MPN EU Issue 11

MPN

MEDICAL PLASTICS NEWS

A GLOBAL INDUSTRY NEEDS WORLDWIDE CONTRACT MANUFACTURING Phillips-Medisize's International Footprint Inspires OEMs

ALSO IN THIS ISSUE: Elastomerics Roundup Medtec Preview Medical PVC Industry Tackles Critics

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All Medical, All Plastics

Contents 5. Editor’s Letter: In the balance Sam Anson writes about diplomacy in finding a balance in the PVC sector and industry responses to the UK prime minister’s views on EU membership.

Silicone polycarbonate TPU—page 18

6. On the Pulse: PVC fights back New European industry members association PVCMed Alliance tackles critics on plasticisers and PVC incineration and recycling.

Synergy stent—page 26

9. Material Diagnosis: Elastomerics A roundup of new elastomeric technologies including resorbable elastomers, valves, PVC, TPEs, silicones and TPUs. 20. Cover Story: Global manufacturing Bill Welch, CTO at Phillips-Medisize, explains why a global approach to contract design and manufacturing is inspiring OEMs around the world.

Additive manufacturing—page 36

23. Show Preview: Medtec Europe Medtec will be held in Stuttgart a month earlier than last year, on February 26-28.

We report on materials, injection moulding, extrusion and diagnostics.

26. Folio: Synergy stent A stent with a drug eluting coating made from a combination of a bioabsorbable PLGA polymer and an everolimus immuno-suppressant drug.

Specialist drying—page 38-43

33. Design 4 Life: Young blood The UK needs half as many more engineering graduates than it currently has while Germany is short of 76,400.

We talk to a grad under 30 years old.

34. Regulation Review: Antimicrobials Laws on antimicrobials will change in September 2013. Are you up to speed with the new requirements? We also look at whether the proposed EU medical device regulation could specify antimicrobials.

36. Product Focus: Orthopaedics We investigate how customised implantable plastic devices are being made from PEKK in the USA using select laser sintering (SLS). In particular we look at mechanical properties and regulatory hurdles.

38. Clean Machines: Specialist dryers It is important that dryers used for cleanroom plastic processing do not contaminate materials. We look at both desiccant and non-desiccant dryers as well as a profile of two installations at drug delivery manufacturing locations.

45. End of Line: Testing Critics of the melt flow rate test say that it is limited when trying to characterise extensional flow or high shear rates. A group of researchers are working to come up with an alternative.

48. Country Report: Scandinavia Scandinavia, the home of so-called “clean med” and Medicon Valley, one of the most densely populated medtech and pharma manufacturing clusters in the world.

50. Events: Diary and Irish awards Medical plastics diary in Q1 2013 and a review of the IMDA awards.

Online and in digital Medicon Valley, Scandinavia—page 48

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

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EDITOR’S LETTER

As a voice for companies involved in medical plastics, it is essential that Medical Plastics News employs diplomacy wherever there is a potential conflict of interest. Editorially, this can be a balancing act. Take, for example, challenges faced by the medical PVC industry.

We report on page 6 about how this sector has faced critics and invited debate on two key issues—plasticisers in medical devices and PVC’s environmental footprint.

Balancing this, an opposer of PVC in medicine, former environmental controller for Karolinska University Hospital in Stockholm, Sweden, Anne Marie Vass, is interviewed on pages 48-49. Anne Marie explains why the hospital considered phasing out the use of PVC, quoting concerns over the safety of DEHP and the economics of PVC incineration as reasons.

On the subject of balancing acts, the UK’s prime minister, David Cameron, has announced his position on EU membership. Aiming for a competitive EU marketplace, he wants to renegotiate terms of membership and then, if his party wins the next election, hold a referendum asking Britons to vote yes or no on whether the UK should stay in the EU. He has had to balance support for membership from many in his party, including stakeholders in the UK’s manufacturing industry, with passionate objections from Euro-skeptics in his backbenches. Without back-bench support, he is unlikely to win the next election.

Philip Law, public and industrial affairs director at the British Plastics Federation (BPF), explains his view: “We want to see an EU that provides a harmonised market with light touch legislation to facilitate internal trade—one which takes advantage of the greater economies of scale to enable the EU to compete successfully in the global marketplace.” He added: “There are serious question marks against the EU's success in delivering these. The debate isn't one for the UK exclusively. It's something all EU states should face up to.”

Some UK-based manufacturing businesses see Cameron’s move as potentially damaging, while others diplomatically say that membership is a vital ingredient to future success.

According to Eddie O’Keeffe, chief executive of Europlaz, a UK plastic medical device contract manufacturer: “A referendum after 2014 could cause uncertainty and a lack of customer confidence in British exports. Chinese and US firms may not be so keen to use the UK as a base for investment if we are not in the EU.” Neil Armstrong, CEO of regulatory affairs consultancy MeddiQuest, believes Cameron will be unsuccessful in renegotiating the terms of membership and described the move as being like “a euro-skeptic anti-business government’s pandering to the lowest common denominator of xenophobia on its backbenches”. He said: “Cameron’s veto in December cost us 20% of our turnover last year. This week we have had two US customers tell us they would not be going further with European representation through us and are looking for alternatives in Germany.”

For a heavily regulated industry like that for medical devices, there is a feeling of disconcern about leaving. Andrew Summerfield, regulatory affairs manager at UK antimicrobials firm BioCote, explains: “Legislation such as that governing trade in medical devices, antimicrobials and chemical products has had significant resources invested in it by member states to ensure an optimal balance of safety, efficacy and ease of trade. If the UK were to leave, new rules would likely be in line with current EU laws. Developing an entirely new set of like-for-like laws would introduce another bureaucratic hurdle.”

Dan Jones, communications director at the UK’s Association of British Healthcare Industries (ABHI), reinforced the value of the status quo: “The UK’s current role within the European Union provides a single regulatory regime ensuring that all devices on the market adhere to the highest safety standards. It provides UK companies with a large unified market and removes barriers to trade while attracting foreign investment in the form of large multinationals choosing the UK as a manufacturing location.”

CREDITS

editor | sam anson advertising | gareth pickering art | sam hamlyn 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, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074

© 2013 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.

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INDUSTRY NEWS | Medical PVC Industry Faces Critics

PVCMed Opens Debate on Plasticisers and Waste Management Challenges Following concerns regarding PVC in healthcare applications, particularly regarding DEHP and PVC waste management, the PVC industry, through the PVCMed Alliance, has released the following report in an attempt to address these issues and stimulate debate.

DEHP The assessment of potential risks related to phthalates and in particular the use of the plasticiser DEHP (di(2-ethylhexyl) phthalate) in PVC medical devices has been subject to scientific and policy review by the European Union (EU) authoritiesi. As of March 21, 2010, a specific labelling requirement has been introduced across the EUii iii for all devices containing phthalates that are classified as carcinogenic, mutagenic or reprotoxic (CMR)iv.

The PVCMed Alliance believes that the EU labelling requirements will probably result in a substitution of DEHP in all medical applications where

alternative plasticisers are either validated or are in the process of validation.

Moreover, the decision by the French government to ban the use of DEHP in specific healthcare applications for vulnerable patient groups, which will come into force in July 2015, will of course also speed up the substitution process.

It is, however, very difficult to determine how fast this substitution will take place. The medical device industry is justifiably a conservative business sector where a substance which has been used with apparent safety for over 50 years is not easily substituted.

The PVCMed Alliance and its members actively support an update the European Pharmacopoeiav by the European Directorate for the Quality of Medicines and Healthcare (EDQM). The EDQM is part of the Council of Europe, an international organisation promoting co-operation between 47 European nations in the areas of law, human rights, and democracy.

The EDQM recently published a request for information on medical devices based on alternatives to DEHP in its magazine Pharmeuropavi, as follows.

“With a view to replacing DEHP (plastic additive 01) or providing alternatives, other plasticisers are being considered in the revision of this chapter; to this end, authorities and manufacturers are requested to submit information on any ‘non-DEHP’ plasticisers, typical amounts used, suitable specifications and analytical procedures for additive testing as well as complete information on relevant authorised medicinal products or certified medical devices”.

The PVC industry welcomes the fact that the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) is currently reviewing the latest scientific evidence on the use of DEHP and other plasticisers in PVC medical devices, with a report expected by March 2013.

New Plasticisers PVCMed is extremely encouraged to see that thanks to its commitment to innovation, continuous improvement of safety, performance and cost efficiency, the value chain has made alternative plasticisers available for almost all

January 1, 2013 Marco Toscano Appointed Chief Operating Officer, Innovative Vinyls, at Kem One December 4, 2012 Baxter Acquires Dialysis Products Maker Gambro for US$4 bn “Baxter has a legacy of innovation in dialysis, including the development of peritoneal dialysis for the treatment of end-stage kidney disease patients in the home. This acquisition further strengthens our global dialysis offerings by extending our portfolio in the hemodialysis segment,” said Robert L Parkinson Jr, chairman and chief executive officer of Baxter.

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January 1, 2013 Bayer Celebrates 150th Birthday

“I see this appointment as really positive both for Kem One and our stakeholders in the biomedical market. It is a strong and clear message that Kem One is strengthening its mission: to develop innovative vinyl solutions with our customers for improving their performances. That means, we will even better meet our biomedical customers’ requirements, by defining in partnership with them a new state of the art.”

January 1, 2013 Netstal UK Relocates to KraussMaffei UK Headquarters in Cheshire

“By amalgamating the operational business units of KraussMaffei and Netstal under one organisational roof we will be strengthening our market presence,” said Mike Bate, managing director of KraussMaffei UK.

“Bayer can look back on a long and highly successful history as an inventor company,” explained CEO Dr Marijn Dekkers. “What started as a small but innovative dyestuffs factory in the Barmen district of Wuppertal is now a global enterprise with more than 110,000 employees. In the past 150 years, Bayer inventions have time and again helped improve people’s quality of life.”

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healthcare applications. Indeed, other plasticisers besides DEHP have been used for years for the large majority of healthcare applications. Alternatives include adipate-based plasticisers, butyryl trihexyl citrate (BTHC), 1,2-cyclohexane dicarboxylic acid diisononyl ester (BASF’s Hexamoll DINCH), di(2-ethylhexyl) terephthalate (Eastman 168 DOTP), polymerics and trimellitic acid, 2ethylhexylester (TOTM). These other plasticisers are said to perform their technological function with PVC just as well as DEHP. Some of them (for example BTHC, Hexamoll DINCH and TOTM) have been shown to be suitable substitutes for DEHP in blood bags as they are capable of stabilising red blood cells and have no effect on the other essential blood properties. [Medical Plastics News has not been given any evidence which confirms that these plasticisers have been used in blood bags which comply with industry standards for shelf life.]

Hexamoll DINCH is used in enteral nutrition for medical tubing systems and in pediatric applications, especially in platelet bags. Migration of Hexamoll DINCH has been shown to be about ten times lower when compared with DEHP. Also, TOTM has been used in medical tubing for enteral nutrition products for a

January 7, 2013 Nexeo is UK and Ireland Distributor of Nakan Medical PVC from Resilia Kem One

“Resilia’s PVC grades reinforce Nexeo Solutions’ product offer for the healthcare market in the UK and Ireland, as we are able to offer high standard PVC grades to our customers in the medical segment,” said Antoni de Pablo, Nexeo’s product line manager for PP in Europe, the Middle East and Asia.

appropriately managed on the basis of the strict procedures and standards set up under the European legislation (EU Directive 2000/76/EC). [Incineration of medical PVC waste is also covered in the Scandinavia report on pages 48-49.]

Innovative recycling solutions: Lately a number of hospitals around the globe have been looking for innovative recycling solutions of non-blood contaminated PVC waste. Many sustainable technologies to recycle PVC have been developed including mechanical recycling, feedstock recycling and energy recovery. Indeed, recent experiences have shown that recycling of medical waste has the potential to be successfully implemented in healthcare settings, therefore, contributing to the smart use of resources and improved costPVC and Waste Management Unlike most PVC applications, the majority efficiency.

When PVC is used as a flooring of PVC medical devices are short-term material, the are opportunities for waste single use products. management and recycling considerations.

Incineration: Traditionally, the only Clean installation waste is collected on the waste management solution for medical jobsite and returned to the factory where plastic waste has been incineration. it can re-enter the production process.

Concerns have been raised about the This avoids construction waste being sent potential emission of waste substances to landfill or incineration. New adhesives from PVC incineration. It is important to (for example spray adhesives) enable point out that the production of waste installed and used flooring material to be substances depends on incineration removed and recycled easily into a new conditions. In modern, well-run flooring material. incinerators, these substances are few years. TOTM is said to have an excellent migration profile, outperforming DEHP with regards to the permanence of the plasticiser.

In December 2012, France adopted a ban on DEHP in medical tubes.

Alternatives such as Hexamoll DINCH and TOTM are available and make the phase-out of DEHP in these applications possible in a safe and responsible way.

PVC medical equipment plasticised with these innovative products keep the key properties of PVC. These include kink resistance, bonding to rigid components without the need for adhesives, ease of sterilisation using various processes, high clarity, flexibility and toughness, hermetic sealing properties and ease of processing.

January 8, 2013 US Clinical Trials Begin for Abbott's Remarkable Resorbable Stent Dean Kereiakes, one of the first clinicians to enrol a patient in the trial, said: “The deliverability of the Absorb device is impressive and similar to a best-in-class drug eluting stent. Absorb combines the unique attributes of a dissolvable material with the established Multi-Link stent design, making the scaffold flexible and conformable to the vessel.”

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January 10, 2013 Solvay Makes Solviva Biomaterials Available in China “With our broad product portfolio we are firmly positioned as a strategic supplier to the Chinese healthcare industry and this expansion in biomaterials signals our further commitment to national and multinational OEMs,” said Shawn Shorrock, global market manager for healthcare.

