented in 1907 and introduced to the medical field in the late 1950s.
In 2016, the World Economic Forum made a prediction that there will be more plastic than fish in our oceans by 2050. While this is certainly alarming, it does pose the question, how have we done so much damage in little more than 100 years? According to Simon Werrett, a science historian and professor at University College London, research suggests that 85 percent of items in the medical industry are disposable — otherwise known as single-use. With a desire to look at how materials were approached in the seventeenth and eighteenth centuries, Werrett’s research looks at reusable and repurposed plastic items. The cost of single-use plastic, both in money and environmental impact is significant. However, naturally there are reasons why single-use plastics are favoured in medical settings. Cleanliness is the most obvious and critical reason for disposable plastics. In an environment ruled by sterilising and standards, it is easy to see that this is where plastics find their place. After all they have made healthcare safer, simpler and in some cases, smarter. For example, disposable syringes are one of the best ways to limit the spread of infection, intravenous blood bags are lighter in weight, and plastics used as key pieces in prosthetic devices make for smoother and smarter joint repairs. However, at what cost are these benefits by singleuse plastics provided? Earlier in 2019, a photographer in Guernsey took a striking photo showing a young baby holding a disposable plastic syringe that had washed ashore. While these single-use medical products are designed with the best intentions, they are disposed of in a similar way to other single-use plastics, and that ultimately means they can come back to haunt us as they float in our oceans or lie in landfill for hundreds of years. After years of researching these issues and obstacles, Teysha Technologies has developed a plug-and-play system that uses natural-product based building blocks to create polymers that react and behave in ways similar
to the plastics we see every day. The physical, mechanical and chemical properties can be tuned to make the polymer viable in a variety of applications including the medical sector. Additionally, the biodegradation rate can also be optimised so the plastics break down in a matter of years or weeks depending on the needs of a specific application, and then return to their natural building blocks. This breakthrough in modern plastics offers a route to a more sustainable plastic solution and addresses the problem we are faced with, head on. Single-use plastics might have earned themselves a bad name, but nobody could argue that plastic syringes or disposable cups for patients are a bad thing in healthcare. If these are manufactured with tuneable, biodegradable polymers, we can ensure that the impact of these products on human life is purely positive.
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DESIGNING MEDICAL DEVICES
DEEPAK PRAKASH, SENIOR DIRECTOR OF GLOBAL MARKETING AND DAVY VAN BAVEL, RESEARCH AND DEVELOPMENT MANAGER - EUROPE, BOTH FROM MEDICAL TECHNOLOGY COMPANY, VANCIVE MEDICAL TECHNOLOGIES DISCUSSES HOW TO DESIGN OSTOMY AND WOUND CARE DEVICES FOR PURPOSE, USE AND MANUFACTURABILITY.
A
round the globe, today’s healthcare providers face mounting pressure to deliver optimal outcomes whilst reducing costs. To help these providers achieve these objectives, medical device Original Equipment Manufacturers (OEM) must demonstrate both compelling clinical evidence and a strong value proposition. For manufacturers of ostomy devices and advanced wound care dressings, it’s particularly essential to keep a keen focus on designing for patient comfort, performance and manufacturing efficiency. DESIGNING FOR PURPOSE Designing for purpose is usually at the forefront of device engineers’ minds, and adhesives play an important part. In wound care devices, adhesive materials often must protect the wound, promote healing and absorb varying levels of exudate. In the case of ostomy
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devices, adhesive materials must protect the skin around the patient’s stoma while securely holding the collection bag. When designing for purpose, a lot of emphasis is placed on material specifications. The most suitable materials for the physiology of the target patient population are considered, as well as the stability of a material, and if it will be able to remain performing at a suitable standard for the necessary wear time duration. Another factor which must also be considered is if the material will be able to be removed without causing any damage or discomfort to a patient’s skin. Additionally, there are a couple of adhesive characteristics that can be particularly important to consider when designing for purpose because they affect the patient experience and product cost: • Repositionability - if a wound dressing or ostomy flange is made of a repositionable adhesive, then healthcare providers and patients may not have to dispose of the device if they are not able to affix it properly on first attempt. • Moisture management - materials that offer high breathability and/or fluid absorption can extend wear time, therefore reducing the frequency of dressing changes. Transparent adhesive materials also can minimise how often providers or patients must lift or replace a dressing to evaluate the wound bed, saving the expense of buying more dressings and alleviating some stress for the patient.
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DESIGNING MEDICAL DEVICES
Adhesive medical materials can be designed to offer varying levels of moisture management. For example, an ileostomy appliance must be able to manage more liquid output than a colostomy appliance. A wound with moderate exudate requires a different dressing than one that is producing very high exudate. An experienced materials supplier will be able to recommend the best adhesive for the use case. In ostomy devices, wear time is also affected by how well the skin-contact adhesive material can protect the healthy skin around the stoma area and keep it from deteriorating. In some cases, the patient’s skin may be damaged around the stoma, and the adhesive material must help promote healing. New hydrocolloids with additives might be a good choice in either circumstance. Examples of additives include essential oils, vitamins, antimicrobials, odour absorbers, topical pain relievers and moisturisers. DESIGNING FOR USE The purpose of a device is one thing, but whether a patient will actually use it as prescribed can be quite another. For ostomy and wound care products, in particular, device engineers can work with material providers and other supply chain partners to master the art of wearability. A number of human factors come into play such as if the device’s form factor is suitable for the patient’s lifestyle and if the device will fit comfortably under the patient’s clothing. Other factors that are considered are if the device can manage perspiration and other fluids from daily activities such as exercising and showering, as well as freedom of movement. Yet again, the right adhesive materials can support a number of usability objectives. Rigorous adhesive biocompatibility testing helps to ensure the device will not irritate the skin or cause an allergic reaction. Adhesive materials that are stretchable and conformable contribute to patient mobility, helping individuals to go about their daily lives as freely as possible, without having to worry about dislodging their device or disturbing their wound. A material can be engineered to allow moisture on the skin to evaporate through the device while keeping fluids from the outside world from entering. In ostomy care, discretion is one of the most important quality of life considerations. An adhesive material supplier with ostomy expertise can recommend flange carrier materials with odour-absorbing properties. Flanges are typically made of thick, mouldable hydrocolloids and conformable foams, films and soft nonwovens. Ostomy bag materials also can be odour-absorbent and engineered to be quiet so that they don’t rustle when the patient moves. Suitable materials can help ensure that the ostomy appliance design has a smooth, non-obtrusive profile under clothing. DESIGNING FOR MANUFACTURABILITY Designing for purpose and use are incredibly important; the device must perform, and the patient must be comfortable wearing the device. Designing for manufacturability is another realm where an experienced adhesive material supplier can help the OEM to save cost and improve performance. For example, a supplier may be able to identify two materials that can be combined to accomplish what previously took three or four different materials. A supplier may also be able to recommend thinner, lighter-weight adhesive materials that will both conserve cost and be more comfortable for the patient.
