MPN EU Issue 6

MPN

MEDICAL PLASTICS NEWS

DEAL OF THE DECADE? TURN TO PAGE 3...

ISSUE 5 March | April 2012 WWW.MPNMAGAZINE.COM

MPN

MEDICAL PLASTICS NEWS

MPN UNVEILS THE HIDDEN GEMS TURN TO PAGE 10

MPN

All Medical, All Plastics

Contents 7. Editor’s letter: Sam Anson Top 5 takeaways from Medtec Europe.

Page 10–11

8. On the Pulse: News from the Industry Bluestar’s new ultra soft silicone, industry-led education and roundup.

10. Cover Story: Phillips-Medisize Deal of the Decade?

Elite European automation meets advanced multi-shot moulding.

Page 16-23

13. Design 4 Life: Dental Special 3D printer helps dental implant modeller,TPE dental floss.

16. Clean Machines: Automation and Robotics LSR injection moulding, 1,000 viper robots, automatic leak testing, UK market growth, in mould labelling and in-line sterile injection moulded packaging.

Page 30

24. Material Diagnosis: TPEs PolyOne update — TPE waste bag, new Velox deal, innovation centre opens, NPE website, TPE for tubing end of line, Mediprene replaces rubber in syringes and API invests in R&D. 28. Material Diagnosis 2: TPUs Hydrophobic Soft TPU from Lubrizol and PolyOne’s NEUSoft classification.

Page 32

32. Country Focus: Singapore - The Gateway to Asia Protect your medical IP in Singapore, Gate 2012 preview and a new microfluidics society.

38. Purging and Cleaning: Moulding maintenance Dry ice cleaning, purging round up and pressure blast cleaning of feedscrews.

42. Product Focus: Inhalers Extractables and leachables for Orally Inhaled and Nasal Drug Products (OINDPs).

44. In the zone: In Vitro Diagnostics Profile of Union Plastic (UP) and how the company serves this sector of the industry.

47. Regulation Review: Material Risk, the FDA and 510(k) Steve Duckworth of Clariant gives insight into changes in materials and the 510 (k).

48. End of Line: Parts Handling Conveyor belts in cleanrooms.

50. Folio: High Res Images Foster Corporation’s Biomedical Polymers and Stock Components from Qosina.

52. Chinaplas: Show Preview Pre-registered visitors enjoy special admission arrangement.

56. Doctor’s Note: Integration with Clinicians OrthoSensor’s Balancer for Knee Arthroplasty and polymers for open heart surgery.

58. Events: Industry Diary Key events including Mediplas.

Online and in digital Page 42

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

MARCH | APRIL 2012 / MPN /5

MPN | EDITOR’S LETTER

MPN | CREDITS

editor | sam anson advertising | gareth pickering art | sam hamlyn

Medtec 2012: Top 5 Takeaways Developments in plastic pharmaceutical packaging shine through at Medtec 2012 The two most important discoveries for me in the area of medical plastics are the use of automated technology for prefillable syringes and blow-fill-seal (BFS) applications.

In pre-fillable syringes, Engel presented the results of a highly successful project, developed from the toothbrush manufacturing industry, to manufacture and assemble pre-fillable syringes in the mould — with the syringe chamber being moulded from a cyclic olefin polymer around the needle.

The project, which enables the replacement of glass in pre-fillable syringes, is a result of Engel’s careful work with its partners, including specialist German toothbrush automation expert Zahoransky, and German pre-fillable syringe contract manufacturer Transcoject.

The technology is proof of concept that highly precise in-mould assembly is now truly possible. Furthermore, it opens up new fields of proven technology in automated pre-fillable syringe manufacturing.

The key aspect to this technology comes from Zahoransky’s needle feeding system (NFS) and is based on the automated handling of toothbrush filaments. Transcoject is responsible for the development work with its strong network of pharma customers.

The growth of blow-fill-seal applications (BFS) for pharma companies was another key takeaway from the show.

Much work is being carried out in the development of new polymer compounds, which can be formed, cooled, filled and sealed in one process, without interruption. This provides exceptional promise for pharma companies wishing to invest in pharma packaging lines in lower cost countries

around the world, especially India.

The third most important development was the onset of TPUs and how these versatile materials are catching the eye of medical device OEMs, particularly with respect to silicone replacement. Representatives from USAbased Lubrizol were at the show promoting their new hydrophobic Tecothane Soft TPU, a potential replacement for silicones in medical applications.

Number four is my own observation of an apparent growth in the number of ISO 13485 certified suppliers. Despite the fact that there is no data to prove this, every time I visit a trade show, which is at least once every quarter, there seem to be more and more companies who have just achieved ISO 13485.

Number five is a piece of insight I gained into polycarbonates from resin manufacturer Styron. Speaking to Martin Lindway, the company’s global medical marketing manager, I captured what it means to be a relatively new entrant in the medical device industry. Previously part of Dow Chemicals, Stryon’s medical prowess is something of a hidden gem.

The company claims to offer the purest and most refined medical grade polycarbonate, ABS and ABS blends thanks to a purpose-built dedicated medical production plant in Germany.

As the third largest polycarbonate resin manufacturer in the world, its line is open for business for custom manufactured polycarbonates, including filled and coloured grades. One visitor told me that Stryon’s ABS is renowned for for glass replacement in drug delivery applications thanks to an exceptionally low level of residual monomer making the resulting polymer incredibly pure.

art | tracey roberts production | jonathan jones subscriptions | tracey nicholls publishers | mark blezard

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

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

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

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MARCH | APRIL 2012 / MPN /7

ON THE PULSE | News from the industry

NewStar Bluestar Silicone producer’s ultra soft 1 durometer grade, its self lubricating grade and its new US facility wow visitors as MD&M West

Bluestar Silicones has expanded its range of Silbione branded liquid silicone rubber (LSR) products for the healthcare market to include two new specialty products. The company has introduced a unique

February 13, 2012 Full turn out for SPE Medical Plastics conference at MD&M West

Conference organiser Len Czuba, past president of SPE Medical Plastics Division said: “MD&M West is one of the largest gatherings of medical device and manufacturing engineers on the planet.

The SPE wishes to thank Medical Plastics News for its help in supporting the conference. We look forward to continued cooperation in 2012.”

8/ MPN / MARCH | APRIL 2012

February 14, 2012 Phillips Medisize Launches New Logo and Tagline at MD M West

new 1-durometer LSR and a new self-lubricating 60-durometer LSR. The new 1 Shore-A hardness product, Silbione LSR 4301, uniquely combines strong physicals and easy processing in a low durometer material. The product delivers high tear strength and high elongation in soft cushioning and vibration dampening applications.

The other newcomer, Silbione LSR 4360 SP, provides self lubricating properties to precision moulded parts, moulded rubber stoppers and O-rings. The material is designed to minimise friction at the interface of the moulded silicone with another substrate or between moulded silicone and skin tissue.

These materials will be produced at Bluestar Silicones’ brand new 226,000 sq.ft manufacturing facility located in York, South Carolina. The site, which includes cleanrooms to support the healthcare market needs, is expected to be fully operational in June 2012.

Talking directly with Sam Anson, Matt Jennings, President and CEO, said: "Medisize has brought an excellence in automation know-how and Phillips brings a strong expertise in multi shot moulding.

As a result we expect to be able to offer low cost automated multi shot moulding, which will give us a competitive edge in our existing markets and as we expand further afield, particularly into Asia."

February 20, 2012 Riverside Medical commissions and validates 8th cleanroom

The ‘Carsington’ cleanroom is specifically designed to house a most advanced, fully automated, 9 station ultrasonic cleaning unit. Medical devices requiring cleaning pass through two cleaning solution ultrasonic baths, are rinsed with filtered/treated water after each and then finally with deionised water.

ON THE PULSE

Medical device industry!

Put your educationfirst...

SPE recognises oustanding achievement at Queen’s, Belfast, Northern Ireland The best programmes at university include participation from plastics industries in the nearby area.

Generally, corporations provide funding and direction for students but a third partner in what I have seen as the finest programmes include government bodies that both provide incentives for industries to connect with university departments that have the capability of supporting new initiatives.

A university, which has churned out hundreds of graduates’ is Queen’s University, Belfast (QUB), under the tutorage and leadership of Gerry McNally. The Polymer Processing Research Centre (PPRC) was formed to provide the research capabilities to industry in the surrounding area in Northern Ireland. The partnerships from industry were concise problem areas or projects that would be assigned to QUB students and directed by the sponsoring company and staff of the PPRC. Thanks to the efforts of Gerry McNally and the PPRC, those companies are seeded with the talented graduates of QUB and the research programmes that were funded. Other such programmes exist, such as the fine programme at UMASS (University of Massachusetts) Lowell, and I strongly encourage more such affiliations

Adding colour during polymerisation prevents additional heating and diminishes variability. This helps to reduce scrap, eliminate defects and offer more consistent batch-to-batch melt indices.

Len Czuba past-Chairman of the Medical Plastics Division and outgoing Councilor of the European Medical Polymer Division

20:03:2012

PREVIOUSLY ON MPN MAGAZINE.COM March 5, 2012 New Lubrizol TPUs - pREcoloured and hydrophobics from Velox

and collaborations. How better can we prepare the professionals of tomorrow than to give them interesting, meaningful research challenges that can help them learn the industry during their education programmes today!

To recognise the years of service to QUB, the plastics industry and to the government agencies involved with the successful programme headed by him, Gerry McNally has been awarded the prestigious Society of Plastics Engineers 2012 Annual Education Award. He will be recognised at the Hall of Fame banquet being held in cooperation with SPE/SPI and the ANTEC/NPE event in Orlando, Florida, on Sunday April 1, 2012.

March 6, 2012 Las Vegas Medical Plastics Conference a Success

According to the participants survey, the conference was rated at 4.27 out of 5, which is clearly a testimony of the quality and content of the presentations that were put together along with the forum for networking.

March 7, 2012 Mediplas UK issues call for papers

This debut UK event is uniquely focused on the highly specialised area of manufacturing plastic parts for the medical industry. Colocated with TCT, MM Live and Sensing Technology, the projected attendance is approaching 6,000.

24 MARCH | APRIL 2012 / MPN /9

COVER STORY

A meeting of minds On hearing the news of the merger between Phillips and Medisize, a number of keywords sprung to mind, such as Euro-US transatlantic cooperation, what a great idea and why didn’t they do it earlier? What I didn’t expect was that the new logo would be everywhere at MD&M West, including on the room key of the Marriot hotel at the Anaheim Convention Center.

However, the most obvious outcome of the event is synergy, the buzz word that describes when the combined effect of a merger is greater than the sum of its parts.

And after analysing what Phillips and Medisize have to offer in terms of technology, innovation and regional prowess, synergy really is the only word that springs to mind.

Already the combination of key strengths are shining through — Medisize is renowned for its industry-leading automated assembly, particularly in the lucrative mid to high volume assembly runs while Phillips’s expertise in multishot moulding is second to none. To give you the full picture, Bill Welch, the newly formed company’s Chief Technical Officer, and Matt Jennings, President and CEO, write exlusively for MPN.

grip) and dampening — sound and vibration isolation.

Another specialty within multi-material moulding is the creation of a Moulded Interconnect Device (MID). An MID is created by moulding two materials — one that can be plated and one that resists plating — to form a 3D circuit board. This can be very effective in eliminating the need for multiple flex or hardboard circuits, and provides the added benefit of creating complex shapes.

Phillips-Medisize has also developed a system for hardcoat (a common requirement for PC lenses) that enables digital printing of the hardcoat, effectively reducing cost and lead time, and masking requirements when a multi-material component requires a hardcoat.

