MPN EU Issue 19

MPN

MEDICAL PLASTICS NEWS

Phillips-Medisize Celebrating 50 years of Partnerships

ALSO IN THIS ISSUE: Drug delivery devices Coatings Cleanroom technology The latest news & opinion

ISSUE 18 May-June 2014 WWW.MEDICALPLASTICSNEWS.COM

MPN Breathe Easy—Page 13

All Medical, All Plastics

Contents

5. Editor’s Letter: Total Recall Lu Rahman, editor, highlights self promotion in the medical device world.

6. On the Pulse: Industry news Top US medtech earners and awardwinning innovation from the sector.

Product Focus —page 18

8. News Profile: Industry reaction to the launch of the UK’s MedCity.

Solvay’s Pulse on Plastics Symposium.

10. Speech Therapy: MPN’s new opinion section offering an insight into the sector’s views.

Materials—page 23

14. Product Focus: Drug Delivery Devices The latest advances, technology and market insight into the drug delivery sector.

23. Materials: Elastomerics Expertise from PVCMed Alliance and Cikautxo.

Coatings—page 36 Cleanroom—page 44

31. End of the Line: Coatings Including innovation from Pekago and Phillips-Medisize 41. Design for Life: This issue we look at the role of 3D printing in a blood recycling machine 43. Show Previews What to expect from this year’s MDM East and Medtec Europe events.

44. Machinery: Cleanroom Technology Connect 2 Cleanrooms and Styron under the spotlight.

48. Testing and Quality Control: Toxikon explains ISO10993 50. Beady Eye: The first in a new regular slot where MPN focuses on a technology, service or company to watch. This month we fix our glaze on Plastic IT.

26. Machinery: Extrusion John Brennan, Kelpac, provides expert knowledge on the role of custom extruders.

Online and in digital Disclosure: Medical Plastics News charges an undisclosed fee to place a contibutor’s image and headline on the front cover.

Medical Plastics News is available online at our brand new website www.medicalplasticsnews.com and via a digital edition.

MAY - JUNE 2014 / MPN /3

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EDITOR’S COMMENT

Total Recall

CREDITS

editor | Lu Rahman advertising | gareth pickering art | sam hamlyn

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o six weeks into the medical plastic device world and what have I gleaned so far?

Well, it’s obvious that while this sector is fantastic at pushing the boundaries of science and technology in the quest to improve the health and well-being of us all, it is also fantastic in its modesty.

Unfortunately much of the time, it’s the negative stories that end up grabbing the headlines – how easy it is to find items on product recalls, for example? The average person could be forgiven for having a somewhat negative view of the medical device sector when the only news that makes it to the front pages is that involving defective implants or faulty devices. It seems to me that we have an opportunity here to redress this balance.

Scanning the health, science and technology stories in some of today’s papers, there’s a car that cleans itself, an umbrella that collects rain data and news of a competition launched by an Looking at the proliferation of news on product astronaut to design a space meal. All well and recalls, it was interesting to read an article in the good and I’m sure one day I’ll understand the Wall St Journal which examined the reasons need to monitor rain behind the increase in the patterns – living in number of product recalls – Manchester, it’s a pretty according to an FDA the safe bet you’ll be rained number of device recalls has upon at some point in doubled in the last ten years. the day. Why I would One of the reasons want to collect that suggested is software-related The average person data, I don’t know. issues – accounting for 15% of all recalls between 2010 could be forgiven But where are the and 2012. It has also been for having a stories about our suggested that the FDA sector? In the last few regulatory process could in somewhat negative weeks alone I’ve written fact be more stringent in its view of the medical about the development initial stages and if so, this of technology that will would reduce the number of device sector when enable medical devices post-approval recalls. to dissolves inside the the only news that body, puncture-resistant Of course, to the untrained makes it to the front gloves, a device that eye, these reasons are unseen makes the insertion of and it’s the scandal of the pages is that grommets easier in recall that makes the news. involving defective children and a synthetic We are all living longer, the tissue-like material for public has an increasing implants or faulty wound healing — all interest in both technology devices. It seems to cutting edge stuff and and its own health and welltechnology that has the being (you only have to look me that we have an potential to make a at the number of healthopportunity here to significant difference to related magazines and the lives of us all and websites that have flooded redress this balance. the well-being of those the market) – so why not working in the make the most of this healthcare sector. opportunity to promote the However, these are stories you’ll be hardcutting edge work that’s taking place within this pushed to find on the pages of the daily sector and get out the stories about the newspapers. scientific advancements we are witnessing on a weekly basis that should really be making the I suspect that the reason behind this lack of headlines? We definitely have the audience for coverage isn’t lack of interest by the media but it and after all, isn’t it about time that those recall that it doesn’t get to know about these stories took a back seat? developments in the first place.

Lu Rahman, EDITOR

production | peter bartley production | tracey roberts publisher | duncan wood Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK: £80 Europe and rest of the world: £115 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

© 2013 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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MAY - JUNE 2014 / MPN /5

MD+DI’s list of highest paid Medtech ceos:

TOP MEDTECH EARNERS IN THE US NAMED The ceo of Abbot Labs, Miles D White, has been named as the highest paid medtech ceo in the US.

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hite topped the list produced by Medical Device And Diagnostic Industry (MD+DI), which named the15 highest paid US medtech ceos in 2013.

According to MD+DI, he made $20.9 million (£12.4 million) in 2013, a 17% drop from his earnings the year before.

Jeffrey Immelt, chairman and ceo, General Electric, came in at number two – making $19.8 million (£11.75 million) and third position went to Lawrence H Culp, Jr, president and ceo of Danaher, who was listed as making $19.7 million (£11.69). Both Immelt and Culp experienced a drop in earnings from the previous year of 23.4% and 10% respectively.

Fourth place went to chairman and ceo of Johnson & Johnson, Alex Gorsky, whose $16.9

million (£10.03 million) represented a 54.1% increase on his previous year’s earnings.

Using research from its Top 40 Medical Device Companies list, including only US-based medtech companies, plus some additional data, MD+DI produced a list of the 15 highest paid company leaders in the US. MD+DI says the results are interesting as in many cases ceos of firms such as Danaher, that have more than a billion in revenue from medtech but pull in much more from other industry segments ended up ranking higher on the list than ceos of pure device firms such as Medtronic. Ceos of diversified firms like General Electric and Johnson & Johnson also did better than other medtech ceos.

Biodegradable stent first for Asia THE ENDOSCOPY CENTRE OF UKM MEDICAL CENTRE (UKMMC), KUALA LUMPUR,

has successfully used a biodegradable stent on a 56 year old patient who presented acute cholangitis.

<< History lesson: The Endoscopy Centre of UKM Medical Centre (UKMMC), Kuala Lumpur, has successfully used a biodegradable stent on a 56 year old patient >>

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he stent for biliary and pancreatic duct was made available by QualiMed Innovative Medizinprodukte, a Q3 Medical Devices subsidiary.

The stent is made of polymers similar to those used in medical sutures. It remains in the biliary duct until the cholangitis is resolved, before it is slowly hydrolysed by the body. According to Dr Hairol Othman, a consultant hepatobiliary and pancreas surgeon at UKMMC, a patient has to undergo another procedure to remove the stents, when using the conventional ones.

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The Archimedes device comes with three degradation times to accommodate the various disease states that require different indwelling times for treatment – fast absorbing (weeks), medium absorbing (months), and a long last (closer to a half year). Unlike traditional plastic biliary stents that are used hundreds of thousands of times per year and have to be removed and/or exchanged routinely, the Archimedes device can be used and implanted using the exact techniques applied with the existing technology with the added benefit of allowing the bile to flow on the outside of the devices as well as through the centre helping to minimise the potential for post-implant obstruction while eliminating the cost and risk associated with the removal procedures. The elimination of removal procedures is expected to significantly reduce total procedure cost for the patients that are treated with the Archimedes device. The device is for investigational purposes only and is not currently CE or FDA approved.

Speaking after the successful surgery, Dr Othman said: "Archimedes biodegradable stents are a revolutionary new concept in the biliary and pancreatic duct drainage. They are easy to deploy and very convenient for the patients.

They negate the need for a repeat ERCP, hence reducing patients' anxiety and inconvenience.

Plus, they do incur only one cost compared with conventional stents."

1. Miles D White, ceo, Abbot Labs $20.9 million 2. Jeffrey Immelt, chairman & ceo, General Electric $19.8 million 3. Lawrence H Culp, Jr, president and ceo, Danaher $19.7 million 4. Alex Gorsky, chairman & ceo, Johnson & Johnson $16.9 million 5. Inge G Thulin, chairman, president & ceo, 3M $16.4 million 6. Robert L Parkinson, chairman & ceo, Baxter International $16.2 million 7. David E I Pyott, chairman & ceo, Allergan $12 million 8. George Barrett, chairman & ceo, Cardinal Health $11.5 million 9. Michael Mahoney, president & ceo, Boston Scientific $10.9 million 10. Daniel J Starks, president, chairman, & ceo, St. Jude Medical $9.7 million 11. Kieran T Gallahue, chairman & ceo, CareFusion $9.6 million 12. Timothy M Ring, chairman & ceo, C R Bard $9.4 million 13. Vincent A Forlenza, chairman, president & ceo, Becton Dickinson & Company $9.2 million 14. Omar Ishrak, chairman & ceo, Medtronic $9 million 15. Kevin Lobo, President & ceo, Stryker $8.4 million

NEWS IN BRIEF GREGOR HETZKE has been appointed head of the advanced intermediates business unit, Evonik Industries. He succeeds Jan Van den Bergh, who will now coordinate the India, Korea, Japan, Sub-Saharan Africa, and MENA regions.

ROBERT BODINGBAUER, the managing director of Engel Machinery Korea, has been awarded the presidential citation order of merit of the Republic of Korea. The order was presented by the Korean president, Park Geun-Hye, to honour people who have made an outstanding contribution to the country.

SHIN-ETSU SILICONES OF AMERICA has hired Anchor Lin as a field market development specialist to oversee the advancement of the liquid injection molding system (LIMSTM) products. Lin’s primary focus will be educating the North American marketplace and identifying new growth opportunities for LIMS applications.

FOSTER is now distributing medical grade DEHP-free PVC in single 55lb bag quantities. Orders can be placed online at www.ecom.fosterpolymers.com SAINT-GOBAIN SEALS’ RULON 1439 MATERIAL has achieved full USP Class VI certification, complying with stringent disposable and reusable medical device requirements.

NELIPAK HEALTHCARE PACKAGING has announced the appointment of Michael Kelly as the group new ceo while Paul Hogan will take on the role of cfo.

ON THE PULSE

SPONSORED BY

Artificial Pancreas scoops British Inventors Award << Win win: The InSmart Artifical Pancreas, has scooped British Inventor of the Year>>

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enfrew Group and De Montfort University's' collaborative project - The InSmart Artifical Pancreas, has won British Inventor of the Year.

The artificial pancreas that automatically releases the correct insulin dose to diabetic patients has won its creators the accolade of Gadget Show Live British Inventor of the Year 2014.

The result of a collaboration between designers Renfrew Group International and Professor Joan Taylor of De Montfort University, the pancreas is an implantable device with the potential to end multiple insulin injections for sufferers of Type 1 diabetes — a large proportion of whom are at risk of over or under medicating with current treatment methods.

The winning inventors were chosen by Gadget Show Live in collaboration with WIRED magazine.

talent in this area. The Renfrew Group has been pleased to help develop an innovative gadget with the inventor of the science behind the pancreas, Professor Joan Taylor at De Montfort University. This beautifully simple device now has the potential to benefit millions of lives."

Professor Joan Taylor said: "This incredible device will not only remove the need to manually inject insulin, but will also ensure that Bruce Renfrew, creative director at Renfrew Group International said: "Renfrew Group and De perfect doses are administrated each and every time. By controlling blood glucose so effectively, Montfort University are delighted that the we should be able to help reduce related Artificial Pancreas has been given the inaugural health problems. We are extremely close to Gadget Show Live British Inventors Award. The embarking on clinical trials. Diabetes is costing introduction of this award and the British Inventors Project by Gadget Show Live are really society more than £1million an hour in treatment, and much of that is spent on treating valuable platforms for raising the awareness of complications."

British innovation and celebrating this country's

ENCAPSON receives second financing round for coatings product

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iomedical company Encapson has closed a second financing round from the Twente Technology Fund and the Innovation Fund Enschede.

Encapson’s lead product is Sono-Coat, which was developed to make medical devices, such as catheters and needles, better visible in the body under ultrasound imaging. Improving a device’s visibility under ultrasound allows a procedure to be carried out faster and more accurately. For several procedures Sono-Coat will allow X-ray imaging to be replaced with safer and cheaper ultrasound imaging.

This investment round will be used to further expand the company’s manufacturing capabilities and clean room facilities in Enschede Encapson ceo, Donato Di Biase, is excited about the investment.