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In order to encourage the development of initiatives in the field of innovative management of non-blood contaminated PVC waste, PVCMed is following several projects in this area. In Australia, for example, a recycling project that has been running for three years has shown promising results so far. It is estimated that 30% of hospital waste at the Western Hospital in Australia is recyclable plastics, of which 30% is made of PVC vii. Similar initiatives are currently running in Sweden and South Africa.

The project in Sweden is being run by Stockholm City Council. The council have collected hospital plastic waste from seven Swedish hospitals. A report on the first steps of the project is expected by spring 2013.

The project in South Africa is a pilot study. A private company has launched a recycling programme at the Kloof MediClinic. The healthcare company Adcock Ingram is in the process of developing a “take-back scheme” for all non-hazardous medical waste that they supply to hospitals (for example IV bags and oxygen masks).

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In the future, PVCMed intends to support and promote recycling initiatives such as those listed above. The fact that PVC is one of the many plastic materials that are particularly well suited for recycling makes these projects even more appealingviii.

To prove a point, PVCMed called upon a recognised LCA-scientist from the University of Manchester in the UK to carry out a critical reviewix of the PVCFreeBloodBag LCA. PVCMed says that the result of this review is alarming as it appears that the goal of this LCA study Unjustified Criticism on PVC is motivated by a desire to phase out PVC Healthcare Applications blood bags regardless of sound science Despite the fact that the use of PVC in and the actual LCA results. The authors healthcare applications has significantly themselves state that “As quantitative contributed to the high level of patient reference to the PVC/DEHP blood bag, a treatment and safety that benefits fictional blood bag made from the everyone, the use of PVC is often material high density polyethylene (HDPE) criticised in the media by unfounded is used.” claims that PVCMed say are lacking For more information about the scientific justification.

PVCFreeBloodBag project see Medical Last year, the PVC industry challenged Plastics News, September-October 2012, page 11. a claim made by an EU-funded project called PVCFreeBloodBag about the life Hexamol DINCH is a registered trademark cycle analysis (LCA) of PVC blood bags. of German chemical company BASF. The project issued a press release based Eastman 168 is a registered trademark of on the analysis stating that “PVC blood bags pose a significant risk to both health US chemical company Eastman. References and environment”. Representatives of the are available from the editor at sam.a@rapidnews.com.

PVC industry said this claim was wrong.

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MATERIAL DIAGNOSIS

Material Diagnosis | Elastomerics

Elastomerics Roundup WORDS | SAM ANSON

Flexible plastics, or elastomers, are << Tensile analysis of films made versatile and necessary for a broad from Poly-Med range of applications. A huge Inc’s variety of polymer chemistries are bioresorbable elastic polymer involved in achieving elastomeric Strataprene properties. This report provides a SVG12 indicate roundup of technologies and that its modulus value is softer industry news categorised under than common the following groups: absorbable surgical films and elastomers, valves, PVC, silicones, closer to that of TPEs and TPUs. human tissue. >> Absorbable Elastic Polymers Strataprene SVG12, produced and marketed by US-based custom polymer manufacturer Poly-Med Inc, is a high molecular weight polymer prepared from a number of FDA-recognised monomers and is already used in compliant medical devices on the market. The polymer is designed to be both tough and elastic while being fully resorbable. It can be processed into a variety of constructs such as films, fibres, and coatings. Once in these forms, the elastic nature of the polymer allows for novel uses of resorbable materials. The polymer can be useful for

indications associated with elastic materials—such as barrier or fixation materials—or areas associated with resorbable materials, like drug delivery or limited-term strength retention.

Poly-Med Inc says that Strataprene SVG12 is commonly prepared into a film. In this form the material is fully transparent, nearly amorphous, and free from defects.

Additionally, the films are highly compliant and elastic. Thus, they easily assume the shape of surfaces to which they are applied. Tensile analysis of such films indicates that the modulus values approach 8.5 Mpa (85 bar or 1,233 psi), which is far

softer than most surgical films on the market and is closer to that of human tissue.

Traditional bioresorbable materials are said to be stiff and lack a significant ability to plastically deform—these samples fail by crack propagation soon after the onset of failure. Strataprene SVG12, on the other hand, is said to demonstrate a high degree of extension prior to rupture. Films exhibit a yield strain of up to 41.5% and an ultimate strain of 1,000% while resisting fatigue in the elastic region. Thus, in this form highly compliant Strataprene SVG12 films show significant promise as flexible barrier films in a dynamic in vivo environment.

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MATERIAL DIAGNOSIS

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Valves Vial Component Enables Airtight Seal for Needle-Free Syringes: Italybased device manufacturer Haemopharm Healthcare has developed an airtight rubber seal for glass vials and needle-free syringes called NIV. The device is particularly useful for formulations which require reconstitution, mixing or transfer before administration to the patient.

In traditional vial seals, the rubber top protects the contents from outside contamination. Needles pierce the rubber stopper easily, allowing access to the medication. When medication is drawn from a rubber-topped vial, users must follow time-consuming procedures to prevent contamination and avoid backflow and dangerous aerosol release from the vial.

With NIV, when a syringe is removed the seal automatically closes and creates an airtight seal on top of the vial. This device is designed to replace both standard vials used with normal needlebased syringes, as well as needle-free vial connectors or adaptors which require additional components for drug reconstitution. The latter are generally very expensive.

NIV won a Best Innovation prize at the recent CPhI pharmaceutical trade show in Madrid. << Haemopharm’s NIV synthetic rubber vial component maintains seal integrity with needle-free syringes. >>

build with what managing director Peter Nijland describes as a “surprising performance”.

He says: “The design of the physical properties of the elastomer material such as hardness, modulus, elongation and resilience are carefully balanced against constructive design elements to achieve optimal valve performance.”

Interestingly, Minivalve makes use of the elastic properties to create undercuts in parts that are impossible to make in plastic, while still allowing the components to release from the high cavitation moulds.

PVC Evonik Invests in Phthalate-Free Plasticiser Production: German chemical company Evonik has announced that it will invest a sum in the region of “double digit millions of Euros” at its facilities at the Marl Chemical Park in Germany to produce a new range of phthalate-free and biobased PVC plasticisers.

Production of the plasticiser—1,2cyclohexane dicarboxylic acid diisononyl ester—will begin in the second half of 2013. An annual 40,000 tons will be produced in Marl. Evonik began building the production facilities at the Marl Chemical Park this summer.

Evonik says that consistent research will successively add additional innovative products to the new generation of plasticisers. These plans include the launch of bio-based plasticisers.

Nexeo to Distribute Resilia Kem One’s Nakan Medical PVC in UK and Ireland: Nexeo Solutions, a global plastics distributor with 2,300 employees, is the new UK and Ireland distributor of Resilia’s Nakan range of healthcare PVC compounds.

Resilia, part of the recently formed Kem One vinyls group, is a leading European producer of PVC compounds. Its Nakan medical products comply with European Pharmacopoeia and USP testing. The Nakan medical range includes a variety of compounds, including ones for resilient extrusion for peristaltic pump applications, ETO and gamma resistant types for blow moulding, as well as phthalate-free and selffrosted effect compounds.

Speaking about valves, Netherlandsbased specialist valve moulder Minivalve International utilises the versatile properties of elastomeric materials for their miniature valve components. The company’s products can be as small as a 1.5 mm diameter one-way valve.

Their valves are designed to replace complex multi-component one-way and relief valve systems. << Nexeo will distribute Resilia Kem Minivalve’s product line is made of One’s Nakan PVC for a variety of medical monolithic elastomeric material, allowing applications, including this drip chamber for a much more compact, lower cost for infusion and transfusion sets. >>

Kem One have named former Resilia general manager Marco Toscano as chief operating officer for the Innovative Vinyls division and a member of Kem One's executive committee (see also page 6).

USA-based sustainable healthcare members association Practise Green Health has launched a DEHP-Free Award. The award will be given to a hospital or system that demonstrates the most success with replacing DEHPcontaining medical devices with alternatives, particularly where there are vulnerable patient populations.

USA-headquartered Teknor Apex has developed a DEHP-free PVC film, according to a recent report on medtech supplier website Qmed.

The plasticiser used is a citrate. Rob Fisher, director of sales in Teknor Apex’s vinyl division, explains: “Citrate plasticisers provide similar benefits to phthalates for device manufacturers with respect to both the performance of the device as well as the manufacture and assembly of the device.”

Talking of new films, Vancive Medical Technologies, formerly Avery Dennison Medical Solutions, has developed a polyolefin film for ostomy bags, InteliShield Barrier Film, which it is marketing as DEHP- and PVC-free.

The film structure has two odour blocking technologies. In addition to a traditional passive oxygen barrier layer that blocks odouriferous molecules based upon their size, InteliShield also incorporates an organic chemical in barrier layers that traps larger molecules due to their shape and size.

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MATERIAL DIAGNOSIS

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Silicones Silicone Moulding Vulcanises Fakuma: In November, a number of injection moulding machine manufacturers demonstrated their companies’ prowess in silicone moulding machinery at Fakuma—Germany’s second largest plastics trade show.

Germany’s Arburg unveiled its twin screw Injester module for the processing of solid silicone (HTV—high temperature vulcanisation) and other high viscosity materials.

A key aspect of the machine is its pair of counter-rotating, servo-electrically driven screws (see bottom left image).

These work together to ensure gentle material feed at a constant pressure resulting in, according to Arburg, a high level of process reliability and part quality.

The screws convey the HTV compound continuously and without bubbles via the pressure-regulated material feed of the injection unit.

Arburg state that refilling is possible with ease during the running process. The twin-screw Injester is also said to be quick and easy to clean. This advantage is particularly useful in the case of singlecomponent silicone, where frequent material changes are often necessary.

The Injester is compatible as a module on Arburg’s Allrounder injection moulding machine.

<< The twin-screw Injester from Arburg for high temperature vulcanisation (HTV) silicone moulding operates with two servo-electrically driven screws. >>

Austria’s Engel demonstrated UV vulcanisation of silicone at Fakuma.

UV vulcanisation enables silicones to be combined with a wide range of temperature sensitive thermoplastics via twin shot and overmoulding, including polypropylene (PP).

A key aspect of UV vulcanised silicone moulding is in the mould itself. Here, UV light is produced by UV lamps which have been integrated in the mould. The light is transmitted into the cavities where the silicone parts form via plastic inserts. Engel’s partner Elmet in Austria supplies the UV lamps and inserts. UV vulcanisation can also facilitate reductions in cycle times.

In the field of traditional liquid silicone rubber (LSR) moulding, Engel’s head of medical, Christoph Lhota, has co-authored a technical report on medical applications of moulded LSR. In the report, Christoph highlights interesting applications for the material through case studies.

The case studies include dialysis filter sealing rings manufactured by Fresnius Medical Care in Germany; needle-free connectors from device makers ICU Medical and Becton Dickinson in the USA, and B Braun in Germany; CPAP (continuous positive airway pressure) respiratory masks produced by Norway’s Laerdal (see image middle-right); a hormone releasing vaginal ring from Germany’s MDS; silicone-based tear duct implants for precise medication dosage; implantable Neuflex prosthetic joints from USA-headquartered DePuy (top right); and Ahmed implantable glaucoma valves from USA-based New World Medical. For a copy of the report please contact the editor at sam.a@rapidnews.com.

<< Silicone devices like this prosthetic implant (top) and CPAP mask (middle and bottom) are included in a technical report written by Engel’s head of medical Christoph Lhota. >>

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MATERIAL DIAGNOSIS

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Germany’s Ferromatik Milacron, a subsidiary of USA-based plastics machinery manufacturer Milacron, used an Elektron 50 moulding machine with a clamping force of 500 kN to produce transparent baby pacifiers at Fakuma in a single shot, made entirely of silicone. The shot weight was 20 g. In contrast to conventional two-component pacifiers (ABS and LSR) all-silicone pacifiers are manufactured as a single part, reducing production costs.

On the subject of moulding, dry ice cleaning is recommended by USA-headquartered dry ice specialists Cold Jet, particularly when manufacturing LSR parts with thin wall sections and multiple undercuts.

According to Cold Jet, it is critical to keep the mould vents clean for proper mould venting. LSR’s low viscosity results in very high injection speeds which tend to cause dieseling or scorching at the end of fill.

This low viscosity also causes LSR to flash more readily than thermoplastics. Traditional vents for thermoplastics are small, but they are even smaller for LSR resins—making them difficult to clean properly and quickly with traditional cleaning methods. However, small, shaved dry ice particles enable an easy vent clean, reducing the chances of gas trapping in the mould.

Cold Jet recommends its SDI Select 60 dry ice system for cleaning tight tolerance silicone moulds.

Silicone Compounding News: In November 2012, USA-headquartered specialist silicone compounder NuSil completed the fourth phase of expansion at its facility in Bakersfield, California. The newest building is NuSil’s fourth on a 15acre campus. It covers 35,000 sq ft (3,252 sq m) of land and is part of a multi-year plan to expand to a total of seven buildings.

NuSil also recently broke ground on the fifth phase of the expansion, with two new buildings and an additional 80,000 sq ft of manufacturing space scheduled to be completed in 2013 and 2015.

NuSil is a specialist compounder of silicones with active pharmaceutical ingredients (APIs). In particular, it is an expert in the modification of silicone chemistry and its influence on release rates of active pharmaceutical ingredients (APIs).

This expertise is evidenced in a case study published by NuSil. The company fabricated the antibiotics rifampin and minocycline into a formulation which was then moulded into a component that maintained mechanical strength according to some fairly challenging elution parameters. Both drugs needed to be completely released after 14 days with elution profiles (the rate of elution over time) which were approximately the same.