Bill Welch, Chief Technical Officer on Multi-Material Moulding and Automation Multi-Material Moulding Multi-material (multishot) moulding has been extensively used in the commercial markets for over 25 years, but has had slower adoption in medical. When properly integrated into a design, it can be the elegant solution to reduce overall cost and improve quality, being mindful to balance the upfront tooling costs with the manufacturing savings and quality improvement. While multi-material moulding was initially focused on two materials, we today have examples of four materials being used in a single injection mould. In cases such as this, multiple benefits are being realised in a single part, including integrated sealing, reduced part count (eliminates assembly), integrated graphics (eliminates secondary printing operations), soft touch (improves tactile feel and 10/ MPN / MARCH | APRIL 2012

<< The OmniPod is a modern diabetic meter and drug delivery device. It contains a multimaterial, multi-shot MID electronic component manufactured by Phillips-Medisize. >> Automated Assembly The Phillips-Medisize approach is to offer customers both technology and market-focused facilities in multiple, convenient locations. Consistent with this approach is the development of Centers of Excellence for varying levels of automated assembly.

Several Phillips-Medisize facilities have unique expertise in advanced assembly, for example, the new Richmond, Wisconsin facility is focused on lower volume, complex single-use products, and heavily leverages low volume “smart” assembly.

The Menomonie facility, also in Wisconsin, is focused on mid- to mid-high volumes and has demonstrated expertise in complex flexible automation cells with many operations, and higher volume automation modules with compact machine footprints.

World English Dictionary synergy — n , pl -gies 1. Also called: synergism, the potential ability of individual organisations or groups to be more successful or productive as a result of a merger 2. The interaction of two or more agents or forces so that their combined effect is greater than the sum of the effect of their individual parts.

[C19: from New Latin synergia, from Greek sunergos; see synergism]

The plant in Kontiolahti, Finland, is focused on high volume, fully automated assembly and is best-in-class in managing and validating complex systems that have many moulded and purchased components.

All Phillips-Medisize facilities leverage robotics and press-side automation to reduce cost and lead time by working within the machine cycle time.

Customised production — partnerships built on innovation The primary benefit of the Phillips-Medisize approach is to develop a customised solution based on programme volume, compexity and risk. By offering our customers options from manual assembly in low-cost countries to highly automated and engineered solutions, PhillipsMedisize is able to select a manufacturing strategy that is in the customer’s best interest. Further, by gaining early involvement via its design centres, Phillips-Medisize can scale operations, starting with low-volume clinical or pilot builds and ending at the desired scale, managing capital cost and manufacturing risk along the way.

<< The images show the automation capabilities of the company. Notice the blur in the first image, reflecting the speed at which devices are being assembled. >>

Matt Jennings, President and CEO on Partnerships Through Innovation Today there’s continued pressure for our drug delivery and medical device manufacturers to innovate with new products appropriate for the global markets to drive top line growth, continually improve quality, stay compliant with the changing regulatory landscape and simplify the supply chain to reduce costs. That is a mouthful but true.

As a result, our customers are looking for partners that understand the market challenges and that can be a valued resource to help them achieve their goals. Partners that can help them design, develop and industrialise their ideas to help with accelerating products’ time to market is critical.

Our customers are also looking for partners that can reduce supply chain length and complexity by offering locations close to end markets. Partners that proactively find ways to take out costs in the supply chain and improve quality is always a requirement. That’s what Phillips–Medisize does well every day. We take a customer-centric approach and align our strategy from design and development through manufacturing with what they’re trying to accomplish around the globe. But true partnerships need to be a two-way street, with the OEM willing to share their strategy and objectives, be open about resource constraints and limitations and have a willingness to share the responsibility.

Medical devices are becoming smaller and smarter and OEMs are placing more focus on cosmetic and human factor engineering into the product design in addition to the traditional form, function and fit of medical design elements.

As a result, drug delivery devices and diagnostic devices that must maintain very high tolerances and quality standards while incorporating cosmetic finishes is something we see more and more, particularly with high-volume patient use items. Another important development is people are increasingly integrating electronics into their devices. It’s something that we’ve been positioned well to do with our advanced capabilities in multishot moulding, automated assembly and quality control and advanced inline coatings and finishing technologies to help achieve the desired design intent and user experience.

Today we offer advanced multi-material (multi-shot) capabilities that include up to four different materials in a single, complex mould. We also have the capability to have one or two of the materials be a silicone. This provides an elegant solution to sealing issues, while reducing part count and creating a shorter supply chain. Also, our metal injection moulding (MIM) is a great process for components that require tight tolerances, with surface finish that is much improved compared with the industry’s early years.

DESIGN FOR LIFE

Digital Dentistry ... now in 3D

Background Enabled by 3D printing, dentistry is undergoing a digital revolution. Digital dentistry represents the merger of mass production with individual customisation, providing a faster and more costefficient dental workflow. The adoption of digital dentistry is increasingly defining and driving the success of dental businesses. Those dental labs that rise to the challenge will be the companies that grow fastest in the years to come.

Dental implants have been used successfully for many years to restore missing teeth. They donâ&#x20AC;&#x2122;t decay and they function just like real teeth. Until recently however, the placement of dental implants involved an invasive and time-consuming surgical procedure. They were placed where they would be guessed likely to fit and frequently not enough planning and thought was given to future functional longevity and cosmetics. Now, with the advancement of digital 3D printing and lab expertise, a dental implant can replace missing teeth with pinpoint accuracy, minimum discomfort, and beautiful cosmetics.

Adoption of 3D printing for dental manufacturing is constantly growing. Many laboratory professionals have discovered what clinicians have been slower to recognise: that 3D printing of dental models is faster, more economical,

<< Objet Eden260V 3D Printer >>

<< Objet 3D printed model printed with Objet VeroDent Material >>

3D printer helps Dutch dental implant modeller save time and money

predictable, consistent and accurate. Return on investment can be incredible if a team approach is adhered to.

The Challenge Located in the Netherlands, Oratio B.V. was one of the pioneers of CAD/CAM design technology for producing dental restorations straight from CAD design imagery.

With excellent experience in services and positive signs from the market, Oratio found itself in an optimal position for initiating growth. At the same time, the company needed to streamline its business. It required a system that could improve throughput without compromising its high standards and without costly expansion of the companyâ&#x20AC;&#x2122;s technician staff and facilities. >> MARCH | APRIL 2012 / MPN /13

DESIGN FOR LIFE >> CONTINUED FROM PAGE 13...

The Solution From its early days, Oratio has worked hard to keep its staff and equipment up to date with the most advanced technologies to ensure the highest quality dental restorations. It was therefore natural for Oratio to carefully examine the possibilities of combining 3D printing with digital imaging to become a fully digital dental service provider.

With its new Objet 3D Printer, Oratio is now able to bypass the slow and expensive CNC milling technology to deliver models faster, at lower costs, and maintain its competitive position even as the market gets tougher.

The Objet 3D Printer has enabled Oratio to introduce non-technicians into the manufacturing workflow, freeing up dental technicians to focus on higher-level tasks. As a result, lab technician productivity can be improved significantly. Oratio can now provide a wider range of dental solutions, with higher accuracy and improved turnaround times.

The printed models that come out of the Objet Eden260V 3D Printer provided Oratio with exceptionally fine details and an outstanding surface finish — all necessary for ensuring the high degree of accuracy required by the Oratio team and its dentist customers.

The Value “Growth came almost immediately,” said Siebe van der Zel, Oratio’s Chief Operating Officer.

“This enables us to increase our productivity and efficiency and continuously provide many new restoration types to attract new orders. We believe that our clients prefer to do all their CAD/CAM business in one place.

“Therefore, we needed to firmly position Oratio as a self-sustained CAD/CAM dental provider offering the widest spectrum of dental indications. For Oratio, outsourcing parts of the workflow was not an option. We wanted full control of the complete process — from the dentist’s initial order, to designing the restoration, through final manufacturing. We were adamant about fulfilling our promises, and therefore we needed to command all phases of our business.”

By adopting the Objet Eden260V 3D Printer, Oratio was able to realise a complete digital workflow for in-house fabrication of models, abutments, coping, crowns and bridges of any size or combination.

More information about Objet Dental Solutions can be found at www.objetdental.com

14/ MPN / MARCH | APRIL 2012

TPEs get the bit between their teeth

Stretchable dental floss makes a fine appearance In addition to collaborating successfully for several years, Gabriel-Chemie UK Ltd has been working on a new project with the Scottish based company Perident UK Ltd. The product, Blue Fibaclean, is an extruded synthetic thermoplastic elastomer — more specifically, a polyether block amide that is designed for dental and food uses. The material is extruded with a GabrielChemie Group masterbatch that allows processing at temperatures of about 250°C and drawn over heating plates and rollers to create a tape with dimensions of 1.3 mm wide and 0.06 mm thick. The resulting tape has good strength properties and elongates by approximately 33% when stretched. This is perfect for fitting between the interproximal spaces to remove food debris.

Perident, established in 1986, is part of the Norwegian Jordan Group of companies and is based in the heart of the beautiful Scottish Borders. It is one of the world’s leading companies in preventative oral care.

Perident’s product portfolio includes dental floss and tapes, premium floss products, dental sticks, interdental brushes, breath freshener sprays and tongue cleaners.

Further information on Perident can be found at www.dentalfloss.co.uk The GABRIEL-CHEMIE Group specialises in the colouring and refining of plastics.

The Company was founded in 1950 and is today one of the leading masterbatch producers in Europe. The independent, privately owned group has its headquarters in Gumpoldskirchen, Austria, with subsidiaries in Germany, Great Britain, Hungary and the Czech Republic and Russia. The annual groups turnover of 85,6 Million Euros is achieved with 461 employees.

More information on Gabriel Chemie's colour & additive masterbatch range can be found at www.gabriel-chemie.com

CLEAN MACHINES

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Automation and Robotics | CLEAN MACHINES

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fully automated production

High precision, high cleanliness, high automation: LSR production cell with high level of autonomy for medical technology In addition to high precision, the field of medical technology also demands an extremely clean working environment. These requirements â&#x20AC;&#x201D; combined with the already highly demanding production of moulded LSR parts â&#x20AC;&#x201D; have given rise to a sophisticated modular production solution that is equal to the task. The autonomous injection moulding system for the production of a medical closure cap can be docked to a cleanroom.

Automatic production of medical closure caps from liquid silicone The white closure caps are produced in a 32cavity mould from Rico. They are injected directly and without sprue via a cold runner system and cold runner nozzles. When the mould opens, all 32 caps are located on the cores on the ejector side. The Kuka six-axis robotic system docked onto the cleanroom moves the handling head into position and uses centring devices to attach itself to the mould. The mould ejector pushes the 32 caps into the demoulding module through an integrated perforated plate.

In this way, all the parts are held in a special guarded enclosure. The robot then moves out of the mould and to the conveyor belt. Here, a flap opens on the demoulding module, enabling all components to be set down together on the encapsulated conveyor belt in a targeted manner.

Flexible six-axis robotic system Working in collaboration with system integrator FPT, Arburg has implemented the Selogica user interface in the control system of the six-axis robotic systems.

This solution brings the user decisive advantages: after just one brief training session, robotic sequences can be

16/ MPN / MARCH | APRIL 2012

independently programmed. The robotic system is directly linked to the machine control system. Online communication extends far beyond the Euromap interface and offers functions such as the synchronisation of movements and simplified machine start-up. This results in shorter setup and cycle times.