He said: “We have completely finished development of this unique technology and are now very busy working with our customers to coat their devices. With this new investment round we are able to speed this process up and to offer our customers an even higher level of service.”

TTF managing partner and Encapson supervisory board member, Harm de Vries, commented: “Since our first investment Encapson has developed a fantastic product portfolio and is working together with some very strong device manufacturers to perfect the coating on their specific devices and bring them into the market.”

“This investment will lead to the introduction of several improved medical devices into the market, leading to better patient comfort and saving hospitals costs” said Bart Blokhuis, Innovation Fund Enschede fund manager. “This fits with the core goals of our fund and we are excited to join TTF and Encapson in this venture.”

HEAD OF DEVELOPMENT Cambridge – Medical Device The Role:

Development of our Client’s novel drug technology into a range of products.

To support business development and IP generation through product development activities. Support implementation of pharmaceutical and regulatory requirements within the product development process.

Experience/Skills needed to fulfil the role • Experience of injection moulded component design • Experience within the medical device arena.

• Experienced man management skills • Track record of mechanism design • Strong user skills with Pro Eng CAD • Experience working within regulated environment (ISO 13485, FDA, MHRA etc) • Versed in tools and techniques (FEA, FMEA, tolerance analysis etc) • Experience of test development • 'Hands-on' mechanical experience • Experience of dealing with suppliers and customers at a technical level • Experience of a start up environment would be an advantage Personal characteristics • Self motivated and proactive nature • Creative • Thrives in an open and less structured environment • Open, honest, inclusive, personable • A team player with good interpersonal and communication skills • Willingness to travel • Resourcefulness

Please apply in the strictest confidence by sending your CV to jane.edwards@listgrove.co.uk quoting reference JE/26355.

MAY - JUNE 2014 / MPN /7

NEWS PROFILE << Triple jump: Linking London, Oxford and Cambridge, MedCity is a £4 million initiative set to tranform the UK’s position in life sciences >>

UK to become health-tech leader WORDS | Lu Rahman

WHEN LONDON MAYOR, BORIS JOHNSON ANNOUNCED THE LAUNCH OF A MAJOR £4 MILLION MEDICAL INITIATIVE LINKING LONDON, OXFORD AND CAMBRIDGE, MANY INDUSTRY PLAYERS HAILED THE MOVE, HIGHLIGHTING ITS POTENTIAL TO ADVANCE THE UK’S GLOBAL RANKINGS IN THE LIFE SCIENCE SECTOR

“We believe that anything that aims – as MedCity does – to enhance collaboration and increase opportunities to translate the best science into products for patients and consumers is a positive step,” said Patrick Verheyen, head of Johnson & Johnson Innovation in London.

“Establishing MedCity in the heart of London should advance the UK’s already strong position in life science innovation,” he added.

Christoph Koslowski, sales development managerhealthcare Europe for Solvay Specialty Polymers, agreed on the effect MedCity will have on the UK life science sector.

He said: "The UK remains a major market for innovative mid-sized companies, exciting start-ups, as well as major global players. The focused research will strengthen the UK’s position and support innovative solutions with exciting high-performance materials; this aligns with our educational efforts for the healthcare industry."

MedCity has been established by the mayor of London and Imperial College Academic Health Science Centre, King's Health Partners and UCLPartners with cooperation from the Universities of Cambridge and Oxford. It has been awarded a £2.92 million grant from the Higher Education Funding Council for England and £1.2 million from the mayor of London’s office.

The initiative will bring together leading medical research centres in the three cities to produce healthcare applications that can benefit patients and the economy. The aim is to build a cluster of practical scientific excellence that will rival financial services in its importance to the UK. The new body is modelled on London’s Tech City Investment Organisation and aims to position LondonOxford-Cambridge life sciences sector as world-leading centre.

Plans include a new district based near University College Hospital,

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The Wellcome Trust and the Francis Crick Institute – a new medical research centre due to open in 2015, as as one of Europe’s major centres for biological research and innovation. Also proposed is a £21 million bio escalator in Oxford and Cambridge’s new £212m MRC laboratory for molecular biology.

Dr Jeremy Farrar, director of the Wellcome Trust, said: “The South East has long been a global centre for excellence in medical research and technology, and the sector is a major contributor to the success of the UK’s economy. This situation is only going to be enhanced by the opening of the Francis Crick Institute in 2015. We welcome MedCity as a way of fostering collaboration between medical research organisations, not only in London and the South East but nationwide, and we are pleased to be based close to the heart of it.”

A spokeserson for the Francis Crick Institute said: “It is too early to say what the precise impact will be but the Crick welcomes MedCity’s ambition to attract more investment to the life sciences sector and promote the effective translation of scientific discoveries.”

Speaking at Imperial College’s Hammersmith campus on the day of the launch, Johnson said: “Together with Oxford and Cambridge we form a ‘golden triangle’ of scientific innovation and we need to channel that intellectual pre-eminence into a positive impact on our economy.

“MedCity will span everything from research to clinical trials to manufacturing, across biotech, med tech and health tech.

“I am in no doubt that having the whole ‘chain’ from small spinoffs to massive companies doing their research, clinical development and manufacturing here in London and the South East can be as important to our economy as the financial services sector is today.”

Professor Dermot Kelleher, vice-president (health) at Imperial College London, said: “London is a world leader in medical research.

Our unique combination of great universities and first-class research hospitals, dove-tailed with access to a critical mass of entrepreneurial talent and a diverse population, puts the capital at the heart of medical discovery and its application.

“MedCity will allow us to intensify efforts to turn medical innovations into patient benefits and economic value on a national and international scale.

“This collaboration will lay the foundations for the next generation of medical advances while helping secure the capital’s long-term growth.”

SPONSORED BY

Pulse on Plastics AIMED AT DEVICE MANUFACTURERS

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olvay’s Pulse on Plastics Symposium in June will examine global trends in healthcare plastics. Sponsored by MPN, its aim is to provide medical device manufacturers with the most up-todate information on technical and regulatory guidelines related to high performance plastics in medical devices and will be of particular relevance to product development engineers, process engineers, QA engineers, those involved in regulatory, purchasing & management and design offices.

Today’s medical devices demand the highest performance materials to meet changing regulations and succeed in critical environments. The Pulse on Plastics Symposium aims to allow industry experts to share their knowledge to help you increase your competitive advantage.

Today’s medical devices demand the highest performance materials to meet changing regulations and succeed in critical environments.

Designing and manufacturing safe and compliant medical devices, instruments and implants made of high performance plastics requires a fundamental understanding of the processes, materials and relevant quality and regulatory standards.

A group of experts representing different aspects of the value chain for the dedicated supply of plastic medical devices will present: Introduction to plastics Insights into designing and prototyping medical instruments using plastics Considerations for material selection for high performing solutions Recommendations for a safe and compliant configuration and controlled manufacturing Overview and comparison of sterilisation methods with an emphasis on autoclaving Practical applications of high performance plastics to medical device development

• • • • • •

Presenters include Rob Freeman, senior bioengineer, DePuys Synthes Joint Reconstruction; Dr Catherine Tremolieres, principal scientist and director of product development, NAMSA; Bernd Beigel, business development engineer, Quadrant Engineering Plastic Products, and Jenni Tranter, business development manager, Synergy Health.

The event will take place June 17 and 18 at the Forest of Arden Marriott Hotel & Country Club, Birmingham, England.

For complete symposium details, including program, speakers, and registration, visit www.PulseonPlastics.com MAY - JUNE 2014 / MPN /9

SPEECH THERAPY In the first of MPN’s new opinion pages, Anthony Vicari, Research Associate, Lux Research, shares his views on advanced medical application of 3D printing – from inoperative to functional prototypes and parts

PRINT WORKS

3

D printing – the additive fabrication of objects by depositing and patterning successive layers of material – has been touted as an enabling platform for applications ranging from lighter, more efficient aircraft and advanced prosthetics to homemade firearms and lab-grown organs. Among all the hype, the true impact of 3D printing is uncertain. Currently, 3D printing’s largest applications are for making prototypes, moulds, and tooling. Direct production of end-use parts, however, is beginning to grow in industries including aerospace, medical, automotive, consumer products, architecture, and electronics as a way to reduce costs and improve performance. Producing a traditional machined mould or other tooling for a part design can require tens of thousands of dollars and weeks to months of time, but 3D printing enables production of the same part, often overnight, for only the cost of materials. This enables affordable low-volume manufacturing applications (one unit to a few thousands of units) or custom or short-run parts and devices. The ability to rapidly iterate designs and to make unique, customised objects with complex shapes can further enable superior end part performance.

Medical device companies, surgeons, researchers, and even private individuals have begun using 3D printing for a range of medical applications. The most commonly discussed of these are in dentistry. However, applications including surgical tools and guides, orthopaedic implants, and prosthetics are already in use in laboratories and small-scale commercial production. For example, some surgeons are using Mcor Technologies’ printers, which build objects out of sheets of paper with adhesive, to produce patientspecific, potentially full colour surgical guides to practice difficult procedures or to use as a reference in the operating room.

Printed orthopaedic implants in particular are beginning to gain traction, in part due to the ease with which they can be customised to individual needs. In 2011, Arcam (a metal 3D printer manufacturer in Sweden) announced that one of its customers received FDA approval for titanium orthopaedic implants made using its equipment. In 2013, Oxford Performance Materials, a 3D printed part developer in Connecticut, announced its own FDA approval for cranial implants made from PEKK using EOS’ laser sintering 3D printers, sold through Biomet. While it is not yet clear whether the customisation from 3D printing leads to improved clinical outcomes, as a manufacturing technology it enables faster design processes and increased materials utilisation (compared with subtractive machining processes), allowing Oxford Performance Materials to reduce its production costs by more than 80%.

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In 2013 and 2014, several individuals designed and printed their own prosthetic limbs, citing improved aesthetics and orders of magnitude lower costs as motivation. Cost reduction and the potential for just-in-time design and production also motivate aid group iLab Haiti to use low-cost desktop 3D printers at clinics in Portau-Prince, where it is difficult to maintain stocks of many standard parts. Instead, the printers make basic supplies such as umbilical cord clamps on-site, as needed, from a single feedstock material.

These applications are just the beginning. University researchers have begun developing materials and showing proof-of-concept demonstrations of 3D printed objects with integrated electronics functionally such as wiring, antennas, touch sensors, and even electrochemical cells. Down the road, these materials could enable one-step production of compact, integrated devices. Bioprinting – the deposition of living cells – goes still further. For example, startup Organovo has demonstrated the ability to deposit and grow layers of functional human cells including liver, lung, kidney, and heart tissue. In the near term, Organovo claims its tissues can reduce the cost of drug development by enabling measurements of efficacy and toxicity to screen drug candidates using a safe human model at lower cost than animal trials. In the long term, the company targets production of complete organs for transplant.

Significant challenges remain before these << Anthony Vicari, Lux possibilities can be realised. One challenge is Research, says current that printable materials, especially plastics, were medical 3D printing developed to meet the needs of prototyping applications are just the applications, where a convenient solution that tip of the iceberg >> worked ‘out of the box’ was more important than functionality. As a result, selection is limited to perhaps a few dozen polymers, and mechanical performance lags behind conventionally moulded plastics.

Numerous start-ups, academic groups, and government laboratories are working independently to improve performance and to develop a wider selection of printable materials, but years of additional research and development are needed to reach commercial maturity.

About the author Anthony Vicari is a research associate on the advanced materials team at Lux Research, where he covers technological and market developments in emerging materials and manufacturing technologies.

VOCAL Exercise Q Who are you and what do you do?

Paul Mazelin, strategic accounts manager, Specialty Silicone Fabricators (SSF)

Q How would you sum up your company?

SSF is a contract manufacturer of silicone components for the medical device industry.

We specialise in longterm implantable applications and are also certified to manufacture drug elution combination products.

Grupa Azoty ZAK S.A.

Oxoplast® Medica Meet our new high quality plasticizer engineered for medical purposes

created ateed to to care... ca are ar are

Q Business achievement you are most proud of I'm most proud of how SSF collaborates with engineers we interface with and provide cost-effective methods to answer the age-old questions of fit, form and function.

On a personal level, when my grandmother needed a pacemaker, knowing that parts manufactured by SSF were being implanted in her certainly exudes a sense of pride.

Q What excites you about this industry?

The diversity of the opportunities continues to amaze me.

Refinements and enhancements of existing devices as well as new concepts and innovative ideas for the treatment of what ails us.

Q Where do you predict industry growth will come from in the next 12 months?

The US marketplace still continues to possess a ‘wait and see’ attitude as to where things are going to shake out in regards to the Healthcare Affordability Act. The sales tax on medical device companies (2.3%) in most cases has simply pushed prices higher to the end-users.