In a process which comprised multiple phases of formulation, encompassing over 100 elution studies, a highly advanced compound was eventually developed

<< LSR mould vent before and after cleaning. >> 14/ MPN / JANUARY-FEBRUARY 2013

which met these criteria. The project was described by NuSil in an interview with Medical Plastics News as being one of the top healthcare research activities over the past two years.

Some of the compounding challenges overcome by NuSil were as follows. The polymer backbone was carefully selected to allow drugs to freely travel within the compound. It was realised after the first attempt that a fluoro-silicone backbone blocks pathways and makes it difficult for the drugs to pass. Optimised levels of reinforcing filler and crosslink density further enhanced permeability.

Lower temperature curing was achieved using a competitive inhibitor instead of a fugitive inhibitor.

And an optimised mix of pharmaceutical grade excipients was added to facilitate improved elution after other excipients were ruled out because they resulted in a tackier raw material that diminished processability.

Overall, in addition to developing a highly effective antibiotic eluting mouldable silicone compound, NuSil concluded that silicone chemistry lends itself very well to optimisation and that modification of the formulation influences the release of actives while maintaining processability. For more details of the case study please contact the editor at sam.a@rapidnews.com.

In other news from NuSil, the company has launched a new range of heat-cure coloured inks, MED-6613-X. The newly released colours—red, white, green, bright blue and dark blue—are suitable for devices intended for implantation for more than 30 days. NuSil says the inks vastly expand the company’s existing colour palette and provide more vibrant, creative marking options.

On the subject of silicone compounding, US-headquartered SaintGobain Performance Plastics are promoting the advantages of working with a custom compounder when developing a new device design.

According to the company’s marketing manager, Aaron Updegrove, working with a knowledgeable supplier from the design stage can help manufacturers identify the material best suited for specific applications, and create a formulation tailored to optimise end product performance.

Continued on page 16

MATERIAL DIAGNOSIS

Sponsored By:

Continued from page 14

Another medical grade silicone manufacturer, Bluestar Silicones with headquarters in France, presented a new range of biocompatible silicone skin adhesives, Silbione HC2, to be used on breached skins and open wounds at the Compamed trade show in November.

According to Bluestar Silicones, both are tacky gels with excellent balance between skin adhesion and atraumatic removal.

In June 2012, Bluestar Silicones was awarded the Frost and Sullivan 2012 Product Differentiation Excellence Award

in Healthcare Applications for its silicone foam technology, Silbione RT foams.

Silbione RT foams are liquid materials with lightweight, breathable, flexible and weather resistant properties to weathering.

US silicone manufacturer Dow Corning has written about the importance of China’s healthcare sector as a key growth area, referring to some impressive trade statistics. The Chinese medical device market grew by 27% to US$22 bn in 2011. Chinese exports grew

by 20% to reach US$8 bn in 2010. The full report is available on www.mpnmagazine.com.

Silicone Moulders: France-based Top Clean Packaging has mastered twinshot LSR moulding.

The “bi-injection” of two densities of LSR has been done in a single step process. The technology, said to be the first in the world, has been developed by the Italian branch of Top Clean Packaging.

Being a thermosetting compound, LSR is difficult to be overmoulded in a twostep process, as it requires a coreticulation and not a fusion process for bonding. However, in a rotary mould it is possible to combine on the same machine two different hardnesses of silicone, or two grades with different properties, allowing production of parts with a structural frame of harder material, as for example 60/70 shore A, with a softer, more comfortable and flexible grade, maybe 30 shore A.

<< Top Clean has mastered the ability to mould two shots of variable hardness silicones. >> Top Clean says this technology can be used to produce respiratory face masks for applications like oxygen therapy, with a hard frame and soft skin-contact part, in a single step. Similarly, the technology can be used to combine standard silicone grades with semiconductive grades to make valves with a self-diagnostic feature.

Top Clean are also able to overmould silicone over thermoplastic, for example, a PBT, using a rotary twin-shot mould. The mould comprises: a hot runner system which allows injection of plastic without requiring removal of the hot runner; and a cold runner system to overmould a “microinjection” of silicone rubber.

16/ MPN / JANUARY-FEBRUARY 2013

polymer department to help aid in TPEs academic projects carried out by final year Polyisobutylene-based Drug Eluting and masters students. At the same time, the TPEs for Breast Reconstruction and university’s polymer department provided Cancer Treatment: According to a recent the expertise and facilities including report on US science news website LiveScience.com, published with support support in the form of MoldFlow from the USA’s National Science Foundation, simulation software to the KTP project. a team of researchers from the University of As a result of the project, Surgical Akron in Ohio have developed a new type Innovations say they have found new areas of material that can be used as the shell of a of usage for TPEs, giving potential savings breast implant. Diagnostic agents that help in manufacturing of up to £40,000 a year. reveal the presence of cancer cells, as well as They also state that there is scope for cancer-fighting drugs and painkillers, can be more research into TPEs and PEEK. embedded into the shell and released into US polymer compounder and the body. distributor PolyOne is promoting the use “We are trying to integrate breast of TPEs for ergonomic enhancement in reconstruction with cancer treatment,” said medical device design. Ergonomic Judit E Puskas, University of Akron considerations, also called human factors, professor of chemical and biomolecular are of importance anywhere on a device engineering, who is leading the project. where a human operator makes contact, The TPE is polyisobutylene-based, for example handles, knobs, buttons and which means it is similar to butyl rubber, or orthotic pads. synthetic rubber. It exhibits advantages Traditionally, TPEs have been used in over silicone, the current material used in order to provide grip. But recently, breast reconstruction, in that it is lighter according to PolyOne, they are being and stronger. Compared to other rubbers, used to protect device operators from the TPE is especially impermeable, injury when using equipment which preventing liquids from seeping through— requires forceful exertions, repetitive essential for prevention of gel leakage in an motions, contact stresses and vibration. implant.

On November 30, 2012, technical research engineer Giles Meakin from UKbased minimally invasive surgical device manufacturer Surgical Innovations plc presented a summary of joint research work conducted on tri-block copolymer TPEs at the University of Bradford, also in the UK. Previously Giles was an associate belonging to a Knowledge Transfer Partnership (KTP) between the University << This non-invasive neuromodulation of Bradford and Surgical Innovations. pain therapy device from US-based Working closely with the university’s device manufacturer Biowave includes polymer research centre—Polymer IRC— a protective bumper moulded from a the goal was to develop TPE compounds custom-formulated elastomeric with specific properties related to material made by PolyOne GLS. >> elasticity and recovery rates, gas permeability, sterilisation resistance and Larry Johnson, global healthcare chemical and lipid resistance. marketing director at PolyOne told Medical Plastics News: “Hospitals are The specific material was also required intense and demanding environments. to meet specific biocompatibility and Ergonomic considerations give more extractable and leachable requirements benefits than just good grip. They can for ISO10993 and United States help to prevent problems like arthritis and Pharmacopaeia (USP) regulations carpal tunnel syndrome.” respectively.

Thanks to the fact that TPEs are soft to Advantages gained via the partnership the touch and adhere very well to a included Surgical Innovations lending extinct mould tools to the university’s Continued on page 18 JANUARY-FEBRUARY 2013 / MPN /17

MATERIAL DIAGNOSIS Continued from page 17

number of rigid plastics like PC/ABS, they are used extensively in hand-held devices.

In 2011 the FDA released a draft guidance document called Applying Human Factors and Usability Engineering to Optimize Medical Device Design. The guidelines, spanning 37 pages, aim to improve the safety and effectiveness of medical devices. They recommend a number of tests which can be performed to demonstrate ergonomic safety. It also identifies examples of medical devices which have already been optimised ergonomically for improved usability.

While the guidance is currently nonbinding for manufacturers in the US market, there are reports that some manufacturers are anticipating a future form of mandatory regulation regarding human factors in medical device design to protect the safety of users.

Two series of biocompatible TPEs— 6042 MD and 6003 MD—have been added to US-headquartered compounder RTP Company’s range of healthcare compounds. The compounds have been pre-tested for compliance with the three most common parts of ISO10993: part 5, in vitro cytotoxicity; part 10, irritation; and part 11, systemic toxicity. These tests are the first data points that help to establish a pattern of concern for safety to the FDA and EU industry regulators and provide confidence that the finished, moulded and assembled device will also pass biocompatibility testing. RTP can provide a statement of biocompatibility to customers.

Naturally opaque, the new TPE compounds are also fully colourable with RTP’s biocompatible colour products, which are also pre‐tested to ISO10993 compliance in precoloured resins and colour masterbatches. Additionally, these products are designated as change controlled formulae to ensure there is no modification to ingredients without customer authorisation.

The 6042 MD series of compounds have a shore A hardness range from 40 to 70 while the 6003 MD series have a range from 45 to 75. These products are formulated to bond with ABS, PC, PC alloys, PBT, rigid TPU, or co‐polyester substrates using either multi‐shot or insert moulding processes.

In a report submitted to Medical Plastics News, Elliott Pritikin, senior medical market manager at USA-headquartered 18/ MPN / JANUARY-FEBRUARY 2013

elastomerics compounder Teknor Apex has written about why Medalist TPEs are an alternative option to “soft” flexible plastics like plasticised PVC, soft TPU and a range of rubbers.

Recognising industry concerns about traditional alternatives to PVC, such as inferior mechanical performance and overall “feel”, Pritkin says that Teknor Apex has taken a system approach to developing its Medalist brand of TPEs. Great emphasis has been placed on meeting “real-world” requirements that are not typically considered in a product data sheet.

The full report is available at www.mpnmagazine.com or by contacting the editor at sam.a@rapidnews.com.

Netherlands-based IMCD Group has announced that it has entered a new distribution partnership with Turkish compounder Elastron Kimya for their medical range of TPE-S and TPE-V compounds. The agreement is valid for all European countries and India. IMCD also distributes medical PVC compounds from US compounder Teknor Apex and medical TPUs from Taiwan’s Greco.

TPUs In October 2012, Netherlandsheadquartered high performance polymer manufacturer DSM revised and extended its existing licensing and supply agreement with AxioMed Spine Corporation, a US innovator in the field of implant devices used in spinal fusion and total disc replacement (TDR) procedures.

Under the agreement, DSM is supplying its proprietary CarboSil thermoplastic silicone-polycarbonateurethane (TSPCU) copolymer for use in AxioMed’s soft implantable spinal discs.

DSM’s CarboSil TSPCU copolymer combines the flexibility and softness of a conventional silicone elastomer with the processability and strength of a thermoplastic polycarbonate-urethane.

AxioMed received CE Mark approvals in May 2012 for its Freedom Lumbar Disc and Freedom Cervical Disc brands of spinal implants in Europe. The Freedom Lumbar Disc device is the first elastomeric disc to

<< The middle layer of this implantable spinal disc is made from DSM’s CarboSil silicone-polycarbonate urethane, an advanced TPU copolymer with the softness of silicone combined with the durability and toughness of polycarbonate. >> receive an Investigational Device Exemption (IDE) from the US FDA. An IDE is a regulatory submission to the FDA that permits clinical investigations for medical devices. Devices covered by an IDE are exempt from legal restrictions related to shipping, making the device available on the market for investigational purposes only.

US chemical company and manufacturer of TPUs Lubrizol has launched an aromatic Carbothane TPU and has broadened its line of Tecothane soft polymers.

As an extension of Lubrizol’s Carbothane line of polycarbonate-based TPUs, new aromatic Carbothane is available in a range of grades and radiopacities.

Lubrizol says that unlike current technologies, aromatic Carbothane TPU features stronger material, improved chemical resistance and increased resistance to creep. These new products are suitable for some long-term implant applications, including catheters and devices introduced in the body for durations of more than 30 days, and for permanent implants used in spinal and orthopaedic applications.

The new aromatic Carbothane TPU from Lubrizol is available in four clear grades and four radiopaque grades. The latter include a 20% loading of barium sulfate. All grades of aromatic Carbothane carry all the necessary regulatory credentials.

Lubrizol has also broadened its line of Tecothane soft polymers designed specifically for healthcare and medical applications to include a wider range of material hardnesses.

JANUARY-FEBRUARY 2013 / MPN /19

Medtec Preview | Contract Manufacturing

Worldwide Contract Design and Manufacturing — How Global Standards and Local Engineering Inspire Efficiency and Flexibility for OEMs Global medtech and pharma OEMs face many challenges in developing products in today’s environment, where cost and speed-tomarket must be managed without impacting quality or patient safety. The focus on reduced healthcare costs and improved patient outcomes is a global imperative, and requires that innovation and technology are applied in a challenging regulatory and competitive landscape. The OEM that can best execute during product development and industrialisation finds itself at a competitive advantage. In order to minimise risk, many OEMs select partners that offer the most attractive combination of development services, and manufacturing location flexibility.

Today, the strongest contract manufacturing organisations (CMOs) offer unparalleled development capabilities and flexibility of manufacturing geography. A few select CMOs have turnkey or near-turnkey product development capabilities with limited OEM oversight, and have expanded capabilities to conceptualise and design complex systems, as well as conduct both component-level design for manufacturing (DFM) and system-level design for assembly (DFA). Medical device companies are primarily interested in getting their ideas transformed into a functional product to handle all the industrycritical factors in the shortest possible time.

Industrial design encompasses the way the device is handled by the user, involving human factor engineering (see page 17 for more on human factors). Typically, several design options are put forward to establish one ideal solution to find a homogenous, clearly identifiable product language which

Global medical device, pharmaceutical, and diagnostic original equipment manufacturers (OEMs) are working with a select group of outsourcing partners which have the ability to provide multiple options not only for manufacturing location, but also for product development services. The following article

by Bill Welch, CTO PhillipsMedisize, explains why global standards, local engineering services, and flexibility of manufacturing location are key benefits when considering a global approach to contract design and manufacturing of a medical device.

