MPN EU Issue 10

MPN

MEDICAL PLASTICS NEWS

M I C R O

M AT T E R

Pushing Moulding Boundaries with Accumold

ALSO IN THIS ISSUE: Bioresorbable polymers Plastic electronics Drug contact plastics at Pharmapack

ISSUE 9 November/December 2012 WWW.MPNMAGAZINE.COM

MPN

All Medical, All Plastics

Contents

Editor’s Letter—page 5

5. Editor’s Letter: A thousand miles As the MPN journey moves into its thrid year, I take a look back at the steps that brought us to where we are today, including the most recent Compamed and Medica shows in November 2012.

6. On the Pulse: Proposed regulation The key changes in the 194-page European medical device regulation proposal are outlined. Also, news of the devices and diagnostics ally MedTech Europe.

Plastic Electronics—page 14-16 Bioresorbable Polymers—page 18-25

11. The SPE: Supercritical CO2 Supercritical gases are being used as plasticisers, to improve processing of viscous high molecular weight polymers, and for injection moulding of foams.

14. Plastic Electronics: Smart switch A report from Engel about moulding wipe-clean capacitive electronic switches by overmoulding film-based printed electronics. Also, news that resorbable electronics are a reality.

Folio—page 26

18. Materials: Bioresorbable polymers US patent applications referencing resorbables have grown by 37% a year in 2005-11. Sam Anson investigates why.

The article covers compounding, mechanical properties and degradation times, moulding and extrusion, additive manufacturing of resorbable tissue engineering scaffolds, Absorb—the first resorbable stent, Purac glass fibre composites, supercritical CO2 sterilisation, and coloration.

26. Folio: Liquid silicone A low-viscosity, addition-curing silicone for soft compression effects.

29. Country Report: Germany Germany is the European leader in innovation—second only to the USA in terms of patent registrations. The report is followed by a round up of medical plastics research institutions in Germany.

34. Cover Story: Micro matter Pushing micro moulding boundaries with Accumold.

37. Design 4 Life: Licensed to Cure Dassault launches dedicated medical device design sofware.

38. Modular Cleanrooms: A guide Sean Fryers of Connect2Cleanrooms gives us a glimpse into the versatile world of modular cleanroms.

41. Doctor’s Note: Plastic and 3D Tomo Machined plastics help physicists test performance of 3D digital breast tomosynthesis imaging equipment.

42. Pharmapack: Drug contact plastic Interview with Steve Duckworth, head of medical and pharma at Clariant, about additives for cyclic olefins, extractables and leachables by Joy Harrison of Smithers Rapra, and “out of the box” packaging design from Team Consulting.

50. Events: Diary and VinylTec Medical plastics diary in Q1 2013 and a review of SPE’s VinylTec conference in Chicago by Jodie Laughlin.

Online and in digital Pharmapack Preview—page 42-49

Medical Plastics News is available online, at www.mpnmagazine.com, and in digital (on the iPad, mobile phones and computers).

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MPN | EDITOR’S LETTER

MPN | CREDITS

editor | sam anson advertising | gareth pickering art | sam hamlyn Illustrating our achievements so far, A journey of a thousand miles Jesper Laursen of Danish compounder begins with a single step. This phrase by Melitek, said to me this month: “I saw Chinese philosopher Lao Tzu, who died your article about DEHP and wanted to in 531 BC and was a contemporary of commend you on the result. You pulled Confucius, sums up very nicely where together information from a lot of things have come in the last 18 months interest groups which had the potential at Medical Plastics News. to get very complicated. You reported The first step on the Medical Plastics the issues accurately, independently News magazine journey was taken two and carefully and this demonstrated years ago—in November 2010—when your professional skills. You have shown I flew to Düsseldorf to visit the Medica that you are a proper journalist and and Compamed shows for the first MPN is a proper magazine.” time. The trip was booked after I had Chris James of Monaco-based presented to my publisher the original medical plastics company Promepla also idea for a magazine dedicated to congratulated me. He said: “MPN fills a medical applications for plastics. gap in the industry for plastic I headed there with the goal of manufacturers. It is highly relevant, the making as many contacts as possible at content is well researched and companies involved in the use of insightfully written. Sam—your plastics for medical applications. I was knowledge of medical is impressive.” pleased to find that the show was a Lao Tzu’s philosophy is helpful hotbed of advanced medical plastic because it encourages people to achieve technologies. things that they would otherwise deem By the time I arrived at Compamed impossible. By breaking things down into the following year, our thousand-mile small parts, a task of a size or complexity journey had well and truly begun. In the too great to tangibly conceive instantly preceeding twelve months, together becomes achievable. And this is a useful with my colleague Gareth Pickering, I outlook on other aspects of work, as well had developed and published three as life in general. issues of a new medical device magazine concept covering the medical << At Compamed 2012, Friedrich plastics supply chain. The model encEchterdiek from moulder Spang & ompasses resin supply and pricing, Brands shone a light on cost saving for design and materials selection, machinbag manufacturers, like investing in ery and auxiliaries, processing methods tooling for a twin shot cap design, including moulding and extrusion, end reducing assembly steps and of line technology, regulation as well as simplifying manufacturing. Image product focuses and clinician reviews. courtesy of PR Portfolio. >> A year on and I have just returned from my third Compamed and Medica event in a row. Being familiar with the layout of the halls at Messe Düsseldorf certainly helps make the most of the short time available at the event. But representing what is now a recognisable brand in MPN is a big plus when lining up interviews with important industry representatives.

Furthermore, our pledge of editorial independence and technical accuracy has clearly built a firm foundation of trust and reassurance in the industry.

production | adrian price subscriptions | tracey nicholls 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

Medical Plastics News is published by: Plastics Multimedia Communications Ltd, Unit 2, Chowley Court, Chowley Oak Lane, Tattenhall, CH3 9GA T: +44(0)1829 770037 F: +44(0)1829 770047

© 2012 Plastics Multimedia Communications Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

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

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INDUSTRY NEWS | Medical Device Regulation

Europe’s Proposed Medical Device Regulation WORDS | SAM ANSON On September 26, 2012, the European Commission issued a proposal to overhaul regulations for medical devices and active implantables. The proposal document is 194 pages long and is a more stringent approach to device regulation. It aims to bring about a transparent and traceable supply chain focusing on the life cycle of a broader range of products.

If implemented, being a regulation rather than a directive, it will be applied “as is”, bringing consistency across EU states.

The terms of the regulation itself are subject to change following discussion and approval by the European Parliament.

Once the final wording of the regulation is published it will enter into force 20 days later and come into full effect three years after that. Therefore, it is likely to be at least 2017 before manufacturers are required to comply.

implementation of existing rules from one member state to another as evidenced by recent reports by UK newspaper The Telegraph. It is also directed towards addressing the problem related to postmarket surveillance, highlighted recently by the PIP silicone implants scandal, whereby competent authorities do not have sufficient mechanisms to monitor information and implement market surveillance.

administration of the regulation and the scrutiny procedure related to high risk class III implantable devices (see later).

Economic Operators With a view to achieving better transparency and traceability, Chapter II sets out requirements for economic operators—manufacturers, authorised representatives, distributors and importers. The responsibilities of all economic operators are defined.

Definitions Manufacturers and authorised There are more definitions in the representatives must have an approved proposal document than the MDD—50 qualified person appointed who is an compared with 14. The definition of a expert in the field with qualifications. medical device has been expanded to include aesthetic implantable devices (for There are also requirements placed on example cosmetic breast implants or non- the manufacturer with respect to quantity-structure-property relationships corrective contact lenses) and invasive (QSPRs), technical documentation, quality devices used in humans with associated management systems, post-market examples. surveillance plans and clinical follow ups and labelling languages.

Medical Device Coordination Group As far as distributors and importers are The proposed regulation would involve Weaknesses of the MDD the establishment of an expert committee concerned, imported devices must bear The new proposal aims to correct the importer’s name on the device or its called the Medical Device Coordination weaknesses in the current Medical Device packaging. There are requirements that Group, made up of members from EU Directive (MDD). The biggest change concerns the oversight of notified bodies— states and chaired by the EC. The group importers must carry out sampling of marketed products while monitoring will be responsible for which has led to inconsistency of

October 1, 2012 EC Publishes Proposed medical device Regulation

Former surgeon and Eucomed chairman Dr Guy Lebeau (pictured) said: “I urge all decision makers who want to make fundamental changes to the European system for medical devices to tread with caution. I fully agree that changes need to be made to the current regulatory framework but let’s make sure we keep the best system for patients and medical progress in Europe.”

October 8, 2012 Abbott Launches First Ever Fully Resorbable Vascular Stent “Abbott has remained committed to meeting the growing physician and patient demand for a bioresorbable vascular scaffold—from the initial device developed nearly 10 years ago to the expansion of our manufacturing capabilities to support this international launch,” said John M Capek, executive vice president, Medical Devices, Abbott.

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October 9, 2012 North American Sales of Medical Plastics to Grow by 5.2 per cent a Year to 2018

“There has also been heightened focus on engineered polymers such as co-polyetherester elastomers (COPE), polyether block amides (PEBA), and acetal chemistries that have more advanced performance properties for niche, technologically advanced healthcare applications, such as tissue engineering and implants,” said research analyst Tridisha Goswami. “These new materials will expand the scope of plastic polymers' application and propel the market.”

October 10, 2012 Eucomed and EDMA Launch MedTech Europe, a New Allied Devices and Diagnostics Association

ON THE PULSE complaints. Furthermore, these entities Notified Bodies must declare that they have complied with Perhaps the greatest proposed the requirements of the relevant clauses in change to the regulatory system surrthe proposed regulation document. ounds notified bodies and their metamorphosis from an industry partner Additional Device Types into what Emergo describes as “a policeNew devices to be included and like extension of the authorities’ market specifically defined are: devices surveillance apparatus”. incorporating medicinal product and Existing notified bodies will be subject devices composed of substances or a to annual monitoring by authorities and combination of substances intended to an assessment once every three years by be ingested, inhaled or administered a joint assessment team. There are also rectally or vaginally; devices incorporating new minimum requirements for notified materials of biological origin; and bodies, set out in annex VI. software in devices and standalone The proposal also sets out terms for software. the so-called scrutiny procedure—how a notified body should notify the Medical Eudamed Medical Device Database Device Coordination Group about new and Unique Device Identifiers (UDIs) implantable class III devices, including the Chapter III proposes a process by which presentation of a Summary of Safety and devices can be tracked within the EU. It Clinical Performance document created consists of a newly established medical by the manufacturer. When explaining device database—known as Eudamed— this requirement, Emergo pointed out with a mandatory requirement on notified that many manufacturers may not have bodies, economic operators and member completed this document at this stage. states to input data. A key component of Overall, the proposed legislation over the system is the unique device identifier notified bodies is expected to be costly.

(UDI), a set of data which must be compiled and submitted for every device sold in the Clinical Evaluation and Investigation EU market. It is proposed that class III As was generally expected, the roles devices will be separated out and subject to of clinical evaluation and investigation are a separate scrutiny procedure and, as part more prominent in the proposed of the data submitted, a summary of safety regulation than in the MDD. There are and clinical performance must be included. requirements quoting specific ISO standards and guidance documents and

“The [MedTech Europe] alliance not only signifies a stronger and more consistent representation of Europe’s medical technology industry, but also provides healthcare stakeholders with one unified industry discussion partner when needed. Being able to speak with one organisation about medtech issues should make the lives of healthcare players easier and makes industry representation more credible and impactful,” said Serge Bernasconi, chief executive officer of Eucomed, the European Diagnostics Manufacturing Association (EDMA) and MedTech Europe.

October 23, 2012 Polycarbonate Producers Condemn French Proposed Ban of Bisphenol A The European Information Centre on Bisphenol A, a sub division of European plastics industry association PlasticsEurope, comprises representatives from the main polycarbonate producers in Europe—Bayer MaterialScience, Dow, Sabic, Styron and Momentive.

October 24, 2012 ABHI Admits Notified Bodies Problem Following Telegraph Undercover Report David Jones, director of Communications at ABHI, said: “The Daily Telegraph’s investigation into Notified Bodies (NBs) highlights an issue that ABHI has raised with authorities on a number of occasions. The control of NBs across Europe has not been rigorous enough and this must be improved.”

Eudamed database registration is itemised. The process for a post-market clinical follow-up is also explained.

Market Surveillance and Serious Incidents Under the proposal, manufacturers are required to report a serious incident within 15 days. The EU database will be used to share these reports to relevant bodies.