Economies from the BRIC(S) nations have recently been referred to as ‘The Fragile Five’ yet we still see heightened interest from these countries. The common denominator is that people do not want to skimp on their healthcare. With the global development of a middle class demanding better healthcare for themselves and their loved ones, I see growth coming from all directions.

Q Which medical plastic device do you wish you had invented and why?

The Alaris Medical needleless access port invented by Karl Leinsing.

I have yet to see a more ubiquitous medical device that both improves patient comfort and allows nurses to more safely perform their duties and responsibilities. It takes full advantage of the physical, chemical and biocompatibility properties that silicone possesses. I have not seen an IV in the last few years that isn't taking advantage of this clever needle access port.

oxoplast.pl/medica x a l/m / dicca Grupa Azoty ZAK S.A., Mostowa 30 30 A A, 4 47-220 7-220 0K Kędzierzyn-Koźle, ęd dzi ziier erzyn-K yn-Koź oź POLA POLAND O oxoplast@grupaazoty.com, 23 65 g y com tel. +48 48 77 481 2

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14 -05, 20 June 03 oth # 5B04 o B , Hall 5 any rt, Germ Stuttga

SPEECH THERAPY

BREATHE EASY Thorsten Fischer of RPC Bramlage-Wiko discusses some of the latest challenges and developments in inhalation systems

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llnesses relating to breathing difficulties are on the increase.

According to a recent report from the European Respiratory Society (ERS), conditions of the lung cause one in 10 deaths in Europe, with mortality as a result of lung cancer and chronic obstructive pulmonary disease (COPD) expected to rise in the future. In the UK, meanwhile, around one in 12 adults and one in 11 children are treated for asthma.

And because these cases are so common, they generate a huge health and societal cost. The ERS report estimates that individual cases of CPD cost €6,147 each year, while for asthma the cost is €7,443.

Counting the cost One reason for these costs has been the development of a range of drugs to treat these conditions, which can vary from individual to individual. There are several different types of asthma – allergies, exercise-induced, cough-variant and occupational. The major cause of COPD is smoking, but it can also be caused by fumes, dust, air pollution and genetic disorders.

This variety of drugs presents challenges for their effective packing and dispensing.

Pressurised Metered Dose Inhalers (PMDIs) have proved particularly effective because they are able to deliver a precise dose of medication and by providing the energy for the drug delivery through the use of a propellant, the required particles are dispensed independently of the patient’s effort.

Of paramount importance in the development of any system is that it is robust and reliable to ensure that the drug is adequately protected

Of paramount importance in the development of any system is that it is robust and reliable to ensure that the drug is adequately protected and that the inhalation system continues to function properly. And since many of the users of these systems will be incapacitated in some way, ease of operation is also vital. Our Twist’n’hale design, for example, features a turning wheel on the side of the container. When the cap is opened, the wheel is rotated clockwise in a single movement up to the stop point, which then releases the dose.

The properties of the drugs need to be taken into consideration as does the method of dispense. There are many different types of powder blends, and the flow rate and fine particle fraction will vary from drug to drug. New powdered formulations for nasal inhalation have also opened up challenges.

Appearance important The appearance of inhalation systems is also important. Patients need reassurance that the drugs they are taking are reliable and of good quality, so how they are packaged can play a significant part in patient confidence. Attention therefore also needs to be paid to the decoration of the inhalers.

It is important that inhaler manufacturers work closely with their customers to understand the particular characteristics of each drug and how it needs to be handled and dispensed.

Ease of filling on packing lines is another critical consideration.

Inhalation systems are complex structures with a number of separately manufactured parts – including the outer body, the dispensing mechanism, actuator and mouthpiece – which then have to be carefully assembled to create the finished inhaler. Packaging suppliers continue to invest in the latest advanced moulding and automated assembly equipment, ensuring each piece is manufactured to precise tolerances and accurate dimensions.

As well as understanding the characteristics of the drug, the other main factor in the initial design of the inhaler is whether it is to be a single-use or re-usable version. For re-usable systems, ease of removal and replacement of the powder is critical. One noticeable recent trend has been the growth in popularity of capsules over the more common blister formats. As drug manufacturers continue to work towards the next breakthrough treatments for COPD and asthma, these will no doubt provide fresh challenges to inhalation system designers and manufacturers.

MAY - JUNE 2014 / MPN /13

PRODUCT FOCUS

GRAND DESIGNS

by George Perros, Greystone Research Associates

I

njectable and infusible drugs together represent the second largest drug market in terms of route of administration or method of delivery but in terms of technology evolution the two segments have experienced vastly different paths. While drugs delivered intravenously have benefited from evolutionary GEORGE PERROS, improvements in infusion GREYSTONE RESEARCH pump design, the infusion ASSOCIATES, OUTLINES sets that deliver the drug to the patient have changed RECENT ANALYSIS very little in the past two CARRIED OUT ON THE decades.

During this period, LARGE VOLUME INJECTION injectable drugs that can be DEVICES SECTOR AND delivered subcutaneously or HIGHLIGHTS THE intramuscularly have OPPORTUNITIES CREATED undergone rapid change as vials continue to be replaced

BY AN UNMET DEMAND by prefilled syringes and specialty injectors, and safety syringes continue to proliferate in response to caregiver safety concerns. The former trend has been and continues to be driven by the economic and logistical issues associated with the long-term therapeutic requirements of chronic conditions such as autoimmune diseases, blood conditions and hormone deficiencies. Prefilled devices that promote dosing accuracy and patient compliance without the need to travel to a physician’s office or healthcare facility ease the burden on both patients and the caregiver infrastructure.

The thinking behind LVIDs While there are several reasons why a drug is formulated for intravenous delivery, one of these is the sheer volume of drug required in a typical therapeutic dosing regimen. These volumes are typically well above the practical limit of 1.2-1.3mL for subcutaneous injection via a syringe or injection device. Intuitively, if there was a practical way to deliver a larger volume of a drug over a longer period of time, for example, 10mL over ten minutes, subcutaneous delivery could be accomplished without causing trauma and discomfort to the target tissue area. This is the rationale behind large volume injection devices (LVIDs).

There are currently eight LVIDs that are market-ready or in latestage development. Two non-insulin drugs have been approved for delivery in large volume injection devices - Herceptin SC from Roche, and Ferring’s LutrePulse which delivers gonadorelin acetate from an Insulet pump - with four more in development and a number of collaborative discussions between device and drug companies under way.

14/ MPN / MAY - JUNE 2014

The primary container is a critical component of any drug development project. Factors such as drug shelf life, efficacy and product quality are dependent on the compatibility of the drug with the primary container. Most of the LVIDs analysed in Greystone’s recent market analysis utilise a rigid drug cartridge constructed of Type 1 glass. In the case of West’s SmartDose, the cartridge consists of cyclic olefin polymer. Use of a primary container that has a large amount of stability data available and that has been FDA-approved for use in existing injectables reduces development time and risk. All of the devices in the report utilise standard legacy materials for all drug contact parts and surfaces.

LVID classification LVIDs can be classified as electronic or mechanical, and as disposable or semi-disposable. Half of the current generation of LVIDs are electronic disposable models. Sensile Medical has developed an electronic disposable as well as electronic semi-disposable model. In terms of reservoir size, volumes range from 2-20mL. It can be argued that a 20mL drug reservoir is close to the practical limit for a wearable injection device in terms of device size and weight. Above this level ergonomics, comfort, and adhesion start to become significant issues.

The devices covered in our analysis employ a number of methods for moving the drug from the primary container, through the cannula or needle, and into the patient. Most of the devices utilise a piston or piston-type method to deliver the drug. Sensile Medical uses a precision rotary micropump to move the drug from the glass cartridge, through the cannula, and into the subcutaneous layers of the skin. The most novel approach belongs to SteadyMed, which uses a microprocessor-controlled expandable battery to push on the primary container and expel the drug.

Drug developer interest Strategically, these devices present several interesting options for drug developers and marketers. Reformulation of brand drugs losing IP protection and/or exclusivity could be highly attractive. Resurrecting high‐volume infusible generics from the commercial graveyard and creating a new brand in a large volume device combination product will be a particularly tempting strategy, especially for smaller drug companies seeking to break out of the overcrowded generics segment.

From a therapeutic standpoint, most of the short-term activity will be centered on efforts to reformulate and/or re-brand existing approved drugs, in the process providing patients and their caregivers with new treatment options. This market will involve wellestablished treatments for oncology, cardiovascular conditions and blood disorders.

PRODUCT FOCUS

Phillips-Medisize starts injector pen production

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hillips-Medisize has begun full-scale production of a finished injector pen at its Suzhou, China facility. It says that the customer for this injector pen is a leader in the development and manufacturing of delivery systems for drug self-administration.

The pens are produced in the company's China facility for use in China and other Asian markets. Phillips-Medisize says that the completion of the commercialisation of this project represents the cornerstone of the its recently announced "China for China" strategy.

This project, which started in 2011, included a global engineering team, led from Europe, which has successfully transferred this product into production. The program features moulds built in Europe and China, and an automated on-line scalable process, which produces a finished injector pen.

Matt Jennings, president and ceo of Phillips-Medisize Corp, commented: “The start of production signifies the successful execution of our China for China strategy. The global PhillipsMedisize team is very excited about the attainment of this milestone, as it validates our fully-integrated capabilities for customers that desire products designed specifically for the China/Asia market and manufactured in a Chinese facility, all with state- of-the-art western medical quality systems and procedures.”

16/ MPN / MAY - JUNE 2014

<< Eastern promise: Phillips-Medisize’s Suzhou facility in China where it has begun full-scale production of a finished injector pen >>

Phillips-Medisize China is located in the Suzhou Industrial Park (SIP), and is ISO 13485 and CFDA registered. In addition to medical device, disposable diagnostics components, and drug delivery device manufacturing, Phillips-Medisize will also be opening a Design Development Center (DDC) in Suzhou later this year. Other investments in the facility planned for 2014 include expanded office space, added moulding capacity, and upgrades to mould repair and maintenance capabilities.

WHO: WHAT: HOW:

GW PLASTICS ING PRODUCTION DEMANDS HELPING A CUSTOMER MEET INCREASINGLY GROW E CONSISTENT MANUFACTURE ENSUR TO DING MOUL ION USING SCIENTIFIC INJECT MES VOLU OF HIGH-QUALITY PARTS AT VERY HIGH

RISING TO THE

CHALLENGE The challenge The demand for a lifesaving drug delivery device used in asthma and other respiratory treatments has been skyrocketing, and one of the world's leading healthcare companies needed to find a new manufacturing partner with the expertise and resources necessary to meet its rapidly accelerating production requirements. GW Plastics knew that the only way to meet its customerâ&#x20AC;&#x2122;s demand was through higher mould cavitation. However, increased cavitation is often accompanied by part variation and potential quality issues - another challenge that GW Plastics needed to address. The project scope also expanded beyond high-volume, plastic injection moulding to include full device assembly and individual device packaging (kitting) with over twenty different product variations.

The expertise One of only a handful of companies with in-house precision tooling capabilities, GW Plastics took the

<< On the up: With demand for drug delivery devices used for respiratory treatments skyrocketing, GW Plastics was able to help it customer meet growing production needs >> challenge to their Dongguan, China internal mould-making facility, where new, higher cavitation production moulds were designed, built, tested, and qualified (IQ/OQ/PQ). GW Plasticsâ&#x20AC;&#x2122; engineers incorporated their extensive knowledge of scientific injection moulding to ensure the consistent manufacture of high-quality parts at very high volumes, starting with installing cavity pressure sensors in the tooling, then incorporating state-of-the-art automation with multiple in-process quality checks into the production process. After moulding the clear, highly cosmetic, close-tolerance polypropylene components, a fully automated, six-axis robot enters the machine to remove the parts from the mould. Then the robot moves the components to

CASE STUDY

a highly-engineered test fixture for 100% air-flow testing. After the components successfully pass this test, the robot removes them from the test fixture and places them into automated assembly lines where the multi-component devices are assembled before final automated quality inspection.

The fully assembled and tested respiratory devices are then kitted in over twenty combinations using Instructions for Use (IFU) and secondary components such as tubing, mouthpieces, and different size face masks. The kitted devices are labeled, bar-coded and packaged for end-customer use.

The solution Throughout this project, GW Plastics is proud to have met each timing and financial milestone, supporting the customer along the way to ensure a successful product launch. The company says its solution of combining high cavitation robotic scientific injection moulding, automated assembly, and manual kitting demonstrates why it is the contract manufacturing partner of choice for the world's leading healthcare and medical device companies. The success of this program generated additional opportunities with this customer, and GW Plastics is continuing to optimise its global footprint and matrix of capabilities to manufacture other innovative drug delivery devices.

MAY - JUNE 2014 / MPN /17

PRODUCT FOCUS

Take my device WORDS | Lu Rahman

The drug delivery device sector is continuing to grow.

Developments in material, manufacturing processes, patient awareness and ways of safely delivering pharmaceuticals mean that innovative products are making their way onto the market.