For successful device design, there is much to be gained from collaboration between supply chain partners, including materials suppliers, OEM designers, converters, equipment manufacturers and healthcare providers.
Manufacturability relates to selection of not only adhesive materials but also complementary release liners. The adhesive and liner combination, each with its own specific release formulation, contributes to smooth material processing on roll-to-roll manufacturing lines. The release liner also helps support adhesive materials during die cutting, ultrasonic welding, sterilisation and other production processes. For ostomy devices, these materials are often weldable, single-coated nonwovens, films and foams. CONCLUSION Ostomy and wound care device design is a multifaceted, multidisciplinary endeavour requiring a balanced approach to performance, cost and comfort. As foundational building blocks of these devices, adhesive materials play a significant role in determining how a device performs, how the patient feels about using it and how efficiently it can be manufactured. For successful device design, there is much to be gained from collaboration between supply chain partners, including materials suppliers, OEM designers, converters, equipment manufacturers and healthcare providers.
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INDUSTRY 4.0
THE FACTORY OF TOMORROW EARL YARDLEY, DIRECTOR OF INDUSTRIAL VISION SYSTEMS (IVS) EXPLAINS HOW INDUSTRY 4.0 IS CHANGING THE MANUFACTURING WORLD.
P
owered by unparalleled levels of developments in Artificial Intelligence (AI), big data, 3D imaging, and robotic process automation, the ‘factory of tomorrow’ is well and truly here. The manufacturing of medical device products is driven by innovative developments in automation that have enabled organisations to create new ways to deploy virtual labour, such as in the form of machine vision to oversee automated knowledgebased inspection tasks. The drive to fully flexible production control for Industry 4.0 manufacturing means that machine vision and AI-driven vision systems are critical to allow mass production where flexible variant manufacture is the key driver. Critical changes to working practices and automation deployment are creating new opportunities, which include cutting edge production ideologies with vision robotics, flexible manufacturing, efficiencies through self-learning, and the ability to bring machine and human interaction even closer. Medical device manufacturing needs to be lean, high-speed, and possess the ability to switch product variants quickly and easily, all validated to Good Automated Manufacturing Practice (GAMP).
Case study The latest generation vision systems from IVS are aiming to help a major medical device manufacturer to include validated documentation support using XML document exchange in their new Industry 4.0 factory. This will allow for the creation of automated documentation once procedures for automated visual inspection have been validated. This documentation is applied for the examination of pump bodies in a similar way to those found in nasal sprays with a pumping atomiser. This system was designed and installed by IVS. The primary inspection standards for the system was the segregation of products against known measurement criteria to control the quality of the final products. In the age of Industry 4.0, it is critical that new variants can be quickly deployed and documented as part of the manufacturing process. The solution consists of multiple inspection criteria all fed into a dial plate system via a bowl feed. The first check involves examining the intermediate piston stroke length, an indicator for the piston stroke for the pump, in the range of tolerance of +-0.01mm. Based on this result, an inspection is developed to distinguish between the five pump types available, allowing for quick changeover and flexible manufacturing. The second check involves examination of the transparent plastic body containing the spring and ball of the spray mechanism. Using a contour matching function, verification of these critical components is completed. Typical errors contained in this area include double ball bearings, bent springs, misaligned springs and wrong intermediate piston. Finally, a medical device injection moulded cap is checked for vital dimensional tolerances, along with shorts and flash detection – a cornerstone of IVS capability. A key to the application was incorporating the machine vision system into the machine’s cycle time, while being mindful of flexible switching for different parts. The optimisation of the matching function meant the image processing could be completed within the necessary performance required. The solution involved the pump bodies and caps fed on a rotary plate, thus, the test position would be well defined in terms of positional tolerance. Once the pump body reaches the inspection station on the carousel, the Programmable Logic Controller (PLC) sends a signal directly to the I/O control within the IVS-CommandAi vision controller, evaluation by all cameras is completed and communicated back to the PLC. Each feature failure is indicated independently via single I/O channels and information is stored in Excel and exchanged to the factory information system by Ethernet connection. Documentation in the pharmaceutical and medical device industry is critical, and once a complete solution is finalised the full inspection criteria is automatically created as an XML document. This gives detailed information on every inspection function used and how it was set-up, making IVS vision systems powerful when deploying multiple systems across the medical device industry. FUTURE VISION SYSTEMS Industry 4.0 is driving IVS to develop new and innovative solutions for the future of medical device plastics manufacturing. Robotics, machine learning and artificial intelligence are reshaping automation, allowing medical
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INDUSTRY 4.0
device manufacturers to improve quality, maximise value, keep costs down or offer new services. New technologies are emerging, which will help shape the future of production control. HYPERSPECTRAL IMAGING Next-generation modular hyperspectral imaging systems provide chemical material analysis in industrial environments, and this can be harnessed to view the chemical composition of a product. Chemical colour imaging visualises the molecular structure of materials by different colouring in the resulting images. This allows the chemical composition analysis in standard machine vision software. Typical applications include plastic detection in different recyclable materials and blister pill inspection quality control. The main barrier for such systems is the amount of data and speed required for processing, but the development of faster processes, better algorithms and on-camera calibration still make this a hot topic. In the production of high-value chemicals, there must be strict control over the final product’s size, purity, form, and morphology. Medical device manufacturing continues to require precision automated inspection at high speeds. The disposable needles used in pen-injectors, for example, need to be straight as well as being sharp. Hyperspectral imaging combined with traditional machine vision can check the contents of a syringe as well as assure that bent or blunt needles and mould defects are rejected as part of the medical device inspection process, long before they reach the enduser. OPTICS DEVELOPMENT There have been significant developments in optics over the past few years, particularly when it comes to reducing the size of optical components for them to fit into tighter spaces on medical device production lines as part of a machine vision inspection solution. This trend is expected to pick up even further pace throughout the next year due to the limitations on space in some production floors. Understanding measurement techniques and uncertainty when specifying and procuring optics for use in machine vision are critical.