20/ MPN / JANUARY-FEBRUARY 2013

comprehensively connects criteria like ergonomics, functionality, aesthetics and emotion on all levels, as well as technology and immediate usability.

Product engineering strengthens the technical, implementation-oriented component of product design. Being familiar with the various disciplines and process cycles, design engineers add their input to achieve maximum quality standards.

They do this by using the latest technologies in establishing and recording data, including protocol development and statistics and enhancing the wide field of CAD/CAM design and implementation. A range of data, such as those relating to product quality, clinical functionality, manufacturability and field use, must play a key role in the product development process.

The data provides critical inputs that give designers visibility into variables if information resides in isolated quality or study management systems. All instrumentation systems need to be fully validated, integrated and traceable, including batch control.

Design assurance—which includes risk management, validation and adherence to all rules and regulations in the industry—guarantees that the design works and that it is manufacturable, repeatably and reliably. For example, device development teams should conduct design of experiments to determine critical process parameters and establish process set points and control limits. The team should exercise the manufacturing process by producing parts made at the extremes of the process settings to ensure acceptance of criteria. Should the product fail to meet specification, preventative actions should be taken to modify either the product or the process until acceptable results are obtained.

Testing and analysis encompasses the entire spectrum of pre-production. In tooling, for instance, from a design engineering aspect the methodology and the metrology must be in place. The testing capability must match what the design engineers put on a drawing. This might involve measurability of minute fractions of a millimetre, tensile tests (materials science) for breakability and other physical properties as well as tests across chemical, microbiological, mechanical, electrical, electronic spheres, both product or process related.

In terms of risk management, there are routine and specific tests, sometimes even involving the use of high speed vision cameras, essential in a design context.

A primary consideration is: what would happen if the product goes wrong, what is the impact and how can the problem be addressed? Ideally, you need to know how to measure, what to measure it with, and how to design out the need for testing it.

Once this is accomplished, you have the required information.

COVER STORY The design is modified to remove the need for further tests as screens and filters—the process thus enters a fully capable state.

At that point the testing process has finished and the process is now efficient and workable.

A second key component of an integrated engineering organisation is consistent programme management. Successful device development requires programme managers who understand the product development process as well as critical manufacturing principles. The programme manager serves as the single point of contact for the customer from the earliest involvement point until launch, and the role takes on greater importance when a programme involves multiple developmental disciplines prior to kicking off tooling and automation for industrialisation, with durations as long as 5 years from concept to launch.

<< The relationship between the programme manager, multi-disciplinary teams, and the development process. >>

<< This illustration shows how integrating manufacturing evaluations within the development cycle, results in a model with an optimised time to market and lower overall cost by eliminating the additional development curve that often occurs. >> Flexibility in Manufacturing Location As the need for enhanced development service offerings evolves, so does the need for greater flexibility in manufacturing location. An OEM has many factors to consider when choosing a final manufacturing source. A clear understanding is important as regards information about things like the product’s end market and associated shipping costs and the location of the product’s

sterilisation and drug filling operations. This will ensure they can maintain a compact and low risk supply chain, good availability of materials, and a pool of the talented people required to manufacture the product. An understanding of the product’s maturity outlook and life cycle management is another important factor.

In addition to the evolution of development services and manufacturing flexibility required from CMO partners, the OEMs themselves have moved towards a more global approach. It is no longer uncommon for an OEM product development team to be located across the globe, or for manufacturing to be targeted for a location that is not in the same region or even the same continent as the product development team. This trend, too, has required the leading CMOs to position themselves globally to serve their global customers.

Ten characteristics create a successful global partner: 1. Flexibility to meet an OEM’s geographical needs for both product development services and manufacturing location.

2. Development and manufacturing expertise in the OEM’s market segment and product type.

3. A dedicated development and prototyping function, rather than shared resources within a production organisation.

4. A well-defined, multi-disciplinary product development organisation, featuring expertise relevant to the OEM’s product type.

5. Demonstrated ability to leverage product development capabilities and expertise from other product development locations within the CMO, or from outside niche partners.

6. A quality system matched with the OEM’s programme needs, including design controls, if required.

7. Understanding of local service and regulatory needs, and global quality and manufacturing standards.

8. The infrastructure to support OEM development needs, including test labs, cleanrooms and equipment for prototype or clinical builds, and a product development process focused on healthcare products.

9. A programme management function to serve as a single point of contact and to guide the OEM through the product development phases, from concept development to industrialisation.

10. Strong integration with the intended manufacturing location to match design, process, and manufacturing capabilities, starting at concept development.

Bill Welch is the CTO of Phillips-Medisize, a global outsource provider of design and manufacturing services to the medical device, diagnostics, drug delivery, pharmaceutical and commercial markets with dedicated, full-service design centres in the USA, and the Netherlands. The latter was opened in April 2012.

Phillips-Medisize will be at Medtec Europe, Stuttgart, on February 26-28, 2012, in hall 1, stand M26.

JANUARY-FEBRUARY 2013 / MPN /21

MEDTEC PREVIEW

2013 MATERIALS Clay Reinforcements Add Torque to Thin Wall Catheters and Improve Burst Strength in Balloons Clay reinforcements are being investigated by the medical device industry as a means to improve the performance of device components. Specialist US medical compounder Foster Corporation remains at the forefront of polymer, additive and processing technology, with reinforced polymers for a variety of applications, including extruded thin wall catheters for diagnostics and stent delivery, as well as other minimally invasive devices.

Polyamide-based polymers, including nylon 12 and polyether-block amide—for example Arkema’s Pebax and Evonik’s Vestamid brands—are popular material choices for catheters used in diagnostic and interventional cardiology.

The use of reinforced polyamide blends has been shown to yield significant improvements in the mechanical properties of the device, including an increase in flexural modulus, with only a moderate reduction in tensile elongation. Improvements can also be seen in increased burst strength for stent delivery balloons. In catheter shafts, the use of these materials can also improve torque transmission, which translates to an accurate navigation of the catheter through the vascular system.

Clay-reinforced polymers incorporate particles which have at least one dimension that is less than 100 nm, with aspect

ratios in the 300:1 to 1,500:1 range. These particles interact at the molecular level to immobilise portions of the polymer chain, creating a reinforcing or stiffening effect that is unmatched by other strengthening agents. Utilising clay particle reinforcement can deliver rigid thermoplastic or elastomeric composites with unique performance properties.

While reinforcement additives can improve mechanical strength, manufacturing this technology can pose several challenges, due to the inherent nature of the clay. In order to prevent agglomeration (or clumping) of the particles, the compound must be specially formulated and processed to promote exfoliation. This process will allow the polymer chains to fully encapsulate the clay particles to create an intimate bond within the polymer matrix. Failure to produce a sufficient bond can lead to erratic processability and reduced compound performance.

Foster Corporation has developed advanced twinscrew compounding technology, as well as formulation expertise, proven to yield maximum dispersion of the polymer-particle blend, while avoiding host polymer degradation. Foster’s reinforced compounds are said to be able to be designed to achieve strict regulatory compliance, while delivering unique properties that can revolutionise the performance of complex medical devices.

Foster Corporation: 3/A10 www.fostercomp.com

Cikautxo Produces Watertight Earplugs Spanish silicone materials manufacturer Cikautxo has begun automated cleanroom production of a silicone earplug designed to prevent ear infections and exostosis. The earplug has been developed specifically for the protection of watersports participants. The earplugs are different to existing earplugs in the fact that they have a waterproof and breathable membrane that stops the water and dust coming into the ear while allowing sound to pass through so the user can still hear.

Cikautxo says that the silicone used is totally watertight, biocompatible, brightly coloured and has a nice feel and attractive shape. In addition, the product has an ergonomic design for user comfort.

Larger sizes of the product with new shapes and colours are anticipated.

Cikautxo: 1/L75 www.cikautxo.es

VitroStealth Coating Enhances Capillary Flow in POC Diagnostic In June 2012 it was announced that an advanced coating from Dutch high performance polymer manufacturer DSM, VitroStealth—a non-biofouling coating for plastics surfaces—was used in Afinion, a new point-ofcare (POC) diagnostic system from Scottish diagnostic manufacturer Axis-Shield. Afinion is able to provide diagnostic results within a matter of minutes.

According to DSM, the value of VitroStealth is in its ability to make plastic capillary surfaces hydrophilic. Its wetting properties, which allow the capillaries to fill completely and prevent analytes from collecting on the plastic walls, help to ensure the accuracy of

the Afinion’s results.

“VitroStealth coating is a safe, superior material that meets our need for robust performance,” said Arve Strømsheim, project manager R&D, Axis-Shield. “We anticipate VitroStealth coating to be a candidate to support additional diagnostic analyses.”

“In a recent study, VitroStealth coating was shown to provide a significant advantage in improving the performance of biosensors.

The Afinion is the first product to make use of this technology,” said John Marugg, business manager of DSM Biomedical’s Coatings division. “We expect that Axis-Shield’s Afinion is the first of many medical products to incorporate the VitroStealth coating technology.”

DSM: 1/M45 www.dsm.com/medical Biesterfeld Acquires Küttner The shareholders of German polymer distributor Küttner have sold all shares of the company to Biesterfeld, based in Hamburg, Germany, with immediate effect.

Biesterfeld is a large distributor of polymers, chemicals and pharmaceutical raw materials.

The transaction is still subject to regulatory approval.

Küttner’s Russian subsidiary, OOO Küttner, will become part of the Biesterfeld group as well.

The trade names and the headquarters of Küttner and its subsidiary will remain unchanged. From Küttner’s point of view, synergetic effects and supplements to the portfolio for the rubber industry are expected, which will especially benefit Küttner’s customers.

The sales force and application engineering and consulting services will remain unchanged.

Biesterfeld: 1/J70 www.biesterfeld-plastic.com Continued on page 24

JANUARY-FEBRUARY 2013 / MPN /23

Medtec Preview | Injection Moulding Continued from page 23

MOULDING Arburg Demonstrates Lab-on-a-Chip Moulding at Medtec

German injection moulding manufacturer Arburg will be producing a component from a lab-on-a-chip diagnostic device on a 600-ton electric Allrounder 370 A with size 70 injection unit at Medtec. The machine will be fitted with a two-cavity mould from specialist Austrian lab-ona-chip and microfluidics mould maker z-microsystems.

The stainless steel in the exhibit is GMP-compliant and is equipped with a clean air module, making it ideal for use in the medical technology sector. Cleanroom elements from Ionstatex in Germany indicate the systemâ&#x20AC;&#x2122;s suitability

24/ MPN / JANUARY-FEBRUARY 2013

for production under cleanroom conditions.

The component being produced will be the bottom layer of a lab-on-a-chip device.

Following moulding, assembly of the device involves the addition of a top layer containing its own microchip for transporting liquids and displaying results.

The bottom layer involves microstructures, so the highest mould and machine precision is of crucial importance. For this reason, Arburg prefers to use electric or hybrid machine technology in this area, completely satisfying the demands for evenness of the parts and reproducibility of production. In the case of the bottom layer presented at the Medtec, the part weight is 3.264 g with a shot weight of 7.98 g and a cycle time of 24 seconds.

As the dimensions of the lab-on-a-chip analysis units

become smaller, it is generally predicted that microfluidics will play a major role in future medical technology. One of the possible areas of application in the medium term may be in the delivery of continuous analysis results, for example from patients with chronic illnesses.

Arburg: 1/H04 www.arburg.com

Carclo Expands UK and Czech Facilities

UK-headquartered plastics moulder Carclo Technical Plastics has made significant investments in moulding

equipment at production facilities in the UK and the Czech Republic.

In the UK, the company has installed new all-electric injection moulding equipment at its facility in south London to provide a dedicated moulding cell for point-of-care medical diagnostic applications. The installation includes two-shot moulding and optical cuvette moulding, operating on a 24hour basis, 7 days per week.

The facility continues to develop with the latest machine scheduled for delivery in January 2013 and further deliveries scheduled for later in the year.

The investments are to support several major customers with a desire for high volume manufacturing in this field.

UK managing director Patrick Ward stated: â&#x20AC;&#x153;Carclo Technical Plastics has long been

MEDTEC PREVIEW involved in manufacture of diagnostic devices and we are delighted to have completed this new facility.”

In the Czech Republic, Carclo has installed additional cleanroom injection moulding machines at its plant in Brno for the production of medical disposables.

Carclo: 1/M50 www.carclo-ctp.co.uk

Engel Open Stuttgart Technology Centre for Gathering on Medtec Eve

One day before Medtec starts, Austrian injection moulding machine manufacturer Engel will open its new technology centre in Wurmberg, near Stuttgart for med.con, a

medical plastics conference for customers, partners and interested parties to purvey practical know-how. According to Engel, the new centre is huge and provides a perfect backdrop for exhibiting several machines to demonstrate efficiency potentials.

At the Medtec show, Engel will demonstrate a twin shot moulding process with ABS and TPE in a 16-cavity mould. The process will produce auto injector parts (see left image).

The demonstration will be in association with Engel's partners Hack Formenbau mould makers, auto injector manufacturer SHL (Scandinavian Health), materials handling machinery supplier Piovan, Max Petek Reinraumtechnik cleanroom equipment and Stäubli robotics and moulding auxiliaries.

Experts will be on hand to answer questions on this moulding technique, Engel’s iQ

weight control ambient temperature sensing software, and a GMP-compliant integrated tray server for contamination-free discharge and feeding of moulded parts.

Engel: 1/I20 www.engelglobal.com Motan-Colortronic to Show Ultrablend 95 Gravimetric Batch Dosing and Mixing at Medtec German materials handling equipment manufacturer motancolortronic will show the latest version of its Ultrablend 95 gravimetric batch dosing and mixing unit.