Advantages of the modular production cell The non-pneumatic demoulding of the parts is completely compatible with cleanroom use and the conveyor belt, on which the parts are deposited, is directly connected to the cleanroom. As a result, production can pass directly on to downstream processing stations, such as tempering, inspection and

www.kraussmaffei.co.uk

packaging. Modularity, high quality and output, as well as consistently clean production conditions – these are the characteristics of Arburg’s flexible production cells in the field of medical technology.

The electric Allrounder 520 A, with a clamping force of 1,500 kN and size 400 injection unit, meets the highest hygiene requirements in accordance with ISO 13485, as well as the specifications of the FDA and the GMP directives thanks to an encapsulated stainless steel clamping unit, which is reportedly unique to Arburg. The stainless steel surfaces can be cleaned much faster and are insensitive even to the aggressive agents commonly used during sterilisation.

Moreover, the raised machine base, which is covered on the injection side, as well as the nickel-coated mounting platens with covered holes are advantageous in terms of cleaning. The resulting reduction in downtimes also brings greater efficiency in production.

A cleanroom module with air ionisation above the machine’s clamping unit ensures that the air in the work area is kept as free of particles as possible. The module generates a high level of air circulation via a prefilter and HEPA filter, as well as neutralises electrically charged moulded parts. Liquid-cooled drives and control cabinets are standard at Arburg and also aid lowemission production.

Furthermore, only FDA/NSF H1-compliant lubricants are used.

Accordingly, the Allrounder meets the cleanroom requirements of ISO classes 5 to 7.

MARCH | APRIL 2012 / MPN /17

CLEAN MACHINES Automation and Robotics | CLEAN MACHINES

Snake Eyes: 1,000 Viper Robots and Counting Seletec has been using injection moulding machines from ENGEL since the 1980s, with the focus switching to automation in its new ENGEL AUSTRIA is projects. That’s why celebrating the delivery of its an ENGEL viper 40, 1,000th viper robot. In the anniversary future, the robot will be used edition robot, was delivered to the to handle inserts and Pinzgau region of prefabricated parts in hybrid Austria as part of a applications at Seletec complete package Plastics Products in the that includes an Austrian town of Uttendorf. ENGEL duo 650 injection moulding machine. “With pressure continuing to build on costs, those of us in western Europe can no longer afford to work without automation,” said Gerald Rauch, Head of Sales and Development at Seletec. “Automation guarantees stable processes, which raises productivity and enhances our production quality.”

The new large-scale machine will be used to make technical parts for a wide range of application fields, including housing components with metal threads. “When several inserts are placed into a mould at once, the speed of the robot is what counts,” stressed Rauch. “We also look for fast cycle times and maximum precision in our handling operations.”

Minimal cycle times, precise movements The ENGEL viper robot is the ideal machine for these requirements thanks to its innovative software packages: vibration control, mass identification and efficiency control. These software packages eliminate

18/ MPN / MARCH | APRIL 2012

the structure-borne vibration of the robots — even with longer axis dimensions — and optimise their movement and dynamic values. This ensures high tracking and positional accuracy and minimises cycle times. The viper robot also adjusts its movements to the respective manipulation weight and avoids unnecessary wait times outside of the machine.

Since ENGEL supplies both injection moulding machines and robots from a single source, full integration of the two control environments is guaranteed. “Operating the robot is simplicity itself,” said Rauch. “Our staff were comfortable with the new system by the second day of training — they can control the robot using the familiar commands on the machine itself.”

From product development to series production Seletec — a Klepsch Group company — has its roots in metalworking. The company started producing high quality injection moulded articles for technical applications in the 1950s. Today, as a global service provider, Seletec covers the entire value chain — from product design and development to mould production and series manufacturing. Seletec’s customers represent many segments of industry, including logistics, materials handling, mechanical engineering, agriculture, furniture production, electronics and medical engineering.

ENGEL viper robots are available in six sizes with nominal load-bearing capacities of 6 to 90 kg. Since the viper series was launched, ENGEL has significantly increased its sales in the field of linear robots. This is partly due to the fact that the linear machines are sold not only in a package with injection moulding machines, but also as replacements for old equipment or use with injection moulding machines of other brands.

Speed Leak Testing ... times 8!

WORDS | Joe Pustka, Uson Medical Device Leak Testing Technical Support Manager, www.uson.com atheters, blood collection kits, check valves, disposable syringes and more — if there is one unifier in their design, it is that plastics take costs out. Everything else you can do to squeeze the fat from production costs is a great value add. That’s a main reason why the competitivelypriced and innovative 8-sensor input, two-channel Uson Optima vT Leak and Flow Tester will likely become the leak detector of choice for most plastic medical products in very short order.

Uson’s Optima vT includes one or two test channels with four sensors each, totally customisable pneumatics, multiple built-in automated calculators, myriad data handling and storage options and other features that combine to define the “v” for versatility in its name. R&D for the multi-function single or dual channel configured Optima vT Leak and Flow Tester began in 2009 and incorporates Uson’s vast and unparalleled knowledge of the wide ranging requirements for leak detection and flow testing for all types of medical plastic products in use today.

If a plastic product needs to be tested once, you can use each of the eight sensors to simultaneously test eight units.

Do the math — that’s an eight-fold increase in the throughput of the leak test stations in automated assembly lines.

Or, think of any number of products that require multiple tests in sequence of sub-assemblies and final assemblies. With

C

the Optima vT Leak and Flow Tester you can deploy these eight-sensors for any combination of vacuum decay tests, pressure decay leak testing, differential pressure decay leak tests, mass flow leak detection (including back pressure and differential), upstream and downstream cracking pressure, pressure rise tests, burst tests, laminar flow tests, force decay testing, and occlusion testing. The eight-sensor inputs are independent, allowing for simultaneous testing in any combination of test sequences. Built-in automated calculators also speed testing and data handling. Pneumatic controls are fully customisable because no two medical plastic products have the same design specifications and square peg in round hole solutions yield substandard results.

MARCH | APRIL 2012 / MPN /19

CLEAN MACHINES Automation and Robotics | CLEAN MACHINES

Wittmann Battenfeld UK sees healthy 2012 ahead Barry Hill and the UK Wittmann Battenfeld team see 2012 as continuing a welcome and upward trend for the Wellingborough — based company sales and demand for Battenfeld moulding machines are steadily increasing this year. The volume demand for Wittmann automation and robotics, however, is even stronger.

A key part of this growth in the UK and Irish market comes from medical and healthcare sectors. “Medical and healthcare sectors are typically committed both to detailed technical moulding and to the process systems that back that production up,” said Managing Director Barry Hill. “When a customer has been through extensive audit and approval processes, FDA or otherwise, the word “compromise” no longer features in their vocabulary. A medical moulder will invariably seek the best possible solutions on behalf of his/her client. And that is where Wittmann robots enter the picture.”

A combination of continuous technical improvement — Wittmann is now on the eighth series of its basis linear robot range — together with very competitive pricing means that the Wittmann automation of the medical plastics marketplace has plenty of growth yet to run.

“Our last slate of robotic innnovations — exhibited at Fakuma 2011 — continued to show me, said Hill, “that no other supplier, certainly no injection moulding machine

UK

<< Wittmann's new W818 robot features a maximum handling load of 6 kg and a possible maximum vertical stroke of 1,200 mm. The appliance is equipped with three powerful servo motors and absolute encoders for all linear axes as standard. >>

company, has the ability to a make a better linear robot. No other company can provide such breadth and depth in automation technology.

Hill noted that “our Series << Some of the Wittmann Battenfeld 8 robots, for UK sales team. From left to right, example, Paul Dummer, Dave Womack, continue to Barry Hill and Danny Williams. >> push the state of the art in terms of value-for-money and performance results. Our clients in medical plastics continue to value: the high-spec and durable build; the reliability and failsafe performance in production; the ongoing ergonomics (less cabling; more modular design); smart-bus technology; simplicity of singlepoint programming and complete flexibility in production; the servo drives; steel components; high capacity linear bearings — and many more factors besides.”

Hill noted that the “one-stop-shop approach” whereby Wittmann supplies all equipment for injection moulding needs — launched at the time of Wittmann”s acquisition of Battenfeld in April 2008 — is producing clear benefits. “The results have been well worth it,” he said.

All of these factors would, however, be nothing, said Hill, without a good team to drive them: “Myself, Paul Dummer and Danny Williams are hopefully becoming more and more familiar to UK moulders as the faces of the company over the past 18 months. With Steven Martin now appointed and looking after the North and Scotland, we are really looking forward to the challenge of new automation projects and even better technology to match.”

To view Wittmann robot and automation technology check www.wittmann-robot.com. For all further details contact Barry Hill or the Wittmann Battenfeld sales team at Wellingborough. www.wittmann-group.co.uk

20/ MPN / MARCH | APRIL 2012

Fighting Counterfeit Pharmaceuticals Using Automated In-Mould Labelling (IML) IML proves effective in foiling counterfeiters in pharma business Pharmaceuticals are extremely profitable for legitimate drug companies. Now, counterfeit pharmaceuticals have become big business for counterfeiters. Recent articles have noted that counterfeit pharmaceuticals “are a major ongoing threat to patients and pharmaceutical manufacturers and harm manufacturer reputations, reduce revenues and lower return on investment (ROI) in research and development.”

To foil pharmaceutical counterfeiters in pre-filled syringe products, a consortium of six companies will showcase a new solution to preventing counterfeit pharmaceuticals in prefilled syringes from reaching patients: in-mould labelling of prefillable syringe barrels. At the time of going to press, this advanced anticounterfeiting solution was about to be demonstrated in a high-speed, hightech automated system at the National Plastics Exposition (NPE), April 1–5, in Orlando, Florida, on booth 3169, CBW Automation.

In-mould labelling technology offers a number of benefits to pharmaceutical brand owners, including the ability to create a label with special inks that will only be revealed under special “black” lights. The label, developed by Inland Label (booth 8939), can also be “coded” so that each syringe has its own identity to ensure it is the “real deal.”

Additionally, the polymer label actually becomes a part of the syringe barrel, making it impossible to remove the label and replace it with a counterfeit one.

Preventing counterfeit pharmaceuticals with IML is a technologically advanced method that exceeds other methods such as lot traceability numbers on cartons or printed code numbers on packaging. It is even superior to peel-and-stick labels, even those with holograms or colourshifting inks or ultraviolet pigments, because once the label becomes one with the moulded part, it cannot be removed without destroying the syringe.

“This high-speed automated IML cell requires unique label placement precision using a small diameter wrapping of the label onto the mandrel for accurate positioning,” explained Jim Overbeeke, Vice President of Sales for CBW. “Due to the registration markings on the labels for accurate dosage level, precision placement is critical. In fact, accurate automated placement of the label is what sets this product apart from ordinary syringes.”

Developing an automated IML manufacturing cell requires attention to detail and a high level of collaboration by all parties involved. “There were a huge number of challenges to overcome in this workcell,” said Dave Carson, President of CBW. “But each of the partners rolled up their sleeves and helped each other out in many ways. In the end the system exceeded our expectations. It was a true collaborative effort and partnership. However, the effort was worth it.”

JULY 2011/ MPN /21

CLEAN MACHINES Automation and Robotics | CLEAN MACHINES

Automated injection moulding of sterile plastic packaging for medical applications

<< KraussMaffei EX CleanForm machine.

In the aseptic manufacturing concept, the whole manufacturing cell is installed in a cleanroom. >> Medical products injection moulded from plastic are normally sterilised in a separate process before being packaged. It AUTOMATED would be more STERILE PACKAGING effective to take the parts DIRECTLY FROM that, in any THE MOULD case, come sterile from the mould and package them immediately.