Lu Rahman looks at the sector and some of the key developments taking place.

I

t is estimated that the European drug delivery market was worth $39.9 billion in 2012. Research carried out by MarketsandMarkets forecasts the sector will continue to grow over the next five years due to the rise in chronic illness such as cardiovascular diseases, diabetes and cancer. The opportunities for the drug delivery device sector are clear.

Scientific developments are reported on a regular basis. Last month, MPN, covered the story of a professor at the Iowa State University who is developing materials that could one day harmlessly melt away a medical device inside someone’s body when it’s no longer needed. Reza Montazami, assistant professor of mechanical engineering, says these special polymers are designed to quickly and completely melt away when a trigger is activated.

Examining these shifts and trends means device manufacturers are constantly looking at ways of offering innovative products that meet the needs of the market. Along with diabetes, cases of Parkinson’s, rheumatism and arthritis have also risen leading many companies, such as Gerresheimer, to examine innovative ways in which these products, such as auto-injectors, can be both made and used.

Medical device development is shifting. From products that were designed for use in a professional environment and then a patient’s home, we now have all sorts of possibilities – be it internal melting polymers or multifunctional wearable devices that can perform monitoring, diagnostic and therapeutic tasks. Devices such as this, which continuously probe physiological activity to understand and treat chronic diseases such as Parkinson’s, are being developed by scientists in Seoul.

Most auto-injectors contain two main modules — the injector and the prefilled syringe. Both modules are combined in one assembly, specified by the pharmaceutical company and supplied to the market in one piece. This is important as medical technology products are subject to high quality standards. However, the production of auto-injectors has to deal with the tolerance requirements of two different materials — the plastic of the device and the glass of the prefilled syringe.

The team at the Institute of Basic Science and Seoul National University in South Korea used silicon nanomembranes in the motion sensors, gold nanoparticles in the non-volatile memory and silica nanoparticles loaded with drugs in a thermal actuator. These components were then integrated in a patch capable of resisting stretch and bend forces so could be worn on the skin. The system is able to measure and record muscle activity – a key requirement to diagnose movement disorders.

One area that has recently been highlighted for growth potential, is the insulin delivery device sector – GBI Research says the market could be worth $13.8 billion by 2019, at a significant Compound Annual Growth Rate (CAGR) of 7%.

Regions such as North America are seeing a shift from conventional insulin delivery devices, such as syringes and pens, to insulin pumps, says Srikanth Venkataraman, analyst, GBI Research. This is due to the need for improved glucose control and flexible, lifestyle-compatible treatment options. However, “The European market will be driven by insulin pen sales thanks to their low cost and ease of use,” he adds.

18/ MPN / MAY - JUNE 2014

<< Simple mind: Developing Gx G-Fix, Gerresheimer created an interface that works without complex two-component injection moulded parts or sophisticated assembly processes >>

<< Got your number: RPC Formatec, has introduced a cost-effective system that enables users of pressurised metered dose inhalers to countdown the number of doses taken from their inhalers >>

Gerresheimer has built a bridge between the two materials using its expertise in glass and polymer products and its Gx G-Fix has been designed as a solution for easy integration of syringes in drug delivery devices — the company has currently applied for a patent.

Design and development firm Cambridge Consultants has worked with pharmaceutical company Novartis and medical device manufacturer Owen Mumford – plus hundreds of multiple sclerosis (MS) patients – to come up with the ExtaviPro 30G autoinjector.

The product has been designed to provide user-friendly drug delivery in a cutting-edge format that puts the patient’s requirements in mind.

More than 500 MS patients and healthcare professionals in the US, the UK and mainland Europe were involved in the development process to ensure the device was underpinned by a deep understanding of the users. An estimated 2.5 million people worldwide have MS and the ExtaviPro 30G is aimed at those who suffer from relapsing forms of the condition – such as clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and secondary-progressive MS (SPMS) – who make up the majority of MS patients.

Like Gerresheimer, innovation in the drug delivery device sector is key.

Whether for manufacturing purposes or for patient use, product development is ongoing.

“When we developed Gx G-Fix, we pooled our comprehensive intelligence in the area of prefilled glass syringes and polymer-based drug delivery devices and created an interface that works without complex twocomponent injection moulded parts or sophisticated assembly processes,” Andreas Schütte, member of the board of Gerresheimer and head of the company’s plastics & devices division, explains.

Attached to the syringe shoulder, the plastic standard adapter provides a precisely defined interface to the device.

In the auto-injector, Gx G-Fix has several functions. The adapter connects the syringe with the device and is specifically adapted to the auto-injector, allowing accurate needle positioning and significantly higher control of the injection process.

Also, the syringe is well protected from breaking by attaching the syringe at the sturdier shoulder. Conventional products couple the syringe to the finger flange. When triggered, the structurally sensitive flange – which is not built for this purpose – is subjected to a lot of pressure and can easily break. If the finger flange breaks, the auto-injector will cease to work at the critical moment. Similarly, breakage is a risk when the auto-injector impacts on a hard surface.

Attaching the syringe to the sturdier shoulder minimizes the risk of breakage during transport and use.

Like Gerresheimer, innovation in the drug delivery device sector is key. Whether for manufacturing purposes or for patient use, product development is ongoing.

“Our aim was to make the ExtaviPro 30G autoinjector very simple and intuitive to use, and enable one-handed injection,” said Andy Pidgeon, head of the industrial design and human factors group at Cambridge Consultants. “Its ergonomic shape leads patients to instinctively hold it correctly – which is vital for those who suffer from tremors, as having a firm grip is key to selfinjecting safely.

“Another key factor was the feedback we received during our extensive user research.

Patients wanted a soft, non-threatening design, for example – so we’ve made it very user friendly. And it’s led to the creation of a drug delivery device that doesn’t look like a badge of infirmity.”

The ExtaviPro 30G auto-injector has been launched in Europe – initially in Germany.

It is clear that patient use is a key factor in the ongoing development of drug delivery devices. While the device in itself may not warrant a total redevelopment, companies such as those involved in the ExtaviPro 30G auto-injector, are seeking new ways to make device use more efficient and simple. RPC Formatec, has introduced a cost-effective system that enables users of pressurised metered dose inhalers (PMDIs) to easily countdown the number of doses taken from their inhalers.

The Single Dose Counter can accurately count up to 999 doses and can be pre-set to count any specific number in between, for example counting down from 200 or 120 to 0. This allows users to easily keep track of their medication and alerts them when the inhaler is nearing the end and requires replacing. The system, which has been designed with reliability and ease of use in mind, can be retrofitted to all types of standard mouthpieces with just minor modifications.

The company also offers the patented Dose Indicator which enables users of all types of PMDIs to accurately and reliably monitor the number of doses taken from their inhalers.

The system is FDA-approved and has been designed to fit all common types of valves including 3M, Bespak, VARI and Aptar Pharma. As well as being available for new inhalers, the Dose Indicator can be easily integrated into existing dosing aerosols with only slight modification of the mouthpiece and can be tailored to specific customer requirements for the number of actuations – between 40 and 225 individual doses.

MAY - JUNE 2014 / MPN /19

PRODUCT FOCUS

FITTING THE BILL Gregor Deutschle, Schott Pharmaceutical Packaging, outlines a new system for ready-to-fill vials that streamlines pharmaceutical production as well as cutting production costs

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ashing, drying, and sterilising pharmaceutical vials usually takes place directly before the drug is filled at the pharmaceutical manufacturing site. Pharmaceutical companies perform pretreatment steps, such as washing and sterilising the vials, using in-house washing machines, clean rooms, and sterilisation tunnels.

But personalised treatments, government regulations, and the rise in generic medications have strengthened their grip on the industry, raising expenses and prompting new capital investments. More drug makers are pressured to cut costs and improve filling line efficiency.

In one effort to eliminate these steps, pharmaceutical manufacturers have sought alternate pre-filling methods that resemble the proven system for pre-fillable syringes. Pharmaceutical packaging manufacturers have long supplied pharmaceutical companies with sterile syringes packaged in nests and tubs. These ready-to-fill syringes save pharmaceutical manufacturers from pretreating the glass or polymer body and installing washing and sterilizing machinery.

With vial manufacturers processing these steps, pharmaceutical manufacturers can increase flexibility, reduce operating costs, and avoid purchasing machines and clean rooms.

<< Schott adaptiQ is a new packaging system for pre-fillable vials >>

20/ MPN / MAY - JUNE 2014

Schott, a pharmaceutical packaging manufacturer, worked closely with filling line manufacturers to develop a new packaging system that fits their requirements. Up to 100 sterile and prefillable vials can be fixed securely inside the nest of the new Schott adaptiQ system. They can no longer touch or be scratched, reducing the reject rate. For the first time, this system allows pharmaceutical companies to freeze-dry, weigh, or close their filled vials inside the nest. This new system for filling vials trims costs and streamlines production.

Building a new system for vials After two years of development, Schott is planning to launch adaptiQ in the third quarter of 2014.

This system meets pharmaceutical manufacturersâ&#x20AC;&#x2122; three requirements: That it uses a nest-and-tub configuration; that the nest be made using a proven material and that the bottoms of the vials be freely accessible for freeze drying sensitive pharmaceutical formulations without removing the vials from the nest. adaptiQâ&#x20AC;&#x2122;s design allows each vial to be easily and safely removed from the nest for certain processing steps, a major roadblock for past ready-to-fill vial systems. Because adaptiQ holds each vial by the neck, vials can be lifted out of the nest without contacting one another on the filling line, preventing scratches or breakage that could affect vial integrity.

With the influx of high-priced medicines, such as biotechnological pharmaceuticals, itâ&#x20AC;&#x2122;s crucial to reduce the vial reject rate to decrease unnecessary expenses. By mirroring the nest-and-tub design used for syringes, adaptiQ can be processed on existing nest filling lines, eliminating the need for further machinery investments.

Continued on page 22

Continued from page 20 adaptiQ also keeps the bottoms of the vials in the nest freely accessible for freeze-drying. The system will accommodate formats 2R and 4R ISO initially and will ultimately accommodate other common ISO formats of 2 to 30 ml.

Improving the design Schott ran a number of finite element method (FEM) tests to ensure accurate and efficient vial filling. The simulations confirmed nest stability during the freeze-drying and sterilisation processes as well as the nests’ ability to bear the weight pressure of all the vials when filled with fluids. Schott created the nest packaging with polypropylene, a well-established material in syringe nests due to its easy development through injection molding.

Schott also worked to ensure a successful vial-nest connection throughout the filling line. The vials are secured by their necks within the nest, held in place by three snap-in hooks. The clips holding the vials in place were the main focus of the FEM calculations, since they are essential to the success of the nest design.

The clips needed to withstand outward bending pressures to ensure the body of the vial could pass through the clips without breakage. Also, the clips had to spring back and hold the vial beneath its curled edge if the vial was inserted to the extent that the clip reaches the vial’s smaller neck region. Schott also tested the clips to ensure they held up to the forces of the filling process.

Reducing operating costs The increased price for ready-to-fill vials compared with conventional vials will be more than compensated. Total cost of ownership (TCO) considerations show that this system can reduce pharmaceutical operating costs.

<< FEM simulation of a nest for vials in the ISO formats 2R and 4R. The colours represent the tensions caused by the weight of filled vials >>

Pharmaceutical companies can save money on washing machines, systems for manufacturing water for injection purposes (WFI), sterilization tunnels, and other components for filling systems.

By avoiding sterilisation and washing, manufacturers can reduce energy and water consumption, shrinking operating costs. The new nest-and-tub configuration also reduces the vial reject rate, saving additional costs.

Although some health care trends continue to strain pharmaceutical manufacturers, it’s possible to reduce total operating costs and succeed in the uneven pharmaceutical landscape. With the implementation of ready-to-fill vials, pharmaceutical companies can provide high-quality packaging products while reducing expenditures.

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meliflex is produced at our state of the art high efficiency plant in Denmark and is based on over 30 years’ experience in servicing medical and pharmaceutical industry with advanced technologies.

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Compliance to ISO 10993 and USP 88 (class VI) requirements No phthalate plasticizers, PVC, BPA, latex, animal based additives Wide range of shore hardness (Sh 10A – 75D) Extensive medical service concept; full traceability, change control, line clearance, segregated production, etc.

- Customized materials on colour and functionality - Cost efficient alternative to soft PVC, TPU, Silicone

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22/ MPN / MAY - JUNE 2014

MATERIALS

SAFETY FIRST Ole Grøndahl Hansen, Project Manager for the PVCMed Alliance and Director of the PVC Information Council Denmark, examines the use of plasticisers in PVC medical devices, underlining the fact that a patient’s safety and comfort should not be compromised

A

s the European Parliament just voted on the Medical Devices Regulation, discussions on classified phthalates and particularly DEHP (di(2-ethylhexyl) phthalate) in medical devices and healthcare applications are currently more prominent than ever.