Industry Response In general, the proposal has been welcomed by the industry. However, there have been concerns that the proposed scrutiny procedure for high risk class III devices is too tough and could stifle technological development and delay device uptake—a key competitive edge of Europe’s medical device industry at present.

At the same time though, other commentators have suggested that the proposal should be taken with a degree of political context. The Eucamed database will require an increase in spend by the European parliament and medical devices may not be outside the current climate of austerity for many member states. Getting the funding for the proposal through parliament may not be as easy as many people think.

Credits: The above article was compiled using information from medical device regulation consultants Emergo Group and Meddiquest.

PREVIOUSLY ON MPNMAGAZINE.COM

12:12:2012

October 31, 2012 European Medical PVC Industry Forms PVCMed Alliance

“The PVCMed Alliance will actively communicate about PVC and its additives, its properties and its essential contribution to quality care delivery for healthcare professionals. It will also promote innovative and environmentally friendly practices in PVC healthcare applications”, explains PVCMed Alliance spokesperson Brigitte Dero.

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ON THE PULSE INDUSTRY NEWS | Devices and Diagnostics Industries Ally

Allied Medical Devices and Diagnostics Industry Group MedTech Europe WORDS | SAM ANSON The alliance will be legally established by the end of 2012 and will collaborate closely on common policy interest areas. All European medtech associations are invited to join.

Initially, MedTech Europe’s focus will be divided into five parts—legislative frameworks for medical devices and in vitro diagnostic (IVD) products; the European medical technology industry’s five-year strategy; health technology assessment; patients and safety; and environmental issues.

Medtech Europe has made a strong start to its role as an ally between the medical device and diagnostics manufacturing industries. It has published a new report on value-based innovation, updated an industry strategy document and overhauled the

On October 10, 2012, the associations representing the European manufacturing industries for medical devices, Eucomed, and diagnostic devices, the European Diagnostics Manufacturers Association (EDMA), announced that they had formed MedTech Europe, a new alliance intended to encourage collaboration between the two industries. The announcement was made at the European MedTech Forum in Brussels, Belgium.

www.reforminghealthcare.eu website. The new report on value-based innovation focuses on how Europe's medical technology industry is delivering on a promise of a “Contract for a Healthy Future”. The updated industry strategy document, entitled Industry Strategy, Contract for a Healthy Future, details the role of Europe’s medical technology industry in steering healthcare systems onto a sustainable path. Together with a third report by the Economist Intelligence Unit on Future-proofing Western Europe’s Healthcare, these reports are available as a free download on the reforminghealthcare.eu website.

The board of Medtech Europe will comprise three representatives from EDMA and three representatives from Eucomed. The chairmanship will rotate between its members. The board will decide future topics of collaboration.

Announced as a European Industry Alliance in January 2012, MedTech Europe will work alongside its founding members and will remain a separate entity, as will EDMA and Eucomed. Medtech Europe is not an umbrella association on top of Eucomed and EDMA. The three associations will be helmed by one chief executive officer—Serge Bernasconi. Mr Bernasconi succeeded the previous chief executive of Eucomed, Luciano Cattani, and director general of EDMA Volker Oeding on July 16, 2012. << Serge Bernasconi is the chief executive officer of the newly formed allied Medtech Europe as well as Eucomed and the European Diagnostics Manufacturers Association (EMDA). >>

Reproduced with kind permission of Eucomed.

The Purpose of a Diagnostic Test

by Lluís Bohígas Santasusagna, director, institutional relations, Roche Diagnostics

In vitro diagnostic (IVD) tests are being created for home use, empowering patients with information about their health and giving doctors the tools to optimise treatments.

Diagnosis is the process of finding out if a patient has a specific disease. A medical professional prescribes a test to make a diagnosis or to exclude possible illness. The results are used to implement treatment or carry out further tests.

Monitoring intends to see if the disease is controlled, a purpose that is very common in chronic diseases such as diabetes. Symptoms can be managed with medication, hormones or lifestyle changes.

Screening consists of studying patients who do not yet present any signs or symptoms of a specific illness in order to find out if it has begun to quietly develop and if so, to be able to apply treatment as soon as possible. These tests are applied to large segments of the population and should therefore be simple and cheap.

Prognosis allows clinicians to assess the likelihood a patient has for developing a disease in the future and therefore take precautions earlier rather than later. Genetic tests, for example, analyse a patient’s predisposition for developing a disease, allowing the patient and doctor to be more attentive to discovering early signs of the disease and to take preventive measures as needed.

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ON THE PULSE Industry News from the SPE | Supercritical Fluids in Medical Plastics

Supercritical CO2 in Medical Plastic Processing The use of supercritical CO2 as a solvent in the processing of various biodegradable and biocompatible polymers for pharmaceutical and medical applications in the forms of particles and microcellular foam has garnered much attention in the last decade. A supercritical fluid is defined as a substance for which both pressure and temperature are above the critical values.

These fluids possess physicochemical properties— properties which are both physical and chemical—such as density, viscosity and diffusivity. Density, viscosity and diffusivity are intermediate between those of liquids and gases and are continuously adjustable from gas to liquid with small pressure and temperature variations. Both the capability of supercritical fluids to replace toxic solvents and the ability of tuning solvent characteristics for highly specific separations or reactions have led to the current scientific and industrial interest in supercritical fluids. A supercritical fluid has the unique ability to diffuse through solids like a gas, and dissolve materials like a liquid. CO2 is a promising alternative to noxious organic solvents and chlorofluorocarbons. It has shown versatility as a supercritical fluid in the synthesis as well as processing of polymers owing to its attractive physical properties. It is non-toxic, non-flammable, chemically inert and inexpensive. Its supercritical conditions are easily attained (Tc = 304.15 K, Pc = 7.38MPa) and it can be removed from a system by simple depressurisation.

A Processing Aid for Viscous High Molecular Weight Polymers The processing of polymers is highly influenced by the viscosity of the bulk materials. Raising the processing temperature or the addition of volatile or harmful plasticisers are often seen as solutions in overcoming the inherent difficulties encountered when processing high molecular weight polymers. However, higher temperatures during processing can lead to thermal degradation. Also, added plasticisers remain in the product and thus alter its properties and performance. The low thermal stability of high molecular weight biodegradable polymers has led to the emergence of supercritical CO2 as a useful processing aid. There are many examples of the use of pressurised gases to lower the melt viscosity of numerous amorphous and semicrystalline polymers. Polyethylene glycol, polystyrene and polydimethylsiloxane are examples of polymers where a viscosity reduction has been demonstrated upon the incorporation of supercritical

BY DR SEAN LYONS, SENIOR SCIENTIST AT BAUSCH + LOMB, IRELAND

CO2. Biomaterials as well as polyethylene and polystyrene blends have exhibited similar behaviour.

Plasticisation The use of supercritical fluids in the processing of polymer melts can also lead to changes in the mechanical properties of the materials. Most mechanical property changes during processing can be attributed to the plasticisation of the polymer by the supercritical fluid and the resultant drop in Tg. Some blended polymer materials have shown significant increases in modulus and strength when formed in a supercritical fluid assisted process, this is often due to the tuning of the morphology and degree of crystallisation of the material by the supercritical fluid.

Changes in the elastic and creep modulii of materials when processed with supercritical fluids can occur in a range of materials. However these changes and their magnitude are dependent on the solubility of the polymer(s) in the supercritical media and the supercritical material’s ability to induce crystallisation in the system in question.

Supercritical Fluids in Fibre Composites Polymer composites processing can also utilise supercritical fluid technology and extensive research has taken place in this area recently due to the burgeoning use of these materials in the electronic and medical industries.

Companies such as Ireland’s SCF Processing have been pioneering research into bespoke industrial polymer processing solutions working with manufacturers to provide tailored materials processing transfer services.

Supercritical fluid can be used to carry the monomer onto the fibres or particles to be used in the composite and to act as a plasticiser for the synthesised polymer matrix when the composite is formed by in situ polymerisation of the monomer. Polymer composites can also be prepared by blending the polymer and the other component in the presence of supercritical media.

Microcellular Foam Products The moulding of microcellular foam products, like many supercritical CO2 processes, entails the formation of a single phase solution. On venting the CO2 by depressurisation, thermodynamic instability causes supersaturation of the CO2 dissolved in the polymer matrix and hence nucleation of cells occurs. The growth of the cells continues until a significant amount of CO2 escapes, the polymer passes Continued on page 13

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ON THE PULSE

Continued from page 11

through its Tg and the foamed structure is frozen in place. An added advantage of this technology is that due to the lower pressures and softer fills, delicate items can be overmoulded without much of the traditional displacement and resultant need for excessive control features. USA-based Trexel’s MuCell process technology is said to have been the first to widely offer microcellular foaming for both extrusion and injection moulding processes and as a result its technology is often licensed to industrial partners. Optifoam licensed

by Switzerland’s Sulzer Chemtech is an example whereby the supercritical fluid dosing element is the nozzle of the machine as opposed to the barrel.

Another example is Ergocell, the injection moulding process operated

by Japan’s Sumitomo (SHI) Demag for the production of microcellular foamed products. The cycle sequences in the Ergocell process essentially correspond to the sequences in the standard injection moulding process. The decisive difference is in the gas delivery, which takes place simultaneously to plasticising. As the screw draws in, melts and delivers material into the space in front of the screw and—in the process—is being pushed back against the back pressure, gas is fed into the melt from a gas metering station. Thus, the screw moves back at a speed that is a function of the plasticising capacity of the screw.

Simultaneously, an amount of gas as preset by the operator is delivered into the melt. In contrast to the MuCell technology, which requires a modified screw assembly, the injection of the supercritical fluid into a module downstream of a conventional plasticisation unit in the Ergocell technology means that it can be easily removed, allowing the injection moulding equipment to be used in a conventional process when required.

50%, reduced scrap rates, and lower energy consumption (energy savings are based on reduced processing temperatures and are process dependent); lower capital costs through the purchase of smaller and fewer machines, and fewer and less expensive moulds; reduced material costs through component density reduction, thinner design, and material substitution; and the ability to mould thermoplastic parts that have a substantially higher dimensional stability which are free of warpage.

The use of supercritical fluids in the medical device sector affords the opportunity to add a new and exciting dimension to the processing of polymeric materials. Examples of medical devices currently being produced commercially using this technology include endoscopes, heart pumps, inhalers and nebulisers. The use of supercritical CO2 as an inexpensive solvent in many polymer processing applications has already brought many benefits to the industrial sector. As usage becomes more widespread, materials that had previously been designated as ‘un-processable’ due to their high viscosity or their thermal instability can now be reinvestigated with the aid of supercritical fluids.

Supercritical fluid technology has not yet reached its potential within industry.

However, considerable research into this field is ongoing which would indicate that the number of applications and the usage of this technology are only likely to grow. Supercritical CO2 is also examined as a sterilant of bioresorbable devices on pages 22-25.

Medical Plastics News would like to thank Austin Coffey of the Society of Plastics Engineers European Medical Polymers Division for his help with this article.

Organisations Collaborate on PVC in Healthcare A new European association, the PVCMed Alliance, has been launched to promote the use and value of PVC in healthcare applications. PVCMed is an alliance of the PVC medical industry chain represented by PVC resin and plasticiser producers and PVC converters.

The alliance’s aim is to provide a focal point for communication with healthcare professionals and regulators about PVC-based healthcare applications, and their fundamental role in quality of healthcare, safety and costefficiency, all whilst being environmentally responsible.

Through an interactive platform, the alliance seeks to consolidate a strong dialogue with all involved stakeholders to continue improving healthcare delivery together.

“The PVCMed Alliance will actively communicate about PVC and its additives, its properties and its essential contribution to quality care delivery for healthcare professionals. It will also promote innovative and environmentally friendly practices in PVC healthcare applications”, explains PVCMed Alliance spokesperson Brigitte Dero. Ms Dero adds: “The quality and safety of PVC-based healthcare applications guarantee efficient and widely affordable healthcare systems to continuously improve and save patients’ lives.”

At the time of going to press, members of the PVCMed Alliance include BASF, Colorite Europe, Eastman, the European Council of Vinyl Manufacturers (ECVM), OXEA, Renolit and Tarkett.

Advantages of Supercritical Gas Assisted Injection Moulding The primary advantages of supercritical gas assisted injection moulding are: reduced operating costs through cycle time reductions of up to

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Electronics in Plastic Devices | Smart Plastics

At the Touch of a Button:

Wipe-Clean Moulded Switches for Medical Engineering For electronic medical devices, control components such as switches and buttons must not only be easy to operate—they must also be easy to clean. They are notorious for attracting germs and dirt particles, particularly in and around the tiny crevices and gaps between the various components and connections. The development of smart plastics—moulded components with capacitive electronic functionality—offers device manufacturers the opportunity to develop wipe-clean electronic buttons and switches while improving production efficiency and achieving better and more complex designs.