The unit is said to have been developed for consistently precise dosing and

mixing of free-flowing plastic pellets and additives. It improves process quality and stability and makes its own contribution towards minimising production costs. With the design in electro-polished stainless steel, motan has placed great emphasis on clear functions, minimum maintenance and easy operation in a hygienically clean production environment. All material hoppers and mixing chambers have been designed without any “dead zones”. All seams are fully welded. As a result, no residual amounts of material can build up and contamination of subsequent batches is therefore eliminated.

To read about a recent installation of motancolortronic’s equipment see page 43.

Motan-Colortronic: 1/K80 www.motan-colortronic.de Continued on page 29

JANUARY-FEBRUARY 2013 / MPN /25

The drug eluting coating on this stent, clearly visible thanks to this impressive high resolution image, is made from a combination of a bioabsorbable PLGA polymer and an everolimus immuno-suppressant drug. The stent, the Synergy from US medical device company Boston Scientific, was given clearance for sale in Europe in October 2012. The coating is proprietary to Boston Scientific and dissipates in three months following implantation. It has the potential to improve post-implant vessel healing and will eliminate long-term polymer exposure, a possible cause of late adverse events.

FOLIO

Medtec Preview | Injection Moulding Continued from page 25

MOULDING Spang & Brands Gets ISO13485

After almost a year of hard work, German medical contract moulder Spang & Brands has been certified compliant to ISO13485, the internationally recognised standard for design and manufacturing of medical devices. German testing, auditing and certification authority TÜV-Süd carried out the auditing and certification.

The certification covers the company’s advanced medical plastic moulding operations.

When commenting on ISO13485, Friedrich Echterdiek, managing director, said: “For just those special ISO13485 relevant projects, we employ the right technologies with CAD-3D development and MoldFlow analysis. We have more than 50 active injection moulding machines, including all-electric machines. Most importantly, we take full advantage of our continuously growing engineering know-how.”

Spang & Brands manufactures in class 8 (100,000) cleanrooms. Fully automatic and manual assembly takes place, not forgetting the packaging of components and assembly units. Product runs range from pilot and preproduction jobs and just-in-time batches to runs of many million parts.

Strategically positioned checkpoints and 3D precision metrology support the company’s stringent quality surveillance and assurance system.

At Medtec, the company will exhibit more than 50

different medical plastic products, for example, syringes, cannulas, push-through membranes, implant components and those for minimally invasive medicine. It will also offer fastening and joining elements, functional parts for infusion solution bags and closure and sealing systems, as well as assembled units and ready-for-sale devices where accuracy and structure must be, and is, exemplary.

Spang & Brands: 1/M49 www.spang-brands.de Starlim Masters Mass Micro Moulding of LSR Parts Under 10 mg

With the naked eye it is almost impossible to recognise high-precision recesses or undercuts on an LSR part with a weight of 10 mg. Such microcomponents, which are used for example in insulin pumps, hearing aids and other medical devices, can be produced using two shot moulding technology, either in a thermoplastic-LSR or an LSR-LSR combination.

In this realm, microcomponents with a minimal weight of 10 mg are already in general mass production. But Austrian LSR moulder Starlim Sterner has mastered the manufacture of silicone components with a weight of less than 10 mg in large runs. In addition, a wide range of durometers can be employed—from 20 to 80 Shore-A. To achieve this, the company employs a small 10ton injection moulding machine.

The machine is fitted with two injection units, one for thermoplastic and the other for LSR components. The precise

mixing ratio of the basic components and additives is secured and the maximum shot volume of both components amounts to 150 mm3. Direct feeding takes place using an open die concept, the available mould area in the die amounting to 17 mm in diameter, while the maximum cavity depth divided between the feed and discharge side totals 12 mm. In order to prevent component damage, the clamping unit is subject to extremely exact control.

After moulding, a handling unit removes the microcomponents and lays them aside while a camera and an image processing system monitors the part geometry.

The process can be performed under cleanroom conditions.

Starlim Sterner: 1/K63 www.starlim-sterner.com Weidmann Doubles Blood Lancet Capacity and Improves Automation and Handling The medical division of Swiss high volume contract moulder Weidmann Plastics Technology has recently doubled its manufacturing capacity for blood lancets. The expansion project was achieved within 24 months of the start of installation of the cleanroom.

Completion was marked by the start of validated production with new vertical injection moulding machines and assembly and packaging lines.

In terms of specific technical processes, Weidmann maintained the original concept approved by the lancet OEM for the moulds, the automation of the needles and the moulding process. However, the process of handling the insert-moulded needles was improved. Weidmann also developed a new optimised concept for the assembly of such overmoulded lancets in a

drum, including the placement of lancets in different sizes of packaging. The in-line-assembly process is fully automated and vision controlled. As already practised for many years, Weidmann runs this production for 24 hours a day, 7 days a week, in a class 8 cleanroom.

Weidmann: 1/L20 www.weidmann-plastics.com No Stress: Wittmann to Demonstrate Hi-Q Shaping in Micro Austrian injection moulding machine manufacturer Wittmann Battenfeld will be demonstrating its newly developed Hi-Q shaping injection-compression moulding process. Wittmann says the technology enables the production and automatic inspection of parts with virtually no internal stress and perfect surfaces.

Hi-Q works when settings for temperature and pressure are added to the settings for time and distance, which makes it possible to regulate the embossing pressure via the clamping force setting for every specific process. This again enables dynamic and accurate application of the embossing pressure to the entire surface of the part just above the glass transition temperature and consequently a drastic reduction in material stress. As a result, parts are produced with a perfectly constant weight, minimal shrinkage and excellent surface quality.

Hi-Q will be demonstrated on a MicroPower 15/10 producing POM micro filters.

The machine on display has an integrated cleanroom production cell with a rotary disk, parts removal handling and integrated quality inspection by imaging.

Wittmann Battenfeld: 1/L52 www.wittmann-group.com Continued on page 31

JANUARY-FEBRUARY 2013 / MPN /29

Medtec Preview | Extrusion and Diagnostics Continued from page 29

EXTRUSION Continuous Extrusion of Variable Flexibility Shafts

US-headquartered Putnam Plastics, a contract extrusion company with a specialism in minimally invasive devices, has introduced a method of producing variable flexibility tubing. Taper-Tie is a proprietary continuous extrusion process which results in tubing with flexibility at the forward, or distal end, and rigidity at the end the surgeon holds. It is said to save manually assembling and bonding segments along the catheter shaft.

The process involves quick material changes from rigid to soft grades for a designated polymer while simultaneously reducing wall thickness. The flexible distal end enables “bendy” trauma-minimised navigation of vascular pathways. The rigid proximal end allows steering as it is pushed into the lumen.

Putnam Plastics: 1/N08 www.putnamplastics.com

Vention Publishes White Paper on Multi-Layer Medical Extrusion AnsaMed, a Vention Medical company, has written a paper about multi-layer tubing extrusion. AnsaMed is an Irish contract extrusion company.

Vention is a US-based medical device outsourcing company.

The paper covers technologies like closed loop and statistical process controls which ensure maintenance of accurate, repeatable dimensional control.

According to Vention, AnsaMed can produce tri-layer tubing with tolerances in outer diameter (OD) of +/-0.0003” (0.000762 cm) and in wall thickness of less than 0.0016” (0.004064 cm).

“We are now able to produce thin-walled, large bore, multi-layer tubing, ideal for delivery systems for emerging therapies such as percutaneous replacement of diseased heart valves,” stated Dominic. At the other end of the scale, he notes, recent trends have emerged for tapered microbore multi-layer structures enabling balloon catheters to reach even further into the anatomy through reduced profiles.

AnsaMed: 1/N64 www.ansamed.com

Teleflex Connects Dissimilar Tubing Segments

US contract design and manufacturing firm Teleflex Medical OEM has introduced a novel process that joins dissimilar tubing segments when fabricating catheters. The process, which is patented, is said to allow the production of catheter shafts with tubing sections of different diameters without sacrificing flexibility.

Teleflex’s process allows: a larger distal section for a medical device, valve, or graft delivery application; larger distal sections joined to a smaller diameter proximal catheter shaft; a dramatic increase of the diameter of the catheter’s distal tip section using a precisely controlled process; and a transition section between sections that is more flexible than conventional bonding methods.

As far as the latter is concerned, the length of the transition section can be changed to suit while transition section can be rigid or flexible without interfering with the strength of the distal or proximal shafts.

With current manufacturing techniques, there are significant challenges associated with catheter designs requiring tubing sections of varying diameters. Once the ratio between the larger and smaller tubing sections exceeds 1.1, assembly over a fluoropolymer liner becomes problematic.

Conventional bonding techniques become difficult and generally result in a rigid bond site and decreased catheter flexibility.

The new technique addresses the challenges of conventional bonding methods. According to Teleflex, the process opens up new possibilities for medical devices since catheter designs can incorporate a combination of rigid or flexible, reinforced or unreinforced tubing sections. There is potential for the process to be applied to valve or graft delivery systems or to any interventional catheter design requiring strong proximal sections.

Teleflex Medical OEM: 1/M40 www.teleflexmedicaloem.com

DIAGNOSTICS Biofunctional Coatings for Microfluidic Channels

Swiss medical moulders at Weidmann are boasting an improved process for manufacturing microstructured

channels in microfluidics, specifically a method to develop customised coatings.

According to the company, the technology is possible thanks to advances in machining, enabling processors to abandon the use of complex lithographic procedures.

Among a diversity of common surface treatments for plastics, specific functionalisation is a scarce commodity, although it is easy to deposit a standard functionalisation for biomolecules within microstructured systems.

Weidmann says that new customised functionalisation, such as that gained from the AziGrip4 brand of biofunctional coatings from Liechtenstein-based optical coatings company Optics Balzers, will provide customer benefits. Although the coating is customised, Weidmann are experienced in its application.

The surface can be functionalised in a short time by dipping, brushing, spraying or rolling. In a first step an adhesion promoter and subsequently the functional polymer will be applied. A few seconds of UV illumination for activation are required.

In addition to the wellestablished methods for the bonding, for example thermal, solvent or primer bonding, more and more spotting and dispensing of PSA (pressure sensitive adhesive) is applied, because it is flexible aligning to the geometry of the microfluidic channels. Minimal differences in the surface level caused by interleaved mould inserts can be resolved and leakage along the parting lines is prevented.

Weidmann: 1/L20 www.weidmann-plastics.com MPN will be at the show.

Contact the editor to meet up.

JANUARY-FEBRUARY 2013 / MPN /31

DESIGN 4 LIFE Design Engineers | 30 Under 30

Young Blood: Tackling the Engineering Graduate Shortage WORDS | SAM ANSON Across Europe there is a growing shortage of engineering graduates. In Germany, the gap between the number of job openings and availability of graduates widened to a record 76,400 in June 2011, according to the Association of German Engineers (VDI—Verein Deutscher Ingenieure), created mainly by the country’s expanding economy.

In the UK, a growing gap is being caused by engineers retiring without there being a sufficient supply of graduates to replace them. Following a slip in the ranking of US patent registrations by country, the Royal Academy of Engineering conducted a study which concluded that the country needs 50% more engineering graduates to remain internationally competitive.

The issue is fairly high up the priority list for politicians, however. In 2012 the UK government’s minister for state and enterprise Mark Prisk and business secretary Vince Cable named 30 rising stars of the manufacturing world in their 30 Under 30 Make It In Great Britain award to help promote the perks of an engineering career to young school leavers.

One of the 30 winners was Alasdair Mercer, a design engineer at UK device manufacturer Surgical Innovations plc with an interest in medical plastics. Alasdair has recently completed a project to develop

a pioneering new product PretzelFlex. The PretzelFlex is the world’s first reusable pretzel shaped organ and tissue retractor for use in minimally invasive surgery which provides improved access and visualisation of surgical sites. It is said to be different from similar products on the market because of its impressive strength and stability achieved by the innovative pretzel shape. The device is easily inserted through a 5 mm laparoscopic (keyhole) port access system and forms into the pretzel shape while inside the abdomen due to high precision segment technology.

The product is being sold to hospitals around the world.

More recently, he has lead a team which developed and introduced a new and challenging range of ultra minimally invasive 3 mm diameter instruments. The range includes micro scissors, micro precision graspers, and the new 3 mm port access system used to deliver the instruments. The team has also redeveloped the PretzelFlex device into a much smaller 3 mm version.

As far as plastics are concerned, the projects involved material selection, mechanical structural design, design for moulding (DFM), design for assembly (DFA) and manufacture. Secondary processes were also required, such as ultrasonic welding, insert or

over-moulding and tool optimisation of plastic flow and layout.

When asked why he went into engineering, Alasdair said: “Since childhood I have been interested in how things work and what their mechanical function is. I remember enjoying Lego and Meccano as well as taking apart broken appliances, bikes, race cars, and motorbikes. This informed my selection of subjects at GCSE where I opted for design and technology as well as sciencebased subjects.”

Regarding life as an engineer, Alasdair goes on to say: “I enjoy the diversity of engineering and have been lucky enough to have worked in many areas including motorsport, the flow control industry, as well as most recently the medical device field. It is very rewarding to see a product which you have helped to develop being used by surgeons in the operating room to save lives.”

His advice to youngsters is: “Young people need to consider career paths such as engineering and manufacturing as they present the perfect opportunity for creative individuals to work in an environment where every day is different.

The current economic climate in the UK lends itself perfectly to the growing focus on good British engineering and manufacturing.”