The assessment of existing potential alternatives to classified phthalates for PVC medical devices has been the object of a recent report by the Danish environment and health authorities: “Alternatives to Classified Phthalates in Medical Devices ”. As part of its commitment to supporting all stakeholders involved in the manufacturing, buying and use of medical devices, the members of the PVCMed Alliance provided data to the Danish Environmental Protection Agency and the Danish Health and Medicines Authority. PVCMed is an alliance of the PVC medical industry chain represented by PVC resin and plasticiser producers and PVC converters.

Alternatives to classified phthalates for medical devices In their report, the Danish authorities outline that the benefits that materials such as plasticised PVC offer — by allowing the most efficient and qualitative treatment of patients — outweighs the potential concerns regarding the presence of some phthalates in a number of medical devices. However, PVCMed believes it is important to continue to innovate in this area to ensure the use of efficient medical devices without compromising patient safety and comfort.

The Danish authorities concluded the report by saying that there are alternatives to DEHP which, as regards to human health and environment hazard profiles, are safe and appropriate for use in medical devices.

PVC’s fundamental role in healthcare PVC-based healthcare applications have a fundamental role in the quality of healthcare thanks to PVC’s technical properties including

softness, sterilisability, clarity and transparency, durability and dependability, resistance to chemical stress cracking, flexibility and resilience, low cost, and many more. The properties of plasticised-PVC are essential for certain types of medical devices which, for example, need to be made extremely soft and flexible.

Concerns raised over DEHP should not impact the use of PVC as a material of choice for healthcare applications.

PVCMed member companies are actively addressing concerns over the use of DEHP in healthcare applications. They support the supply chain as well as medical professionals in their willingness to use the appropriate plasticisers, while keeping all the key properties of PVC. Many different plasticisers have been developed and are increasingly being used in a wide array of medical applications allowing medical equipment purchasers to benefit from PVC’s unique properties for patient comfort, economic affordability and hospital hygiene. PVCMed encourages the value chain to commit to continuous improvement of safety in order to develop innovative products for all PVC healthcare applications.

On 27 March, an event was held in Copenhagen on the occasion of the publication of the report. During her speech, Christel Schaldemose, a member of the European Parliament, stressed the importance of having efficient medical equipment to save lives and said that, “if no alternative to classified phthalates are available for some medical devices, these products should remain allowed.”

The conference brought together the industry, healthcare professionals, environmental and health authorities and NGOs. All agreed that the mutual benefit of collaboration between them is the key to finding innovative solutions for quality healthcare PVCMed believes this type of collaboration and open dialogue is crucial in order to continue ensuring patient safety and quality healthcare, even more so at a time of a new Medical Devices Regulation and on-going review of the SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks) scientific opinion on the use of phthalates in medical devices.

MAY - JUNE 2014 / MPN /23

MATERIALS

Cikautxo Medical to Manufacture MICRO-MOULDED VALVE RANGE

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ikautxo Medical is to begin serial production of three new micro-moulded liquid silicone rubber (LSR) valves for tracheostomy cannula applications. They have been specifically developed in close collaboration with a European OEM company to significantly improve the comfort of the patient.

According to Cikautxo, the fully biocompatible LSR micro-parts assure the sealing function as well as being attractive to look at and in a bright colour. With this new product range Cikautxo Medical is aiming to strengthen its LSR micro-moulding expertise for silicone parts below 0.5 grams and very tight tolerances. The production process has been fully robotised in the cleanroom manufacturing facilities of the headquarters which are located in the north of Spain. The company plans to expand its current moulding cleanroom facility area with the purchase of a new micro-injection machine this year.

The company has much experience in polymer contract manufacturing products using specific machinery for medical shortterm applications or long-term implants. Cleanroom manufacturing conditions are used as per ISO 14644-1/2 standards and also cGMP

24/ MPN / MAY - JUNE 2014

<< Spanish steps: Cikautxo Medical is to begin serial production of three new micromoulded liquid silicone rubber (LSR) valves at its Spanish headquarters >>

manufacturing standards. In addition, the company has dedicated cleanrooms for each technology, for improved control and traceability of each specific product line.

A specific ISO 7 cleanroom (FDA class 10000) is used exclusively for extrusion technology. Due to the high demand in polyurethane catheters manufacturing that Cikautxo is currently experiencing, it has recently installed a new moisture control system in its catheters manufacturing cleanroom to help guarantee increasing manufacturing process control and stability and assure a higher product quality for its customers and end-users.

Passionate about Polymers

Follow our heart and meet us at Medtec Europe!

Extrusion - Moulding - Assembly www.RAUMEDIC.com

Hall 5 Stand E60

MAY - JUNE 2014 / MPN /25

EXTRUSION

SPONSORED BY

Custom fit As pressure increases on OEMS to get medical devices to market as quickly as possibly, John Brennan, plant manager at Kelpac Medical Ireland, discusses the valuable role custom extruders can play in this process

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edical Device OEMs and their contract manufacturing partners are under increasing pressure to get new devices and iterations of current products from concept through the regulatory channels and into the market place in a short time period with minimal cost.

Those OEMs with in-house tubing extrusion capabilities are now outsourcing the development and manufacturing of tubing for their new devices to a custom extruder. They realise that extrusion is not part of their core competency and they can better concentrate their efforts on supporting and growing higher revenue finished devices.

The custom extruder can provide a dedicated team to partner with the customer, providing focused expertise in polymer materials, extrusion technology and process development. The result is shorter lead times, faster development cycles and ultimately a reduced time from concept to market.

Once the OEM requires volume, the custom extruder can increase volume rapidly, usually on the same equipment used to develop the product, at a rate much faster and with less cost and waste when compared with a vertically integrated OEM. The custom extruder utilises their process expertise to drive cost from the process resulting in savings for the customer.

<< John Brennan, plant manager, Kelpac Medical Ireland >>

The distinct advantage of the custom extruder is the experienced engineering and quality resources that utilise the latest technology in the areas of material selection and testing, polymer processing and quality inspection to provide the customer with high quality, repeatable medical tubing.

In an effort to reduce cost and increase output the current trend for device manufacturers is to assemble and pack their products using complex automation cells. The success of this automation often lies in the repeatability of the critical inputs with the tubing component being a significant factor due to its flexibility and challenges in handling. The difficulties encountered in the automated assembly processes would not have been a factor in manual assembly due to the operatorsâ&#x20AC;&#x2122; ability to manipulate the product into position.

Close cooperation between the device manufacture and their extrusion partner is critical in the early stage development of the automation process to ensure all of the tubing characteristics are understood and captured on a specification. Dimensionally accurate product is a given however subtle differences in parameters such as transparency, flexibility, orientation and hardness can have a major impact on the throughput and yield of an automation cell. A deep understanding of the extrusion process and the ability to capture, monitor and review key process indicators and data is pivotal to the successful partnership between device manufacturer and custom extruder.

Continued on page 29 26/ MPN / MAY - JUNE 2014

EXTRUSION

SPONSORED BY Continued from page 26 Most OEMs will demand that their suppliers are ISO 13485 accredited or at the very minimum have ISO 9001:2008. This ensures both parties have a similar quality management system and talk the same language from design control right through to continuous improvement. Process validation is an essential component of any new product and the custom extruder should be able to remove as much as possible, the burden of validation from the customer.

Working in a controlled environment is a distinct advantage. Class 8 cleanrooms are becoming the norm for component manufacture for medical devices.

Working in a controlled environment is a distinct advantage.

Class 8 cleanrooms are becoming the norm for component manufacture for medical devices.

If a custom extruder has global operations, located in the various medical clusters, this can be a big win for the device manufacturer as they can enjoy reduced transport costs, taxes and tariffs through local sourcing.

They have a global risk management strategy with built in redundancy and the device manufacturer can reap the benefits of a global supply agreement through economies of scale and the custom extruders leverage in terms of volume purchasing of raw materials. The global extrusion sites give the OEM global options to easily transfer production to different international manufacturing locations without changing component supplier.

We like to think of it as a partnership with our customers, where we can support their product development, process validations,

<< Production floor, Kelpac Medical Ireland >>

and production and even manage their inventory and incoming inspection through VMI and supplied data programmes.

To provide a best in class service to our customers we use the latest extrusion and inspection technology combined with data acquisition and statistical process control. We use data collected electronically from the processing equipment and inspection systems to add as much science as possible to the art of extrusion.

Our key strengths are our people â&#x20AC;&#x201C; their knowledge of materials, processes and operating in an ISO regulated, controlled environment is key to providing cost focussed solutions and exceptional service.

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Intelligent Packaging Solutions for Medical Engineering, Dental, Healthcare and Laboratories rose plastic have dedicated themselves to developing, producing and selling intelligent plastic packaging solutions.

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COATINGS TARGETTED APPROACH Katja Thierschmidt, Raumedic, offers advice for selecting the right material for catheter production

P

rostate cancer is one of the most common forms of cancer in men, accounting for around 10% of all male cancer deaths.

One treatment option is radiotherapy. The challenge here is to hit the prostate — it can move significantly during the treatment — with a focused dose that will kill the tumour and a low dose to the surrounding healthy tissue. Because organ motion is normally not detectable from the outside, a margin around the tumour is applied in order to make sure that the cancer is treated — the motion and the margin increases the risk that the patient will suffer from side effects like impotence, incontinence and rectal bleeding.

To counteract these risks, Raumedic was commissioned by Micropos Medical to develop a localisation probe to be placed in the organ to be treated. This, in combination with an external antenna system, can continuously position and track the prostate throughout all treatment sessions to increase precision and make a better treatment available.

Aided by ultrasound, the probe is accurately placed directly at the tumour and is easily removed after the final treatment (two-12 weeks after implantation). The implantation of this probe enables the physician to quickly and accurately localise the cancer in real-time and

allows for radiation to be focussed on the affected area. The implant will also allow the physician to continuously record and monitor the strength of the radiation dose.

Material world When selecting a suitable material for the probe tubing, we chose polyurethane. This possesses excellent biotoxicological characteristics as well as blood compatibility and flexibility and is therefore well-suited for application in implants.

Based on its long-term extrusion experience, Raumedic used a radiopaque polyurethane that is suitable for implantation in this newly developed device. In addition to the extrusion, this material is also suitable for the encapsulation of the electronic components that are located in the catheter tip. The micro-cables are pulled into the tubing before the encapsulation. At the proximal catheter tip, a connection is established with an electronic element and at the distal end with a plug element. During these manufacturing steps, various processes are used such as glueing or soldering. A secure connection can be ensured in a variety of ways. Epoxybased or UV-curing adhesives have proven to be a good solution. Well-trained personnel use microscope-equipped work stations for the sol-

PRO RO EN. EN With a sole focus on med ion, With medical device packaging production, ical de vice pa ckaging design and product

dering of wires with tiny diameters. An alternative to the insertion of wires into one of the lumens of the tubing is to embed the wires into the tubing wall during the extrusion process. Raumedic develops optimal manufacturing concepts depending on the product and the required quantities.

We were able to use our experience in processing plastic materials along with our manufacturing expertise for the integration of electronics such as microchips, storage elements or cameras into medical technology products. In the case outlined above, we developed the RayPilot Transmitter catheter system in cooperation with the customer.

As a system supplier possessing the manufacturing skills extrusion, injection moulding and assembly, Raumedic can provide everything from one source – from the development process to serial production. We can also develop and produce proprietary pressure measurement catheters for neuromonitoring, urology, gastroenterology and traumatology for clinical and practical applications.

Author: Katja Thierschmidt is product manager business unit assembly/catheters

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The coating applied to a medical device is a crucial part of its production. Getting it wrong can cost money and even lead to injury and death in patients. Many factors need to be considered to select the correct coating and achieve optimum results.

But sometimes it can go wrong.

Lu Rahman, takes a look

It’s a wrap WORDS | Lu Rahman

C

oatings are a key element in the manufacture of medical devices. The point at which a medical device comes into contact with bodily fluid or tissue, and the biological reaction that occurs, is a key consideration for the performance of the coating and its potential effect on or inside the body.

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The purpose of the device – single or re-use, for example – its clinical application, chemical resistance requirements and also aesthetics, are some of the factors that need to be taken into account as part of the process. Coatings expertise is widely evident in the medical device sector. Unfortunately however, things can go wrong which highlight just how important a role coatings have to play in the safety of a device.

Recently Covidien voluntarily recalled two medical devices used to treat people with brain aneurysms. Covidien said it was unaware of any injuries or deaths caused by the devices but it was reported that there was a risk that the Teflon coating — polytetrafluoroethylene (PTFE) — applied to the delivery wires in the Pipeline Embolisation and Alligator Retrieval devices could fall off, or delaminate, and block the flow of blood through the arteries.

It has been reported that the company has since received notice of one case where delamination had occurred. PTFE coating is used to reduce friction between devices and ease navigation through the vasculature. Delamination of the PTFE coating could potentially lead to embolic occlusion in the cerebral vasculature with the risk of stroke and/or death.