To show how this could be achieved, KraussMaffei has designed a concept manufacturing cell for producing these products aseptically.

In manufacturing sterile products, certain criteria must be met to keep the risk of contamination by microorganisms, particles and pyrogens as low as possible. A great deal depends on the skills, training and behaviour of the operators. Quality assurance is of critical importance and the manufacturing processes must meticulously adhere to methods and procedures that have previously been defined and validated.

22/ MPN / MARCH | APRIL 2012

Sterility, or any other aspects of quality, should not only depend on the last manufacturing step or on testing the end product.

Most medical products made of plastic are manufactured in a GMP Class C or D cleanroom environment and then sterilised in a separate process stage.

Depending on the process used, sterilising plastic parts can cause problems. For example, if plastic parts are sterilised by irradiation, the mechanical properties of the polymers may be affected. This, in turn, needs to be taken into account in the design of the part â&#x20AC;&#x201D; for example, by making walls thicker than would otherwise be necessary.

The fact is that post-mould sterilisation will always be required if the parts, which are sterile in the mould, get recontaminated through contact with people, equipment and the air. The logical conclusion is that production of simple, bulk components could be drastically simplified by utilising the fact

that injection moulding is an autosterile process â&#x20AC;&#x201D; the high melt temperatures and the pressures reliably kill all germs.

Up to now, the industry has paid too little attention to the potential savings here. At the moment when the mould opens, the parts can be regarded as sterile. If they were packaged immediately, it would be possible to eliminate the post-mould sterilisation stage. This approach would also sharply reduce the particle contamination that normally occurs during post-mould processes.

The fundamental requirement of such a solution would be that the entire process complies with GMP criteria for aseptic production. On this basis, KraussMaffei Technologies GmbH has designed a manufacturing cell capable of running an aseptic process to manufacture sterile medical products.

The concept is based on an all-electric EX CleanForm injection moulding machine and the matching automation.

The other major component is the

CLEAN MACHINES

cleanroom in which the manufacturing cell is installed. A complete system would also include a packaging system and possibly other equipment, depending on the application. Three criteria were applied to the design of the manufacturing cell: - the product defines the production environment; - the clean and sterile state of the particles when the mould opens must be << Zone concept: Once the maintained until they are enclosed in the requirements had been identified, appropriate sterile packaging; and - the manufacturing cell must be capable product zones and system zones were defined and allocated the of running an efficient and productive appropriate cleanroom areas. >> process while at the same time complying fully with GMP criteria for the Automated processes reduce the risk target cleanliness class. of contamination These requirements make it clear System Zone 1 is surrounded by a that, especially in medical technology applications, quality has to be planned in System Zone 2, which complies with GMP B (with the air supply separated by from the start. The demands on the a pressure differential or by air flow), injection moulding cell are highly complex. The decisive factor is the ability and/or by a System Zone 3 compliant with GMP C (separated by a barrier). to match the manufacturing concept These zones are planned to meet GMP perfectly to the product and also take cleanliness classes B and C. account of the production environment.

The limits of System Zone 1 are In tackling the complexities of this type formed by the housing of the clamp unit of solution, KraussMaffei has the and by the walls of the cleanroom area, advantage of years of experience in which surrounds the handling and engineering for cleanroom packaging equipment. This Class A manufacturing. cleanroom is flushed by a lowRisk analyses were carried out to turbulence displacement flow of clean align the process-related features of air (laminar flow). injection moulding with the The travel of the robot gripper, internationally valid GMP guidelines. which handles the product, is restricted Using the results of the analyses, to the defined product zone — from the KraussMaffei engineers developed a list mould cavity to the intake area of the of definitions and adaptations that packaging machine. formed the basis for the aseptic GMP requires that the manufacturing production concept. systems and materials should not pose a Once the product- and technologyrisk to the quality of the product. If the related requirements had been aim is aseptic manufacturing, stable and identified, the engineers went on to reliable processes must be the main define product zones and system zones concern in order to avoid human and to allocate these to different interventions, which are a major source cleanroom areas. System Zone 1 is the heart of the aseptic manufacturing cell. It of particulate and microbiological comprises all the production equipment contamination. This makes a high level of automation absolutely essential. (mould, clamp, robot and packaging All the machinery and equipment system) that is directly involved in making used must meet the criteria for the and packing the product. The whole of cleanliness class in which it will operate.

System Zone 1 must comply with GMP The criteria cover control of particle cleanliness class A. The handling area is emissions, unimpeded air flow and ease defined as the product zone; here the of cleaning. The CleanForm version of risk of contamination for the open KraussMaffei’s EX all-electric injection product must be minimised.

moulding machine is specifically engineered for cleanroom compliance.

The main drives use water-cooled, hermetically encapsulated, direct-acting servo motors. The moving platen moves on precision linear guides rather than on the tiebars, so that these remain clean and free of lubricant. The clamp is operated by KraussMaffei’s patented Ztoggle system. It has only eight pivot points and these are lubricated in a closed oil circuit. A high-performance extraction hood removes any particulate and/or thermal contamination emanating from the injection process. The entire injection moulding process operates at close to zero emissions.

In areas with low-turbulence displacement air flow (cleanliness class A) the laminar air flow should not be impeded. For this reason, the EX CleanForm machines have been adapted for optimised vertical airflow in order to maintain a stable laminar flow despite the movements of the mould. Like the machine, all the automation components meet the requirements for the target cleanroom as regards particle emissions, unimpeded airflow and ease of cleaning.

Dipl.-Ing. (FH) Hans Malinowski Product and Technology Management All-electric Machines KraussMaffei Technologies GmbH Krauss-Maffei-Str. 2 80997 Munich Germany www.kraussmaffei.com

MARCH | APRIL 2012 / MPN /23

MATERIALS

TPEs | MATERIALS DIAGNOSIS

PolyOne is Number One in TPEs Versaflex HC TPE-based Medical Waste Bag — odour barrier debuts at MD&M West Augmented European Reach Through New Velox Distribution Deal Technology Gap Narrows with Brand New Innovation Centre Feast Your Eyes - New Microsite Launched in Time for NPE PolyOne GLS Thermoplastic Elastomers, a global leader in high-performance, custom-formulated thermoplastic elastomer (TPEs) solutions, has announced that Polyzen Inc, a leading USA-based medical products manufacturer, selected Polyone’s Versaflex HC TPEs to develop a waste management bag.

Polyzen is one of the first companies to use Versaflex HC to create a film that forms the foundation of a waste management collection bag. This Versaflex HC TPE significantly reduces the odour that leaches through the structure, an ongoing problem with bags made of traditional materials.

An alternative to traditional materials used for medical films and bags, Versaflex HC TPE provides significant performance advantages. These include more effective odour barrier properties, the ability to be extruded in thinner wall thicknesses (down to 4 mm) with no trade-off in strength and excellent tensile properties.

“As a medical manufacturer, we supply high quality, sustainable products that create value for our customers in a very competitive market,” said Rubin Shah, Director of Business Development, Polyzen.

“Versaflex HC TPE enabled us to develop an effective odour barrier in a waste collection bag and also offered us the environmental benefits and cost savings that come with reduced material usage.

This further demonstrates Polyzen’s commitment to help customers increase business with innovative products.”

“Polyzen’s engineers immediately understood the benefits that Versaflex HC

24/ MPN / MARCH | APRIL 2012

could provide,” said Rick Noller, Global Marketing Director, PolyOne GLS Thermoplastic Elastomers. “We worked closely with Polyzen to develop the material specification as well as processing parameters and the result is an innovative product that is getting a lot of attention in the medical sector.”

Versaflex HC material is commercially available globally. PolyOne GLS will provide technical support for the product to OEMs and converters and assist in developing applications for different markets.

Customers to benefit from VELOX European resources and expertise In reflection of its leading position as a TPE supplier, PolyOne has broadened its European reach thanks to a new distribution TPE agreement with VELOX. Included in the agreement is the Versaflex TPE used for the Polyzen waste bag.

With this agreement, PolyOne combines its expertise in application development and value creation with VELOX’s extensive reach and service excellence in order to improve the ability to collaborate with customers.

VELOX, the first European TPE distributor appointed by PolyOne since its acquisition of GLS, will increase the resources available to help customers select and optimise their use of PolyOne’s extensive TPE materials portfolio. In addition to Versaflex, TPE products include Dynaflex, Versalloy, Dynalloy and OnFlex.

Walter Ripple, General Manager for

m << TPE tubing made fro >> PolyOne’s Versaflex.

PolyOne GLS Thermoplastic Elastomers, said, “VELOX understands our products, solutions and customisation services. We look forward to building upon this strong foundation to jointly provide improved service to customers and explore new opportunities for GLS TPEs in Western Europe. Working together, we can help customers develop and commercialize their products quickly and cost-effectively to accelerate time to market and help customers achieve business success.”

François Minec, General Manager for VELOX GmbH, said, “We are pleased to have earned the confidence of PolyOne, as demonstrated by this appointment as a preferred distributor. We believe our experience, broad geographical presence and years of work with GLS TPEs will help PolyOne enhance its customer relationships and expand its market reach.

The distributor appointment was established in December 2011 and is aimed at significantly increasing the presence and penetration of GLS TPE products in a range of markets across Europe.

<< Polyone’s new innovation center in Georgia, USA. >> << Versaflex HC TP E in Polyzen’s waste ba g. >>

New US-based innovation centre If new TPE applications and a new distribution agreement wasn’t enough, PolyOne have also announced the opening of an expanded customerfocused innovation centre in Suwanee, Georgia, USA. Highlights of the centre include: - a comprehensive design idea library showcasing the impact of colour and special effects on different shapes and materials; - a state-of-the-art training facility; - new equipment to expand capabilities in cast film, blown film and thermoforming and to build on the extensive multi-layer olefin, PET blow moulding and injection moulding expertise; and - additional twin screw extrusion capacity to provide quicker solution turnarounds and advanced equipment to address

increased demands for specialty performance additives.

These investments further strengthen PolyOne’s ability to work with customers to enhance their products and help them substantially reduce their product development time.

“The Suwanee Innovation Center expansion is further evidence of our commitment to working with customers to understand their unique needs and provide them with customised solutions that improve their profitability and speed to market,” said John Van Hulle, President of PolyOne Global Color, Additives and Inks.

New communications microsite ready for NPE Created for customer and media use, PolyOne's NPE microsite provides an initial look into the messages and announcements the company intends to feature at the show, along with a free guest pass registration area, live Twitter feed and blog.

Interested customers can also schedule a meeting at PolyOne's NPE booth using the site or request a solution to a specific problem for more immediate feedback.

Customers are invited to view the "Featured at the Show" tab to obtain preshow announcement information — and do not forget to bookmark the "PolyOne at NPE 2012" page for a live blog from the show floor starting on April 2.

MARCH | APRIL 2012 / MPN /25

MATERIALS TPEs | MATERIALS DIAGNOSIS

In Europe the Medalist range of medical elastomers is managed

by Stef Hordijk, senior market manager for Teknor Apex Europe.

Two medical contract manufacturers have demonstrated the ease and precision with which tubing made from Medalist MD500 Series medical elastomers can be fabricated in diverse post-extrusion or “downstream” processes, enhancing the suitability of these compounds as replacements for PVC. In production runs by US contract manufacturers Dunn Industries, Inc. and Pelham Plastics, Inc., Medalist-based tubing exhibited outstanding performance when subjected to in-line cutting to length and secondary operations including hole punching, tipping, printing and insert moulding, according to Elliott Pritikin, Senior Medical Market Manager for the Thermoplastic Elastomer Division of Teknor Apex.