DEEP LEARNING New deep learning technologies are utilising advanced artificial intelligence which is taken from the development in machine vision for autonomous vehicles, social media processing and robotics. Deep learning algorithms using convolutional neural network classifiers allows image classification, object detection and segmentation at speed. Development of these new AI and deep learning systems is expected to increase across pharmaceutical manufacturing. These algorithms can also be utilised for surface inspection and defect detection on blister packs, moulds and seals – enhancing the quality and precision of deployed machine vision systems. HIGHER SPEEDS Faster processes allow more data and image processing in realtime. Higher resolution cameras are utilised for greater processing leading to increased accuracy of vision systems over the next few years. However, one of the biggest challenges in the adoption of machine learning is how the data is handled. Cloud-based image collection and processing will become the norm to allow higher bandwidth image processing, as well as data saving and image collection for warranty protection for medical device production. CONCLUSION Industry 4.0-related technologies in plastics manufacturing are driving much of the changes that are currently taking place in production. This applies in all sectors, but it is particularly vital in high-specification and highly regulated industries such as pharmaceutical and medical device plastics manufacturing. There are many reasons for companies to move towards factory automation technologies, including creating more efficient production, increased production flexibility, making more effective use of resources, and improving productivity. We fully expect to see the growing demand for production processes which are highly flexible utilising real-time vision inspection to cope with multivariant production in this age of flexible manufacturing.
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Plastic Solutions Dedicated to the Global Life Science Industry Scientific Injection Molding Injection of Highly Technical Resin Materials High Precision Plastics Parts, Microfluidics, and Consumables Fully Automated Process Clean Rooms ISO 8 - ISO 7 High Quality ISO 13485 - ISO 14001 - GMPs
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INDUSTRY 4.0
The digital twin is here MARTIN GADSBY, DIRECTOR AT OPTIMAL INDUSTRIAL TECHNOLOGIES, LOOKS AT WHAT DIGITAL TWINS ARE AND HOW PROCESS ANALYTICAL TECHNOLOGIES (PAT) CAN HELP DIGITALLY CLONE MANUFACTURING PROCESSES.
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he global importance of plastic-based medical and drug delivery devices is increasing the number of business opportunities within the medical plastics market. These opportunities help to improve the competitiveness offered by the fourth industrial revolution (Industry 4.0) and help those medical plastic manufacturers that recognise and adopt them. One of the key emerging Industry 4.0 technologies, the digital twin, has the potential to drive dramatic increases in process responsiveness, productivity and efficiency. There are a plethora of definitions and interpretations of what digital twins are. At their simplest, they are virtual replicas of physical entities that can be used to understand or predict real-world outcomes. These can represent single components, machines, end products, systems within a production line or entire manufacturing processes. Also, they can be static, e.g. not interact with their real-world counterparts, or dynamic by using sensor-based feedback received from the physical entities to adjust their models accordingly and deliver optimised outputs and forecasts. Digital twins are suitable for a wide range of applications, such as Product Lifecycle Management (PLM), predictive maintenance of industrial machines and personnel training in virtual environments. In addition, digital twins can support predictive manufacturing and advanced quality based Multi-Variate Statistical Process Control (MSPC). In the medical plastics sector, a digital twin for quality based MSPC could carry out processes to predict how Critical Process Parameters (CPPs), e.g. melt temperature or injection velocity, would affect real time product quality, durability and reliability. The concept of digital twins, particularly when combined with MSPC, is relatively new. However, a well-constructed system based on Process Analytical Technology (PAT) which will leverage both of these concepts, and as a result maximise your process’s quality and performance is beneficial. In fact, it provides a framework that is promoted by regulatory bodies such as the European Medicines Agency (EMA), to create cyber-physical systems of entire manufacturing processes. As a result, businesses that are embarking with PAT can leverage their existing infrastructure together with new PAT technology and techniques to implement digital twins for Industry 4.0 applications.
PAT facilitates the creation of in-depth knowledge of the process in order to deliver accurate actionable insights. By understanding the correlation between CPPs and product’s Critical Quality Attributes (CQAs) - measured in real time in-line, on-line and/or atline by suitable analytical instruments, the process can be controlled in real-time based on quality predictions to ensure the end product will fulfil any given specifications. Manual or automated control is possible as the process models can either direct the operator as to the desired action or act independently. One of the most advanced and popular regulatory-compliant PAT knowledge management platforms currently available is Optimal’s synTQ. The software’s latest ‘test mode’ function is a true process digital twin. It allows authorised users to run either partial or complete PAT methods (or orchestrations, as they are called in synTQ), virtually at any point during the process’s lifecycle. Thus this ‘test mode’ digital twin can be used effectively to create and test the process data flows before the real process is started up, and then used to optimise the process as more data and knowledge is generated and the models are refined. The net result is that process start-ups are much more straightforward, and that improved models can be tested within the digital twin environment. Once the optimal virtual orchestrations have been created, tested and set, operators can systematically connect these with the physical plant to transmit the optimal operating conditions. As a result, businesses can fine-tune their processes whilst incurring substantial savings in terms of cost, time, raw materials and waste. In addition, synTQ can be used as a tool to realise wider Industry 4.0 principles, by helping to create an interconnected factory through linking Distributed Control Systems (DCSs) with higher-level Manufacturing Execution Systems (MESs). Manufacturers of plastic-based medical and drug delivery devices could use reliable systems to futureproof their plants and processes.