Some people have earmarked smart plastics as a converging technology where capacitive electronics have been combined with injection moulding. Others have described them as a new type of composite technology.

Fundamentally, they consist of a plastic part moulded over a film which has had electronic components printed onto it (see image below left). The result is an aesthetically pleasing part with smooth lines and a clean shiny finish.

The part has electronically interactive parts built in to it to form switches and buttons.

The electronics components consist of capacitive sensors which utilise the principle of electrical capacity— the reciprocation between two spatial points (as in the electric force field between two electrodes). The electric flux lines within an electric field may be changed by introducing a conductive object (such as a fingertip). The capacitive sensors pick up these changes and respond with a voltage variation that can be used to initiate a particular function—such as an on/off or up/down command. Since the field lines penetrate non-conductive solid bodies, the sensor effect also works from a distance through a thin surface layer such as a thermoplastic or an operator's gloves. << Below: Sensors and conducting paths are printed onto the film; the malleability of the film gives product designers ample scope. >>

<< Above: Smart plastics represent new opportunities for the medical engineering sector, especially in the design of operator control units. >>

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PLASTIC ELECTRONICS The films can be configured in three dimensions and cut before being overmoulded or back-injected with thermoplastic. In this way, capacitive electronics can replace mechanical switches, buttons and control knobs.

The operating elements are covered by a continuous, even and highly resistant interface.

Smart Plastics in Cars According to Austrian injection moulding machine manufacturer Engel, smart plastics have undergone most development in the automotive sector. Michael Fischer (pictured right overleaf), sales manager (technologies) believes: “The cars of the future will be easier to operate than smartphones, simply by touch, feel and interaction.”

At its open house in June 2012, Engel presented its first close-to-production application for smart plastics (see image). Centre consoles for cars with a sensitive interface were manufactured using an Engel duo 350 injection moulding machine with reversing plate and combination mould. A capacitive, three-dimensional pre-formed film was placed into the mould by a robot and overmoulded with PC/ABS. The component was then flow-coated with polyurethane to protect the surface and produce a high quality impression.

no assembly is required, productivity is also increased sharply.

Pushing the Boundaries of Product Design Ample scope for design through injection moulding is a real benefit here. The flexible print production for the films makes it possible to position sensors almost anywhere; films can also be formed into virtually any shape. Sensitive surface technology is therefore the ideal means by which to develop operator control units cost effectively—units that Engel say are unbeatable in terms of usability and ergonomics.

<< Injection moulding covers the electronic elements with a continuous and highly resistant plastic interface. >>

<< The manufacturing cell for centre consoles with capacitive electronics delivers outstanding cost effectiveness. A high level of automation—and the sensitive surface technology itself—are critical factors. >> The technology will now be marketed under the name Sensitive Surface by Engel and its project partners. “We are in discussion with various automobile companies and OEMs with a view to mass-producing the first sensitive surface applications in three to four years”, reveals Fischer.

In the case of vehicle construction, the hygiene aspects of a continuously sealed interface are less important than ease of use and high efficiency in the manufacturing process. Whereas conventional manufacturing often involves the individual production and assembly of more than 100 small parts, capacitive films and plastic granulate facilitate the production of functional, ready-to-install components in a single work step. “Taking the centre consoles as an example, production costs are reduced by at least 30% if we look at the whole process”, emphasises Michael Fischer. Since

Of course, ergonomics and cost-effectiveness have been key considerations in other sectors of industry for many years. With this in mind, a design study for the control panel of a washing machine was recently presented. Meanwhile, Engel and its partners are starting to field enquiries from the medical engineering sector.

“I think the fact that this technology addresses a whole set of requirements at a stroke represents a major opportunity for medical engineering”, says Christoph Lhota (pictured middle overleaf), the head of Engel's medical business unit. “Firstly we're doing more to address stringent hygiene requirements, secondly we're improving the ergonomics of medical engineering products and thirdly we're drastically cutting production costs. Pressure on costs is rising in the medical engineering sector too.”

At present, lessons learned from the automobile industry are being developed and applied to the medical engineering field. Alongside Engel, a company heavily involved in the specialist development and production of intelligent, multi-layered interfaces is Austriaheadquartered smart plastics technology developer plastic electronic. One key development issue at present is the sterilisability of intelligent electronic components. “We successfully carried out function tests for the automobile industry in the temperature range of -40°C to +85°C”, reports Philipp Weissel (pictured left overleaf), CEO of Continued on page 16

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PLASTIC ELECTRONICS Electronics in Plastic Devices | Smart Plastics Continued from page 15

plastic electronic. “We're now working on raising the temperature range for critical applications in medical engineering.”

Upper Austria Hailed as Epicentre of Smart Plastics Evolution As far as the future research activity of Engel and plastic electronic is concerned, Upper Austria promises ideal conditions. Few places elsewhere in the world are such a high concentration of companies and research institutes to be found alongside the infrastructure needed for smart plastics. Early in 2011, this density of specialist expertise led to the foundation of a smart plastics networking group, the Smart Plastics initiative. The aim of this group is to accommodate the entire value chain for intelligent electronic plastic products within Upper Austria so that world-leading system solutions may be developed in partnership. To further this goal, Smart Plastics is hosting a congress in Linz, Upper Austria—the same place where Engel’s headquarters are—on June 10-11, 2013.

Editor’s Outlook Plastic electronics may help designers find an alternative to conventional membrane keyboards in medical situations. These membranes attempt to integrate a continuous seal over an interface, but are said to be less than robust in practice and constitute a source of infection in sterile environments like operating theatres.

Thanks to the commitment in Austria for smart plastics and Engel’s lead in the moulding expertise, observers can expect product designers to turn to smart plastics for improved functionality, aesthetic design, not to mention the wow factor of a highly sensitive button which requires absolutely no pressure to activate. It takes the phrase “at the touch of a button” to a whole new level.

<< Left to right: Michael Fischer, Engel sales manager (technologies), Christoph Lhota, Engel’s head of medical, and Philipp Weissel, CEO of plastic electronic. >>

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Bioresorbable Electronic Devices a Reality It’s not often that a doctor can claim two gamechanging inventions in less than a year. That’s what Dr Marvin J Slepian can boast, having developed a new class of small, high performance electronics that are biodragradable and capable of dissolving completely in water or bodily fluids following a predefined period of functionality. Earlier this year, Dr Slepian’s company, Syncardia—a US-based medical device manufacturer— developed and successfully implanted the first artificial plastic heart. In the 1980s, Dr Slepian developed one of the first prototypes for biodegradable stents.

Dr Slepian is director of interventional cardiology and professor of medicine at the USA’s University of Arizona (UA) Sarver Heart Center with a joint appointment in the UA department of biomedical engineering. He is also cofounder and chief technical officer of Syncardia.

Details of the technology on which this dissolvable electronic device is based—known as transient electronics—were published in a September 2012 copy of Science, a leading US scientific journal.

The paper describes a number of examples of transient electronic devices, including a system designed to monitor and prevent bacterial infection at surgical incisions which has been successfully demonstrated in rats. The paper was written by Fiorenzo Omenetto, professor of biomedical engineering at the Tufts School of Engineering in Massachusetts. Omnetto worked with researchers at University of Arizona and Northwestern University in Illinois. Materials found in conventional integrated circuits are used—silicon and magnesium—but in an ultrathin form that is then encapsulated in silk protein, which is dissolvable. Device dissolution is reportedly further controlled by sheets of silk protein in which the electronics are supported and encapsulated.

Omenetto and his team have discovered how to adjust the properties of silk so that a wide range of degradation times can be predetermined.

Photo Source: Beckman Institute, University of Illinois and Tufts University.

Material Diagnosis | Growing Popularity of Bioresorbable Polymers

Bioresorbable Polymers: Patents Growing by 37% a year WORDS | SAM ANSON

Bioresorbable polymers are nothing new. They have been used in dissolvable sutures for a number of years. But according to the United States Patent and Trademark Office database, the number of patents referencing bioresorbable and medical grew from 48 in 2005 to 311 in 2011, an average annual growth rate of 37%, or 548% in absolute terms. In the last two months, the first fully resorbable drug eluting stent was CE marked for sale in Europe.

Here Sam Anson looks at bioresorbable processing considerations while reviewing examples of application success.

Bioresorbable polymers, also referred to as bioresorbable or degradable polymers, are polymer materials which can be safely absorbed by the body so that the materials from which a construction is made disappear over time.

The following report examines bioresorbables from the following perpectives—compounding, mechanical properties and degradation times; moulding and extrusion; degradation testing; additive manufacturing of resorbable tissue engineering scaffolds; Absorb—the first ever resorbable stent; Purac glass fibre composites; supercritical CO2 sterilisation; and coloration.

Polymer Types The most common bioresorbable polymer is polylactic acid (PLA), also known as polylactide, and is made from a lactide monomer. Generally speaking, PLA is the main building block for bioresorbable polymer materials.

Common derivatives of PLA are poly-L-lactide (PLLA), poly-D-lactide (PDLA) and poly-DL-lactide (PDLLA).

When in the body, PLA degrades into lactic acid, a nontoxic chemical which occurs naturally in the body.

Polyglycolic acid (PGA), or polyglycolide (PG), is another type of bioresorbable polymer usually used for bioresorbable sutures. The material can be copolymerised with lactic acid to form to form poly(lacticco-glycolic acid), or PLGA, with e-caprolactone to form poly(glycolide-co-caprolactone), or PGCL, and with

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trimethylene carbonate to form poly(glycolide-cotrimethylene carbonate), or (PGA-co-TMC). PGA degrades to form glycolic acid.

Compounding, Mechanical Properties and Degradation Times The mechanical properties and degradation time of a bioresorbable device can be tailored to a specific application by adjusting the molecular weight, crystallinity and hydrophilicity of the polymer. This is achieved by varying the percentage of polylactide D or L forms, and polyglycolide. Tony Listro, managing director of specialist US medical polymer compounder Foster Delivery Science explains: “Compositions with higher hydrophilic and amorphous structures and a lower molecular weight resorb faster, yet often sacrifice mechanical strength.

Conversely, higher crystallinity and molecular weight improve mechanical properties and decrease resorption rates.”

Bone growth additives, such as tricalcium phosphate (TCP) or hydroxyapetite acid (HA) can be melt blended into these polymers to enhance bone growth during degradation. Additionally, the low melt temperatures of many bioresorbable polymers allows for melt blending active pharmaceutical ingredients (APIs) for controlledrelease drug delivery during degradation. However, higher molecular weight polymers often require higher melt temperatures and thus limit melt blending of some APIs with low degradation temperatures.

Twin screw extruders optimise bioresorbable polymer blending, including distribution and dispersion of additives.

Due to the high cost of bioresorbable polymers, which can often exceed US$1,000 per lb (US$2,200 per kg) and the relatively small nature of the implantable applications, small scale twin screw extruders—between 16 mm and 27 mm— are ideal. Since these polymers begin degradation when exposed to moisture, desiccant and vacuum driers are required prior to melt blending. Unlike non-resorbable polymers that are often water cooled upon exiting the extruder in strand form, bioresorbable compounds must be air cooled. Pelletised strands destined for finished device processing must be thoroughly dried and properly packaged to prevent exposure to air moisture that can cause premature degradation.

BIORESORBABLE POLYMERS Moulding and Extrusion Considerations The processing of bioresorbable polymers must be handled with care. The materials themselves are highly hydrophilic, which is to say that they love water and will absorb any moisture with which they come into contact.

Unless properly dry, the materials will not melt and recrystallise as expected, making moulding and extrusion difficult. At the same time, bioresorbable polymers are sensitive to heat, and molecular structures can be damaged through exposure to excessive temperatures during drying.

With this in mind, careful and thorough drying at low temperatures is needed, while the humidity of the processing environment must be considered.

Knowing the melt and recrystallisation behaviour of bioresorbable materials is important, as is understanding the melt flow viscosity. Often materials will have a low melt temperature, a high crystallisation temperature and generally be extremely viscous—like hot honey—except at a small temperature range between the two. This means that there is a very small temperature range at which materials can be processed—that is to say, the range at which the material is molten, at which the viscosity is at the right level for injection moulding or extrusion, and at which the material won’t crystallise prematurely.

Due to their delicate molecular structures, bioresorbable polymers are limited in terms of the amount of time they can remain molten, so cycle times must be kept within this range, which is often not very long.