Pritikin pointed out that these successes follow two other recent demonstrations that Medalist MD-500 Series compounds provide a practical alternative to PVC in tubing: 1) demonstration runs by American Kuhne Inc. showing the capability of Medalist MD-500 Series compounds for production in high-speed (over 800 ft./min.) tubing lines; and 2) development

by Teknor Apex of patent-pending technologies for bonding Medalist-based tubing to traditional connectors.

“Teknor Apex has recognised from the start of its development of Medalist MD500 Series elastomers that they must perform as well as or better than PVC throughout the long sequence of processes to which tubing is subjected in the real world,” said Pritikin. “We interviewed experts throughout the medical device supply chain, including OEMs, to understand the ‘Voice of the Customer’ requirements, and these became our developmental scoreboard.

During the past two years we have steadily progressed in meeting these requirements, including crystal clarity, kink resistance, clamp resilience, PVC-like haptics, extrusion at high speeds, sterilisation by gamma irradiation and ETO, bonding assembly in clinical settings and everyday handling by 26/ MPN / MARCH | APRIL 2012

healthcare workers. Now we have demonstrated ease of fabrication in downstream techniques for medical tubing.”

Dunn Industries — which specializes in medical tubing — extruded Medalist MD500 Series compounds at its Manchester, NH facility. “The Medalist elastomers exhibited a wide processing window and maintained close tolerances,” said company President Duane Dunn. “Tubing was easily cut to length in-line with extrusion.”

Pelham Plastics (Pelham, NH), which specializes in custom injection moulding and assembly of medical devices, readily carried out a variety of downstream assembly techniques with tubing produced from Medalist MD-500 Series elastomers, according to John J. Mackey, President.

“The fabrication performance of tubing produced from Medalist compounds was outstanding,” Mackey said. “The tubing was easy to work with even in our most innovative techniques, such as holepunching and tipping, and we were able to carry out every fabrication technique with great precision.”

Pelham Plastics reported on these techniques: - Hole punching posed no problems, even allowing for tube rotation producing a serpentine pattern; though this process is typically difficult for elastic materials because of stretching or tearing.

- Tipping — the process of forming a tapered closure at the end of a tube —

<< Assembled tubing shows results of postextrusion processes, including hole punching, tipping, printing, and insert moulding. >>

Medalist TPE works for tubing extrusion end of line

was carried out without need for pretreatment or release agents, which would require additional regulatory approvals. “The tipping performance of tubing produced from Medalist compounds was awesome,” said Pelham Plastics Sales Manager Ray Pellerin. “Cycles were fast, there was no sticking, tapers were consistent and the aesthetic quality of the finished product was excellent.”

- Printing was carried out successfully using standard automated corona surface treatment and traditional pad printing with conventional inks. Teknor Apex also has suggested inks that could be used without the need for pre-treatment.

- Insert moulding, in which luers were applied to the ends of tubing, involved short cycle times, no tube distortion and excellent bonding of the tubing to precoloured luers made either of polypropylene or Medalist elastomers.

Compared with PVC, Medalist MD-500 Series tubing compounds exhibit: comparable crystal clarity and mechanical properties; provide similar clamp resilience and resistance to kinking and necking; have a similar “feel”; and are substantially more flexible and significantly less dense than PVC. At the same time, they undergo minimal colour shift upon heat aging after exposure to gamma irradiation, the most severe type of sterilisation. A typical compound in the series, Medalist MD-575, actually exhibits 70% less heat-aged colour shift than a gamma-stabilised PVC compound of comparable hardness.

Mediprene TPE offers alternative to rubber in plunger seals for single-use syringes Producing consistent, quality products in a cost-efficient manner with fast cycle times; this is the challenge facing the medical device manufacturer of high volume, disposable devices. ELASTO is helping customers achieve this with the development of Mediprene thermoplastic elastomers (TPE) for plunger seals in single-use syringes.

The TPE seal, which is mounted on the end of the plunger, needs to provide a leakproof seal with the syringe barrel. As ease of use for the medical practitioner and patient comfort are also key requirements, the seal helps to optimise plunger movement for accurate dosage control and ease of injection.

The Mediprene materials are latex free, which reduces the risk of allergic reactions.

Representative grades have passed cytotoxicity tests according to ISO 10993-5 and biocompatibility tests according to USP Class VI. ELASTO offer these grades as translucent or coloured compounds, made from medical grade raw materials. The colour masterbatch supplier has been selected with care, ensuring that not only the pigments and carriers are compliant but also that the masterbatches are manufactured under rigorous controls with regard to traceability, consistency and change control, thereby fitting the Mediprene concept

at ELASTO’s ISO 13485 accredited facilities.

Mediprene TPEs are being specified as an alternative to thermoset rubber. They require no vulcanisation and are 100% recyclable. Fewer process steps without the need for additional operations such as trimming means less energy is used and production is faster and more costefficient. TPEs have a lower specific gravity compared with several alternative materials, so users can therefore not only create lighterweight parts, but can also make more parts per kg.

Niklas Ottosson, Medical Technical Manager at ELASTO, commented, “We are happy to introduce our new grades for plunger seals, Mediprene 500584M (translucent) and Mediprene 502584M (black), on the market.

With these grades as starting points, we will continue to engineer intelligent solutions that precisely fit customer part design and specific requirements.”

Leading Italian TPE and TPU Compounder Invests in Innovative Machinery and Research elastomers (TPE) and its Apinat brand of bioplastics, increasing production capacity by 15%; • an integrated system for automated packaging and palleting; • a new technologically advanced system of industrial scale-up; • a new line dedicated to the production of microgranulated TPE and TPU; and • a complete overhaul of the sample and masterbatch production departments so as to create lean processes and optimise

production efficiency.

As well as the above, construction of the new research and development labs and relative office space for technical staff is nearing completion, a project that will see overall R&D space increase by about 80%. << API’s investment will result in 4 new lines. >>

API Spa, one of Italy’s leading producer of thermoplastic compounds (TPE, TPU and Bioplastics), is in the process of making significant investments in production machinery and R&D infrastructure.

In line with its corporate strategy for the next three years, the company has made the following investments: • a new production line for thermoplastic polyurethane (TPU), bringing the total number of lines to five and increasing production capacity by 25%; • two new lines for the production of thermoplastic

MARCH | APRIL 2012 / MPN /27

MATERIALS TPUs | MATERIALS DIAGNOSIS

Hydrophobic Soft TPU — Tecothane Soft can replace silicones in medical applications Ohio, USA-based specialty chemicals company Lubrizol has announced a new, low density hydrophobic thermoplastic polyurethane (TPU) technology for medical and healthcare applications. The product was launched at at the 2012 Medical Design & Manufacturing (MD&M) show in Anaheim, CA, on February 14, 2012.

The new hydrophobic technology, Tecothane Soft, eliminates the need for plasticisers to produce softer grades of material. In addition, these TPUs exhibit relatively low tack with use of significantly reduced amounts of lubricant.

Deb Langer, General Manager, Life Science Polymers, explained, “Our unique soft TPU polymer can be utilised in areas where silicones are traditionally required.

The Tecothane Soft polymer technology may be extruded or injection moulded utilising traditional processing equipment.

Tecothane Soft’s unique features provide performance for the designer while maintaining comfort for the patient.”

According to Laura Hall, Marketing Comminications Manager at Lubrizol, the key benefits of Tecothane Soft include:

- improved adhesion and bonding characteristics; - unique solvent solubility; - highly elastic properties; - extremely hydrophobic; - processed using standard meltprocessing equipment; and - excellent electrical insulation properties.

VELOX shows Lubrizol’s new TPUs at Medtec 2012 PRE-COLOURED ISOPLAST TPU RESINS AND NEW HYDROPHOBIC TECOTHANE SOFT TPU TECHNOLOGY 28/ MPN / MARCH | APRIL 2012

<< Example of Tecothane Soft in a tubing application.

These TPUs exhibit relatively low tack with use of significantly reduced amounts of lubricant. >>

The ideal application areas include: - peristaltic pump tubing; - ultra-small diameter tubing and catheters; - neo-natal feeding systems; and - guide wires or pacemaker leads.

Tecothane is a registered trademark of The Lubrizol Corporation.

For more information or to review a complete array of Lubrizolâ&#x20AC;&#x2122;s innovative technologies, visit www.lubrizol.com/medical

At Medtec 2012, VELOX, Hamburg-based raw materials distribution and sales specialist presented two new TPU solutions for the medical and healthcare applications, produced by The Lubrizol Corporation, Cleveland, USA. Several grades of pre-coloured Isoplast thermoplastic polyurethane (TPU) resin were offered in white for nonimplantable applications.

Adding colour during polymerisation prevents additional heating and diminishes variability. This helps to reduce scrap, eliminate defects and offer more consistent batch-tobatch melt indexes.

MARCH | APRIL 2012 / MPN /29

MATERIALS TPUs | MATERIALS DIAGNOSIS << PolyOne recently worked with a pulmonary device manufacturer in switching from a blend of polymers to a single compound, resulting in production efficiencies and reduced costs. >>

PolyOne’s NEU Receives USP Class VI And ISO 10993 Certifications NEU Specialty Engineered Materials, LLC, a subsidiary of BIOCOMPATIBLE PolyOne NEUSOFT TPUS ARE Corporation IDEAL FOR SOFT and a leading CATHETER TIPS AND provider of SHEATHS polymer solutions for healthcare device manufacturers worldwide, has announced that its trademarked NEUSoft polyurethanebased materials have been certified as meeting USP Class VI and ISO 10993 biocompatibility requirements.

“Medical device manufacturers are constantly looking for a material that will meet their product needs. NEU offers pre-certification of our materials as well as the NEUSpeed service to help our customers accelerate the research and development process and increase speed to market,” said Eduardo Alvarez, Business Manager, 30/ MPN / MARCH | APRIL 2012

NEU Specialty Engineered Materials.

“NEU understands the rigorous medical device testing process and is dedicated to delivering quality polymer solutions that help our customers reduce regulatory compliance costs and gain a competitive edge.”

NEUSoft materials are transparent polyether-or polyester-based TPU formulations and blends designed to meet the specialised requirements of applications such as soft catheter tips and sheaths. Because the formulated polymers have been tested and precertified to USP Class VI and ISO 10993 standards, medical device manufacturers can have confidence in developing devices with these materials and in moving forward with regulatory testing of their products.

NEU’s global NEUSpeedSM Rapid Response service fulfills orders for select, stocked medical-grade

materials in just one business day, enabling device manufacturers to move more quickly through the iterative process of refining a formulation to meet their specific product requirements. All material solutions available through this service are now also USP Class VI and ISO 10993 certified.

SINGAPORE FOCUS The Gateway to Asia | SINGAPORE FOCUS

SINGAPORE, THE GATEWAY TO ASIA Protect your medical IP in Singapore SINGAPORE HAS ESTABLISHED ITSELF AS A KEY CONTRIBUTOR TO THE GLOBAL MEDICAL TECHNOLOGY (MEDTECH) VALUE CHAIN. THE CITYSTATE MANUFACTURES 10% OF THE WORLD’S CONTACT LENSES, 30% OF THE WORLD’S HEARING AIDS, 50% OF THE GLOBAL DEMAND FOR THERMAL CYCLERS AND MORE THAN HALF OF THE WORLD’S MICRO-ARRAYS.