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CATHETERS AND STENTS
A closer look DESIGNER AND MANUFACTURER, ASH TECHNOLOGIES, EXPLAINS HOW DIGITAL MICROSCOPES COULD BECOME AN ESSENTIAL TOOL IN QUALITY CONTROL, INSPECTION AND PRODUCTION FOR THE MEDICAL DEVICE INDUSTRY. IMPROVING STENT INSPECTION There are a number of common defects which occur during the manufacture of stents, such as cracks, pits, score marks and scratches. It is essential that these defective stents are repaired or rejected from production.
KEY APPLICATIONS FOR DIGITAL MICROSCOPES WITHIN THE MEDICAL DEVICE INDUSTRY INCLUDE: • Inspection of the surface of a medical device to detect defects • Measurement of medical device parts
High resolution imaging, high magnification, large field of view and lighting are important factors for stent inspection. With full high definition 1080p at 60 frames per second, the Omni provides suitable resolution to see defects and reduce any lag effect which can disorientate the operator. Lighting is also critical in achieving a sharp image. Diffused Light-Emitting Diode (LED) lighting reduces reflection on the stent surface and greatly improves the image clarity. The Omni digital microscope has a large magnification range and large field of view, which makes it easier to switch from an overview of the stent to a close-up view of a particular area. This in turn saves time as the operator can quickly identify a problem area and focus in on it. One of the challenges when visually inspecting a stent is its cylindrical shape. A convenient way to manoeuvre the stent is by using a rolling stage. This allows the operator to easily rotate the stent and inspect all areas for defects. IMPROVING BALLOON CATHETER INSPECTION The manufacture of balloon catheters is a complicated process that can occasionally result in defective products. Common defects which occur during the manufacturing of balloon catheters include gel spots, ‘fish eyes’ and foreign particles. Due to the safety critical nature of balloon catheters it is essential that all defects are eliminated before being shipped. Balloon defects can often be difficult to identify and categorise with traditional inspection tools. However, digital microscopes provide an effective solution to inspect and measure balloon catheters. Polarised lighting is very useful for detecting surface defects in materials like balloons. The polarisation interference patterns uncover common defects such as gel spots and ‘fish eyes’. This technique involves using a polarising filter on both the lens and sub stage light. The lens polarising filter is rotated to produce the interference patterns.
Measurement overlays of specific part dimensions can also be created to enable a qualitative inspection against on-screen templates. These overlay templates can be configured with part-specific camera and lighting parameters to ensure reproducibility and standardisation of inspection conditions. A repeatable inspection process ensures produced parts are of consistent quality. The automatic edge detection feature in the Omni measurement software ensures that measurements are repeatable thus reducing variability between operators. Digital microscopes are also appealing for the medical device industry, due to their efficiency. The Omnis are able to maintain calibration whilst zooming, so there is no need for time consuming recalibrations between changing magnifications. Additionally, all data captured using the Omni digital microscope can be saved to the network.
MEASUREMENT OF MEDICAL DEVICE PARTS Omni’s integrated measurement software can be used to carry out measurements of stent struts and to add text if something needs to be labelled. Technical drawings of medical device parts can be imported as Drawing eXchange Format (DXF) files and used to create overlay templates with tolerance limits ensuring continuity of quality control from the design of the part. DIGITAL MICROSCOPES CAN OFFER ADVANTAGES TO THE MEDICAL DEVICE INSPECTION PROCESS SUCH AS: Improved ergonomics: Operators can inspect and analyse samples while sitting or standing comfortably for longer periods of time Improved workflow efficiency: Reduces the number of steps and tools involved in inspection and analysis through integrated, easy to use inspection and measurement software applications Documentation of inspection: Offers traceability and documentation of inspection and analysis through image capture for reporting and quality control purposes User control: Offers improved traceability and control if many different users work with the same microscope
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ADHESIVES
HOW TO AVOID MEDICAL DEVICE ADHESIVE FAILURE DEL R. LAWSON, WHO CURRENTLY LEADS NEW PRODUCT DEVELOPMENT AND COMMERCIALISATION EFFORTS IN 3M’S MEDICAL SOLUTIONS DIVISION AND TONY KAUFMAN WHO LEADS NEW BUSINESS VENTURES FOR 3M’S MEDICAL MATERIALS AND TECHNOLOGIES BUSINESS, DISCUSSES WHAT YOU NEED TO KNOW TO AVOID MEDICAL DEVICE ADHESIVE FAILURE.