Degradation Testing of Bioresorbable Medical Devices On November 28, 2012, the FDA held a public workshop on the testing of bioresorbable medical devices at its White Oak campus in Silver Spring, Maryland, USA. The workshop, entitled Workshop on Absorbable Medical Devices: Lessons Learned From Correlations of Bench Testing and Clinical Performance, was cosponsored by ASTM (American Society for Testing and Materials) International, a US organisation responsible for the development and delivery of international voluntary consensus standards for engineered products, including medical devices.

The purpose of the workshop was to provide a forum for highlighting and discussing the use of bioresorbable materials in medical devices across a broad range of indications with the aim of defining successful and unsuccessful methods to predict clinical performance.

The main topics discussed included identification of test methods for establishing correlations between in vitro and in vivo degradation of absorbable implantable devices, and the interaction of mechanical loading and mechanical performance with degradation. While there was an emphasis on cardiovascular indications as part of a panel session, characterisation techniques and experiences from both cardiovascular as well as noncardiovascular devices were discussed and encouraged.

Additive Manufacturing of Resorbable Tissue Engineering Scaffolds Additive manufacturing is being used to produce scaffolds for tissue engineering from bioresorbable polymers. A number of years back, researchers from A Star, a leading Singaporean research institution, successfully developed a technology for fabricating resorbable polymeric tissue scaffolds with high strength and porosity using additive manufacturing. Dr Margam Chandrasekaran (Chandra), now CEO and chief scientist at Singapore-based tissue engineering scaffold manufacturer Bioscaffold International, was one of the lead inventors of the technology. Along with a team of clinicians at the National University of Singapore, at A Star Chandra developed an application of the technology to produce a commerical product for high strength resorbable dental scaffolds using additive manufacturing.

Chandra explains: “We used a combination of PLGA with PVA and changed the binder used in the 3D printing process to produce parts in a desired shape and then used a post processing technique similar to particulate leaching to strengthen the structure. In fact, besides PLGA, we did work on << The 3D–Bioplotter from PCL, PLA and PGA. A EnvisionTec is specially designed paper was published in to process a large range of 2007 in the Journal of materials, from hard polymers, Materials Processing and through ceramic pastes to soft Technology.” hydrogels including cells. >> Today, Chandra’s company manufactures implantable tissue engineering scaffolds for dentists made from PLGA. The scaffolds are used by dentists to preserve tooth sockets following removal of a tooth. The implant encourages bone growth, thereby preserving the socket while the gums heal. This means that any further restorative procedures, such as dentures or implantable false tooth fittings, are vastly improved.

Another resorbable scaffold application, manufactured in the USA by tissue engineering device pioneer 3D Biotek, is a three dimensional PLGA-based degradable porous cell culture device for medical research processes. The device is special because its three dimensional nature allows cells to grow in three dimensions. Its 100% porous nature allows cells to be seeded very easily. Because PLGA is biocompatible, the scaffolds, with or without cells, can be implanted into animals. Degradation time is approximately 4-5 months.

Germany-headquartered 3D printer supplier Continued on page 20

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BIORESORBABLE POLYMERS Continued from page 19

EnvisionTec’s 3D-Bioplotter is an all-purpose direct manufacturing tissue engineering machine for the production of hard and soft scaffolds from biomaterials, cells as well as synthetic materials. It is specially designed to process a large range of materials, from hard polymers, through ceramic pastes to soft hydrogels.

According to EnvisionTec, the 3D-Bioplotter is specially designed for work in sterile environments in a laminar flow box, a requirement of biofabrication, for example when using alginate cell suspensions for the construction of cell-laden scaffolds. Additionally, the 3DBioplotter can use up to five different tools per job. This means that scaffolds fabricated using the 3D-Bioplotter can have up to five different materials, or five different types of cells in specific positions.

In contrast to other rapid prototyping techniques the 3D-Bioplotter, EnvisionTec says, uses a very simple and straightforward technology, invented in 1999 at the Freiburg Materials Research Centre in Germany. The manufacturing process works by air pressure being applied to a liquid and liquefied material, which solidifies upon dispensing.

The 3D-Bioplotter is delivered together with a PC workstation which operates and monitors the system. After transferring the 3D CAD data to the PC it is processed by the Bioplotter’s software package. The preprocessed data is then transferred to the 3D-Bioplotter using a network connection. The Bioplotter software monitors the working process until it is completed.

Abbot Launches First Ever Bioresorbable Vascular Scaffold USA-headquartered Abbott, one of the world's leading medical device OEMs with 91,000 employees, has launched Absorb, the first fully resorbable drug eluting vascular scaffold.

Absorb is available for use by clinicians in treating coronary artery disease (CAD) across Europe, Asia Pacific and Latin America. It works by restoring blood flow to the heart—similar to a metallic stent—but instead of being permanent it dissolves into the body. After dissolution it leaves behind a treated vessel that may resume more natural function and movement because it is free of a permanent metallic stent.

In order to create the backbone of the device, PLLA resin is extruded into a tube, then radially and axially expanded in a process that resembles stretch blow moulding. The scaffold pattern is then cut with a laser, and the finished product is coated with a drug and polymer mixture and crimped onto a catheter before being packaged and sterilised.

According to Abbott, PLLA has an intrinsic degradation rate that is influenced in vivo by very few factors. Device performance over its degradation lifecycle is tuned to match physiological requirements for vessel support. The polylactide molecular weight in the finished product and

the degradation rate govern this performance.

The potential long term benefits of a scaffold that dissolves are significant. The vessel may expand and contract as needed to increase the flow of blood to the heart in response to normal activities such as exercising.

Treatment and diagnostic options are broadened. The need for long-term treatment with anti-clotting medications may be reduced. And future interventions would be unobstructed by a permanent implant.

“This innovation represents a true paradigm shift in how we treat coronary artery disease,” said Patrick W Serruys, a medical doctor and professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands. He added: “With the launch of Absorb, a scaffold that disappears after doing its job is no longer a dream, but a reality.”

Absorb is now available in a broad size matrix to support the needs of physicians treating patients with CAD. There are 7 sizes available—varying in length from 12 mm to 28 mm and in diameter from 2.5 mm to 3.5 mm. The strut thickness and width are approximately 150 μm and 180 μm respectively.

At the time of going to press, Absorb is neither approved nor authorised for sale and currently is in development with no regulatory status in the United States. << The backbone of Absorb, the first fully resorsable drug eluting stent, is produced by extruding PLLA into a tube and then radially and axially expanding that tube in a process which is similar to stretch blow moulding. The tube is then lasered to produce the scaffold pattern. >> Bioresorbable Glass Fibre Composites for Load Bearing In August 2012, Netherlands-based bioresorbable polymer manufacturer and owner of the Purasorb brand of medical resorbable polymers Purac acquired FiberLive, an advanced resorbable glass fibre composite technology.

The acquisition included the intellectual property of the FiberLive technology and its key personnel.

According to Purac, FiberLive is a unique patented composite consisting of a matrix of resorbable silicabased glass fibres and resorbable polymers, forming an exceptionally strong resorbable composite material—up to six times stronger than cortical bone. This unique composite material widens possibilities to use resorbable Continued on page 22

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Material Diagnosis | Growing Popularity of Bioresorbable Polymers Continued from page 20

materials into the fields of bone fixation, where in the past it has been impossible due to a lack of load-bearing properties of conventional biopolymers. The material can be used in different kinds of orthopaedic treatments, including craniomaxillofacial (skull and jaw), sports medicine, trauma and spinal procedures.

When commenting on the acquisition, Menno Lammers, managing director Purac Biomaterials, said: “This technology will be a game changer in the orthopaedic resorbable market, where load bearing properties are needed. The FiberLive technology is the strongest fully resorbable material available for human implants, with strength up to six times higher than cortical bone, comparable to metal. For decades Purac Biomaterial has been the leading company in the field of medical resorbable polymer materials having strong commitment and enthusiasm towards innovation and development in the field. With the acquisition of this innovative resorbable composite material we are able to further widen our capabilities to serve our customers according to their requirements.”

The Purasorb brand of resorbable polymers covers a broad range of grades, including polymers—poly-Llactide (PLLA), poly-D-lactide (PDLA), poly-DL-lactide

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(PDLLA), polyglycolide (PG), polycaprolactone (PCL)— and copolymers L-lactide/DL-lactide (PLDL), L-lactide/D-lactide (PLD), L-lactide/glycolide (PLG), Llactide/captrolactone (PLC) and DL-lactide/glycolide (PDLG). The company also offers custom synthesis of bioresorbable polymers. << Implantable resorbable screws made from Purac FiberLive. >>

Supercritical CO2 Sterilisation of Bioabsorbable Polymer Devices A team of researchers at NovaSterilis, a supplier of supercritical carbon dioxide (scCO2) sterilisation technologies and equipment based in the state of New York, working with Dr Chih-Chang Chu, a professor from Cornell University (Ithaca, NY), have developed a novel process for sterilising devices made from bioresorbable polymers using scCO2. The technology is being distributed in Europe by European Medical Contract Manufacturer

BIORESORBABLE POLYMERS (EMCM) based in Nijmegen, The Netherlands.

According to a poster presentation from the team displayed at the Ninth World Biomaterials Congress in China in June 2012, which reported the feasibility of NovaSterilis’s scCO2 sterilisation method for an absorbable suture, scCO2 is preferable to ethylene oxide when sterilising bioresorbable devices for a number of reasons, as follows.

Devices can be processed at low pressure and temperature, which reduces costs and energy requirements.

Low temperature processing makes it ideal for specialist bioresorbable devices due to their highly sensitive molecular structure (as explained earlier). Furthermore, the CO2 molecule has a low surface tension which also reduces the likelihood of damaging delicate molecular structures commonly found in bioresorbable materials.

The fact that scCO2 sterilisation can be used to sterilise in between the pores of a material—it is said to penetrate deeply into a substance—plays perfectly into the hands of bioresorbable polymer devices as by their very nature they are very porous. The poster points to the fact that spores can live in the pores of the material and the method can get right between the microscopic holes to ensure they are completely sterile. Furthermore, reinforcing the delicate nature of the method, the scCO2 can penetrate inside the spore and oxidise it to render it

inactive, which means that when the spore is killed, there is little or no effect on the delicate surrounding material.

Sterilisation can be done inhouse as there are low capital expenditures required, meaning that device manufacturers can retain full control and sight of their products during sterilisation. Furthermore, the time taken for this method is much shorter than traditional ethylene oxide—according to NovaSterilis president and CEO David C Burns, “you are talking minutes to hours rather than hours to days”.

Residual chemicals are non existent or negligible following sterilisation. Any that do remain are non-toxic as confirmed by toxicity testing.

ScCO2 sterilisation is a new technology. The first 510k submission is expected within the next 12 months. Four companies are currently using the technology to sterilise allograft tissue because of its gentle effect on collagen (biopolymer)—three in the USA and one in Australia.

According to David C Burns, president and CEO NovaSterilis: “Today’s highly technical products require very specialised handling, including sterilisation in smaller batches. Moreover, the desire to maintain custody of product is more important to many of our customers.”

The NovaSterilis scCO2 process is said to be safe for many polymers, allograft tissues, plastics, and surgical Continued on page 25

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BIORESORBABLE POLYMERS Continued from page 23

metals. NovaSterilis manufactures 20-litre and 80-litre fully automated, computerised, and network capable sterilisation units. Designed with a small footprint, these units are ideal for biomedical material companies that require high value and flexibility. NovaSterilis provides supportive technical services, assisting customers to determine if this process is appropriate for specific products, establishing cycle times and developing validation and regulatory plans.

In 2007 NovaSterilis won the Presidential Green Chemistry Challenge Award Presented by the US Environmental Protection Agency. << This is a highly magnified scCO2 sterilised Dexon suture, manufactured by USAheadquartered device manufacturer Covidien.

Note the scale—100 μm— on the left hand side. The image is courtesy of Dr Chih-Chang Chu of Cornell University’s Department of Fiber Science and Apparel Design. >> Profile of a Bioresorbable Expert: Degradable Solutions, Switzerland Degradable Solutions (DS), based in Switzerland, manufactures a number of bioresorbable products. The company is a spin-off from the Swiss Federal Institute of Technology Zurich (Eidgenössische Technische Hochschule Zürich—ETH) and was taken over in November 2011 by Swiss oral care device manufacturer Sunstar Group. It is a technological leader in its field and has extensive experience of working with bioresorbable polymers. Two areas of interest are bone graft substitutes and tissue fixation devices.