32/ MPN / MARCH | APRIL 2012

Supported by a world-class R&D and medtech manufacturing infrastructure, and a robust cluster of companies with extensive experiences from collaborations with global MNCs, Singapore’s medtech manufacturing output is expected to reach €3.70 billion by 2015.

The demand for medtech devices and services in Asia Pacific is expected to reach revenue of US$6.3 billion by 2015. Located at the heart of the region with close proximity to China and India, Singapore is well-positioned to be the nerve centre for development and manufacture of high technology medical devices.

Over 30 global medtech companies, including Medtronic and Siemens Healthcare, have set up facilities in Singapore to tap into the city-state’s clinical and scientific infrastructure, pro-business environment with a highly effective intellectual property (IP) regime. These also

SINGAPORE FOCUS

include all of the top 10 medtech companies that have their regional headquarters in Singapore to drive business expansion in Asia.

SINGAPORE’S MEDICAL TECHNOLOGY CAPABILITIES Singapore’s medtech cluster boasts capabilities and know-how driven by its experience at the forefront of electronics and semiconductor manufacturing and design. Building on an established track record of reliability and quality, Singapore’s medical technology companies have been contributing to the growing global medtech sector. For instance, leveraging their expertise in plastics technologies, Singapore companies Sunningdale Tech and Inzign boast partners comprising the world’s top medical device manufacturers that spread the entire spectrum of drug delivery and pharmaceutical devices. Others such as Univac continue to push the envelope of systems design, moulding and injection technologies; and Racer Technology is a one-stop

provider for thermoplastic manufacturing, from industrial design, prototyping, tooling to testing and box building.

Singapore’s medtech companies also offer ISO 13485 and ISO 9001 certification and adhere to FDA cGMP protocols. In accordance with the industry’s stringent requirements, these companies also offer cleanroom capabilities that comply with ISO 10K/ISO 100K standards. Global medical technology players also can rely into their Singapore partners for prompt and expert engineering and manufacturing capabilities ranging from integratedcircuit design and software development to prototype manufacturing. Many have also tapped on Singapore companies’ extensive web of manufacturing sites in Asia, including China and Malaysia. In fact, Singapore companies have been working with global names including AB Sciex, Roche and GlaxoSmithKline in a wide range of design and development areas, including prototyping, marketing and manufacturing for the past 30 years.

MARCH | APRIL 2012 / MPN /33

SINGAPORE FOCUS The Gateway to Asia | SINGAPORE FOCUS

Global-Asia Trade Exchange (GATE) 12 Medtech

Gate12 Medtech will be held in conjunction with Medical Manufacturing Asia 2012, on September 12–14, 2012, in Singapore. Centring on the medical device industry, this event aims to facilitate private, one-to-one meetings between procurement decision makers from leading medical device manufacturers and Singaporebased suppliers offering capabilities in precision machining, surface treatment capabilities, plastic moulding and injection technologies.

GATE12 Medtech is the premier one-stop sourcing platform for global procurement decision makers to establish new strategic connections and develop opportunities vital to their Asia-centric business. They can achieve this by leveraging Singapore companies’ extensive networks, experience and manufacturing bases in the region.

In addition, GATE 12 Medtech will allow global medical device manufacturers a better understanding of what Singapore’s medical technology players can offer through individual engagements with the suppliers, site visits and other activities.

For enquiries, please contact: Mr Timothy Chua / Peter Tan IE Singapore / Singapore Precision Engineering and Tooling Association (SPETA) Phone: +65 6433 4827 / +65 6291 6430 Email: timothy_chua@iesingapore.gov.sg / peter@speta.org.sg

34/ MPN / MARCH | APRIL 2012

<< Photograph: Bio-Scaffold International >>

A B2B business matching platform co-organised by IE Singapore and Singapore Precision Engineering and Tooling Association (SPETA)

SINGAPORE FOCUS Microfluidics | SINGAPORE FOCUS

A*STAR SIMTech Launches Comprehensive Microfluidics Foundry for the Worldwide Microfluidic Community The Singapore Institute of Manufacturing Technology (SIMTech), a research institute of the Agency for Science, Technology and Research (A*STAR), launched the SIMTech Microfluidics Foundry (SMF) in September 2011. SMF offers an integrated spectrum of capabilities for developing and manufacturing specialised and low-cost microfluidic devices for applications in healthcare, biomedical, pharmaceutical, energy, water quality monitoring and chemical processing. Reflecting A*STARâ&#x20AC;&#x2122;s strategic investments in R&D of innovative high-value manufacturing solutions, this will make Singapore a focal point for publicprivate sector microfluidic devices investments, R&D and manufacturing.

The Government continues its steadfast investments in growing R&D in Singapore.

As many as $16.1 billion Singapore dollars have been earmarked under the Research, Innovation and Enterprise 2011 to 2015 Plan, or RIE 2015. This is an overall increase of about 20 percent over the previous quinquennium and a commitment of 1 percent of expected Gross Domestic Product (GDP) to public sector research and innovation. With this increased commitment, there is also increased expectation and emphasis on economic impact and fostering commercialisation of R&D. Singapore aims to increase its Gross Domestic Expenditure on R&D (GERD) to 3.5 percent of GDP by 2015.

The global microfluidics market is estimated to grow to US$5 billion in 2016 (Yole Developpement 2011, Microfluidic Substrates Market and Processing Trends), driven largely by the advancement of biotechnology and microtechnology.

Although Singapore does not presently have a microfluidic industry, Fluidigm and microfluidic start-ups such as CAMTech, Clearbridge Biomedics, JN Medsys, Molbot and Fluigen have setup operations in 36/ MPN / MARCH | APRIL 2012

Singapore for medical/life science applications, seeding the growth of such an industry in Singapore. A key enabling technology that cuts across multiple industry sectors, microfluidics is an important capability that has yet to be exploited.

A*STAR aims to exploit opportunities in the microfluidics space through harnessing our strengths in multidisciplinary research across the biomedical, physical and engineering sciences. One of the reportedly unique and significant value propositions of A*STAR is the spectrum of capabilities that the company has and its ability to organise the relevant parts in a synergistic way both within and beyond its remit to develop meaningful public-private partnerships.

The microfluidic industry, with its diverse applications spanning from pointof-care, clinical diagnostics, energy, water quality monitoring and chemical processing, is an ideal avenue for diversification and growth for the Singapore precision engineering and electronics industries.

Although microfluidic devices offer rapid analysis and diagnostic functions, the current high manufacturing cost and lack of design and manufacturing standards for large volume manufacturing of microfluidic devices inhibits its widespread commercial adoption. Furthermore, microfluidics with its diverse applications and the distinct requirements for each application make it difficult to standardise for mass production.

Currently, many biochips are fabricated using silicon wafers or glass slides. The special processes required during the manufacturing of these silicon-based biochips prove to be expensive for disposable applications. Polymer materials, on the other hand, are better suited for fluidic sample analyses and fabrication can be achieved in bulk at a fraction of the cost for disposable applications. Through its competencies and capabilities to address these challenges, SMF can help nurture and grow the microfluidic industry in Singapore.

SMF provides the emerging microfluidic industry with an integrated spectrum of competencies from design, simulation and prototyping to scalable

SINGAPORE FOCUS of microfluidic research in Singapore and Switzerland.

Dr Lim Ser Yong, Executive Director of SIMTech, said, “The SIMTech Microfluidics Foundry provides a low-risk environment for companies to place their capitalintensive investments for testing and implementing microfluidic technology solutions. It also offers a strong base for precision engineering and electronics companies to expand and pursue growth in other industries, assisting in the development of microfluidic products for biomedical, pharmaceutical and chemical companies and help start-ups to accelerate their commercialisation processes by providing robust manufacturing capabilities and innovative microfluidic solutions.” technology development for mass production of polymer-based microfluidic devices. Companies can leverage on the integrated suite of services provided by SMF to reduce cost and improve efficiency as well as translate their laboratory concepts or prototypes to market in the shortest time cost-effectively by accessing the existing competencies and capabilities

Recently, SIMTech signed three research agreements with Rhodia Asia Pacific, CAMTech Management and Molbot to develop high-throughput microfluidic tools for applications and product development in pharmaceuticals; for water quality monitoring and for gene cloning respectively. SIMTech has also

signed a Memorandum of Understanding with CAMTech Innovations (UK) and Clearbridge Biomedics to jointly develop design and manufacture technologies of microfluidic devices for life science companies. It also intends to collaborate on the development of manufacturing technologies and solutions for microfluidic devices for potential commercial use respectively. These microfluidic R&D commitments reflect the confidence of industry in SMF’s competencies and capabilities, seeding a growing microfluidic industry in Singapore.

Dr Mario El-Khoury, CSEM Chief Executive Officer, said: “The SIMTech Microfluidics Foundry is a successful outcome of the research collaboration between CSEM and SIMTech. Today, SMF is a milestone for Singapore to grow the microfluidic industry. We look forward to furthering our collaboration with SMF to advance the microfluidic technology and its applications that impact the quality of life, such as healthcare, biomedical and life science research.”

MARCH | APRIL 2012 / MPN /37

PURGING & CLEANING Picture 1: Here Cold Jet’s i³ MicroClean precision dry ice blasting system is used to clean a product mould.

DRY ICE CLEANING TAKES MEDICAL PLASTIC MOULDERS TO SUB ZERO TEMPERATURES edical device manufacturers face many challenges when it comes to cleaning and maintaining equipment and deburring or deflashing products. Many of the innovative parts and products produced by manufacturers are intricate and the equipment is finely detailed and expensive. Residue build-up in the small mould cavities on the high tolerance medical device production tooling can greatly impact the quality of the end product. This build-up can prevent the parts from meeting tolerances, elevate scrap rates and eventually clog the mould vents and impede tooling performance.

Cold Jet’s patented, shaved dry ice technology for sensitive and delicate applications brings advantages over the competition in mould, forms and tool cleaning. It allows medical device manufacturers to improve quality, increase production, prolong equipment life, improve worker safety, reduce costs and support environmental initiatives.

Dry ice cleaning uses recycled CO2 in the form of dry ice particles that are accelerated at supersonic speeds to

M

<< Picture 1 >>

38/ MPN / MARCH | APRIL 2012

delicately remove residue from parts and equipment. Unlike abrasive cleaning methods, the combination of the kinetic and thermal gradient effects break the bond between the residue and the

<< Picture 2 >>

surface. When the dry ice hits the surface, it sublimates — or returns to its gaseous state — and expands approximately 800 times in size, removing the contaminant from the inside out and eliminating any secondary waste.

Moulds and equipment can be cleaned up to 75% faster because they are cleaned in place at operating temperatures, eliminating cooling, disassembly, reassembly and reheating.

This also reduces the risk of damaging the equipment and increases quality output.

Picture 3: Instead of abrasive media to grind surfaces (and damage them), Cold Jet uses dry ice (Solid CO2) accelerated at supersonic speeds that sublimate upon impact and lift contaminants from substrates.

Labour costs for cleaning delicate moulds are also reduced as the cleaning can be done by one person with a single cleaning system.

Dry ice cleaning is an environmentally responsible cleaning process that supports the green initiatives of medical device manufacturers. It eliminates the need for chemical solvents and, because the process does not produce any secondary waste, it also reduces the possibility of downstream contamination.

Overall, dry ice cleaning has proven to be faster, safer and more effective than the alternatives at removing materials used during the manufacturing process. It will not wear away at metal surfaces, alter the shape or fit of moulds or damage the equipment in any manner.

The process provides medical device manufacturers with a more effective cleaning option to replace outdated manual methods.