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hile there’s no recipe for designing stick-to-skin medical devices, an adhesive is likely to be a key ingredient. Innovations in adhesive and wearable technology have transformed the way doctors and patients are able to make critical medical decisions. They’re mobilising chronic disease management and lending patients the freedom to monitor and manage their health on their own – anytime and anywhere. Although wearables have simplified the care management process, the engineering that brings these products to life is no easy feat. With so many device and user variables, thoughtful adhesive selection is essential to develop a design capable of achieving the intended purpose and wear time while delivering accurate readings under a variety of circumstances. But what happens if adhesive selection isn’t given proper consideration? We list three important things to consider. COMPATIBILITY WITH THE MANUFACTURING PROCESS It’s important to confirm your chosen adhesive is compatible with the manufacturing process intended to mass produce the final product. Thinking beyond the design phase to manufacturing can help dodge a number of ways adhesives can derail the project. For example, soft adhesives have the potential to gum up equipment during production and converting processes. Other adhesives may be unable to withstand the speed and friction of a specific method or the liner materials could break during production, which may compromise integrity. Should any of these mishaps occur, you could run into problems with assembly line flow and function, such as unscheduled stops for cleaning. Being proactive and engaging an adhesive supplier early in development can help you to bypass potential redesigns, avoid cost overruns and proceed with bringing your device to market.
moisture. Two of the most common issues to be aware of are allergic reactions and medical adhesiverelated skin injuries. Over-designing to create a super sticky product that provides a longer wear time than is intended could lead to undesirable outcomes. Design and device issues are largely preventable if you select your materials and adhesive carefully. Three key questions to think about when you start mapping your design and development plan are: 1. What are the needs of the substrate and user? 2. What environmental factors will the device encounter? 3. How long will the device be worn? In addition to considering these questions, seek the counsel of a material supplier or adhesive expert that has experience with designing, researching, and testing adhesive technology.
CHOOSING THE RIGHT ADHESIVE FOR THE DEVICE Choosing the wrong adhesive can have undesirable effects even after the device is manufactured. When it comes to stick-to-skin products, it’s usually the adhesive’s main job to keep the device adhered to the user’s skin for a specified wear time. If the adhesive fails, the device could prematurely detach and/or provide inaccurate readings. For continuous glucose monitors and other devices that help manage chronic illnesses, prompt and accurate data is critical to users’ health, independence and ability to manage their care at home. In these applications especially, adhesive failure would be simply unacceptable. For adhesives holding device components together, reliability is one of the main concerns. Components need to stay in place in order to provide results users can trust. Another potential device issue adhesives can cause involves the electronic component layer de-bonding if it’s incompatible with other materials. You need to be sure that the pressure sensitive adhesive you select ensures and maintains a consistent connection. Not only is it troublesome when device materials fall apart, it can be just as problematic when two incompatible materials combine. CONSIDERING THE RISK OF INJURY TO THE USER Since human skin is a living, breathing organ that’s constantly regenerating itself, it is different than other substrates, like metal or plastic. In order for it to function normally, skin needs to be able to move, flex and expel
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INJECTION & MICROMOULDING
Lifelong lessons MANUFACTURER PENTAGON PLASTICS GROUP, EXPLAINS HOW PLASTICS INJECTION MOULDING AND MOULD TOOL MANUFACTURE PROVIDES SOLUTIONS TO MANY APPLICATIONS IN THE MEDICAL SECTOR.
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ach new product range brings its own challenges, and therefore it is crucial to have the right network of support in place from the outset. In order to achieve a successful manufacturing experience, it is necessary to have a product designer, material expert, mould tool manufacturer, plastic injection moulder, multiple medical engineers and marketing staff within each team. It is also vital that areas of concern are addressed within the manufacturing process, and factors such as ease of use, comfort, flexibility, repeatability and the longevity of a product are monitored.
“It is particularly rewarding when working within the medical industry on a project that can provide a life changing solution to a patient with a medical condition. The parts that are produced can affect processes, products, functionality and in the end provide a better quality of life for the end user.
There are a range of products available, and today these are often made of very soft materials. Products designed with soft materials allow user comfort and the ability to retain strength in order to prevent deformation whilst being used. Products which are manufactured from a slightly harder material are done so in order to achieve a secure ‘snap’ fit.
“It has been a pleasure over the years to support some of the largest industry names with the great work that they do in relation to stoma care and we are proud to have played a part in manufacturing innovative ideas for urostomy, ileostomy, colostomy and tracheotomy product ranges.”
Additive manufacturing is widely used in the development process as it is able to rapidly achieve initial samples. Manufacturers can then enhance this by constructing development mould tooling for the full part, or for a section of an assembly item. Samples can then be produced in various thermoplastic grades of material. This ability to adjust the tooling allows customers to develop the key features to ensure the end part is fit for purpose before committing to what can be expensive production mould tooling. In order to produce a seamless product to the highest standards, tool configuration must be considered. By lessons learnt from the development process, manufactures can ensure the right number of cavities are applied and the correct hardness of steel is chosen. This will guarantee the life of the tool, as well as achieving the product design and volumes required, whilst ensuring that the budget is met. Once the tools are produced, they are trialled to gain final production approval and to set the quality standards. These standards will be applied over the life of the mould tool to ensure repeatability. Due to the nature of the application, product ranges have a long life. It is proven that once a patient is comfortable with a specific product, they are hard to convince to change even when a new improved version arrives in the market. West Sussex based moulder and toolmaker, Pentagon Plastics Group are involved within the medical industry, with a particular focus on ostomy appliances and devices. Paul Edwards, managing director and owner, Pentagon Plastics Group says: “Being involved at the very early stage of a new project and seeing it grow and develop into the final product is one of the thrills that comes with being a technical injection moulder and toolmaker.
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Handhelds
INJECTION & MICROMOULDING
BETTER TOGETHER KRISSY DEMPSEY, MEDICAL MOULDING MARKET MANAGER AND ANGIE ALT, MARKETING COORDINATOR, BOTH FROM MANUFACTURER, SAINT GOBAIN EXPLAINS WHAT TO DISCUSS WITH YOUR VENDOR WHEN CREATING A PART THAT WILL BE MICROMOULDED UTILISING LIQUID SILICONE RUBBER (LSR).