<< Alasdair Mercer, a design engineer at UK-based minimally invasive device manufacturer Surgical Innovations plc, was named as one of the UK government’s top 30 engineers under the age of 30 in 2012. >> JANUARY-FEBRUARY 2013 / MPN /33

Antimicrobial Legislation: European Changes in September 2013 Legislation in the EU In the EU, antimicrobial substances most relevant to medical plastic processors—such as those used in the manufacture of antimicrobial surfaces or disinfectants—come under legislation for biocides.

Pharmaceutical substances designed to be used on or inside patients—like antibiotics and other drugs, which can also be referred to as antimicrobials—are treated separately.

In September 2013 a single set of EU-wide rules covering biocides will come into force in all member states—the Biocidal Product Regulation (BPR) EU 528/2012.

The BPR will replace the Biocidal Product Directive (BPD) 98/8/EC, originally introduced in February 1998.

The replacement of the directive with a regulation is a continuation of a common trend in the EU. It is similar to the course being set for medical devices in the proposed Medical Device Regulation, designed to replace the current Medical Device Directive (for a guide to this directive see Medical Plastics News NovemberDecember 2012, pages 6-7).

The main difference between the regulation and the directive here is how the rules are implemented by member states. The regulation is a single group of laws set by the EU with mandatory adherence by member states. The directive is a group of directions for law makers in individual member states to follow when making their own laws in their own countries.

So for biocides, prior to the BPR, member states had their own rules and regulations in line with the directive but retained ultimate control over the supply of biocides in their own country.

Come September 2013, the BPR will bring the legal control of these substances under the EU. Many elements will stay the same in the switch from the BPD to the BPR. For example, the two stage process of i) registration of an active substance at EU level and ii) authorisation of biocidal

There are strict rules about what can and cannot be claimed by manufacturers of devices which have an antimicrobial surface. In the following article Dr Andrew Summerfield, the new regulatory affairs manager at UKheadquartered BioCote—an antimicrobials company with products and services comprising additives, masterbatches and associated regulatory, technical and marketing support— guides us through new legislation in the European Union and current laws in the USA.

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REGULATION REVIEW Device Advice | Making Lawful Antimicrobial Marketing Claims products at member state level will remain—as well as many other themes and practices.

There are some administrative tweaks under the BPR. Categories of biocidal product will be authorised centrally by the European Chemical Agency (ECHA) while several other measures have been made for streamlining trade, data requirements and the like.

But perhaps the biggest change for the antimicrobial polymer and powder coatings industry is that treated articles will be brought into the scope of regulation.

Under the new rules, treated articles will need a label detailing the nature of the biocidal treatment. It is not yet clear what exactly defines a treated article in Europe. But the previously accepted rule of thumb was if the product would be on the market without a biocide in it, then it is a treated article.

Public health claims for treated articles are also being discussed and industry awaits the findings of the European Commission as to exactly what the requirements (and possibly restrictions) will be.

The United States Under US regulations, antimicrobial substances are treated as non-agricultural pesticides and require registration with the Environmental Protection Agency (EPA). Data is submitted for a pesticide product in terms of efficacy, environmental fate and safety. Once a registration is completed, you are provided with a label from the EPA which specifies which claims can be made.

Relatively recently, pesticide-treated products made something of an explosion on to the consumer market in the USA, with what the EPA considered inappropriate claims regarding public health benefits to consumers.

Public health?: The EPA states that if you want to control a public health organism like bacteria, you need to register your pesticide or pesticide device and provide data that the pesticide works effectively and safely.

But there are tough regulations on what manufacturers of finished devices can and cannot claim with respect to protection from microorganisms. Taking the example of a cup treated with a biocide. The cup itself is protected from “microorganisms”, but it cannot be legally claimed that the user of the cup is protected. If we want to market our cup as cleaner, safer and more hygienic— that it protects the consumer—we must register the actual cup with the EPA as a pesticide device. Any registration applies only for this cup, so any other products must go through the same registration process. In many cases is not practical or economically viable to register individual devices.

Treated articles?: In the United States in order not to prevent trade of these pesticide-treated products, something of a half-way house was developed—the Treated Article Exemption. This allows non public-health claims to be made about the product, allowing labelling and associated marketing of the product to detail the preservative nature of the antimicrobial properties.

The pesticide must still be registered with the EPA for its use as a preservative, however if guidance about the language used in a marketing claim is followed, the treated article itself remains outside of true regulation. It is, therefore, important for

distributors of treated products into the United States to understand the restrictions placed on language used for claims on the labels of these products.

Medical Device Regulations: Could Antimicrobial Functionality be Treated as Drug Delivery?

Adding a biocide to a medical device might seem like an obvious step to improve the surface hygiene of the device. In addition to the standard regulations mentioned above, the antimicrobial additive must be compliant with medical device regulations in the target market.

In order for the antimicrobial biocide to have an effect on the target microorganisms, it will be present in clinically significant quantities and be bio-available.

If this biocide can act on the patient—for example by killing bacteria on the surface of the skin—it may be considered to be a drug or to have a drug-like effect.

Essentially, the surface—if within the body or in contact with the skin—may become a drug delivery system and if so, may change the class of the device due to increased risk or uncertainty.

In Europe, medical device legislation is under revision, and whilst in the current draft of the new regulation there is no specific measures for biocides, biocides are mentioned. The document states that groups may be set up to aid the commission and member states in regulatory coherence and expertise for medical device related sectors such as “medical devices, intra venous devices (IVDs), medicinal products, human tissues and cells, cosmetics and biocides”.

In the US, the 510k notification on antimicrobials published in 2007 remains in draft form. But revision is expected to continue as additional guidance documents are published in 2013.

Conclusion Clearly the regulatory situation for biocides is in a state of change, and although opportunities for implementing this technology are on the rise, care must be taken when making this technology available on the market. Obviously, the more critical the applications, the more stringent the legislative framework will be.

A guide to antimicrobial materials was published in Medical Plastics News, July-August 2012, pages 11-15.

<< Dr Andrew Summerfield is regulatory affairs manager at UK-headquartered antimicrobials company BioCote. BioCote manufactures antimicrobial additives and masterbatches and provides associated regulatory, technical and marketing support. >> JANUARY-FEBRUARY 2013 / MPN /35

ORTHOPAEDICS

PEKK Pioneer: Additive Manufacturing of Customised Cranial Maxillo-Facial Implants WORDS | SAM ANSON

The global market for additive manufacturing technologies is set to double in 2012-17. While much of this expansion will be in product design and prototyping, a growing niche of custommade, one-of-a-kind implantable devices are being made from computer aided design (CAD) files drawn up using a patient’s actual anatomical dimensions. The attraction of these is that fit can be improved substantially, compared with more traditional generically-sized products. A leading light is USA-based Oxford Performance Materials, co-founded by Scott DeFelice.

Oxford Performance Materials (OPM) was founded in 2000 as a supplier of PEKK (polyetherketoneketone) polymer compounds and stock shapes for industrial applications under the brand OXPEKK. As its name suggests, PEKK is part of the same family of highperformance polyether ketone polymers that PEEK belongs to and exhibits similar properties.

During 2003-09 OPM enjoyed a partnership with DSM and part ownership

by Arkema before those shares were bought back by OPM in 2011. In 2006 OPM produced its first ever biomedical material for long-term orthopaedic implant and achieved ISO 13485 certification.

In 2011, under its OsteoFab brand, OPM produced and shipped its first custom-made long term implantable medical device using select laser sintering (SLS) additive manufacturing. The device is a cranial maxillo-facial (CMF) plate for skull reconstruction.

Since the first product was made, OPM has manufactured approximately 50 36/ MPN / JANUARY-FEBRUARY 2013

long-term implants for use outside the USA. The majority are CMF plates for procedures like craniotomy (skull surgery to gain access to the brain or reconstruction) and orbital and mandibular reconstruction (corrective surgery to the face and jaws, respectively).

At the time of going to press, OPM expects to receive its first 510(k) clearance of a long term implantable additively manufactured device for sale in the US market by Q2 2013.

The technology is also suitable for manufacturing devices for the replacement of small bones in the hands and feet and other non-load bearing applications.

The devices are made by a process called selective laser sintering (SLS), an additive manufacturing procedure which melts molecules of OPM’s OXPEKK polymer powder one layer at a time.

Precise layer thickness is strictly confidential but a typical build would have several thousand layers of material.

The laser is controlled by a computer, which reads data from a three-dimensional

CAD file. The CAD file contains the dimensions for the device and is created from the patient’s CT or MRI scan. OPM uses an P800 SLS machine under special license from German additive manufacturing machine supplier EOS. When commenting on the manufacturing process, Scott told Medical Plastics News that an additive process inherently provides a better orthopaedic device than machining—a subtractive process.

“The additive manufacturing process allows for the design and production of anatomically and physiologically optimised implants as it enables better load distribution compared to other manufacturing methods such as machining or moulding.”

Scott also points out that the material has a natural surface “roughness” and this is thought to improve osteointegration. The company’s website quotes a study published in March 2011 by Timothy Ganey, director of research at the Atlanta Medical Center, which suggests that PEKK offers improved osteointegration compared with titanium.

In terms of regulation and compliance, Scott explains that he takes an “end-toend” approach to validation. “Busy surgeons are not accustomed to the detail required with patient-specific design and manufacturing. They rely on their suppliers to ensure parts are compliant.”

OPM approaches compliance by establishing business processes which deal with every possible event that could cause interference during design,

Sponsored By:

Select Laser Sintering | Patient-Specific PEKK Implants production and distribution, including power outages and even handling by the surgeon. Every product is shipped with the appropriate technical documentation.

In terms of leadtime, if OPM receives a CAD file on a Friday a device can be built by the Tuesday and shipped the following Friday. Typical turnaround time is under two weeks.

When asked about the possibility of developing more advanced materials for additively manufactured implants, for example those containing radiopaque additives such as barium sulfate or

antimicrobials, Scott said: “We’d look at the economics of any such project and see if it’s feasible. In fact, the development of custom materials is a historic competence within the firm.”

With all this knowhow, it’s not surprising that OPM’s horizon is flushed with opportunity. Scott says that partnerships built through the supply of OXPEKK pellets and stock shapes, means that not only is OPM a direct supplier of bespoke devices to major orthopaedic companies but it can also deliver directly to surgeons around the world.

Typical properties of PEKK OsteoFab product Specific gravity

1.31 g/cm3 (81.8 lb/ft3)

Tensile strength (break)

83 Mpa (12,000 psi)

Tensile modulus

3,940 Mpa (571,000 psi)

Elongation (break)

2.5%

Flexural strength

180 Mpa (26,000 psi)

Flexural modulus

3,640 Mpa (528,000 psi)

Compressive strength

160 Mpa (23,000 psi)

All numbers represent typical in-plane values

Electrospinning Creates Degradable Load Bearing NanoFibre Cell Scaffolds Researchers at the University of Pennsylvania, USA, have taken a step forward in the engineering of load bearing fibrous tissues for regenerative medicine, according to work published last year in the US journal Proceedings of the National Academy of Sciences.

It is hoped that the work will help medical scientists working to find bioengineered replacements for tendons, ligaments, the meniscus of the knee and other weight-bearing tissues.

Nano-fibre cell scaffolds are already being used by orthopaedic surgeons to guide tissue growth in an organised way.

However, there has been reports that uptake has been slow due to poor osseointegration of the tissue along the scaffolds.

The researchers in Pennsylvania have found a way of producing nanofibrous polymer scaffolds which they say have a loose enough structure for cells to colonise inside while still being able to direct them in order for new tissue to grow in the desired direction without impediment.

According to a report in US science news website Phyorg.com, the fibres are the product of electrospinning two polymers—a slow degrading polymer and a water soluble polymer. While the first polymer is designed to degrade in the body, the water soluble polymer can be selectively removed prior to the scaffold’s use to increase or decrease the spacing between the fibres. The resulting matrix can have cells added to it to grow tissue inside or outside the body.

JANUARY-FEBRUARY 2013 / MPN /37

Specialist Dryers | Supplier Roundup

Specialist Drying Equipment: Dry as a Bone WORDS | SAM ANSON

Generally, in all types of plastic processing, energy efficient drying equipment is available to optimise energy usage—one of the key operational costs for plastic processors. In medical processing, certain resins require specialist drying technologies. For example, when manufacturing class III implantable products and delivery devices for highly sensitive drugs, equipment must be engineered to prevent contamination. In other applications, dryers need to handle delicate materials like bioresorbable and high performance PEEK polymers.

<< Kreyenborg’s infra red (IR) batch dryer can process 54 kg per hour of semi-crystalline polymer. It is recommended by Kreyenborg for small and numerous batches of coloured masterbatches. >>

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Infrared Drums for Small Batches of Amorphous Resins At US plastics trade show NPE in 2012, German plastics machinery supplier Kreyenborg launched an infra red (IR) batch drying system. The system is for drying polymer masterbatches whose polymer chains need to be changed from an amorphous to a crystalline structure like PET, PPS, PLA and high temperature PEEK. These materials become sticky when they heat up to glass transition temperature. The system prevents them from sticking together during crystallisation and drying.

The systems take the form of a drum, which is operated on its own—or “discontinuously”—rather than as part of a continuous line. The drum speed can be adjusted according to the physical properties of the materials being heated.

A typical process performed on the dryer is the fast heating of PET masterbatch. To achieve fast heating, the drum is rotated slowly and temperature is set to the required crystallisation temperature of the masterbatch.

Once the material begins to crystallise, the rotation speed can be increased to a faster speed to prevent clumping and ensure good mixing. Following successful crystalisation, materials are automatically discharged and the drum refilled. Up to 120 lbs (54 kg) per hour can be processed.

An optional ionisation unit can be added to the system to prevent sticking caused by elecrostatic effects—common with highly filled masterbatches.

Easy cleaning is achieved thanks to the fact that the infrared module can be slid out in a separate frame to be cleaned outside the unit.