Medical device manufacturers that have already integrated dry ice cleaning into their cleaning processes have experienced a reduction in labour time and costs, eliminated secondary waste and implemented an environmentally responsible process that promotes a safer and healthier work environment for employees.

For more information about Cold Jet Dry Ice Cleaning, visit www.coldjet.com or contact Cold Jet +32 13 539 547, info.eu@coldjet.com.

<< Picture 3 >>

As Cold as Ice:

Picture 2: Cold Jet’s i³ MicroClean table-top cleaning system is designed to clean small, complex cavities and crevices and delicate surfaces without abrasion or disassembly.

PURGING & CLEANING

Purgex Removes Inclusions & Contaminants when Purging Medical Plastics

Purgex commercial purging compounds (CPCs) are designed to improve colour and material changeovers and remove inclusions and contaminants (e.g. black specks) when purging injection moulding, blow moulding or extrusion equipment. All Purgex grades use ingredients that are non-toxic and USA-FDA approved for food, pharmaceutical and medical plastics use.

Typical Purgex applications for medical products include: bottles and containers (PE, PP, PBT); test tubes (PBT); syringes and plungers (PP, PS); electrical connectors (acetal, nylon, PBT, LCP); tubing (nylon, PVC); and other medical device components (e.g. PP, PPO, ABS, PC/ABS, PVC, TPE).

Purgex is safe to use in hot runner systems with gates as small as 75 mm and has a variety of grades available to clean filled or unfilled resins from machinery at processing temperatures ranging from 138°C to 316°C.

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Pressure Blast Cleaning of Feedscrews Maxi-Blast, Inc of Indiana, USA has developed two new systems to clean the plastic residue from feedscrews. The keys to the system are the use of Maxi-Blast’s non-abrasive plastic blast media and their specially developed pressure blast systems. One system (MBB-A) has screw stands and portholes in the machine doors to accommodate screws up to 8 foot in length that can be handled manually.

The newest system (MBS-B) will accommodate feedscrews of any length, even long and heavy screws up to 20 feet long. The new system (MBS-B) is designed for the typical feedscrews for compounders with twin screws. Typically, a 12 foot long screw can be cleaned in about one hour.

The non-abrasive plastic blast media has sharp angular edges that cut and chip away at the thermoplastic residue, which adheres to the screw. While sandblasting with an abrasive will damage the metal surface, the plastic media is softer than the steel and causes no pitting or rounding of edges whatsoever.

The typical methods of cleaning feedscrews is very slow, incomplete and not only damaging to the feedscrews but hazardous to the operators. A typical 6 foot screw is cleaned by an operator using a torch and burning off the residue.

This results in inhalation of hazardous fumes by the operator and overheating and possible warping of the screw. The operator then uses a harsh wire wheel to finish removing the residue. This results in more damage to the surface of the screw or removal of chrome plating and again hazards to the operator from wires being flung off the wheel. This manual process takes four to eight hours while the MaxiBlast process for the same size screw takes 30 minutes on average.

Black speck, black schmeck...

<< Ultrapurge products neutralise any carbon formations on the screw. >>

One of the main challenges for companies producing thermoplastic medical parts is to solve their black speck issues. Black specks form due to carbon contamination; they can potentially result in an excessive loss of production and create quality control issues.

Ultra Purge, a chemical purging compound, has been specifically designed to remove carbon from the screw, barrel and hot runner systems. It can be used in a preventive maintenance fashion in order to prevent the carbon from forming on the screw and in the hot runners.

Ultra Purge is also effective at reducing the downtime on machine start-ups. It is common for thermo-

Improved Dyna-Purge C for High Clarity Resin Purging Without “Milky Drag” Case studies show new formula lowered downtime by as much as 60% versus other purging products The Dyna-Purge division of Shuman Plastics, Inc., Depew (Buffalo), NY, USA has introduced the company's latest technology breakthrough — New & Improved Dyna-Purge C, a clear, nonabrasive, non-chemical purging compound, formulated to purge high clarity resins without any residue.

According to Tim Cutler, DynaPurge Business Manager, New & Improved Dyna-Purge C was specifically formulated for transitioning to clear parts and to address what plastic processors refer to as “milky drag.”

“In a survey to plastic processors, over 78% of respondents stated that they run clear and transparent resins with nearly 50% experiencing issues with ‘milky drag’,” he explained. “New & Improved Dyna-Purge C eliminates this and other common residue problems, resulting in faster changeover and less downtime.”

Ease of use, unique cleaning characteristics and a broad temperature range (380 - 590°F) make New & Improved Dyna-Purge C extremely effective for injection moulders, extruders, compounders and blow moulders. It enables processors to purge through hot runners and other tight clearances and improves overall changeover times with

sensitive resins to have black specks appear in the parts on the startup. Thus, purging a machine on the shutdown with Ultra Purge will neutralise the carbon from forming on the screw and in the hot runners, resulting in a faster start-up.

Ultra Purge can be safely used to clean hot runner systems and it is easily removed from the machine. All Ultra Purge grades are residue free; within a few shots after the cleaning process, the machine will be free of carbon contamination and Ultra Purge. Typically, Ultra Purge has the ability to reduce scrap 40–70% and reduce downtime 50–80 percent.

All Ultra Purge grades are FDA approved and food contact certified,

significant scrap reduction. In addition, all ingredients of the new formula are FDA-compliant.

Several case studies have shown significant reduction in machine downtime when using New & Improved Dyna-Purge C, including a custom injection moulder in San Diego, CA that cut its downtime by 60%.

Copies of the recently published case studies are available from Dyna-Purge by visiting www.dynapurge.com.

As part of the new product introduction, plastics processors can choose one of two special offers: a free 10 pound sample of New & Improved Dyna-Purge C, or the purchase of a 55 pound box of New & Improved DynaPurge C with the company’s Satisfaction Guarantee — if the user is not satisfied that it performs better than their current purging compound, DynaPurge will fully refund the cost of the product.

For additional information, contact Shuman Plastics, Inc., Dyna-Purge Division, 35 Neoga Street, Depew (Buffalo), NY 14043; Phone: (716) 685-2121; Fax: (716) 685-3236; E-mail: info@dynapurge.com; Website: www.dynapurge.com Dyna-Purge is a registered trademark of Shuman Plastics.

thus, Ultra Purge has exceeded the global migration tests. Therefore, medical companies will have no issues using the Ultra Purge to clean their thermoplastic processing machinery.

Ultra Purge is produced by Moulds Plus International (MPI) with production sites in Italy, the US, Mexico and Brasil.

Also, Ultra Purge distributors are located all around the globe in order to supply material in a fast and efficient manner to the local plastic processing market. MPI engineers and chemists operating from the company’s on-site laboratories are dedicated to continuous research, product development and the manufacturing of high-quality Ultra Purge products.

MARCH | APRIL 2012 / MPN /41

PRODUCT FOCUS PRODUCT FOCUS | Inhalers

IMAGE courtesy of Gerresheimer Medical Plastic Systems

Extractables and Leachables, for OINDPs 42/ MPN / MARCH | APRIL 2012

n recent years there have Table Risks associated with various pack types based on degree of been great advances in concern and likelihood of interaction the understanding of Likelihood of Packaging Component-Dosage Degree of extractables and leachables Concern Form Interaction Associated with for Orally Inhaled and HIGH MEDIUM LOW Route Nasal Drug Products Inhalation Aerosols Sterile Powders and HIGHEST and Solutions; Powders for (OINDPs) due to their Injections and Injection; Inhalation Injectable Powders combined high degree of Suspensions concern associated with the Ophalmic Solutions route of administration and HIGH and Suspensions; Transdermal Ointments and the likelihood of packaging Patches; Nasal Aerosols and Sprays component interaction with Topical Solutions Topical Powders; Oral Tablets and LOW the dosage form, as can and Suspensions; Oral Powders Oral (Hard and Soft Topical and Lingual Gelain) Capsules been seen from the table Aerosols; Oral Solutions and Suspensions produced by the FDA. The recent publication Table 1 in 2006 by the PQRI Table adapted from ‘Guidance for Industry. Container Closure (Product Quality Systems for Packaging Human Drugs and Biologics.’

Research Institute), covers U.S. Department of Health and Human Services, general principals as well Food and Drug Administration; Rockville, MD, May 1999 as establishing limits of qualification and quantification. It What does the future hold for E&L introduced key concepts of the safety for OINDPs? The adoption of ICH Q8, 9 concern threshold (SCT), the limit below and 10 and the PAT (Process Analytical which a species would pose no Technology) initiative could have a big toxicological concern [0.15 μg/day], and impact for OINDPs, especially for the analytical evaluation threshold (AET). extractables and leachables. Whilst The SCT is used to determine the AET, OINDPs continue to lead the field in the which in turn, defines the limit of understanding and implementation of detection required, analytically. These extractable and leachable testing and this key concepts and principals are now knowledge is rapidly being transferred to being applied to other dosage forms, other dosage forms, there are still such as PODPs (Parenteral and unanswered questions for extractables Opthalmic Drug Products). A number of and leachables. A couple include: how international working groups are working do you carry out a risk assessment for in this area, there is the Pharmaceutical extractables and leachables on the Aerosol Consortium on Regulation and container closure system? How would Science (IPAC-RS), working on amongst you implement quality by design (QbD) other activities producing webinars for extractables and leachables? covering extractables and leachables.

The ELSIE group (Extractable and Smithers Rapra is recognised as a world leading rubber and plastics consultancy Leachable Safety Information Exchange) delivering a comprehensive and strictly is developing both a toxicological safety independent service covering: design and database but a degree of material selection, material and product standardisation of the testing. Very testing, chemical analysis and specialist recently a book by the leaders in the polymer processing and production. These services, including extractables and leachables field of E&L for OINDPs has been testing, have been tailored to meet the produced — “Leachables and requirements of the medical device and Extractables Handbook: Safety pharmaceutical industries where polymers are Evaluation, Qualification, and Best widely used.

Practices Applied to Inhalation Drug Products”. This is a must for new entrants to the field of E&L for OINDPs.

I

Biography Dr Andrew Feilden joined Smithers Rapra as a principal consultant in June 2011. He is specialising in extractable and leachable testing and the selection and assessment of materials for medical and pharmaceutical applications. For the previous 12 years he was at AstraZeneca, leading their extractable and leachable testing. He has been working in the field of trace analysis using hyphenated techniques such as GCMS and LC-MS for over 12 years. Whilst at AstraZeneca he was an active member of industry working groups, the IPAC-RS container closure group and he was the co-chair of ELSIE material group. He is a scientific advisor to the IPAC-RS Materials working group. Andrew gained a degree and D.Phil from York University.

Dr. Andrew Feilden, Principal Consultant, Smithers Rapra

afeilden@rapra.net References Product Quality Research Institute (PQRI), Leachables and Extractables Working Group, Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products, Product Quality Research Institute; Arlington, VA, 2006. http://www.ipacrs.com/index.htm http://www.elsiedata.org/ Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products Douglas J. Ball (Editor), Daniel L. Norwood (Editor), Cheryl L. M. Stults (Editor), Lee M. Nagao (Editor) ISBN: 978-0-470-17365-7.

MARCH | APRIL 2012 / MPN /43

IN THE ZONE

In Vitro Diagnostics How does Union Plastic serve the In Vitro Diagnostics (IVD) Industry?

Our profiled contract manufacturer this issue is Union Plastic (UP).

ith now 75 recent moulding and assembling machines in an The medical plastic ISO7, ISO8 and ISO9classified environment, UP component producer has quickly grown on the presents its key success diagnostic market in the factors in the diagnostic field, last five years. How could from product development this long-standing to large scale injection healthcare specialist keep moulding. a two digit turnover increase in a market that is now slowing down: By producing in low-cost countries?