Bone graft substitutes are sold under the brand name easy-graft and are the company’s most important product. Easy-graft consists of resorbable granules of calcium phosphate which have been coated with polylactic acid. The granules are injected into parts of the body where bone needs to grow, particularly broken bones and teeth. An activator liquid is added to the granules just before injection. The activator causes the polylactic acid coatings to form a sticky putty which allows the granules to be applied directly through a syringe.

When in contact with blood, the biomaterial solidifies and forms a defect-analogue, mechanically stable mass of material which is porous and will be replaced by bone tissue over time.

This occurs thanks to the fact that the calcium phosphate degrades over time, allowing bone cells to grow in and around the calcium phosphate granules as they degrade. DS is also talking about incorporating active pharmaceutical ingredients into the material, such

as doxycycline antibiotics and cell growth substances.

The process whereby these granules are made is an inhouse developed proprietary process of DS. The materials start out as soft porous granules of tricalcium phosphate (TCP). Then using a sintering process, the granules are hardened and coated with PLA before being packaged into easy-to-use kits ready for orthopaedic surgeons.

Tissue fixation implants are injection moulded degradable PLA-based components for fixing tissue in place during surgery. Processed by closely controlling cycle times and temperatures, DS manufactures a range of devices, including cages for spinal applications, knee interference screws, small pins for foot surgery, implants for cranioplasty and suture anchors for shoulders. In this area, the company offers full device development and manufacturing services, including design and development, manufacturing, packaging, sterilisation, registration as well as development and manufacture of the instruments required for application.

Coloured Bioresorbables Visibility of small transparent implantable devices can be difficult intra operatively. Coloured devices can support precision and quality control of the surgeon.

Bioresorbable colours are another product offering of DS. The company is an expert at integrating FDA approved implantable colours into bioresorbable devices. The issue with pigments in implantable devices is that there are very few suppliers of biocompatible colours. DS has secured the supply of compliant pigments.

<< Degradable Solutions, based in Switzerland, has developed granules (left) of resorbable tricalcium phosphate coated with PLA. When mixed with an activator liquid the granules form a sticky putty which can be injected (above) into the body before setting to form a bioresorbable porous bone cement that allows bone to grow in and around it as it degrades slowly over time. >> << Degradable Solutions is also an expert injection moulder of resorbable materials. This screw, Sysorb, is a patented turbine shaped screw head for reconstruction of the cruciate ligament. >> NOVEMBER/DECEMBER 2012 / MPN /25

FOLIO

This wonderful image was sent to us by German silicone manufacturer Wacker. The image is one of the companyâ&#x20AC;&#x2122;s latest silicone rubber grades for medical applications marketed under the Silpuran trademark. This particular grade, Silpuran UR 34xx, is a low-viscosity, addition-curing silicone rubber suitable for use in medical applications requiring a soft compression effect. Two viscosity levels are available: 25,000 mPas (Silpuran UR 3420) and 15,000 mPas (Silpuran UR 3440). The product consists of an A and a B component, is easy to process and cures at room temperature.

Silpuran products are said to be highly pure, free of organic plasticisers and stabilisers, and have passed selected tests for biocompatibility according to ISO 10993 and US Pharmacopeia Class VI. They are manufactured in accordance with Wackerâ&#x20AC;&#x2122;s own inhouse clean operations standard, and are filled and packaged under cleanroom conditions. Furthermore, specific Silpuran silicone rubber grades are also suitable for long-term medical applications. Potential applications cover a broad range and include port catheters, voice prostheses, gastric rings, and pacemakers through to disk, joint and hearing implants.

GERMANY

Profile of the German Medical Technology Industry WORDS | SAM ANSON In terms of innovation, there is little doubt that Germany is the European leader in medical technology. The country is the third largest supplier of medical technology products and associated services in the world and in terms of new patent registrations it is second behind the USA. In 2009 the German government successfully implemented compulsory health insurance. In 2011 it distributed photographic electronic health cards to facilitate treatment.

German medical technology companies achieve approximately one third of their revenues from products which are less than three years old. On average, medtech companies invest a large share, around 9%, of their revenues in research and development.

As a medical technology market, the country is third largest in the world after the USA and Japan and is by far the largest in Europe—twice the size that of France and three times those of Italy, the UK and Spain. Germany’s share of global medtech sales is estimated to be 11%. The US and European markets, by contrast, take a share of 41% and 30% respectively.

The Market for Medical Devices in Germany Germany’s total spending on medical devices and related services (excluding investment goods and dental prostheses) is currently at a total of around €25 billion a year. A further €1 bn is spent on dressings and bandages, which are grouped under drugs.

The Medical Technology Industry’s Revenues Growth in revenue generated by the German medical technology sector slowed to 6.9% in 2011 from 9.4% in 2010, according to official statistics. In 2011, revenue totalled €21.4 bn << Germany’s catchment area by air, rail and road. >>

compared with €20 bn in 2010. Despite the deceleration, 2011 was a better year than 2009 when revenue fell by 4.3% to €18.3 bn due to dampened demand for Germany’s medtech exports.

A breakdown of revenues into domestic sales and exports shows that at €14.2 bn, exports during 2011 were up compared with 2010 by 10.6% while domestic sales grew by a slow 0.4% to €7.2 bn. As a result exports as a percentage of total revenues, at 66%, was higher than the norm of 60-65% and far higher than the approximate rate in the 1990s of around 40%.

In 2010, exports rose by 12% to a total of €12.8 bn while domestic sales rose by 5%.

German Medtech Export Markets Germany’s largest export destination is the EU, which in the third quarter of 2010 accounted for around 40% of total medtech exports. The EU is followed by North America with a share of 20%, Asia with 17% and the rest of Europe (non EU) with 11%. The fastest growing market for German medical technology companies in the third quarter of 2010 was Latin America with a 28% increase compared with the corresponding period a year earlier, followed by Asia with a 26% rise. Despite being one of the hardest hit regions by the global slowdown, sales to North America rose by a healthy 13%.

A Geographical Snapshot of the German Medical Technology Sector A large proportion of the industry is concentrated in south Germany, primarily in the federal states of Baden-Württemberg and Bavaria. There are 350 companies with more than 20 employees in these states and impressively, these firms account for more than half of the total turnover achieved by the entire German sector.

Approximately a quarter of revenues are generated by medical technology companies in Hessen, the state which contains the city Frankfurt, Germany’s northernmost state Schleswig-Holstein, North Rhine-Westphalia—the state in the west whose capital is Düsselforf and largest city is Cologne, and the state of Berlin.

<< Concentration of German medtech companies with more than €5 mn turnover. >> Continued on page 30

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GERMANY Continued from page 29

Employment in the German Medical Technology Sector According to recent estimates, the medical technology industry employs approximately 175,000 workers. This total consists of more than 100,000 people at 1,250 businesses which employ more than 20 employees and 75,000 employees at 10,000 businesses with 20 employees or less. A further 29,000 employees work in sales of medical and orthopaedic goods.

Medical technology in its narrower sense employs 137,000 people in Germany, according to a study on the health satellite account published by the Federal Ministry of Economics. For the year 2005, the Fraunhofer Institute for Systems and Innovation Research ISI calculates that the number of indirect employees of the medical technology sector was at 68,000. This means that each job within the industry provides another 0.75 jobs in other sectors.

During the years 2000 to 2008 the number of employees in the medical technology sector in Germany rose by 12%. By comparison, over the same period the number of employees in the pharmaceutical industry decreased by 4%.

As much as 15% of the medtech employees work in research and development, also with an upward trend.

Apart from a few large companies, the medical technology sector consists mostly of medium sized businesses. As much as 95% of all businesses have fewer than 250 employees. In 2010, the 1,065 medtech companies in Germany with fewer than 250 employees provided jobs for around 54,000 people.

The rate of inflation in labour costs in Germany is among the lowest in Europe and is stable with an average of just 2.0% a year during 2000-08. By comparison, the average inflation in the twenty seven nations which make up the EU was 1.7 percentage points higher than in Germany at 3.4% while in the UK it was 4.9%, in the Netherlands it was 3.8% and in France it was 3.4%.

The reason given for Germany’s competitive labour supply is a high rate of productivity and steady wage levels. German productivity rates are almost 10% greater than the average of the EU’s 15 core nations and almost 25% higher than the OECD average.

Specialisms of the German Medtech Industry The German medtech sector covers a wide range of product categories—from high end specialist devices to commodity items for general healthcare provision. A wide range of experience in international markets means that products can be easily tailored to international customers requirements.

In a study entitled The Identification of Hurdles to Investment in the Medical Technology Sector, published in 2008, the Germany’s Ministry of Education and Research identified some key developmental trends in the sector.

Operational and Interventional Devices and Systems: This area of innovation includes devices and procedures for operational interventions on the human body, meaning direct, manual or instrument based interventions.

Key themes and particularly innovative subareas in this field include minimally invasive surgery, robotics and navigation in surgery, surgical instruments, and intensive medicine.

In addition to this, networking concepts in the context of interoperable devices and systems play as much of a specialist role as simple and intuitive ease-of-use. A specific feature is the 30/ MPN / NOVEMBER/DECEMBER 2012

strong industrial base in Germany, primarily in the small and medium sized family owned company sector.

In Vitro Diagnostics: In-vitro diagnostics (IVDs) consists of instruments and apparatus (including software) which are used together with reagents for the laboratory or on-site examination of samples which originate from the human body. They provide information specific to physiological or pathological states, congenital defects, recipient tolerance levels, and therapeutic condition monitoring. In this context, important innovative subareas include labon-chip technology, molecular diagnostics, immunodiagnostics, decentralised diagnostics, and individualised medicine.

Prostheses and Implants: Important areas in this field include technical aids for the disabled and rehabilitation products, neuroprosthetics and functional electro simulation devices, as well as intelligent and nano and bio-functionalised implants.

In terms of industry structure, prosthesis and implant innovation is largely carried out by small and medium sized companies. The sector is also characterised by a wide range of technology which stretches from simple mechanical systems to complex, active implants.

Telemedicine and Model Based Therapy: Telemedicine, or telehealth, is the name given to diagnostics and therapy measures which make use of telecommunications to bridge location and time distances between doctors and patients or between consulting doctors.

E-health refers to specific concepts, ways of thinking, approaches and obligations towards networked and global thinking for the improvement of healthcare using information and communications technology (ICT).

Key themes and particularly innovative subdivisions include electronic patient records, telemonitoring, expert systems, ambient assisted living, and virtual reality in medicine.

Imaging Systems: In addition to classic imaging procedures (x-ray, computer tomography, magnet resonance tomography and ultrasound), new methods such as positron emission tomography (PET) and single photon emission tomography (SPECT) are gaining in importance.

Other important innovations include screening and early diagnostics, therapy monitoring, molecular imaging, multimodal systems, image guided intervention, 4D functional imaging, and image and data processing. Wide ranging financial measures supporting the development of imaging procedures have been put in place by the German government.

Device and System Networking in Healthcare Settings: In most application areas today, medical technology devices tend to be operated as individual devices. However, the linking of medical technology devices to systems and their incorporation into hospital IT infrastructure is on the increase. This integration is creating new possibilities in therapy and process optimisation terms.

Moreover, it also provides a complete picture of the patient’s medical history, the procedures undertaken and their current status.

By comparing the progress of previously evaluated standard procedures with the progress of the current operation, it is possible to acquire information about its subsequent progression.

With a workflow analysis of this kind it is possible, for instance, to determine the forecast ending of the operation and therefore arrange the scheduling of the next patient in optimum and timely fashion.

R&D | Medical Plastics in Germany

German Medical Plastics As German medtech firms continue to enjoy widespread growth, a commitment to innovation is blindingly obvious in the medical plastics sector. The country enjoys the second highest number of patent registrations in the world after the USA. Medical plastics are not an outlier in this statistic. To find out who is leading innovation in medical plastics we spoke with plastics engineer and independent consultant with twenty years experience Monika Verheij.

“When looking at German innovation in medical plastics, the first places to look are the research institutes,” says Monika.

“Near Nuremburg we have two very important research institutions which are working with medical plastics to develop innovative applications. SKZ— Süddeutsches Kunstoffzentrum (South German Plastics Centre)—is involved in a good deal of medical plastics research.”

An example of some of the areas in which SKZ is involved is non-destructive testing (NDT) of test cracks in medical plastics led by Dr Kurt Engelsing.