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arket research company, BIS Research, estimates the global minimally invasive surgical systems market is estimated to grow at a Compound Annual Growth Rate (CAGR) of 10.9% to over $40.52 billion by 20251. As with the minimally invasive surgical market, the general trend in medical devices (for markets such as ophthalmic, drug delivery, vascular access and intravenous therapy) is a smaller footprint, lower cost, and disposable - when possible. In order to keep up with these trends, the supply chain must adapt in order to be able to provide components that are designed to be micro-sized yet still maintain the integrity of the design, the high-quality requirements and meet the volume expectations of the Original Equipment Manufacturer (OEM). The evolution of micromoulding a variety of materials from metals to plastics to thermosets, such as silicone, are all spurring new design changes and updates to meet the expectations of OEMs and patients for smaller devices. With LSR, parts can be made as stand-alone parts or overmoulded to a variety of substrates for sealing, soft-touch, and other functions. Silicone is very inert and is a good choice for fluid path components. Depending on the application, there are a variety of grades you can choose from. However, it is important to think if the application of the silicone part will be static or dynamic. Other critical factors to consider are if the silicone needs to return to shape, if it is sealing and if it needs to be medical grade (class VI) or if an implant grade is required. Micromoulding vendors should be able to help you determine the appropriate grade based on physical properties, application requirements and certifications. In addition to material expertise, OEMs will want to find component suppliers that can deliver high precision, shot-to-shot repeatability, and achieve very tight tolerance targets on your complex medical device components. Silicone can be a very difficult material to work with so working with a vendor that is well versed in the processing of this material will be key.
There are specialised techniques which exist and can help with automation. Additionally, silicone attracts debris and holds on to it so it would be a good idea to ensure that the vendor is using a certified cleanroom that meets your expectations. Micro-overmoulding of silicone to substrates such as stainless steel, polycarbonate, nylon or PolyEther Ether Ketone (PEEK) provides a range of design possibilities. However, adding the substrate to the moulding process does add a layer of complexity for your vendor. If you work closely with your vendor to allow for design tweaks early on in the design process this will allow for manufacturability and save both of you time in the long run. By working with your silicone micromoulding vendor on your material choice and part design, the vendor should be able to create a technically accurate mould design combined with highly controlled processing conditions with the right equipment. This should result in a successful micromoulded component for your medical device. REFERENCES
Silicone has the ability to flash at <0.0001” or <0.003mm making mould design and precise mould-build key factors to a successful micromoulding project. The tool design and manufacturing equipment used (press) will need to allow for the ability to control a very small shot size. From SaintGobain’s experience, parts can be moulded as small as 0.001g with a hole size as small as 0.003.” These micro-parts can contain complex part geometries, undercuts, threads and blind shutoffs. By working with a vendor on the design you can ensure the component functions as intended and is able to be manufactured in such a way that will meet the dimensional, tolerance and volume requirements for the life of the device. Some other challenges to keep in mind and discuss with your vendor include being able to develop a reliable and reproducible measurement technique, particularly when cross-sections are required. Silicone is not rigid and therefore using non-contact measurement equipment is recommended and a thorough gage repeatability and reproducibility study. Part handling is another factor which is important to discuss with your vendor. As the parts are so small, they are often difficult to handle manually, and so automation, when volume supports it, is a suitable option.
1) BIS Research. (2018, July 18) Global Minimally Invasive Surgical Systems Market - Analysis and Forecast, 2018-2025.
If you work closely with your vendor to allow for design tweaks early on in the design process this will allow for manufacturability and save both of you time in the long run.
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INJECTION MOULDING
Under the spotlight HOW AN INJECTION MOULDING SPECIALIST AND LIGHT DESIGNER COOPERATE TO DEVELOP INNOVATIVE COMPONENTS FOR LIGHT EMITTING DIODE (LED) LIGHTS.
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njection moulding specialist, Starlim//Sterner, together with light designer firm, Bartenbach, discusses the innovative new optical attachment for LED lights. This attachment will aim to ensure homogeneous distribution of light in every beam angle. It is thought that the mixing dome will create lasting and unique lighting effects on both public and private buildings. Bartenbach has been developing lighting solutions for over 30 years. With a skilled team of 75 specialists the company are able to draw upon experts for every significant stage from light planning and design, to development of its own and customised lenses. In addition to targeted illumination and lighting of spaces and surfaces, Bartenbach always considers the physiological and
It is thought that the mixing dome will create lasting and unique lighting effects on both public and private buildings.
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psychological impact of a lighting concept on behalf of its customers. This is because research and development are, of course, of paramount importance. Christian Reisecker, project manager at Bartenbach comments: “We value our long cooperation with Starlim//Sterner very highly. It’s a perfect combination of silicone injection moulding experience with our light design expertise, continually producing unique, innovative product solutions.” The latest product of the cooperation between Bartenbach and Starlim// Sterner is the RMJ mixing dome. This dome is a highly transparent silicone optical attachment which aims to offers multiple advantages. Silicone’s properties are able to be exploited to the maximum in the innovative RMJ mixing dome. Lenses are light-diffusing elements that, as in this case, are positioned in front of LED chips to ensure light diffusion and homogenisation through reflection or refraction. In contrast to conventional solutions such as polymethylmethacrylate or polycarbonate elements, the adhesive force of the silicone lens means it clings to the LED module like a seal, simultaneously providing protection against all external influences. Silicone also possesses electrically insulating properties that provide touch protection. The enormous ultraviolet and heat resistance of the material means that the proximity to the light source is completely uncritical in this regard. The silicone type selected for this special application is highly transparent, has transmission properties comparable to glass and does not yellow in the long term. A high-end silicone optical attachment has been developed in cooperation with Bartenbach which is extremely thin and distinguished by undercuts and additional freeform surfaces of the highest quality and dimensional accuracy. Thomas Setz, business area manager at Starlim//Sterner concludes: “Our core competencies include being a co-designer and developer for our customers and partners. Aside from jointly selecting the best material for the application, we also cooperate to develop an optimum component and mould geometry for mass production. We have also upgraded our machine technology to produce the polished microfacetted surface of the RMJ mixing dome which, in turn, ensures the desired lighting effect."
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Smarter Healthcare.