The drum has no small crevices or hidden areas allowing it to be cleaned easily using a vacuum cleaner or compressed air.

Sponsored By:

Next Generation Maguire Vacuum Dryer US materials handling equipment manufacturer Maguire will launch what its sales and marketing VP Pat Smith describes as “next generation” vacuum drying technology in 2013.

Maguire has a new design of its low pressure systems originally introduced in 2000. The new systems feature a streamlined process with larger throughput incorporating load cells which weigh the material. Previously dryers were filled using level sensors. Weighing sensors achieve a much more accurate load and therefore more precise drying.

According to Pat Smith, vacuum drying is six times faster than conventional drying and, thus, much kinder to materials.

Vacuum drying works by heating the material at low pressure, which lowers the boiling point of water and causes it to boil off from the materials at a faster rate than if they were being dried at atmospheric pressure. By boiling off the water faster, it means that drying times are reduced, thereby providing energy savings and reducing the risk of damage of material properties due to prolonged exposure to high temperatures.

Talking to Medical Plastics News, Pat Smith explained: “Compared with desiccant drying, which transports moisture away from the pellets using directed air flows, our vacuum dryers effectively flash off the moisture. Users can expect a 50-70% energy saving for hygroscopic materials.”

He added: “50-70% is possible thanks to the fact that no desiccant is used. Desiccant gets saturated with water and must be regenerated using heat. All the energy spent regenerating desiccant is lost. A vacuum dryer has no desiccant, so that energy is never spent.”

CLEAN MACHINES The vacuum dryers work in a three-step continuous process.

First, material in the heating hopper is brought to set point by means of a centrifugal blower through a 40 kW heating element.

The requested heating temperature is adjusted on a control panel.

Next, upon reaching the desired set point, heated material is discharged from the heating hopper into the vacuum vessel. The vacuum is brought to 75 mm absolute pressure and held to a 20 mm differential for the set cycle time. Finally, the dried material is discharged into an insulated retention or take-off hopper for consumption. A positive pressure heated dry air purge is maintained on the material.

According to Mike Jordan, managing director of Summit Systems, Maguire’s agent in the UK: “Vacuum drying provides a very fast preparation of the material. It causes less heat stress and less air is needed.

The other significant difference is there is no desiccant. So compared with traditional twin desiccant dryers, there is no chance of any dust contamination from the clay that degrades over << Maguire’s next generation time in the desiccant vacuum dryers, due for release chambers. At the same time in 2013, flash off moisture and heat cycles are typically 20 reduce drying time compared mins compared with 2-3 with desiccant alternatives. >> hours with desiccant dryers.”

Continued on page 40

JANUARY-FEBRUARY 2013 / MPN /39

Specialist Dryers | Supplier Roundup Continued from page 39

Modula System Automatically Adjusts Conditions for Sensitive Materials To overcome problems involved with drying very sensitive materials, Italy’s Piovan has come up with a special drying system called Modula that, unlike traditional central systems, automatically adjusts and controls all operating parameters for each individual hopper. In addition to being precise in terms of temperatures, the system is said to be efficient in terms energy usage. Specific software interfaces the settings for each hopper with data collected by the sensors installed on the system.

<< Piovan’s Modula drying system automatically adjusts the temperature in each individual hopper thanks to sensors installed throughout the system. >>

40/ MPN / JANUARY-FEBRUARY 2013

This means that by using a patented measuring unit located in the air supply line and under each hopper, the airflow can be adjusted and controlled instantaneously and independently, hopper by hopper.

In addition, the overall flow of process air is modulated automatically by the central drying unit, resulting in optimum process operating conditions.

According to Piovan, Modula is available for medium capacity applications (200-300 kg/h) and provides savings of as much as 50% with respect to ordinary centralised drying systems of equivalent capacity.

Moretto’s White Big Bag and Octabin Unloader Italy-based materials handling supplier Moretto is promoting its White Oktobag unloader for octabins and big bags, specifically aimed at medical processors.

Normally, many steps are required for the unloading of octabins and bags. As the vessells empty, more and more human interventions are required, especially as big bags become limp and make the drawing of material more complicated.

Moretto’s Oktobag solves this problem as it unloads the packaging without needing corrective interventions, thereby reducing the risk of contamination.

The system works using four oscillating arms moving independently, working on the containing bag. Managed by an apposite programmable logic controller (PLC), the arms have a sequential wave-like movement which unload the big bag and/or the octabin completely. The arms are equipped with pliers which,

Sponsored By:

driven by gravity, make hooking-up operations quick and simple so no fixing or tools are required.

White Oktobag unloaders are equipped with automatic recovery of the suction probe. In case of a bridge, there are specific bridge-break programmes in addition to the automatic adjusting of the octabin height, also by barcode.

Particular attention has been paid to integral antistatic protection, which allows protection of the bag and its content from electrostatic dusts.

Automatic control of the Oktobag is achieved through the application of a barcode which manages the machine and its functions automatically.

An empty bag sensor is said to be useful, since there is an infrared system that advises once the bag contains no more granules. << Moretto makes a specialist materials unloader for medical plastics processors. The unloader is fully automated, with oscillating arms and an infrared sensor to signal when the bag is starting to empty, thereby reducing contamination risk. >>

CLEAN MACHINES Wittmann’s Aton Desiccant Wheel Dryer Continuing the theme of efficient drying, speaking with Medical Plastics News Markus Wolfram of Austria’s Wittmann Battenfeld said that the design of Wittmann’s Aton desiccant wheel dryer saves energy in three ways. First the ambient air is pre-heated. Second, the Aton segment wheel is designed in such a way as to reflect heat back towards to the centre of the wheel.

Also, the heater is placed in a horizontal position which supports the heat-air exchange and which is more efficient compared to a quick heater element passing air flow. Thirdly, is the Aton’s use of a counter-flow regeneration method. It is not needed to press the moisture through the whole wheel. The biggest amount of moisture is at the top of the desiccant bed.

When asked about specific energy consumption, Markus said: “Energy consumption can be similar to a well-designed and modern twin-desiccant bed dryer and significantly lower than a honeycomb dryer. An EcoMode is a great feature and automatically helps moulders find the right drying operation.”

He added: “We believe there’s a need for this approach to drying; especially within small to medium sized companies. The Aton F70 is designed for them—and has a very competitive price point to match.” << Wittmann’s Aton desiccant dryer features three energy saving aspects—preheating of ambient air, a wheel with internal heat reflection and horizontally positioned heat exchange. >> Continued on page 43

JANUARY-FEBRUARY 2013 / MPN /41

Sponsored By:

CLEAN MACHINES

Specialist Dryers | Dry as a Bone

Recent Installations Continued from page 41

Energy Efficiency Rated Wittmann Dryers Installed at Bespak UK The UK arm of Austrian moulding machinery manufacturer Wittmann Battenfeld has recently supplied a materials handling system to UK-headquartered Bespak, a leading manufacturer of plastic drug delivery and airway management devices. The equipment has been bought for a recent expansion of Bespak’s cleanroom moulding operations to increase output of its production of metered dose dispensers.

Wittmann Battenfeld UK managing director Barry Hill said: “We are delighted indeed to be once more partnering Bespak in their moulding technology needs.”

A key feature of the installation is Wittmann’s Drymax 100 dryer equipped with dewpoint measuring to ensure consistant drying. Three Wittmann Silmax hoppers were installed—two with a capacity of 150 litres and one with 30 litres. The hoppers feature Wittmann’s Smart Flow intelligent air distribution valves.

These automatically adjust to differing throughputs of material flow and prevent over-cooking of materials.

The Drymax was sized for optimum drying and for providing the dry air used to convey the materials over the lengths of pipework to the moulding machines. Purge valves were fitted to pipe runs to ensure material was not left sitting in pipes after conveying.

According to Wittmann, the Drymax technology is extremely energy efficient. Wittmann Battenfeld UK has set a precedent in the Bespak production environment by stating energy efficiency ratings (kw per kg) on the front of each dryer.

“Wittmann sets great store in our leadership for low energy materials dryers,” said Barry. “And we are very clear about pledging that performance to the customer in every dryer sale that we make.”

Each new Bespak moulding machine was also equipped with a B series loader sized for the appropriate machine throughput.

Bespak’s new Wittmann hopper loaders do not use a troublesome flap and switch. Instead they utilise a bell shape shut off which is pneumatically powered in order to give complete seal of the material flow. This configuration is ideally suited for cleanrooms.

All equipment, including the dryers, were linked to a Wittmann M7.2 control unit, which gives a visual display of functions of the drying cycle such as desiccant regeneration. On commissioning, a material menu is automatically produced and all drying temperatures and drying times are set. This automatically prevents any given material being used until its drying time is complete.

Temperatures are also preset from the initial M7.2 menu, thereby eliminating operator errors and maintaining quality.

Bespak is part of UK airway management device maker Consort Medical plc and has facilities in the USA and India as well as the UK.

Medical Plastics News would like to thank Adrian Lunney PR for the above information.

Shiny: motan-colortronic Completes 11-year Cleanroom Project In October 2012, Germany-headquartered materials handling machinery supplier motan-colortronic completed the entire replacement and refurbishment of the raw materials handling systems at the headquarters of Aero Pump, a German plastic drug delivery device component manufacturer. The start of the project began in 2001 and has involved more than 50 installations of motan's Ultrablend precision gravimetric batch dosing and mixing systems.

Aero Pump, a successful family-owned company founded in 1976, is a leading international producer of drug delivery systems. “Our company’s history began with one innovative product. We developed our first pump system without propellant gas in 1976,” company founder Egon Schwab explains while talking about the success of the Aero Pump brand.

Annually, the company supplies more than 140 mn dosing and atomiser spray pumps for nasal, throat and ear sprays, as well as eye-drop dispensers worldwide.

Already proven in pharmaceutical and medical areas, the electro-polished stainless steel housed Ultrablend 95 systems are used for gravimetric dosing and mixing of four granular plastic components: PE, PP and POM as virgin materials and regrind, plus masterbatches. Motan say that the equipment is particularly suited for applications involving frequent changes of material. The dosing slide gate and hopper form one unit, helping to ensure that no material can be spilled when dismantling the equipment.

As the mixing chamber is hemispherical, it does not give rise to dead mixing zones. Maximum throughput performance with two components amounts to 260 kg per hour. In terms of dosing precision, the units run within extremely tight tolerance bands— this high accuracy is an essential feature for pharmaceutical primary packaging.

<< Shiny motan-colortronic feeding systems have been electropolished for pharmaceutical and medical cleanroom moulding operations. >> JANUARY-FEBRUARY 2013 / MPN /43

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Measuring Melt Strength | Technical Research Network

Melt Strength as an Additional Tool to the Melt Flow Rate Test?

WORDS | SAM ANSON In spite of the increased sophistication of polymer resins— developed with many molecular parameters in mind—choosing a particular material can sometimes be more of an art than a science.

A recent project organised by the UK’s MaterialsKTN (Knowledge Transfer Network)—a publicly funded technical networking group designed to promote knowledge sharing in materials science—has made progress in the development of a quick and cost effective method to measure a thermoplastic’s melt strength, also known as its extensional flow behaviour. The goal is to develop an additional tool to the widely used melt flow rate test. Melt strength is an indirect measure of elongational flow and, according to a definition published in May 1998 by the Society of Plastics Engineers (SPE) extrusion division, it is the maximum tension that can be applied to a melt without it breaking.

The melt flow rate test, described in international testing standard document numbers ASTM D1238 and ISO1133, is used to measure the ease of flow of the melt of a thermoplastic polymer. It is defined as the mass of a polymer, in grams, flowing in 10 minutes through a capillary die of a specific diameter and length by a pressure applied using gravimetric weights at a specified temperature. The weight and temperature used are material dependent and are specified by standards.

Participating in the project are leading UK polymer researchers, including: the National Physical Laboratory (NPL); Durham University’s Centre for Soft Matter; PMMA manufacturer Lucite International; and PEEK producer Victrex.

Work is being done in anticipation of the possibility that, in some cases—particularly when characterising extensional flow behaviour at high rates—an additional melt strength index will be useful to certain processors who are limited by the current melt flow rate test.

The researchers hope that as a result of their work, processors will gain an additional tool to enable them to better understand the properties of a particular polymer prior to processing, thereby making efficiency savings in terms of time and material usage during manufacture.

Speaking to Medical Plastics News, Dr Martin Rides, the representative involved from the materials division of the NPL, said: “While the melt flow rate test has a purpose, it is not fit for all material characterisation purposes. It is a case of horses for courses, as the saying goes.”

He added: “For characterising predominantly shear flow behaviour at low rates, the melt flow rate test method is satisfactory. But for characterising extensional flow behaviour, for example for materials to be used in blow moulding or vacuum forming, then it has shortcomings. Furthermore, the method is not aimed at characterising the flow properties at very high shear

rates and to use it for predicting behaviour at a very high rate is potentially misleading. Molecular differences are differentiated better at low rates and this is its target.”

A principle advantage of the melt flow rate test is that little cost is involved in its measurement. The time taken to obtain a result is short while obtaining the skills required to generate the result is relatively easy.

A criticism which has been levelled at the melt flow rate test, however, is that a particular value of melt flow rate can be generated by two different rheological situations, and so the indication of flow of a material by the standard melt flow rate test is not unique.

A starting point to an alternative to the melt flow rate test was in 2002 when NPL investigated the use of a short length melt flow rate die, of 0.25 mm length rather than the standard die length of 8 mm, to evaluate the extensional flow characteristics of polymers. The principle of this approach is that the resistance to flow is dominated by the extensional flow in the converging flow region upstream of the die, rather than by the predominant shear flow in the case of the standard die. Details of the research were published and are available from the editor at sam.a@rapidnews.com.