“The University of Erlangen’s Institute of Polymer Technology (LKT—Lehrstuhl für Kunststofftechnik) is another leading plastic research institute with strength in medical” Monika advises. “I met

<< The president of Rosenheim University of Applied Sciences, Prof Heinrich Köster (left) and Dr Karlheinz Bourdon, vice president of KraussMaffei at the time of the opening of the university’s cleanroom competence centre. >> 32/ MPN / NOVEMBER/DECEMBER 2012

GERMANY

Research Community representatives from there at a recent SPE [Society of Plastics Engineers] European Medical Polymers conference at Queen’s University, Belfast,” she added.

Rosenheim University of Applied Science, where Monika actually studied, is notable in terms of its expertise with medical plastics. On January 29, 2010, the university opened what it calls a cleanroom competence centre, kitted out with KraussMaffei injection moulding machines. Led by Prof Peter Karlinger, students and academic researchers are able to explore future possibilities for cleanroom moulding.

“I met Prof Peter Karlinger at Fakuma 2012,” said Monika. “He is in the SPE’s network of plastics engineers.”

The university at Rosenheim has had a longstanding association with KraussMaffei’s—one of Germany’s leading manufacturers of injection moulding machinery. The machinery installed at the competence centre in 2010 includes an EX 80/380 all-electric injection moulding machine and an integrated IR 50 F/K industrial robot. For its role as a laboratory machine, the EX is equipped with a number of measuring systems capable of collecting data on over 100 parameters, including performance, torques and pressures.

Other German research institutes of note are RWTH Aachen on the Dutch border west of Düsseldorf and the Fraunhofer

Institute, headquartered in Munich. RWTH stands for ReheinischWestfaelische Technische Hochschule—the Rhein-Westphalia Institute of Technology.

Medical Technology Trade Shows While there are no trade shows dedicated to medical plastics (unlike the UK where Mediplas debuted in September 2012), there is a biannual medical plastics conference, Kunststoffe in der Medizintechnik, organised by the German Association of Engineers—the VDI. Germany hosts the largest plastics trade show in the world— K, short for the German word for plastic Kunstoff—every three years. In the two years when K is not taking place, the Fakuma show in Friedrichshafen, a much smaller but still sizeable dedicated plastics trade show, opens its doors.

As regards medtech suppliers events, there is always a strong contingent of plastics exhibitors at both the country’s leading medtech trade shows—Compamed in Düsseldorf every November and Medtec in Stuttgart every February or March.

Monika Verheij serves on the board of directors of the Society of Plastic Engineers European Medical Polymers Division.

NOVEMBER/DECEMBER 2012 / MPN /33

Making Materials Work | Talk to Your Moulder Before Calling it Quits

Micro Matter: Thin Wall Aspect Ratios, Multiple Component Parts and End of Line Growing interest in micro moulding technology, especially within the medical device community, has prompted many questions in the marketplace. What do you need to know about micro moulding? How is it different from traditional moulding? Are there any guidelines? Considering these questions, micro moulding experts at USAbased Accumold have written below, hoping to shine a light on these issues for design engineers and product developers.

According to US micro moulding experts Accumold, simple answers to these questions are difficult to give.

There are subtleties and complexities which often can only be engineered through experience. In its basic form, the micro moulding process is very similar to standard moulding. It still requires the ability for the mould to open and close. There still needs to be a place to gate, eject and split the part, and concepts like draft and aspect ratio are very much still in play.

Where the process starts to divert from conventional moulding and what makes these questions difficult to answer is the fact the each and every project can bring its own set of complexities on the micro scale. When dealing with micro sized parts how you approach elements like the design, material selection, gate and/or parting line locations can be the difference between success and failure. Knowing how to approach each of these requires a high degree of expertise and experiences not necessarily readily available in the marketplace.

Thin Wall Aspect Ratios: Beyond Material Data Sheets The company recommends a general guide of a 6:1 aspect ratio when it comes to applications like thin wall moulding. However one recent Accumold study on the relationship of material choice to feature performance demonstrated that some materials in a thin wall section (76 μm) only ran with an aspect ratio of 3:1 while others ran at 42:1. The wide variety in the response makes it difficult to give a hard and fast rule on aspect ratio when dealing with such small features. This was also one mould in one situation with optimal design. Other designs may or may not perform the same way with any given material 34/ MPN / NOVEMBER/DECEMBER 2012

<< These parts are moulded in one step from two materials—a hard transparent outer ABS and a soft TPU ring measuring just 2.4 mm across. >>

“Keep the creativity maximised; the impossible is done every day.” basically insisting that each part design and material choice can have its own set of rules.

The other main barrier to the success of this study was when resin experts were asked which materials would run a 42:1 aspect ratio at 76 μm all of them said none. Resin material data sheets are often consulted to understand what the melt flow characteristics and what gate sizes may be recommended. The problem is that most of these data sheets are developed by studying a much larger part design and gate size. In fact most gate size recommendations are larger than many micro moulded part themselves. This is why Accumold recommends you consult with your micro moulder before calling it quits on a project you are told is not producible. Hands on experience with processing high temperature thermoplastics at the micro scale beyond what the data sheet may imply is often essential to the success of a project.

MICRO MOULDING

<< The parts on the red background are an overmoulded fabric mesh. The delicate fabric is automatically articulated through a fourcavity mould where it is cut then encapsulated in plastic. >>

Multiple Component Moulding Another key aspect when designing for micro moulding is knowing what other processes or value added components are available. When space is a factor, interest in multiple component parts or even part consolidation ranks high. Processes like lead frame moulding, insert moulding, two-shot moulding or overmoulding are enabling technologies and opening up a vast array of possibilities at the micro scale. However, adding the additional complexities to what may be an already complicated situation requires a tremendous amount of pre-design work and design for manufacturability.

Working with your experienced micro moulder at the concept stage is ideal for situations like this.

Traditionally one might wait until there is a part to quote before approaching a moulder. The more complex the project, the earlier in the design phase the better.

Many times a system will have to be custom built or the lead strip will have to be designed to the moulder’s specifications so that it can articulate through the mould, possibly even be die-formed or singulated to make the final desired part.

A true micro moulder can overmould all sorts of metals, plastics, fabrics, glass, flex-circuit or another delicate medium. In a general sense, most items that can withstand the temperatures and pressures of moulding can be overmoulded. Keep in mind, whatever it is to be overmoulded needs a way to be held in the mould while being processed. This is an often overlooked but a necessary part of the design process.

<< This image demonstrates the range of parts available from Accumold. >>

End of Line—Inspection, Measurement, Assembly and Cleanroom Packaging When in the early concept phase of a project it can be easy to overlook post-moulding processes. Sometimes part handling can be equally or more difficult than the mould build itself. Making the small part may be mission one, but delivering it in a manufacture-ready fashion can be a whole new challenge not to be taken lightly. The inspection, measurement, packaging, and/or cleanroom processing of a part that’s only 800 μm long can be more difficult than meets the eye. If your incoming inspection can’t validate the specification or your manufacturing schemes can’t manipulate the part successfully you’ve not really finished. Don’t overlook the backend of the process; it’s not always as easy as other, larger parts you may have moulded in the past.

As a rule, reach out to your micro moulder as you embark on any project you feel will require expertise beyond a traditional supplier. Know that micro moulding is more than the size of the press one may have. It takes years of experience and a high level of expertise to pull off the most complex of projects. And most importantly keep the creativity maximised; the impossible is done every day.

Accumold is situated in Ankeny in Iowa in the Midwest region of the USA. It serves markets worldwide. The company developed their micro moulding process and techniques more than 25 years ago and is solely dedicated to pushing the limits with micro technologies. For more information on the company visit their website www.accumold.com. For more details on their reports or case studies click on Corporate Resources on the home page.

NOVEMBER/DECEMBER 2012 / MPN /35

DESIGN 4 LIFE

Dassault Launches Dedicated Medical Device Design Software France-headquartered software developer Dassault Systèmes has launched a new product for medical device manufacturers called Licensed to Cure.

Based on Dassault Systèmes’s 3DExperience design software, Licensed to Cure is said to help accelerate the delivery of innovative, safe and fully compliant medical devices.

According to Dassault, Licensed to Cure ensures a single source of information for innovation, as well as a fully transparent and documented change process allowing medical device manufacturers to optimise resource allocation, maximise IP reuse, and streamline the regulatory filing process. By creating an end-to-end, traceable, and compliant product development process that is directly linked to quality management, medical device manufacturers can expedite time to market and minimise regulatory overheads.

“An increasing regulatory scrutiny is putting pressure on medical device manufacturers to achieve total quality and safety,” said Monica Menghini, executive vice president, industry and marketing, Dassault Systèmes. “With the number of FDA warning letters issued on the rise, the time and budget that manufacturers spend on regulatory activities is increasing. Our 3DExperience platform, with dedicated industry solution experiences, enables companies to manage their business objectives in a complex regulatory environment while meeting consumers’ expectations for safe products.”

In terms of individual elements, the new software has a range of new features. << The screenshot gives an idea of the specialist medical device related features of the Licensed to Cure design software. >>

One Quarter of Supply Chain Has Improved Business Performance and Growth, Study Concludes

Embedded Regulatory Concepts Licensed to Cure allows companies to eliminate scattered processes and data, and to embed regulations as an asset, optimising quality and compliance and reducing cost and time to market.

Single Source of Information Licensed to Cure ensures a single source of information that allows manufacturers to always get relevant, upto-date information and establish true collaboration with the same, accurate set of product data.

Automated Tasks Licensed to Cure automates “bureaucratic” tasks and ensures procedural enforcement that leads to making products right the first time, speeding time to regulatory approval.

Structured Process and Documentation Licensed to Cure provides structured process and documentation such as “living” design history files (DHFs) and device master records (DMRs), bringing full traceability and automated reporting and filing.

Innovation Pipeline According to Dassault, Licensed to Cure helps medical device manufacturers accelerate and increase the innovation pipeline to sustain market expansion in new countries and with specialised products to meet patient needs without limits from risk mitigation and regulatory restrictions.

During the first half of 2012, market research and analysis firm Cambashi performed a survey of the medical device and life science manufacturing sector and their suppliers. The survey was carried out in association with USAbased UBM Canon Medical Device Media Group and sponsored by French design software developer Dassault Systèmes. In a white paper summarising the survey results, one of the conclusions drawn was that a quarter of respondents were enjoying growth while making major improvements in their business performance. The paper has drawn a profile of these respondents, which Cambashi describes as Advancers.

Advancers, the survey says, focus on what customers care about while innovating aggressively. At the operational level they have improved in manufacturing, planning and development. They have implemented measurement, production and management processes and a wide variety of information systems.

The report also pulls forward some of the strategies that appear to be effective to achieve specific goals and to balance trade-offs. For example, most respondents believe they conduct more quality process checks than are required, which is inefficient. To help focus on this and not only grow but also improve profitability, companies must measure and improve not just their quality but the cost of quality and the cost of compliance.

The white paper is available for download from the Dassault Systèmes website www.3ds.com.

NOVEMBER/DECEMBER 2012 / MPN /37

MODULAR CLEANROOMS

The Versatile World of Modular Cleanrooms

BY SEAN FRYERS, MARKETING MANAGER AT CONNECT2CLEANROOMS A cleanroom is a room in which the concentration of airborne particles is controlled and which is constructed and used in a manner to minimise the introduction, generation and retention of particles inside the room.

Modular cleanroom constructions are typically built as freestanding, solid and robust structures suitable for use for injection moulding, extrusion and thermoforming environments.

They are designed to be an alternative to static cleanrooms.

A modular cleanroom will use standard off the shelf proprietary components that when combined with the customer’s requirements will create a 100% bespoke room, thus reducing cost and lead time. Examples of customer requirements include specific ISO classification, lighting and whether they want a hard or soft wall.

Modular cleanrooms use air filtration technology to reach the required cleanroom classification. The two main types are high efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filtration. Filtration creates an exceptionally clean environment.

HEPA filtration is able to remove particles as small as 0.3 μm while ULPA can handle those as small as 0.1 μm. Variable speed adjustments means that air changes in the room can be changed as required—maintaining quality but giving the flexibility to benefit from reduced energy costs during off peak times.

Cleanroom ISO Classification A cleanroom can be designed to achieve various ISO 14644-1 classifications of air cleanliness. ISO 14644-1 is the international standard for air cleanliness for cleanrooms and associated controlled environments.

Often, the type of product being manufactured will dictate the ISO classification required. Long term implantable products need to be manufactured in a cleanroom with a higher standard of air cleanliness than non-sterile products which are used outside the body. The main rule of thumb is to 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.