Positive Patient Outcomes DuPont now offers a 80-year heritage in engineered polymer and silicone chemistries tailored for demanding Healthcare applications, like drug delivery devices, wearables or advanced wound management. DuPont smarter healthcare solutions help to improve patient compliance and the overall experience by increasing medical device design flexibility, enhancing connected devices, and improving process efficiencies. Through our process, application and regulatory expertise dedicated to healthcare, we collaborate with you to create new design opportunities and to build the next generation of healthcare solutions.
Our broad portfolio of safe, durable, and reliable medical grade solutions include:
• Pressure sensitive adhesives • Soft-skin adhesives • Liquid Silicone Rubber
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• High Consistency Rubber • Nylon • Zytel® Nylon
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DuPont™, the DuPont Oval Logo, and all trademarks and service marks denoted with ™, SM or ® are owned by affiliates of DuPont de Nemours, Inc. unless otherwise noted. © 2019 DuPont.
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WEBINARS
CREATE | ENGAGE | INSPIRE Our webinars offer an insightful and professional means of connecting with your target audience through thought leadership and direct interaction. • Showcase your expertise and industry knowledge • Raise brand awareness • Transform the way you engage with customers • Run a cost-effective and convenient alternative to conventional seminars • Gain more insights into your target audience • Attain clearly defined and qualified sales leads
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EVENTS
Med in Irelnd: Why you should attend A ONE-DAY EVENT WHICH AIMS TO SHOW HOW IRISH COMPANIES ARE ATTEMPTING TO TRANSFORM THE FUTURE OF HEALTHCARE AND MANUFACTURING.
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ed in Ireland provides attendees with the opportunity to meet with industry experts, whilst also creating the chance for attendees to conduct on-site visits and arrange one-to-one meetings with exhibitors. The show also hopes to increase attendees’ understanding of the medtech research which takes place within Ireland’s Higher Education Institutes. WHY IRELAND? Ireland is a logical location for this trade show as Ireland is home to 18 of the world’s top 25 medical device manufacturers. Additionally, Ireland claims to export €12.6 billion worth of goods to 100 countries each year, which makes the country the second-largest for exporting medical devices in Europe. The country is also home to 350 medtech companies which employ 38,000 people, and 80% of the world’s stents are produced by medtech companies within Ireland.
EXHIBITORS This invite only event has been running biennially since 2005, and this year over 70 healthcare and manufacturing companies from sectors including medical devices, subsupply, precision engineered components, diagnostics, connected health and research and development will be exhibiting. Exhibitors will be given the opportunity to network with manufacturing and healthcare sub supply buyers from all around the world, as well as being able to create global partnerships and generate new business. There are multiple exhibitors set to attend the event including but not limited to, Avant Medical, Bemis Healthcare Packaging Europe, Nelipak Healthcare Packaging, Phillips Medisize, SteriPack, Teleflex, VistaMed and Zeus Industrial Products Ireland.
CONFERENCE A conference will be hosted all day alongside the event and will include presentations by speakers from all around the world. The talks will take place before the exhibition officially opens, and speakers at the event will include: • Chris Coburn, chief innovation offer, partners healthcare system • Ibtesam Al Bastaki, director of investment and private partnership Dubai health authority • Tanja Valentin, director external affairs at medtech Europe • Paudie O’Connor, multi-site vice president manufacturing at Boston Scientific MEDTECH INNOVATION ZONE There will also be a Medtech Innovation Zone showcase where Irish supports will be in attendance. The names of some of the companies taking part in this are AventaMed, Neurent Medical and Signum Surgical.
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KEY DETAILS AND REGISTRATION The event will take place on 10th October 2019 in Dublin, Ireland. Doors will open for registration at 7:15am and the event will finish at 5:30pm. To register for this event attendees need to submit their interest on the event website.
2017: The numbers
800+ delegates 40+ countries 270+ buyers 1200+ business meetings 140+ site visits
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EVENTS
What to see at K Show 2019
*
A MUST ATTEND TRADE FAIR FOR THE PLASTICS INDUSTRY Location: Fair Ground Düsseldorf Time: 10am until 6:30 pm Date: 16th to 23rd October 2019 K Show 2019 hopes to build on the success of the previous show in 2016 which experienced top feedback from both visitors and exhibitors, and saw 232,000 visitors from 160 countries and 3200 international exhibitors attend the event. WHAT WILL EVERYONE BE TALKING ABOUT? The main product categories at this year’s K will be: • Raw materials and auxiliaries: The materials of the future will be presented by well-known companies • Machinery and equipment: Live demonstrations and world premieres of complex production units are set to take place • Semi-finished products, technical parts and reinforced plastics: How climate change offers huge opportunities for the plastics industry will be discussed
• Services, research and science: There will be the opportunity to talk to experts from research institutions and service providers WHO WILL BE EXHIBITING? Company: Albis Location: Hall 8b, Stand A61 Exhibiting: Albis will be presenting its range of high-performance plastics, compound solutions and master batches at K. The company will also be discussing it’s range of recycled and bio-based products. Company: Davis-Standard Location: Hall 16, Stand A43 Exhibiting: A range of extrusion and converting technology which highlight how the company support sustainable processing practices and waste reduction. Alternative polymer use will also be presented. Additionally, the DS Activ-Check and Bluebox will be on display alongside elastomer developments, profile capabilities, extrusion die, blown film and aftermarket advantages.
Company: Engel Location: Hall 15, Stand B42-C58 Exhibiting: Engel will be showcasing the process where housing parts for medical devices are produced using twocomponent injection moulding. Company: Polyplastics Location: Hall 7a, Stand B02 Exhibiting: The company will display Duracon POM grades which are used for the production of injection moulded automotive fuel system components within Europe, alongside other products within the portfolio. Company: Sumitomo Demag Location: Hall 15, Stand D22 Exhibiting: The newest IntElect S medical machine will be revealed at K. This machine was built for speed and precision with the aim of offering repeatability and cleanliness.