COATINGS

Laser Plastic Welding Class I recall Following the recall, the US Food & Drug Agency placed its most severe category – Class I on Covidien’s devices, meaning "there is a reasonable probability that use of these products will cause serious adverse health consequences or death," in the agency's words. It urged customers to stop using the recalled devices and separate them from other inventory as well as issuing lot numbers of the recalled devices.

The company became aware of the issue when it was informed of a manufacturingprocess change by a supplier

Peter Lucht, a Covidien spokesman told the Wall St Journal that the company became aware of the issue when it was informed of a manufacturing-process change by a supplier that makes and applies the Teflon material to Covidien's delivery wires. Covidien can't manufacture more of the products until the US Food and Drug Administration clears the supplier's manufacturing-process change, he said.

Devices affected A total of 32 Pipeline Embolisation devices and 621 Alligator Retrieval devices are affected by this recall. The products were manufactured and distributed from May 2013 to March 2014.

The Pipeline Embolisation device was indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the

internal carotid artery from the petrous to the superior hypophyseal segments. The Alligator Retrieval device was intended for use in the peripheral and neuro‐vasculature for foreign body retrieval.

Last year, Medtronic identified a potential problem with its Interventional Wires and Attain Hybrid guide wires, where the PTFE coating could delaminate and detach from the guide wire. As a result, the company recalled specific lots of its products. A similar incident occurred with Abbott Laboratories which recalled some of its HT Connect Peripheral guide wires due to a small number of devices exhibiting partial delamination of the PTFE coating. To date, the frequency of worldwide reported incidents of delamination of the coating is 0.08%.

It is clear that the choice of coating is a crucial element within the life cycle of a medical device.

Thankfully, in the recent Covidien case, there have been no reports of severe injury or death but the incident is not without cost for the company as products recalls and ongoing stories in the press, can ultimately take their toll. The company’s quick action to withdraw the product has no doubt helped prevent further risks but the incident as whole highlights that the choice of coating on a medical device, its quality and interaction with bodily tissue and fluid, is a pivotal factor in the ongoing success of a product and its safety for patient use.

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MAY - JUNE 2014 / MPN /33

Cover Story

Many housings in the medical sector are coated, not just for aesthetics but for chemical resistance purposes. All these products have to be cleaned so the right coating, giving protection against cleaning agents, is paramount. Pekago’s white paper examines “Coating plastics: Optimum result due to integrated approach”

WORDS | Jeroen van Dijk, Wil Matthijssen and Erik Janssen

T

hose who think that plastic products can be coated ‘just like that’ can be very disappointed with the results: surface faults such as flow lines, marks and spots are all too common.

Housings for equipment such as measuring and analytical devices are frequently made of plastic. There are various technologies available to this end, including compact injection moulding and structural foam moulding (SFM for short). SFM is a form of injection moulding in which, by the addition of a foaming agent, very robust and visually attractive plastic components can be manufactured. These often form interesting alternatives to metal housings and frames.

Equipment used in hospitals and laboratories has to be resistant to chemical cleaning materials. It has to withstand knocks and bumps and is, of course, expected to have a high quality appearance. In outdoor applications, such as toll checking systems and parking terminals, the housings in question are exposed to every kind of weather - hail, snow, ice and ultraviolet radiation. Finally, many devices must also meet requirements in the areas of fire safety or electronic shielding.

The optimum combination of a plastic housing with a suitable coating system is needed if all these requirements are to be met. It is not enough for both technologies to excel in their own rights. The two technologies have to be tailored to suit one another. After all, the product that comes out of the injection moulding machine (the plastic component) is the direct input for the coating process.

It is sometimes thought that any imperfections which have arisen during the injection moulding process can be camouflaged during coating, but this is only partly true. If, however, the finishing is taken into account during the design and making of the plastic component, the high costs of (manual) reworking afterwards can be avoided.

Importance of pre-treatment Before the coating can be started, the plastic component must be pre-treated in accordance with the client’s requirements. Seams and sprue or gate marks can, for example, be ground down and sink marks can be remedied by filling. This pretreatment requires expertise, is labour intensive and is, therefore, relatively expensive.

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Designing coated SFM housings It pays to pay attention to the finish. Expensive manual work can be obviated by taking the surface requirements into account in the design phase. The following may be useful to bear in mind:

• Choose the right plastic. There are a great many plastics available, which makes it difficult to determine the most appropriate one for the product in question. Firstly, the material must meet the requirements laid down in terms of rigidity, dimensions, fire and UV resistance and so on. It is also advisable to incorporate ‘coatability' in this choice. Polyamide, polyethylene and polypropylene, for instance, are materials which must have a special (and therefore relatively expensive) pre-treatment. Substances which are added to the plastic to influence its properties (such as glass and talcum) may affect the coatability of the plastic component, too.

• Ensure that SFM products have the optimum wall thickness.

Although the use of foam does indeed decrease the likelihood of sinks, a better wall thickness ratio reduces the cycle time and results in fewer stresses in the product;

• Take the seams into account in the development phase. If two components, such as the bottom and top of a housing, are assembled together, or a housing is composed of multiple components, seams will inevitably be visible between the various parts. If this is the case, a great deal of effort will be needed to achieve an acceptable appearance. The simplest solution for this is to allow the various parts to overlap slightly, thus producing a shadow along the edge, but ‘clever’ mould parts can also help;

• If a component is to be coated in two colours, the interface between them is always the subject of discussion. A clear transition in the product geometry, that is, which is already clear in the plastic part, is helpful in this case.

The high costs resulting from masking work can thus be avoided.

• Furthermore, the integration of suspension points and the spray mist must also be taken into account when designing the product.

COATINGS Moulds Coating is a vital aspect in the development of production tools.

Besides the aspects which have a direct effect on the product design, matters such as the mould construction, cooling and type and position of injection point are of great importance. A wellchosen position for the injection point and runners can prevent undesirable swirling, flow disturbances and sinks. The fewer the injection moulding-related technical problems, the easier it will be to coat the product.

The last fine-tuning can take place during the trial spraying. Often the shortest possible cycle time is opted for so that the component can be delivered as cheaply as possible. The consequence is that the coating mechanic has to deal with a more labourious product than strictly necessary. Sometimes it is advisable to allow the component to foam for rather longer in the mould or to operate the injection process slightly differently. This is always cheaper than having to grind or fill imperfections manually afterwards.

Choice of coating system Coating and primer are essential aspects of the processing time and quality The correct choice of coatings and primers is an art in itself. There is ample choice when it comes to coating systems and the most expensive is not necessarily the best. Important points to consider when choosing a coating system are as follows:

• What is the material to be coated? What plastic will be used and what fillers (such as glass) or foaming agents are envisaged?

• What is the desired effect? Does the client want a ‘splashed effect’ or a coarse or fine structure? The various possibilities all have a specific effect on the price. Some coatings partly ‘disguise' surface faults on the plastic component but require a longer coating time.

• The application: indoors or outdoors, chemical resistance,

A well-chosen position for the injection point and runners can prevent undesirable swirling, flow disturbances and sinks.

hygiene requirements, cleanability of the surface.

Finally The production of plastic SFM housings and the coating of plastics are both distinct areas of expertise. But substantial gains can be achieved in terms of quality, costs and lead times if the right choices are made in the development phase and the two technologies are well harmonised with one another. If a supplier has both technologies under a single roof, the risk of making the wrong choices in the preliminary stage is minimised and expensive mistakes in the execution can be avoided.

MAY - JUNE 2014 / MPN /35

COATINGS

Vue from the top Vuecoat, from Phillips-Medisize is a spray technology that hard coats selective patterns on polymer-based materials.

The company also offers on-site coating to improve speed to market and increase competitive edge

A

<< Clear winner: Vuecoat makes it possible to apply high-gloss finishes with excellent scratch resistance to polycarbonate substrate components, such as clear windows. Can use digital printing for excellent print clarity >>

brasion coatings are an essential step in the process of manufacturing many components. Surface abrasion coatings provide window and high-gloss applications to increase scratch resistance, as well as cleanability and chemical resistance to surfaces. In addition, they provide lubricious wear surfaces between parts. There is a variety of abrasion-coating processes available. Spray coating, for example, is ideal for single-sided abrasion-coating applications on flat parts. The process involves mask tooling, creation, application, and removal to apply to selective areas of components.

Another abrasion-coating process, known as spin coating, is ideal for applying non-selective abrasion coating on single-sided parts. A third common abrasion-coating process, dip coating, is ideal for all-sided, complete abrasion-coating coverage.

In response to customer engineering requirements, Phillips-Medisize developed an alternative to these abrasion-coating processes Vuecoat technology. Smooth medical coatings with consistent characteristics and advanced capabilities contribute directly to increased precision and superior performance of the medical device such as insulin pump programs, which use multi-shot cases. The Vuecoat process uses micro spray technology to hard coat selective patterns on medical or handheld devices made of polymer-based materials (typically polycarbonate) and can help boost the product’s speed-to-market and competitive edge.

According to Phillips-Medisize, the process is ideal for the precise application of abrasion coating on selective areas of components. It allows precise control over generation and placement of hardcoating particles on a single part side which is ideal for achieving high-quality selective hard

VistaMed, a Helix Medical joint venture company, is a leading thermoplastic extrusion and catheter provider to the medical device industry worldwide. VistaMed provide innovative solutions to challenging complex extrusions including high pressure braided tubing.

Vistamed’s Polyurethane, Nylon reinforced, High Pressure Braided Tubing (HPBT) used in high pressure applications such as the injection of contrast media is available in different formats offering; - Superior resistance to dimension distortion under pressure - Constant working pressure of 1200 psi - Burst pressure over 1700 psi.

Contact VistaMed today to see how we can be the perfect fit for all your catheter needs.

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COATINGS coating results on flat parts with curves up to 3 millimetres from flat surface, 5 millimetres in width, and 12.5 millimetres in length.

This process involves fewer hands-on procedures so reduces the chances of human error and product fallouts during part supply chain like high scrap rates from other hard-coat methods. It also eliminates the need for masking on injection molded parts, meaning no mask tooling, creation, application, or removal tasks are required. With the masking step eliminated, exposure to foreign mask particles is reduced, says the company, which could cause parts to be rejected. There is also no need to eject or peel away masks â&#x20AC;&#x201C; a process that could compromise part edge quality.

The advantages The process means manufacturers can overcome design challenges. For example, it allows for a select area on a component to be exposed for abrasion coating, rather than the entire component, with no masking required. Manufacturers can create products with coatings that are integrated from different materials into a single part prior to the coating process. An example might be a two or three-shot handheld surgical tool with a clear window, a rigid, opaque frame and a gripping surface made of soft elastomer.

Part designs for snap and assembly features have also been a great engineering challenge How does it work? when considering coating processes. Typically, Vuecoat uses ink-jet technology and proprietary such assemblies must be designed around special coating chemistry to apply high-gloss finishes to coating requirements, and snap-feature designs polycarbonate, substrate components. Because of must be tweaked with coating thicknesses in its selective application properties, the process mind. The Vuecoat process eliminates these steps eliminates the need to create, assemble, and seal â&#x20AC;&#x201D; keeping all assembly features clean and free of separate components. It can also increase the sur- any coating, without the use of masks. face hardness in desired areas, while allowing for the elimination of masking on injection-molded Fewer manufacturing steps reduces costs parts.

Vuecoat should reduce overheads for manufacturVuecoat can also be performed in ers. It decreases typical fallout on coating cleanrooms â&#x20AC;&#x201D; the machine has its own processes and allows for rapid changeover. Nonventilation system to maintain cleanliness of the recurring engineering (NRE) costs and material air surrounding the coating application to costs are also reduced. Ultimately, the elimination decrease exposure to particles. Parts being of masking-related steps in the abrasion-coating coated first are loaded into custom nests and process helps manufacturers achieve speed to indexed to the cleaning station. Once the surface market, as well as the competitive edge, with highhas been cleaned of any residual dust or quality products that contain precise, selective contamination, the parts move to a surfaceabrasion coating. activation station, are then coated and moved into the ultraviolet curing station, then the load station for packaging. No masking is required in the Vuecoat process, which eliminates flaking, as well as incidences of carried contaminants on components.

<< Point of vue: Vuecoat makes PhillipsMedisize a one-stop-shop for custom injection moulding and selective hard coating services. It is performed on-site so doesn't require the moulding, bagging, boxing and shipping of parts to a coating company >>

MAY - JUNE 2014 / MPN /37

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We are partners that help our clients develop next generation technologies that change the world. To discover more about Zeus contact us by phone or visit us online at www.zeusinc.com.

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COVER DRIVE Dr. Hinke Malda, director of coatings, DSM Biomedical, shares with MPN, her knowledge of medical coatings, offering advice on finding success with a supplier and the coating application process

D

SM has expertise in the design and manufacturing of medical device materials.