Selected Airborne Particulate Cleanliness Classes The standard ISO 14644-1 defines the various classifications for cleanrooms. The main criterion for classification is the maximum concentration of airborne particles up to a certain size per cubic metre of air. In medical plastics, typically the most stringent cleanroom class found is up to ISO class 5 while typically the least stringent is class 8. In a class 5 cleanroom, the maximum number of particles permitted per cubic metre of air is as follows: 100,000 of a size which is greater or equal to 0.1 μm, 23,700 of a size which is greater or equal to 0.2 μm, up to just 29 of a size which is greater than equal to 5 μm. A class 8 cleanroom, by contrast, doesn’t identify particles smaller than 0.5 μm and allows up to 29,300 particles greater than 5.0 μm in size.

38/ MPN / NOVEMBER/DECEMBER 2012

Benefits of Modular Cleanrooms: Lean Manufacturing Demand for modular cleanrooms is on the increase as more processes, particularly in the medical plastics sector, are benefiting from a cleanroom environment. With this demand comes a cost and companies are obviously going to look for the best solution to fit their needs and budget. Due to recent years of cut backs that many industries have witnessed, small, medium and large organisations have had to re-think their company strategies and become leaner in the way they manage processes. Modular cleanrooms are part of that leaner way of thinking, as contract manufacturers are finding they can dramatically increase their scope of work by introducing cleanroom facilities.

With traditional build cleanrooms, retrospective modifications are often a lengthy and costly process, so future demands must be accounted for in the initial specification. Modular solutions are more flexible as expansions and relocations can be accommodated much more easily. In these uncertain times companies are seeing the fact that they can stagger their investment to grow with contract wins or developments as a real benefit.

Dramatic design improvements have also led to an increased demand for modular cleanrooms. The use of clear, solid wall panels has led to an improved perception of the modular design of cleanrooms. They are no longer seen as the temporary, low budget option and now offer a reliable and robust alternative to the traditional build cleanrooms.

Hard or Soft Wall and Entrance Control Modular cleanrooms are available as hard and soft wall options.

Hard wall modular cleanroom options are manufactured from clear polyethylene terephthalate. This material is aesthetically pleasing yet limits access to the cleanrooms while allowing in light and ensuring that processes can be overseen.

Softwall options are also aesthetically pleasing, ensure minimum opening only when entering or exiting the cleanroom, maintain the integrity of the room and are a low cost investment. A modular cleanroom can be housed within a dirtier area, for example a warehouse, and still maintain their ISO integrity.

Tacky mats outside the cleanroom remove dust particles from footwear and changing rooms can be built within the modular cleanroom to ensure that the user can change into cleanroom apparel in a controlled environment prior to entering the cleanroom.

By including a mid-height rail to a softwall cleanroom enclosure, you can direct people to a dedicated entrance and prevent people from entering the cleanroom at any point thereby maintaining full control of access. Mid height rails also offer extra strength to soft wall cleanrooms.

Bespoke Design Various cleanroom solutions can be offered to fit the many different processes offered within the medical plastics sector. The modular design creates a localised clean area which offers a solution that can be tailored to suit each organisationâ&#x20AC;&#x2122;s specific machinery.

A fixed ballroom design with no internal supports, allows cleanrooms to be designed to house large machinery with access panels located in the ceiling. These panels can be removed to allow a crane travelling above the cleanroom access to the machinery in the cleanroom.

Localised or part coverage of a machine by a cleanroom is often used when a specific area of the process needs to achieve a cleanroom standard. This can be, for example, at the packaging end of a machine where the product would have to be transferred and packed in an environment where particle reduction would be imperative.

Whole coverage of a machine by a cleanroom is also a common prospect which can unearth interesting variables such as the height of a robotic arm housed on top of an injection moulding machine. The advantage of a modular cleanroom is that it can be designed in such a bespoke manner that all variables are more often than not catered for.

High performance cleanroom solutions can be designed to be integral to the machine in the form of air conditioned laminar flow hoods that can feed cool, particulate-free air onto the machines.

The airflow over the injection moulding tool can be kept at a predetermined cool temperature to ensure that condensation does not harm the processes.

Summary Whatever cleanroom solution is chosen, an investment is being made which will have to be looked after. Regular validations of a cleanroom are recommended to ensure that it is achieving the correct ISO classification. Correct processes and procedures should be carried out, and cleanroom apparel should be worn, cleanliness should be maintained with appropriate lint-free cleanroom wipes and cleaning solutions. Stainless steel furniture is also available for cleanrooms to reduce particle output. A cleanroom should become an integral part of production and with the correct maintenance, care and attention it can open new opportunities, diversifying offerings.

<< Left to right: Installations of modular cleanrooms in Holland, Latvia and the UK. >>

NOVEMBER/DECEMBER 2012 / MPN /39

DOCTOR’S NOTE

Machined Plastics Help Physicists Test Performance of 3D Digital Breast Tomosynthesis Imaging Equipment Over twenty years ago a national breast screening programme was established in England and Wales which invited all women aged between 50 and 70 to have their breasts screened for cancer every three years. The programme saves approximately 1,300 lives a year at an annual cost to the UK’s state-funded National Health Service (NHS) of £96 mn.

Recently, critics have said that the programme has led to over diagnosis. The screening technology highlights cancers, some of which may not have caused a problem if they had not been detected. However, in some cases, the risks associated with this have not been properly explained to patients before they started treatment.

Putting criticisms to one side, the NHS is a pioneer in cancer screening technology. Breast screening was one of the first national screening programmes and the process has been taken up by healthcare providers in other countries.

The commitment by the NHS to breast screening over the last 20 years or so has supported the development of advanced X-ray screening technologies. Most recently, the advent of state-of-theart three-dimensional digital breast tomosynthesis (DBT), also known as 3D tomo, is helping clinicians achieve even more accuracy during scanning.

Implementing DBT scanning equipment in UK hospitals requires type testing—the process of comparing and testing the technical performance of different systems before recommending they be used in addition to conventional imaging technology in trials to evaluate their clinical effectiveness.

In order to test the equipment, operators use phantoms—flat acrylic plates which are designed to mimic the properties of the breast tissue—to ensure that the equipment is functioning properly before the x-rays can be taken.

A UK-based team of research physicists at The Royal Surrey County Hospital in Guildford, UK, are in the process of type testing new DBT machines. The team is part of the UK’s National Coordinating Centre for the Physics of Mammography.

They are using phantoms manufactured specially for 3D DBT machines by UK-based plastics machining expert Carville. Carville have supplied phantoms to the NHS for 2D equipment as well as radiology delivery devices for many years.

The phantom used for the 3D equipment is made from a cast acrylic. Acrylic is ideal for the phantoms because it has very similar attenuation characteristics to human tissue and can be used in various thicknesses—between 20 mm and 70 mm—to simulate human tissue when x-ray performance is being calibrated.

The acrylic is stressed and fully normalised (heat treated) to remove this internal stress. The material is then diamond machined and polished to produce clear flat plates. The latest acrylic phantoms contain 25 aluminium balls with a diameter of 1 mm

<< Carville manufactures a number of phantoms for the UK’s state-funded National Health Service (NHS). One of the specialist skills here is the inclusion of aluminium balls positioned to the nearest 0.1 mm using Carville’s diffusion bonding process. >>

arranged in a square grid arrangement in the centre of the acrylic plate. The balls are arranged 55 mm apart in a rectangular array, the distance being accurate to within 100 μm (0.1 mm). The reason for specifying this precision in positioning the balls was so that the images could be used to evaluate geometric distortion.

Carville is able to achieve these high levels of accuracy by encapsulating the balls between two plates and then bonding the two plates together using a proprietary diffusion bonding process.

According to Carville, the process ensures a seamless joint as if the phantom was produced as a solid block. The dimensions of the phantoms are 300 mm x 240 mm x 5 mm.

These phantoms are being manufactured by Carville now and will be used by 13 regional health authorities in England and Wales later this month.

Carville has also manufactured a block of acrylic containing just one aluminium ball with a diameter of 1 mm. The single ball in the block allows radiographers to test a feature with a particular density and shape in order to perform a regular check on their tomosynthesis images.

Medical Plastics News would like to thank Celia Strudley at the Royal Surrey County Hospital NHS Foundation Trust in Guildford, Surrey, UK. NOVEMBER/DECEMBER 2012 / MPN /41

Drug Contact Plastics | Cyclic Olefin Additives

Colours and Additives for Cyclic Olefins Enable High Tech Bioactive Drug Delivery Interview with Steve Duckworth, head of medical and pharmaceutical at Clariant’s masterbatch unit.

The overlap in technologies across traditional medical instruments and drug delivery devices is gaining prominence. Healthcare providers are on the look out for more innovative mechanisms from drug companies to allow as many patients as possible to treat themselves from home, thereby saving hospital expenditure. Being inert, durable, low cost, lightweight and colourable, plastic is the material of choice for designers of these mechanisms, particularly as new biotech drug formulations enter the realm. Ahead of next year’s Pharmapack show in Paris on February 13-14, Medical Plastics News interviewed Steve Duckworth, head of medical and pharmaceutical at Clariant’s Masterbatch unit.

Sam Anson: Looking at the name Pharmapack in a literal sense, readers might be forgiven for thinking that the exhibition is only for traditional packaging products like drug blister packs, fluid bags and disposable films. But they’d be wrong wouldn’t they?

Steve Duckworth: Absolutely. The show is more important than they might initially realise. Despite the name, approximately half of the people there are involved in drug delivery devices. And it’s really worth visiting. Being in Paris, the show attracts people from all over Europe. And it’s a really nice format too.

Sam Anson: You’re not the first person to recommend it. What can visitors expect to see there from Clariant?

Steve Duckworth: Clariant will have two stands. A team from Performance Packaging, part of the Functional Materials business unit—formed following Clariant’s acquisition of Süd Chemie in 2011—will be there to talk about desiccant and barrier packaging solutions used in both primary packaging of pharmaceuticals and secondary packaging products for drug delivery devices, which help protect sensitive products from oxygen and water degradation.

42/ MPN / NOVEMBER/DECEMBER 2012

Sam Anson: And what about Clariant’s Masterbatch unit?

Steve Duckworth: On our stand, number 333, we will be focusing on our recently introduced range of Mevopur USP/ISO compliant additives aimed at improving the final product or the productivity.

Sam Anson: I heard that you are working closely with Topas and their cyclic olefins. Can you tell me a little more about this?

Steve Duckworth: Topas cyclic olefin copolymer is a very interesting material from a number of stand points but particularly its clarity combined with rigidity. It is clear like glass. This makes it ideal for the replacement of glass in syringes or ampoules.

Sam Anson: I was told that syringe and ampoule manufacturers have the biggest appetite for cyclic olefins. What is driving this?

Steve Duckworth: Demand is being fuelled by three factors. First, there are safety concerns related to breakages of glass-based syringes during transportation. The Topas olefins are shatterproof so there’s more durability there. Second, the fact that plastic syringes and ampoules can be injection or blow moulded gives opportunities for reduced costs while maintaining high clarity.

Third, injection moulding also gives options for designers to begin to think about newer and more intricate shapes.

Sam Anson: According to a report published by USA-based consultancy firm Greystone Research Associates in April 2012, demand for prefilled syringes is expected to grow at double digit rates to 4.75 bn units in 2016. The report says that cyclic olefins are a “material to watch”. How is Clariant helping to supply this demand?

Steve Duckworth: Working with Topas, we have developed a number of standard colorants and additives for cyclic olefins. Two to note are our UV filters in amber and pink and our additive which can prevent yellowing following up to two rounds of gamma sterilisation. Both technologies have been developed from tried and trusted technologies.

Sam Anson: Tell me about the UV filtering first.

Steve Duckworth: Some contents of prefilled syringes and ampoules, particularly new ‘biologic’ products can be highly sensitive to light and thus need to be protected using a colorant which filters out UV light. Clariant already manufactures a range of USP grade amber and pink colorants for polyolefin-based ampoules and syringes. We have worked with Topas and have developed USP/ISO pre-tested pink, amber and other colours

PHARMAPACK 2013

which can be used with cyclic olefins to filter out different parts of UV light, depending on the customer’s requirement.

Sam Anson: And the yellowing preventing additives?

Steve Duckworth: Some polymers, and particularly polypropylenes and cyclic olefins, undergo a yellowing effect under gamma or e-beam sterilisation. Clariant offers a USP/ISO grade additive that counteracts this yellowing effect to maintain colour and clarity.

Sam Anson: You mentioned that repeat sterilisation is a particular problem. Tell me more.

Steve Duckworth: We know that there is a demand from manufacturers to offer products which can be repeat sterilised, as end users wish to have the option to re-sterilise devices. In addition, even with a single sterilisation, if problems are encountered during the process, the sterilisation may be repeated.