Company: Wittman Battenfeld Location: Hall 15, Stand C06 Exhibiting: They will be producing a valve for medical technology from a liquid silicone rubber formulation on their allelectric EcoPower series of machines at the event. Company: Vecoplan Location: Hall 9, Stand B59 Exhibiting: Machines and systems which shred, convey and process both primary and secondary raw materials will be on display. There will also be a single-stage shredder from the new Vecoplan Infinity Shredders (VIZ) series on the stand. Vecoplan claims
WWW.MEDICALPLASTICSNEWS.COM
USEFUL TIP:
With an admission ticket all attendees are entitled to free travel to and from the exhibition grounds on the day of their show visit. More information on this can be viewed on the event website.
to offer meaningful ways of recycling plastics. In addition to those listed above, there will be many other exhibitors at the show including wellknown names such as Arburg, Cannon, Covestro, Dow Europe, DuPont, Moretto, Sabic, Sodick and Zotefoams. WHO WILL BE ATTENDING? The target groups for the K Show include people from multiple industries including but not limited to plastic product manufacturing, machinery construction, packaging, medical technology, energy technology and universities. Attendees from the last K Show were from the following sectors: Industry (69%), trade (8%), services (7%), skilled crafts (3%) and university/college of higher education/technical college (2%). REGISTRATION Registration is still open and can be done via the event website. It is necessary to register prior to the event in order to attend K Show 2019.
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3 things to look out for at K 2019 1
The science campus: This will be a forum for teaching and research where universities, colleges and scientific institutions will be presenting their latest research
2
Plastics shape the future: How the future can be shaped with plastics will be discussed on the stage in multiple formats throughout the event
3
Hot topics: Industry 4.0, sustainable development, systems integration and young professionals will all form part of the show’s supporting programme
10:2019 NO MORE NEEDLES A team of scientists at the University of California, Berkeley have announced they are developing wearable skin sensors. The goal of the project was to find out more about the composition of our sweat, and therefore reliable sensors needed to be developed. The sensors have a spiralling microscopic tube or microfluidic that is able to wick sweat from the skin. The microfluidics are fitted with chemical sensors to detect concentrations of electrolytes and metabolites, and the sensors can
be rapidly manufactured using a ‘roll-to-roll’ processing technique that prints the sensors on to a sheet of plastic. This processing technique enables a high-volume production of disposable patches at a low cost. One interesting finding by the team is that a person’s local sweat rate could indicate overall liquid loss during exercise and identify if they are pushing themselves too hard. A second is that there is not a simple correlation between sweat and blood glucose levels.
PHD CANDIDATE EVERT FUENMAYOR. ATHLONE INSTITUTE OF TECHNOLOGY ©
MASS PRODUCTION OF PERSONALISED MEDICINE
I
n an effort to make the lives of those who have to take multiple drugs at various times every single day easier, researchers at Athlone Institute of Technology are attempting to achieve personalised medicine on a mass scale via local pharmacies through the use of a 3D printer. Expertise in material science, additive manufacturing and injection moulding was required to create this idea. Initially patients’ genetic profiles are used to predict drug efficacy and guide dosages. This enables the researchers to create blueprints for customisable tablets that combine and release drugs in the prescribed amounts and conditions over
prolonged periods of time. The 3D printing technique relies on specific polymers and printing parameters in order to deliver active ingredients. The end goal is for pharmacists to have a 3D printer and the correct drugloaded polymers in stock to be able to print tablets for a patient within the pharmacy. There are limitations however, such as the time it takes to print the drugs. For example, one tabletting machine can produce thousands of tablets in an hour, however, this 3D printing method takes four hours to print 30 pills. The research is currently at an early stage, but the researchers involved believe it shows great promise.
CHECK OUT... THE LATEST EPISODE OF THE MEDTALK PODCAST In our latest episode Ian Bolland, web content editor and Reece Armstrong, editor of our sister title European Pharmaceutical Manufacturer, speak to Dr Ian Jackson, medical director and clinical safety officer at Refero. The editors discuss the appointment of Matthew Gould at NHSX, the recently announced plans for an NHS artificial intelligence laboratory and current digital technologies and investments in solutions within the NHS. You can listen to the latest episode on Soundcloud, iTunes and Spotify.
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2019 NORTH AMERICA EVENT CALENDAR
JAN 29-31, 2019 // SANTA CLARA, CA
AUG 27-29, 2019 // SANTA CLARA, CA
DesignCon
Drive World Conference & Expo, ESC
FEB 5-7, 2019 // ANAHEIM, CA
SEP 10-12, 2019 // NOVI, MI
ATX West, MD&M West, Pacific Design & Manufacturing, PLASTEC West, WestPack
The Battery Show, Electric & Hybrid Vehicle Technology Expo
MAY 15-16, 2019 // BOSTON, MA
OCT 23-24, 2019 // MINNEAPOLIS, MN
BIOMEDevice Boston, Design & Manufacturing New England, ESC
ATX Minneapolis, Design & Manufacturing Minneapolis, MD&M Minneapolis, MinnPack, PLASTEC Minneapolis
SANTA CLARA CONVENTION CENTER
ANAHEIM CONVENTION CENTER
BOSTON CONVENTION & EXHIBITION CENTER
JUN 4-6, 2019 // TORONTO, ON TORONTO CONGRESS CENTRE
Advanced Design & Manufacturing (ADM) Expo featuring PACKEX, PLAST-EX, ATX, Design & Manufacturing, Powder & Bulk Solids
JUN 11-13, 2019 // NEW YORK, NY
JACOB K. JAVITS CONVENTION CENTER
Atlantic Design & Manufacturing, ATX East, EastPack, MD&M East, PLASTEC East, Quality Expo
For more information please e-mail us at: amgpartners@ubm.com
SANTA CLARA CONVENTION CENTER
SUBURBAN COLLECTION SHOWPLACE
MINNEAPOLIS CONVENTION CENTER
DEC 4-5, 2019 // SAN JOSE, CA SAN JOSE CONVENTION CENTER
BIOMEDevice San Jose