In January, the company opened its first inhouse medical coating service plant, which offers medical device manufacturers custom-designed coating application processes and high quality coating services for our ComfortCoat hydrophilic lubricious coating. DSM’s expertise allows it to select the optimal coating for its partners, based on the clinical application and need addressed by their medical device.

Manufacturers need to consider a range of factors before choosing a coating for their medical device. It is important to seek out a coating supplier who can serve as a strategic partner and add value throughout the entire lifecycle of device manufacturing and commercialisation. For example, a coating supplier that makes it a priority to learn about all of the materials that make up a device and understands the device’s intended clinical use, can provide better counsel when proposing a specific coating to meet the device’s needs.

Ultimately, it is the customer that decides if the coating is suitable for its device. Elements to take into consideration include the conditions in which the device is produced, sanitised, stored, and ultimately, used to treat patients. Like DSM, the coating supplier should work closely with device manufacturers to create a custom-designed coating application process that continues through each phase of development – feasibility, verification and validation, regulatory approval, commercial production and bringing to market.

By keeping all of the steps involved in formulation and application within the same organization, device manufacturers can gain a competitive advantage through streamlined processes and first-hand knowledge.

When determining a coating application process, device manufacturers should also consider how much of their device they want coated based on the size, shape and function of the device. For example, unlike disposable devices, reusable devices require cleaning and sterilisation prior to use and should be paired with coatings that have a high resistance to wear.

DSM equipment operates in an ISO class 8 cleanroom and our quality management system is compliant with ISO 13485 standards. We also provide device manufacturers with a letter of authorisation to reference master files on file at FDA. These files contain technical information

COATINGS

<< Got it covered: Dr. Hinke Malda, director of coatings, DSM Biomedical, offers coatings advice >> about a material, namely, manufacturing procedures and testing data that demonstrates safety and efficacy. Device manufacturers should consider the facility in which their device will be coated and ask questions about equipment, throughput, quality systems and compliance with regulatory and international standards such as ISO. The medical device manufacturing community continues to innovate and build smaller products used for minimally invasive surgeries that reduce risks and increase recovery time for patients. Providers who create advanced coating application processes that serve a wide range of medical device component sizes and geometries are well positioned to serve the needs of the market.

MAY - JUNE 2014 / MPN /39

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Blood lines

DESIGN FOR LIFE

A blood recycling machine developed using Stratysys 3D printing has undergone successful patient trials. Ideal for use on patients with religious beliefs, the device is also said to cut down on the cost of prototypes

<< Good point: Stratasys 3D printed saline probe produced from ABS Plus material >>

B

rightwake has developed a blood recycling machine, the Hemosep, using a Stratasys Dimension 1200es 3D printer.

The success of Hemosep’s use during Penoyer’s operation presents new possibilities for patients across the globe, whose religious beliefs mean that receiving donated blood is not an option.

The Hemosep recovers blood spilled during open heart and major trauma surgery, concentrating the blood cells ready for Prototyping costs slashed transfusion back into the patient. This autotransfusion reduces the For Brightwake, with medical device production demanding exvolume of donor blood required and the problems associated with tremely accurate parts, capable of enduring the stress of functional transfusion reaction. The and safety tests, the comprototype device features a pany’s use of 3D printing has number of Stratasys 3D printed presented significant cost- and parts, including the main time-saving benefits. filtration and cooling systems, “Previously we had to enabling the Brightwake team outsource the production of to functionally test the system in these parts which took around its intended environment, three weeks per part,” explains before the final device is Cotton. “Now we’re 3D produced from metal. The printing superior strength device has been awarded the parts overnight, cutting our CE mark and is attracting global prototyping costs by 96% and interest from distributors and saving more than £1,000 for healthcare providers. each 3D printed model.

“The Hemosep consists of a “3D printing has not only bag that uses chemical sponge enabled us to cut our own technology and a mechanical costs, it has also been crucial agitator to concentrate blood in actually getting a functional << End result: The final Hemosep following sucked from a surgical site or device to clinical trials,” he Stratasys 3D printed parts >> drained from a heart-lung adds. “The ability to 3D print machine after surgery,” says Steve parts that look, feel and perform Cotton, Brightwake’s director of research and development. like the final product, on-the-fly, is the future of medical device “The cells are then returned to the patient via blood transfusion. manufacturing.”

In a climate of blood shortage, this recycling methodology has the Originating in Nottingham’s traditional textiles industry, potential to be a game-changer within the medical industry, saving Brightwake is a creative development, engineering, production and the National Health Service millions.” research company specialising in innovative manufacturing solutions.

With nearly 35 years’ experience, Brightwake has extended its Reduced need for blood transfusions expertise into the medical field, starting with the production of Clinical trials of over 100 open-heart surgery operations in Turkey wound dressing for the UK National Health Service. With its confirmed the Hemosep’s ability to significantly reduce the need Stratasys’ Dimension 1200es 3D Printer from UK reseller Stanford for blood transfusions, and further trials are now continuing in the Marsh, the company has the in-house capability to extend its UK. medical device manufacturing program beyond the Hemosep.

One of the first patients to benefit from the new Hemosep “In the fast-paced, competitive medical device industry, we are device is 50-year-old UK heart patient Julie Penoyer, who, as a seeing more and more of our customers use 3D printing to bring Jehovah’s Witness, requested not to receive donated blood their products to market more efficiently and cost-effectively,” products. Because the device captures, cleans and puts back lost reports Andy Middleton, senior vice president and general blood lost during an operation, Hemosep was the perfect manager EMEA. “The ability to turn ideas into functional products solution. quickly is something that in the long-term we believe will improve the quality of care, and in some cases, save lives.”

MAY - JUNE 2014 / MPN /41

EVENTS

Stand and deliver June is key point in the calendar for the industry with two pivotal events taking place MEDTEC EUROPE, IN STUTTGART AND MDM EAST IN NEW YORK In early June, MEDTEC Europe will be welcoming numerous suppliers and providers of medical technology on 3-5 June, Messe Stuttgart. This year, the focus is on new processes and materials for design and production. 3D printing, innovative materials such as technical plastics and high-performance polymers are a few of the trend topics.

Around 900 exhibitors are expected to attend from sectors as diverse as medical automation and clean room technology, as well as materials and packaging. They will be presenting tried and tested components as well as the very latest trends associated with development and production in the medical technology sector.

As in previous years, the exhibition areas are divided into nine interest zones. New arrivals include trade fair forums such as the inaugural i-Zone, where several innovative start-ups will present together for the first time, the new match-making area for business contacts and meetings in a peaceful atmosphere, and the networking area for visitors to interact and talk with fellow experts, industry representatives and colleagues.

One of the highlights of this year's MEDTEC Europe is innovations and solutions associated with 3D printing for the medical technology sector.

New materials and substances are another focal point for the medical technology sector.

"Trends like 3D printing processes and innovative materials are changing the face of medical technology in a comprehensive manner,” said Fabienne Valambras, event manager of MEDTEC Europe. "The sector is moving rapidly — ably demonstrated by the exhibitors and topics at this year's MEDTEC Europe. Anyone seeking the very latest developments and innovations will find answers to their questions in Stuttgart.” www.medteceurope.com

The Medical Design & Manufacturing East Exhibition and Conference, is returning to New York City June 9 -12 at the Javits Convention Center. Organisers says the conference will attract more than 3,000 professionals and highlights will include: Keynote addresses by key industry figures such as Mark Scott P Bruder, chief medical and scientific officer, Stryker Corporation, and Eric Brown, "If you want to director of Watson Technologies; network within More than 80 hands-on your trade, stay training sessions by senior representatives from Philips up-to-date on Healthcare, Covidien, Siemens industry Healthcare, Medtronic, Abbvie, developments, and Coopervision, DePuy Synthes and more; reach your next Real-world case studies and expert insight covering the most customer or challenges including 3D supplier, this is the pressing printing and user interfaces; best practices and detailed technical place to be." training in risk management, process validation, eHealth, and quality and design control; sourcing and supply management; More than 10 hours of conference-exclusive networking including a VIP reception and 3D- printing, mobile-health and polymers trade show tours; Complimentary access to the MD&M East trade show which will provide sourcing and networking across the world.

"We are very excited to bring MD&M East back to New York City; it's the optimal location to unite the industry's leading professionals to explore and discuss the most relevant issues impacting medical design and manufacturing," said Stephen Corrick, executive vice president and managing director of UBM Canon Medical Portfolio.

"If you want to network within your trade, stay up-to-date on industry developments, and reach your next customer or supplier, this is the place to be." www.MDMeastconference.com

MAY - JUNE 2014 / MPN /43

Keep it clean

by Sean Fryers, Connect 2 Cleanrooms

A Google search of the top 10 inventions of the 21st Century comes up with the following list: 1) 2) 3) 4) 5) 6) 7) 8) 9) 10)

Hydrogen powered cars Robotics Automation Anti-gravity Cloning of humans Nanotechnology Artificial intelligence Free energy Hypersonic transportation Genetic engineering

One of the common factors that makes all these inventions achievable is a clean environment provided by modular cleanrooms.

A modular cleanroom construction is typically a freestanding, solid and robust structure that is suitable for use within an existing cleanroom, laboratory, manufacturing area or warehouse. A modular cleanroom uses off-the-shelf proprietary components to build a facility that meets the customers exact requirements such as classification (ISO 14644-1), size, soft or hard wall (clear or opaque) and various lighting. As with all modular cleanroom providers there is a degree of consultation with the client to establish their desired criteria, the initial preparation paves the way to a smooth installation and a happy customer.

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In the last ten years, technology has moved at a significant pace. As we celebrate scientific advancements such as the hydrogen powered car or hypersonic transportation, we may forget the critical role of the environment in which these developments are created. From human cloning to artifical intelliengence, a clean environment is critical. Sean Fryers, Connect 2 Clearooms provides the Top 10 Tips when considering a modular cleanroom Tip 1 â&#x20AC;&#x201C; Do I really need to spend my budget on a cleanroom?

Potentially harmful particles exist in everyday critical manufacturing environments and can cause potential failure to production which is susceptible to contamination or every day micro-organisms. The question is really; can you afford NOT to have a cleanroom? As processes and technology become smaller, particle contamination becomes a real issue. Contamination can cause serious product failure that could result in costly product recalls or in worst case scenarios can potentially be life threatening.

Tip 2 â&#x20AC;&#x201C; Traditional cleanrooms versus modular cleanrooms?

Once you have established the need for a cleanroom it is important to consider which type of cleanroom you require. Traditional cleanrooms are typically containment rooms, where the air is filtered and recirculated, integral to the building. Modular cleanrooms, on the other hand work on positive airflow, drawing air through a HEPA or ULPA filtration system. Due to the advancements of innovation and technology within the modular cleanrooms, they have become an affordable and quick way to production for processes that require clean environment. Dramatic design improvements include features such as hard PetG walls, sliding doors, transfer hatches, offering a customer much more choice, making the modular cleanroom a viable option for your mission critical environment. The Top 10 innovations listed previously, required flexibility when developing their life changing processes and the option of mini environments and the modular cleanroom helped to expand their scope.

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Tip 3 – Modular cleanrooms are bespoke by nature It is important to remain solutions focussed and understand the environment where a cleanroom will be situated as well as the process it will contain. Modular cleanrooms consider both; from the exceptionally small modular cleanroom, housed in a warehouse, part covering the packaging process of an injection moulding machine, to the large modular cleanroom housing a 100 strong workforce.

The overall objective is to minimise risk to the process and consider the parameters of particulate count per volume of the room as well as pressure, temperature, humidity and lighting.

Tip 4 – Do I need to consider building regulations?

The Building Regulations Advisory Committee released the updated policy (on 21st March 2014) – Providing effective building regulations so that new and altered buildings are safe, accessible and efficient. The policy ensures that building regulations are fair, efficient, up to date, safe and effective. A modular cleanroom does NOT require building regulations as they are a room within a room and not an integral part of a building. This incurs benefits such as, cost savings, less red tape, and quick lead times. A modular cleanroom concerns itself with providing a solution for your process and not the alteration of your building.

CLEANROOM TECHNOLOGY Always consider your process, determine the quality that you need to achieve using industry regulatory guidelines and if in doubt, speak to a reputable cleanroom company to gain professional advice.

Tip 6 - Sector considerations Once you have controlled your air borne particles, through your modular cleanroom environment, you should address the surface particulate and this is particularly important in the semi-conductor, nanotechnology industries. Modular cleanrooms are used across many sectors including healthcare and medical device manufacturing, energy, pharmaceutical, electronics, laboratory, and manufacturing — virtually any environment that is considered mission critical to your process.

Tip 7 – Quick to production A traditional cleanroom would involve numerous people within the business to plan the construction, from building manager, to purchase manager to landlords. A modular cleanroom is a much less complicated process, less people need to be involved in the planning, meaning a quicker lead time to production. There is also the benefit of using standardised components which increases the project turnaround such as fan filter units, gauges, powder coated steel. The very nature of a modular cleanroom means that you can start small and grow your cleanroom as production grows allowing you maximise on budgets.