As part of a radiation study, we sterilised three grades of Topas material at 0, 25, and 50 kGy to determine the amount of additive required to reduce the colour shift. As a result we can now offer a Mevopur additive for protection of up to two cycles of gamma or e-beam sterilisation of devices made from cyclic olefins.

Note: Topas cyclic olefins are usually used for one sterilisation cycle but should a manufacturer need to repeat a gamma cycle due to a line malfunction for example they can do so without issue from Clariant’s gamma testing. That said, Topas do not recommend repeat sterilisation in general.

Sam Anson: Fascinating. That’s advanced thinking. As a leading supplier of colours for plastics, you must have a privileged view of how things are changing in this area for USP/ISO materials.

Steve Duckworth: I do. And things are changing quickly. Just over a year ago I said to Medical Plastics News that I thought colours are coming. And that trend is certainly showing no signs of abating. For example colour coding has become a key aspect to device design, particularly in drug delivery. For example a new generation of insulin treatment offers patients the opportunity to only require a single daily injection, replacing insulin which required three or more doses a day. The insulin is typically self-administered by a convenient pen device However, manufacturers are concerned that despite labelling, patients may mix up these devices and mistakenly give themselves an insulin overdose by injecting the single dose more than once in a day. Their solution to this is to use

<< At Pharmapack 2013 Steve Duckworth will be talking about Clariant’s Mevopur range of USP Class VI approved additives and colorants, including those which are compatible with Topas’s cyclic olefin copolymers. >>

bright colours to safely differentiate between the two pens to minimise the risk of a mix up.

Sam Anson: What additives are you offering which help plastic processing?

Steve Duckworth: A popular product range is our USP/ISO laser additives for marking and welding that comes with USP Class VI compliance. Of particular interest is the welding additive. It allows clever things to be done with the design, offers more reliability than adhesives and eliminates the potential problem of residues. Also as part of this range we offer UPS/ISO nucleants to help reduce cycle time, optimise wall sections and solve production problems.

Clariant will be at Pharmapack on stand 333.

NOVEMBER/DECEMBER 2012 / MPN /43

PHARMAPACK 2013

Understanding Chemical Interaction During Material Selection

BY JOY HARRISON, PRINCIPAL CONSULTANT AT PLASTICS TESTING AND ANALYSIS CONSULTANCY SMITHERS RAPRA, UK.

Source: Topas.

There are many factors to take into account in choosing the right plastic material for pharmaceutical packaging applications and successfully converting it to the finished product. Joy Harrison summarises the main considerations for producing packaging of appropriate quality which compliments the pharmaceutical product.

Continued on page 47

NOVEMBER/DECEMBER 2012 / MPN /45

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PHARMAPACK 2013 Drug Contact Plastics | Extractables and Leachables Continued from page 45

The key requirements for pharmaceutical packaging materials are that the packaging contains, protects and prevents deterioration of the pharmaceutical product during storage, transportation and possibly in use.

However, the packaging material must not cause any adverse effects to the pharmaceutical substance which render it less effective in its function or render the product harmful.

Understanding Interactions Between the Plastic and the Pharmaceutical The most important consideration is that there should be no chemical reaction between the pharmaceutical substance and the packaging material. Developers must ascertain that there is chemical compatibility and stability over the productâ&#x20AC;&#x2122;s shelf life at the stated storage conditions.

Interaction between the pharmaceutical substance and the packaging materials can take several forms, some more obvious than others.

In the most severe case, the substance may attack the packaging material such that the integrity of the packaging is breached. Such a material would be clearly unfit for purpose.

The substance may attack the packaging, causing plasticisation and softening of the packaging, leading to dimensional instability. In addition the packaging material could contaminate the pharmaceutical material.

All plastic materials contain an additive package which will include thermal stabilisers to enable processing. Elements of the additive package may leach out with time in contact with the pharmaceutical product. The amount that may be acceptably transferred to the product will depend on the nature of the additive and potential toxicity.

Flexible materials often contain oils and plasticisers, some of which have a high propensity to migrate to contacting substances. The plasticiser itself may be deemed harmful and loss of the plasticiser will lead to the packaging becoming more stiff, brittle and prone to accidental damage.

Furthermore, in Europe, as the REACH regulations continue to change, awareness and careful selection of the plasticiser system is essential.

Sterilisation Sterilisation of the packaging is sometimes required. Radiation, steam and ethylene oxide techniques are commonly used. Irradiation is preferred as it is much quicker but is another potential source of material degradation. Ethylene oxide is more innocuous to the plastic packaging but can leave harmful residues.

Manufacturers of polymer resins and compounds for packaging are, of course, aware of these issues. Grades of material are produced, with reduced or tailored additive packages, specifically aimed at applications which are in contact with pharmaceuticals, as well food and medical devices. Superior resistance to irradiation may be another feature. These grades are usually subjected to additional quality controls and have undergone extensive testing. These materials may be recognised by FDA food contact compliance or USP 88 Class VI claims.

In addition, processing may change the plastic material. For example if the material is overheated during processing, degradation substances may be produced which are toxic or carcinogenic in nature and therefore extremely undesirable.

Steps for Selecting a Drug Contact Plastic The key steps in selecting a plastics packaging material and ensuring its suitability for the application may be summarised as follows.

Select a material type where there is a minimal amount of known primary chemical interaction between the pharmaceutical substance and material.

In terms of the grade, selecting one which has been tailored for use in food or medical applications is a wise choice. It is recommended that you discuss your application with a technical representative of the manufacturer. The manufacturer knows the formulation of his material and should be well placed to advise on the grade and if there are any potential problems.

Process according to the manufacturerâ&#x20AC;&#x2122;s guidelines and avoid material degradation at all costs.

Remember that the material probably has a reduced stabiliser package compared to standard grades.

Contamination by other materials must be avoided. This may arise after changing materials in the moulding equipment.

Production in a cleanroom is often deemed necessary and many moulders offer this service.

Where sterilisation is required, select a plastic type that will withstand the chosen sterilisation technique or select a technique that is compatible with the plastic to avoid excessive degradation.

Carry out extractables and leachables testing on the moulded product in contact with the pharmaceutical substance. The material supplier may be able to advise which substances must be quantified.

Smithers Rapra Forecasts Medical Plastics Market Growth In a new report published by Smithers Rapra, sales of medical plastics are forecast to grow rapidly, particularly in developing regions such as Asia and Latin America, boosted by rising demand for sophisticated medical devices and improving medical care. The forecasts are part of The Future of Specialty Plastics: Market forecasts to 2017.

Looking at the contents, the report covers specialty medical grade materials such as ABS, COC, LCP, PC, PEEK, PEI, PET, PMMA, POM and PSU/PES. In terms of specific application areas, the report focuses on medical device housing, fluid transfer systems, opthalmics, surgical instruments and other medical equipment.

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Packaging Design | Interactive Aesthetics

More than Packaging: << Team Consulting’s design consultant David Robinson said that his inspiration for this innovative injector pen packaging came from online videos where consumers film themselves unboxing, or opening, the latest piece of technology. >>

At the Pharmapack conference and exhibition in Paris in February 2013, UKbased medical device development consultancy Team Consulting will be showcasing concepts for how packaging of medical products can improve usability and make essential products like auto-injectors and inhalers more appealing to the patient. Team is seeing demand for their services go beyond the design and engineering of the device itself to the wider patient experience and has responded with innovative ideas which take packaging “outside the box”.

“It has always been the case that devices have to be safe, but with new regulations around human factors over the last few years, the devices also have to be proven to be usable,” explains Team’s director of design Paul Greenhalgh. “This focus on safety and usability is opening the market up to some really encouraging innovation around how you make medical devices more usable, and how we can make them even more appealing to patients. We are all aiming for greater patient adherence and by tackling the big issues around why patients aren’t complying with their treatment we can make some improvements”.

The firm says that this is now leading them and other pioneers in the medical devices space to think about all aspects of the patient’s interactions with the device, such as the instructions, the packaging, the device itself and supportive aids like mobile apps.

“We are working with our pharmaceutical clients to improve their IFUs (instructions for use) and this led me onto these concepts for device packaging,” explains Team’s David Robinson, 48/ MPN / NOVEMBER/DECEMBER 2012

PHARMAPACK 2013

Team Takes Drug Delivery Outside the Box “Think of them as pop-up books. As each page is turned to access the device, information is presented to users in bite size chunks, firing their ‘mirror neurons’ as they explore the device, intriguing and delighting them, and drawing them further in.” a design consultant. “I’d seen ‘unboxing’ videos online, where consumers film themselves opening that latest piece of technology, and I thought about whether we could use the same principles in our clients’ packaging.”

The result, according to Team, is that it could really help patients to understand how to use their device correctly. This could help reduce anxiety in patients and, in some cases, even generate some levels of excitement.

At Pharmapack, Team will be showcasing its concepts and demonstrating what is possible if the industry thinks creatively and actively challenges the status quo.

Robinson explains, “Think of them as pop-up books. The auto-injector or inhaler sits behind a thermoformed plastic and can be seen through a cut-out in the instructions. As each page is turned to access the device, information is presented to users in bite size chunks, firing their ‘mirror neurons’ as they explore the device, intriguing and delighting them, and drawing them further in.”

Team seems to take great delight in challenging the sector to think about their devices as more than just the packaging around the drug. As they’ve said a number of times during our discussion, the device is the interface between the drug and the patient, and the packaging and peripherals are an extension of this.

“Medical devices are prescribed by doctors; patients don’t choose an inhaler or injector pen as they would a smartphone or tablet computer. There is usually a lot of anxiety and concern as patients get their heads around their treatment regime and of course the enormity of any condition that they have been diagnosed with. Anything that we can do to reduce this—even slightly—is well worth doing,” Greenhalgh concludes.

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EVENTS medical plastics | DIARY 2012/13

Ireland Medical Technology Excellence Awards December 13, 2012 Galway, Ireland

Plastics trade show January 7-10, 2013 Dubai, UAE

10th Indian Medical Devices & Plastics Disposables conference January 12-13, 2013 Ahmedabad, India

Medical devices and health insurance conference January 15, 2013 Berlin, Germany

Polyolefins conference January 30-31, 2013 Amsterdam, The Netherlands

Polyolefins conference February 24-27, 2013 Houston, Texas

Medtech trade show February 11-14, 2013 Annaheim, California, USA

Drug delivery and packaging trade show February 13-14, 2013 Paris, France

Medtech trade show February 26-28, 2013 Stuttgart, Germany

SPE Conference Success: Vinyltec 2012 in Review

By Jodie Laughlin Declared a great success by attendees and organisers alike, Vinyltec 2012 boasts 165 conference attendees, 25 presentations, a stellar slate of exhibitors and sponsors, 13 new Society of Plastics Engineers (SPE) members as well as 3 keynote speakers including SPE President Jim Griffing with the Boeing Corporation. In addition, the one-day pre-conference seminar hit record attendance with 78 seminar attendees. The strong conference attendance again this year is consistent with numbers delivered the previous two years: 166 in 2010 and 151 in 2011.

With Versatile Vinyl Plastics: Formulating for the Future the focus of this year’s conference, presenters addressed a range of PVC topics including plasticisers, phthalates, sustainability, safety, performance, recycling and regulatory update. In his keynote, Formosa’s Plastics USA’s Brad Esckilsen delivered a Resin Market Update while Kevin Ott of Flexible Vinyl Alliance recapped Flexible Vinyl Business Issues.

Injecting medical plastics into the conversation, Len Czuba (pictured top right) presented Flexible PVC in the Medical Device Industry—A Review of the Concerns Related to Its Use, introducing the idea that if a specific patient population is adversely affected by phthalate plasticisers, it may be prudent to avoid exposing that segment of users to DEHP. However, Len said that 40 years of proven safety and effectiveness should continue to justify the use of DEHP plasticized flexible PVC in medical devices for the majority of users, the non-affected population.

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Sponsored by SPE and SPE Vinyl Plastics Division, this year’s conference was hosted by the Chicago Section Educational Foundation. Held at the very newly renovated Marriott O’Hare Chicago, Vinyltec 2012 attracted engineers, technicians, researchers and managers involved in the PVC product value chain. Looking forward, Iselin in New Jersey will host next year’s Vinyltec on October 21-23, 2013.

Jodie Laughlin, a member of the SPE for 14 years, is vice president of SPE Chicago Section Educational Foundation, serves on the board of directors of the SPE Medical Plastics Division and is channel director, alternative distribution with GE Healthcare Americas.