A recent research project showed that a particular melt flow rate does not necessarily indicate a particular usage.

Indeed, an investigation into changing the melt flow rate by a large factor showed that the end product was not affected, however, the resulting production was improved.

Both of these issues have been indicated in studies carried out by Durham University’s Centre for Soft Matter in the UK. Recent MaterialsKTN << A new range of melt flow discussions with testers from equipment convertors and end users manufacturer Instron meet confirmed the need for a stricter requirements imposed reassessment. It was

by ISO1133-2 with regard to especially evident that temperature control for highly processors were looking sensitive materials. >> for reassurance that a Continued on page 46 material’s performance JANUARY-FEBRUARY 2013 / MPN /45

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Measuring Melt Strength | Technical Research Network Continued from page 45

properties would be consistent across different batches of resin.

So, once a polymer had been chosen for a production process, processors wanted to know whether a testing method could be found to ensure that subsequent deliveries of the material matched the performance of the polymer used in the original component approval process.

Usual practice is to depend on a certificate of conformity accompanying a material delivery. This usually quotes a melt flow rate which is based on the polymer delivered.

The melt flow rate value indicated in the certificate of conformity does not normally quote a range—plus or minus—but comprises just a single figure. Provided this is within an accepted range that is close enough to the value agreed by the manufacturer and the converter, delivery of the material is accepted.

Melt Strength Test One simple, affordable idea the group has is to adapt the existing melt flow rate test. According to Dr David Hoyle at the department of physics at Durham University: “We propose carrying out the test with the normal die and then following this with another test on the same material using a hyperbolic die.”

A hyperbolic die provides a graduated change in the radius of the test section, as oppose to the sudden contraction used with the melt flow rate test die. The graduated decreasing radius would increase the amount of time that a fluid element experiences a stretching flow. It is hoped that this type of die will affect the flow sufficiently to create a second measurement different from the original melt flow rate to be tested.

The two values in combination would then determine the required flow properties to be used by the processor, thus eliminating the problem with the melt flow rate test—that is to say two types of flow.

Looking forward, if the use of two different dies in a melt flow rate instrument proves successful and the change of dies is cheap and quick, combining the melt flow rate with a melt strength test may well prove to be of considerable value to the polymer conversion industry.

David Hoyle added: “A hyperbolic die will increase the amount of melt strength to some degree. The question to be answered is: in such a weak flow will the amount of melt strength generated be significant enough to give an easily measureable result that indicates the true nature of a given material’s melt strength.”

Fleming Polymer Testing Acquires Elasticity Measurement System UK polymer testing and consultancy bureau Fleming Polymer Testing & Consultancy has added a laser die swell system to its Malvern Instruments Rosand RH7 twin bore capillary rheometer. The system allows the accurate and continuous measurement of polymer die swell, which is an important rheological measurement, instrumental in the understanding of elasticity. Elasticity is important in polymer extrusion, since most polymers in the melt phase are viscoelastic. Such materials will swell to some degree on exiting a production die; a problem if you want your extrusion to share the dimensions of your die. Melted polymers, in most cases, experience stretching through extrusion dies, and due to the restoring forces generated, will try to return to their original state on exit (swelling). The magnitude of the restoring forces defines the elasticity, which can be hard to measure in an absolute fashion. However, die swell, is a convenient way to infer the elasticity; the greater the swell, the more elastic the polymer. In this way, screening of various grades can predict which are more elastic and which will swell more. Once elasticity is inferred, a designer can work on either refining the die design and/or process 46/ MPN / JANUARY-FEBRUARY 2013

conditions to achieve the desired degree of swell, or the grade could be switched altogether in favour of a more suitable alternative. In either case, knowledge of this important rheological parameter allows choices to be made which may otherwise appear impossible. The measurement is described in ISO11443:2005, 8.7 under Determination of Extrudate Swelling and constitutes an extension to the already comprehensive rheometry test suite offered by FlemingPTC.

<< Installation engineers Steve Bladen (left) and Mark Hewitt (right) from Malvern Instruments instruct FlemingPTC laboratory manager Terry Common (bottom). >>

Camera Controlled Dosing Swiss extrusion machinery supplier Maillefer is promoting its Cinegran brand of materials dosing control equipment.

Dosing is monitored by a camera.

<< Cinegran responds to unexpected disruptions with an alarm. >> The system's compact camera housing is positioned just below the material feeding hopper. It functions by measuring granular movement within the dedicated feeding column. Response is immediate, Maillefer says.

The Cinegran will be helpful in handling unexpected issues like a break in material supply, a feeding blockage or throughput variations. It immediately detects the event and reports back with a descriptive alarm.

It can be used with most polymers, for example PE, PA, PVC, TPU and FEP. Only very soft materials or fine polymer powders are not suitable for measurement.

Scandinavia | Home of CleanMed

Medicon Valley WORDS | SAM ANSON

This profile of Scandinavia focuses on Medicon Valley, the area around Malmö in Sweden and Copenhagen in Denmark with a high concentration of medtech and pharmaceutical manufacturers, research institutes and hospitals. It will also explain why Scandinavia is a pioneer in "clean" healthcare, that is to say an industry which is committed to sustainability and its environmental impact while maximising the safety of patients.

Medicon Valley is a large cluster of medtech and pharmaceutical companies located in the Øresund region in eastern Denmark and southern Sweden. It covers 21,000 sq km (8,108 sq miles) and contains around 398 companies, 3 universities, 9 hospitals and Scandinavia’s most accessible airport Copenhagen. According to a government report, these companies employed around 43,500 workers in 2008. Of this total, 37,000 were on the Danish side and 6,500 were in Sweden.

A total of 11,797 employees were employed in medtech, 22,308 in biotechnology and 21,363 in pharmaceuticals.

Between 2003 and 2006, the number of companies in Medicon Valley increased by 9%—comprising rises of 10% on the Danish side and 5% in Sweden—making the area the fastest growing region in both countries.

Geographically, the Øresund area connects the southern Swedish port of Malmö with the Danish capital Copenhagen to the west. The Øresund strait runs between the two cities. The strait is around 70 km long and at its narrowest is 3.4 km wide. It is one of the busiest waterways in Europe, linking the Baltic Sea with the North Sea and Atlantic Ocean. There is double track railway and dual carriageway bridge across the strait (see image above).

One of Medicon Valley’s strengths is its culture of collaboration across industry, academia, research and clinical practice. These close-knit communities have strong and interlinking foundations that are leading R&D in some advanced medical technologies.

One of the ten largest manufacturers in Medicon Valley and a big user of medical plastics is Coloplast, a manufacturer of devices for ostomy and wound and skin care with 8,000 employees. The company is headquartered on the Danish side of the Øresund strait in Humlebæk.

Other large OEMs in the valley include one of the world’s largest insulin pen manufacturers Novo Nordisk in Bagsværd, Denmark. Novo Nordisk is so large it represents approximately 20% of the top tier index of the Copenhagen stock exchange.

There is also home dialysis device maker Gambro, recently acquired for US$4 bn by Baxter Healthcare, in Lund, Sweden, device maker Ambu in Ballerup, Denmark, ostomy and woundcare device firm ConvaTec, previously UnoMedical in Birkerød, Denmark, and point of care testing device company Radiometer in Copenhagen.

SP Medical, a specialist medical plastic contract manufacturer is also on the Danish side of the cluster in Karise. With class 7, 8 and 48/ MPN / JANUARY-FEBRUARY 2013

9 cleanroom capacity, the company is primarily a moulder of devices such as dispensers, implants, needles and cannula, dosage systems, single use devices for hospitals and components for electronic diagnostic equipment. The company also offers its own brands of coated guidewires and dispensers as well as customised PTFE and hydrophilic coatings.

Home of “Clean Med”: Scandinavia, particularly Sweden, is a pioneer of so-called “clean med”, a recent trend which has been echoed in the States—and especially California—whereby hospitals are making a conscious effort to ensure their operations are ecologically sustainable and environmentally responsible.

The term clean med also encompasses an awareness by clinicians of not just treatment of a disease and physiological symptoms but also the general well-being of all people for whom the hospital is responsible. The idea includes employees and contractors of the hospital as well as its patients.

A key theme involved here is the procurement of devices used in a healthcare setting and an awareness of potentially hazardous side effects they might have on clinicians and patients.

An active institution is Karolinska University Hospital in Stockholm, Sweden. The hospital has a policy of setting environmental requirements during procumbent.

Under scrutiny is PVC, particularly that which has been softened with DEHP. The hospital is concerned there may be health risks associated with DEHP and that the incineration of PVC may be bad for the environment. For more information about DEHP and PVC in medical devices see Medical Plastics News, September-October 2012, pages 6-11.

Talking to Medical Plastics News, former environmental controller for the hospital Anne Marie Vass said: “Sweden is a pioneer in the healthcare sector because regional authorities have given public bodies resources to employ more people working in environmental issues than other hospitals I have seen.”

She added: “Stockholm county council and Skåne regional council in the southern part of Sweden have larger environmental departments than other similar organisation I have seen.”

Commenting on the incineration of PVC at hospitals, Anne Marie said that the problem is an economic one, not environmental.

She said: “Hydrochloric acid must be neutralised during incineration. If it is not, the acid causes damage to the chimney of the incinerator. The more chlorine present in the waste to be

SCANDINAVIA

<< Medtech companies in Medicon Valley. >>

burnt, the more the chimney needs to be maintained.”

Anne pointed out that while there may not be a problem in Sweden, there may be issues in countries where controls on incineration are not as tight.

She said: “If incineration temperature is too low, dioxines may be formed in the effluent. The incinerators used in Sweden are run at temperatures that are high enough to avoid the formation of dioxines and there is, therefore, no problem here. However, other countries may have incinerators which are designed to be run at lower temperatures. In these cases, incinerating PVC waste would emit dioxines thereby creating an environmental problem.”

Another Scandinavian, Jesper Laursen of Danish polyolefin compounder Melitek, highlights a cultural norm in the region

which explains a commitment to the environment and well-being.

“Scandinavian culture is one of a harmonised population. We pay high taxes and expect high standards in return. Scandinavians are highly educated, the gap between the poor and the rich is smaller here than in other developed nations and people place values on other things than economic wealth”, Jesper says.

“We are very aware of our environment. Nature is close to our hearts and we are protective of our clean air. Just like Volvo was a pioneer in car safety, the authorities are committed to people’s well-being,” he added.

These issues were discussed at the CleanMed conference in Malmö in September. The US version of the event will take place in Boston on April 24-26, 2013.

JANUARY-FEBRUARY 2013 / MPN /49

EVENTS medical plastics | DIARY 2013

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

Medtech trade show March 5-7, 2013 Tel Aviv, Israel

Plastics additives and colours conference March 6-7, 2013 Königswinter-Bonn, Germany

Medtech trade show March 6-7, 2013 Orlando, Florida, USA

Plastics trade show March 6-8, 2013 Sofia, Bulgaria

PVC conference March 12-14, 2013 Düsseldorf, Germany

Healthcare conference March 13-14, 2013 London, UK

Healthcare conference March 15, 2013 London, UK

Orthopaedics conference March 19-23, 2013 Chicago, Ohio, USA

The Irish Medical Device Association Awards, December 2012 The Irish medical device industry gathered in Galway in December for one of the most eagerly awaited annual ceremonies in the European medtech sector—the IMDA Awards.

The IMDA is the Irish Medical Device Association. As many as 15 of the world’s top 20 medical device manufacturers have manufacturing operations in the country. Austin Coffey, president of the SPE European Medical Polymers Division, reports.

The Medical Technology Industry Excellence Company of the Year was evaluated on a range of criteria including strategic vision, demonstrated quality of products and services, along with marketing and innovation, while demonstrating long-term vision with regard to building and financing sustainable business growth.

Competition was intense for the coveted 2012 Gold Award.

Stryker, De Puy and Hollister were shortlisted along with Lake Region Medical. However, it would have been an anathema should any company other than Lake Region Medical have won this award. Lake Region Medical achieved international recognition at receiving a Shingo Bronze Medallion for 2012 (they will be officially awarded the medallion at the 25th annual Shingo Prize awards gala in May 2013). The Shingo is an award for manufacturing excellence awarded by the Jon M Huntsman School for Business at Utah State University, USA. Barry O’Leary, CEO of the Irish Development Authority (IDA) presented the award to the vice president of operations, John Harris, in front of more than 350 attendees. The awards ceremony was preceded by an outstanding CEO forum with the seminar title “Building for a Healthy Future—The Evolving Face of Global 50/ MPN / JANUARY-FEBRUARY 2013

Healthcare”. Presentations from Helen Ryan, CEO of CregannaTactx Medical, Frank O’Regan, VP global operations, Bausch & Lomb and Pauline Oakes, director of operations, CR Bard, reinforced the message that Ireland’s medtech sector is best in class, plays a key role in leading device innovation, and contributes to Ireland’s economic recovery.

Lake Region Medical, based in County Wexford, began life producing around 4,000 guidewires a week in 1994, primarily for a small section of the European market. It now ships over 600,000 devices a week with an increasing product portfolio to over fifty countries worldwide.

The winner of the Emerging Company of the Year was Technopath, an Irish supplier of interventional diagnostic products to endovascular, cardiology and vascular laboratories as well as systems and consumables for cardiac and vascular surgery.

The prestigious Medical Technology Outstanding Contribution Award was given to John O’Shaughnessy, a paragon of the Irish Medical Device sector. John was a founding director of MedNova, a company which pioneered the development of embolic protection and carotid stent medical devices and also president and manageing director of CR Bard Ireland. John is currently Chairman of Neuravi, an early stage company in the large emerging acute ischemic stroke thrombectomy market.