Tip 8 - Validation A critical part of the modular cleanroom process is validation. Once a modular cleanroom has been installed the cleanroom is validated to ensure that the cleanroom is performing to the exact ISO 14644-1 specification as dictated by the customer. All manufacturing companies are used to ensuring that their equipment is calibrated and the validation service is the equivalent for a modular cleanroom. Good cleanroom practice would promote regular validations offering peace of mind plus it would tick the box for any external audits from clients.

<< Cleaning up: Cleanroom environments are vital for a variety of scientific breakthroughs and modular cleanrooms are used across many sectors including healthcare and medical device manufacturing >>

Tip 5 – A cleanroom has various classifications of cleanliness ISO International Standards ensure that products and services are safe, reliable and of good quality. ISO 14644-1:1999 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness is the standard which all cleanrooms must conform to.

The very nature of the process dictates the ISO classification required, for example certain medical products implanted within a human body or certain food packing processes would need to be manufactured in a cleanroom, with a higher classification than a noncritical process. For instance a plastic lid manufacture may only require a cleanroom for the production of lids that come in contact with food; this environment will need to be a higher ISO classification than less critical areas.

Tip 9 – A cleanroom should be kept clean Good practice dictates that a cleanroom should be kept clean before use and after use. People are massive generators of contamination and reputable cleanroom companies can offer gowning guides for assistance.

There are now even free apps that can recommend clothing for the varying ISO 14644-1 classifications, such as Gown Me. Change areas are very popular in modular cleanrooms to help reduce the introduction of contamination. Raw materials and equipment used within the cleanroom also generate particle contamination. Double bagging of products, transfer hatches and a general awareness of your external environment will help to reduce contamination.

Tip 10 - Good cleanroom protocol Reputable cleanroom companies will offer training /open Days for their customers where demonstrations are held to promote best practice within a cleanroom. A modular cleanroom will add value to your processes by ensuring standards are met, particle contamination is reduced and clients are kept happy.

MAY - JUNE 2014 / MPN /45

CLEANROOM TECHNOLOGY

SPONSORED BY

For plastics company Styron, cleanroom technology is crucial for the manufacture of its polycarbonate resins

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leanroom technology has become both essential and expected by device manufactures and moulders in the medical industry today. This technology works to control the level of contamination to create a sterile manufacturing environment. Styron, a global manufacturer of plastics, latex and rubber, utilises cleanroom technology at its polycarbonate manufacturing facility in Stade, Germany. The company’s Calibre polycarbonate resins play a vital role in the production of applications such as syringes, insulin pens, surgical instruments, and dialyser housings. Using cleanroom technology at both the material production and packaging level, Styron is able to minimise the risk of foreign contamination in its polycarbonate resins and provide customers with what it calls a superior product and an industryrecognized level of cleanliness.

In the past, clean room technology for medical applications was mainly utilised in the fabrication and assembly stages, yet it is now becoming increasingly important in the material production process as well. Device manufacturers demand the highest-quality products, free of defects and contaminants, with many applications requiring a tolerance level of “0” for defects in material composition. Cleanroom technology meets these stringent requirements and as a result, resins

produced in a cleanroom environment are in high demand throughout the medical industry.

Cleanroom technology is especially essential in activities where cross contamination can occur. As a result, Styron has implemented the use of cleanroom technology in three separate areas at its Stade facility - extruder (resin processing); laboratory (resin compounding) and packaging (pellet transfer and final packaging).

Styron takes many precautions in maintaining its cleanroom facilities for the production of its polycarbonate resin grades.

Operators are given comprehensive instruction on cleanroom procedures and are required wear full-body dust gowns with shoe and head covers in dedicated changing rooms. They wear a new clean suit for each shift and damaged suits are disposed of. Styron has implemented a monitoring system to collect temperature, humidity, pressure and particle count data in each cleanroom area.

The data is collected and stored in a standalone personal computer that is alarmed to alert operators if the measured value of particulate matter is outside the specified limits. In addition, a light signal notifies the control room operator of the status to ensure operations are within parameters at all times.

creating modular cleanroom solutions for critical environments

Connect 2 Cleanrooms protecting critical processes by minimising airborne and surface contamination

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TESTING & QUALITY CONTROL

<< Testing testing: Larry Lister, Toxikon, discusses ISO10993 and issues of biocompatability >>

Passing the Test Laurence Lister, Toxikon, shares his white paper – Points to Consider in ISO 10993 Testing

by Laurence Lister, Toxikon

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edical device manufacturers are required to have their product tested for biocompatibility. A product which is biocompatible will not have any adverse effects on a living tissue or system. Biocompatibility testing is a material-based assessment, so not only do device manufacturers do this testing but component and material vendors do so as well.

Which evaluations to perform as well as how to perform these tests, are governed by the International Standardization Organization (ISO) 10993 series of standards. There are currently 20 chapters in the series. Typical nomenclature is to reference the series, then the chapter number and the effective date. For example the chapter that specifies what tests are required is ISO10993-1:2009. With a little creative web searching you can find a version of the table which specifies which testing categories need to b addressed for each category of patient contact.

Of particular note is the FDA’s document, “Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing”. But that is where the trail will go cold. The 10993 chapters are under copyright and must be purchased individually from ISO. The subsequent chapters spell out how the biocompatibility tests are to be conducted and what is expected to be reported. These specifications become what FDA evaluates the testing to for compliance and each deviation from the appropriate ISO 10993 standard a justification and an evaluation of the impact.

nents or materials. The device manufacturer has to do its testing with the final finished device. It is really late in the game to find out the tubing that they used is cytotoxic or a skin irritant. Therefore, it is more than prudent for the device manufacturer to purchase only biocompatible materials or components. Simply stating, “this material has historically demonstrated biocompatibility” is not sufficient. Let’s use polypropylene for example.

The sentence, “polypropylene has historically demonstrated biocompatibility”, is true but an incomplete sentence. The sentence and the speaker are making the assumption that there is no need for quality control and that every sales person tells the complete truth. The sad reality is people make mistakes and try to hide the mistake and hope it goes undetected. I have seen “polypropylene” fail routine biocompatibility tests and I have seen ‘stainless steel’ rust. True stainless steel will not rust and true polypropylene is completely biocompatible. Someone in these supply chains was not truthful.

Passing the test So, what makes something biocompatible? As the device as a whole is required to conform to ISO 10993, the manufacturer will be looking for components which by themselves can pass ISO10993 and/or USP <88> Class VI testing. The tests are conducted the same whether it is a finished device, a component or the raw resins. The device manufacturer may require the vendor to provide testing certificates to substantiate the claims of biocompatibility. Their levels of risk management will Truth will out dictate whether or not your testing is enough or The device manufacturer has the ultimate rerecent enough. quirement of biocompatibility testing as well as There are eight categories of testing under needing to demonstrate a proactive risk manage- ISO 10993-1 and they are cytotoxicity, ment process in the design of its product. For sensitization, irritation, acute systemic toxicity which many this involves using pre-qualified compoincludes pyrogenicity, subacute/sub-chronic 48/ MPN / MAY - JUNE 2014

toxicity, genotoxicity, implantation and hemocompatibility. The majority of biocompatibility testing is performed using extracts. An extract is where the material is submerge in different vehicles and then placed in an oven at elevated temperatures for a given period of time. The vehicles are then decanted off and used to conduct the tests.

Regardless of what a device is, it needs to demonstrate testing to cytotoxicity, sensitization and irritation. Once product has more contact than just skin, acute systemic toxicity is required. The USP <88> Class VI is a battery of tests which include an intracutaneous irritation test, acute systemic toxicity and a one week implantation.

This is a designation of a material and not to be confused with the designation of medical devices using the same nomenclature. It was originally designed for plastics but has now become a standard for many kinds of materials. If all three tests are passed the material gets a designation of being Class VI. Sub-acute, subchronic and genotoxicity tests are lengthy and expensive and typically left to the device manufacturer. A typical battery of biocompatibility tests on a plastic would consist of cytotoxicity, irritation, acute systemic toxicity, short-term implantation and hemocompatibility.

About the author Laurence Lister is director of biocompatibility services at Toxikon Corporation in Bedford, MA. His 22-year industry experience encompasses every aspect of biocompatibility and toxicology testing, from study design to execution. He is the author of “Biocompatibility Testing: Tips for Avoiding Pitfalls, Parts 1 and 2” as well as a number of other articles.

BEADY EYE Keeping an eye on the next big thing can be hard. Each issue MPN selects a company, service or technology that it thinks is one to watch...

The IT crowd Plastics IT’s 3D scanning technology means medical micro moulders are presented with a costeffective, accurate, and speedy method of validating design intent of micro moulded parts

Who are you and what do you do?

Plastic Integrated Technologies (Plastic IT) is a knowledge-based company in Shropshire, UK, with experience and expertise in the area of plastic injection moulding. It is run

by Graham and Richard Webster, both of whom have an in-depth working knowledge the plastics industry.

The company — founded in 1995 — approaches work on behalf of its clients from a broad-based perspective, looking to optimise the injection moulding process. The key is to ensure that, where appropriate, its customers receive assistance in material choice, product design, tooling, processing, analysis, and training.

The company runs a CAE bureau to allow for optimisation of product design prior to tooling, and hosts on-line and on-site training focussed on individual and workforce solutions. In addition — working with a Seoul, South Korea-based company — Plastic IT can provide high quality steel moulds for injection moulded parts in as little as seven days.

Recently, Plastic IT introduced a truly innovative and versatile 3D cross sectional scanning technology that produces a highly accurate 3dimensional point cloud, which accurately ‘describes’ a part’s geometry and captures internal and external features. This technology is ideal for the validation of micro or precision parts, and fits neatly with Plastic IT’s growing focus on the micro moulding sector.

What has the company been focussed on recently?

Much effort in recent months has been centred around the integration of the 3D scanning technology into Plastic IT’s existing portfolio of services. Plastic IT has exclusive distribution rights in the United Kingdom and Ireland for the technology, which is manufactured in the United States by CGI, Eden Prairie, MN. The company also utilises the technology on behalf of its clients in a 3D scanning studio housed at its Shropshire premises.

Describe your latest innovation Plastic IT is gearing its portfolio of services to the every burgeoning micro moulding sector, and the CGI 3D scanning technology that the company is now selling in Europe provides huge possibilities for medical OEMs that are manufacturing micro and precision parts.

Until now, companies wishing to inspect the integrity of parts have had to rely on CMM machines and optical comparators.

However, when looking at the complex micro moulded parts that are often produced by medical OEMs, CMM touch probes are often too big to capture the data on small parts, and optical sensors only provide 2D profiles or features.

In many instances when looking at inspection of micro parts, fixturing is also an issue, and because of this many manufacturers of micro moulded parts end up inspecting the mould rather than the part. This assumes that variables such as temperature, pressure, dwell time, and shot size have no bearing on part quality, which is a dangerous and often inaccurate assumption when looking at micro

50/ MPN / MAY - JUNE 2014

<< Micro management: Graham Webster, one half of the thinking behind Plastic IT, a knowledge-based company with expertise in plastics injection moulding>> moulded parts.

The cross sectional scanner that Plastic IT is now selling — or allowing access to through its bureau service — the CGI Pearl 700 desktop machine, overcomes a number of the issues present when looking to analyse micro moulded parts.

To gather complete 3D data sets which eliminate judgement calls and also provide measurements of internal not just external dimensions, the part to be inspected is first encased in plastic resin which is then sliced into ultra-thin layers. As each layer is removed, an optical scanner captures the newly exposed profile at extremely high resolution. Cutting and imaging is repeated until the part is consumed.

The machine then automatically processes all the 2D images and formulates them into a 3D point cloud that provides a precise and 100% accurate representation of the component’s shape. This data can then be inspected, allowing verification of features that are both visible and concealed in the part geometry.

The 3D scanner enables verification of CAD design intent and deviation cost-effectively and quickly, which makes a significant contribution to the design and manufacture of accurate and functional parts in a way that also allows for adherence to strict timeto-market requirements. Complete part validation can be completed in a matter of a few days.

What does it mean for the medical sector The medical sector is at the forefront of research and innovation in product design, and is also pushing the boundaries of what is possible in terms of miniaturisation and micro moulding. As such, any technology that allows for validation of design intent in a truly accurate, cost-effective, and timely fashion will be of enormous value in this dynamic sector.

Plans for the Future Plastic IT will continue to educate the micro moulding marketplace as to the advantages of using its 3D scanning technology, and will encourage companies to trial the technology through use of the machine that it runs for client projects at its premises in Shropshire, UK. The company will also continue to customise its portfolio of services to address the particular concerns and contingences that exist in the area of plastic micro moulding.

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