By dramatically increasing product prices? “Definitely no!” answered Fabrice Bourdier, CEO of the company employing now 170 persons. He added, “We just believe in industrial and scientific methods and always focus on our basics, innovation capability and wellproven quality approach. ISO 13485 is not the single factor, but this is a good workflow to build an organisation.” So instead of this magic recipe, here are the main lessons we learned from UP.

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Risk management All development phases start with Device Failure Mode Evaluation Analysis (DFMEA), according to the ISO 14971:2007 standard. The Directive 98/79/EC about IVD devices requires such a risk analysis: “Any risks that may be associated with their use must be acceptable when weighed against the benefits to the patient and be compatible with a high level of protection of health and safety.” Then the Process Failure Mode Evaluation Analysis (PFMEA) is an open method that must be fed all long the product development and setting up cycle.

Project management Once again, this might seem obvious, but developing IVD reagents in an efficient way is linked to organised project management. In a field where time-to-market is critical, and product life cycle shorter than in the other healthcare businesses, working with horizontal project teams is a must.

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At first, the Project Manager has to know his target, the purpose of the IVD device, the Directive 98/79/EC requirements and the end-user expectations. He shall have a patient concern and a healthcare-oriented vision and use the know-how of the company specialists in design, tool making, QA (quality assurance) and production to get the right part. Then the Project Manager coordinates the communication with customers and suppliers. He has to filter the pressure and avoid misunderstanding caused by several information sources.

Process validation For a decade, injection moulders tried to cut and paste the usual qualification approach of the pharmaceutical industry to their own manufacturing process. The IQ (installation qualification) was based on utilities connections check, the OQ (operational qualification) consisted of checking tool moves and static performances and the PQ (performance qualification) was performed during the first industrial batches production with increased monitoring. This empiric qualification approach resulted in a huge document package, with poor benefits for the manufacturing process.

It happened frequently that the production setters had to adapt or change the process at each new batch manufacturing. By implementing innovative qualification approaches based on scientific methods, UP has really given sense to the qualification step. The target is not only to check the moulding capability, but really to optimise its

efficiency within a process window, which is defined thanks to a rheologic curve. The OQ lets UP define a parameter that varies significantly to each minor process change, which will be named “key parameter”. This key parameter must be monitored accurately, during the PQ, of course, and also along the product life time. On an IVD plastic disposable with many critical features like optical properties, dimensions, integrity and mechanical behaviour, this makes sense to monitor the routine quality based on a single key parameter.

This eases the in-process control, by improving the global quality level. This also allows implementing either 100% in line inspection or a relevant Statistical Process Control (SPC) on this key parameter first.

In-process control automation for cost optimisation On its two sites dedicated to injection production and assembling, UP has implemented 100% product control systems based on several technologies:

• function testing via flow measurement; • presence and position detection via sensors and photometric cells; • leakage tests via pressure reduction (syringe manufacturing); • friction force measurement (piston sliding); and • vision control via several cameras coupled to computer processing.

The latter technology has greatly evolved over the past decade, benefiting from the increase in the processing

speed of microprocessors and from the development and increased use of digital photography, which allows for very brief integration times. It also allows the simultaneous control of product size, aspect, presence or print quality.

“During the release of the batch we can work more calmly and focus our efforts on what really matters for the customer, namely cleanroom environmental controls, product performance, [and] production record analysis,” said Bruno Duterte, Quality Director at UP. Statistical Process Control (SPC) Despite the fact that UP’s business has nothing to do with the automotive industry, tools like Capability Performance factors really have their interest in the large scale production of IVD disposables. Trending and multi-parameter monitoring is easier to analyse with proper statistical models. The choice of the monitored parameter will depend on the component, but this measurement of the process capability has to be carried out at first on the key parameter, and then on various functional features.

With over 47 years of proven performance on the healthcare market, Union Plastic has the strong willingness to make further progress regarding IVD products safety.

For more information, please contact Philippe ROULET (p.roulet@union-plastic.com) or visit our website: www.union-plastic.com.

MARCH | APRIL 2012 / MPN /45

IN THE ZONE Microfluidics for Point of Care Diagnostics Point of care testing continues to drive better healthcare by delivering diagnostic information while the patient is with the healthcare provider.

Microfluidics enables rapid, point of care testing and will successfully address this market need when the cost of manufacture meets customer price points

ALine has experience in developing commerically viable devices using its proprietary Polymer Laminate Technology (PLT) platform. By creating subassemblies that perform different device functions, ALine has created a modular approach to developing sophisticated, highly functional devices.

Subassemblies are created for: 1) the fluid resevoirs and air manifold for the pumps and valves; 2) a flexible subassembly for the pumps, valves, vent membranes and vials to connect the fluid resevoirs to the channels; and 3) a final subassembly for the channel layer. The bottom of the channel layer conveniently attaches to the detector, either optical or electroactive.

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Having the separate subassemblies allows for inprocess QC of the card's critical components before the finished product is made.

This laminate required numerous design iterations to empirically optimise the pumping function and materials, which were easy to accommodate with ALineâ&#x20AC;&#x2122;s PLT. ALine supported GenMark Diagnostics from early prototyping through clinical trials and product launch. ALine continued its support through volume production of 10,000 parts per month. GenMark won the 2009 Medical Device Excellence Award, and ALine was honored as its supplier.

Alineâ&#x20AC;&#x2122;s proprietary Polymer Laminate Technology (PLT) platform for microfluidic diagnostic devices

REGULATION REVIEW

Changing times: material risk, the FDA and 510(k) In 2009, more than 4,000 medical devices went through the 510(k) notification process to fast-track the FDA clearance process. Compare this with only 30 Pre-Market Approval (PMA) applications for new devices and 1,550 additions to existing PMAs and the popularity of the 510(k) process is clearly evident.

However, concerns by the FDA that 510(k) may have opened up the market to more risk mean that it now demands more information from manufacturers to demonstrate equivalency between an existing device and its new counterpart.

Clariant is a leading supplier of colour and performance masterbatches and compounds to the medical and pharmaceutical sector. Steve Duckworth, Head of Global Market Segment Medical and Pharmaceutical at Clariant, provides insight into the key areas to be aware of in the use of colour and other additives in medical devices.

Change and 510(k) Material changes are one of six types of changes that typically warrant a new 510(k) submission.

In the industrial world changes to raw materials for polymer compounding and colouration are not unusual because raw material availability and costs fluctuate.

For medical and pharmaceutical applications, a change in material composition can impact the mechanical performance and reliability of a device. Worst-case scenarios include mechanical failure or jamming of the often tight-tolerance device components.

But what constitutes change and what is practical to control when using colour and other additives in medical devices?

Looking beyond colour The industry often uses a visual standard. However, while the colour may appear the same to the naked eye, the raw materials used and / or any changes in supplier may change the performance of the device / packaging.

For example, many differences can be seen when comparison is made of the Fourier Transform Infra-Red (FTIR) spectrum of two suppliers of a typically used phthalocyanine blue pigment (Pigment Blue 15:3) used for example in blue/green colours (see chart).

Differences in pigments and / or additives in a recipe can result in different influences on the polymer. The question is whether these differences will cause a variation in mechanical properties, such as more warpage, or impact extractables/leachables. For regulatory purposes, it is

Pigment Blue 15:3 â&#x20AC;&#x201C; Phthalocyanine pigment

Comparison of the FTIR spectrum of FTIR of 2 suppliers compared two suppliers of Pigment Blue 15:3 Phthalocyanine pigment

<< Above: The red circles show that even though a pigment may have the same name, it is chemically different, evidenced by differences in the FTIR. >>

important to understand whether material used now is the same as that used in the originally approved device or package.

Production methods also play a role in the consistency of a polymeric material. Manufacturers of devices need to understand that in industrial production of polymer compounds and masterbatches, the normal operational parameters are open to the possibility of cross contamination.

Checking for change and 510(k) For a 510(k) submission, the device manufacturer faces two questions for consideration. Firstly, for the new device do I have all of the information on the materials used and the risk of changes to these materials and options to control them in the future? Secondly, to demonstrate the new device is â&#x20AC;&#x2DC;equivalentâ&#x20AC;&#x2122; to the existing one on the market, do I have a history of the material changes from the launch of the existing device until today?

Ideally, therefore the relationship between supplier and manufacturer of the device or packaging should be based on transparency, with the manufacturer receiving supporting data profiling the ingredients used for a formulation, the process controls, and updates from the supplier on any defined changes.

At Clariant, it is believed that with the right support for manufacturers to identify change and/or help them demonstrate equivalency, innovation in device design can continue as always.

MARCH | APRIL 2012 / MPN /47

END OF LINE END OF LINE | Parts Handling

A clean affair Conveyor Belts in Cleanrooms MTF Technik goes beyond the call of duty belts for your product, as well as the FDA Due to special surface quality standards of technical parts or due to legal requirements, for pharmaceutical and medical products, it is often necessary to produce plastic parts in cleanroom conditions or in so-called “controlled zones”.

n this context, customers are inevitably confronted with the question how to convey these parts from the machine or to separate them from the sprue and to buffer them. However, in spite of standardised cleanroom classifications, there is no general specification for the layout of conveyor belts in order to be suitable for the relevant cleanroom class. In fact, there are institutes that measure the particle quantity at conveyors, but as the conveying jobs are so various it is not possible to infer a common rule. Yet, the results are completely divergent when belt speed, dimensions or exposures have been changed.

Therefore, the detailed features of each conveyor have to be fixed depending on the individual task and customer philosophy. In general, the basic demands are to minimise any kind of abrasion and to ensure an easy cleaning of the machine.

MTF Technik, an expert for conveyor technique, situated in North RhineWestphalia, Germany, offers an extensive range of product features in order to meet most varied customer requirements.

A common requirement is to use belts that are FDA-approved. However, this label only specifies the surface or the material of

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the belt. Whether the belt produces abrasion depends on other design features of the conveyor. For example, it is relevant if the belt is tracked by a compulsory guide.

In this case, some suppliers provide grooves in the drive and deflexion rollers, in which runs a V-ledge that is fixed at the rear side of the belt. Yet, MTF Technik designers do without this tool and insert rolls turned spherically instead. This feature prevents abrasion consistently, even at the belt body.

Moreover, in case of angled conveyors the so-called “lateral stability” of the belt is very important. This lateral stability makes sure that the belts do not buckle in the bend area and run exactly in the lateral guide rollers. The level of product quality becomes evident especially in this area of a conveyor, because abrasion determines the wear lifespan after all.

Here MTF Technik offers the critical technique with a patented method to realise a constant belt tension, even with changing conveyor angles between 0 and 60°.

In this context, we would like to mention that the closed surfaces of belt conveyors in cleanrooms can be cleaned much more easily than plastic or steel plate conveyors.

Consistently, dirt gets stuck in the plate conveyors and all the small hinges produce a lot of abrasion. In addition, closed belts are more convenient when lubricants or coolants drop onto the belt surface, because dirt can be washed away easily with Isopropanol or other detergents.

Next to considering abrasion, conveyor engineering has to prevent “dead spots” or any areas that are difficult to clean. Using standard motors could be problematic, as they often have cooling fins that are difficult to access. In addition, the air swirling of the motor cooling is often not accepted. In this case, drive concepts integrated to the belt body or drum motors are the solution, as both concepts allow sleek surfaces at the belt body. Moreover, the drum motors do not need any cooling fins and therefore are the best choice for cleanroom conditions.

As well, drum motors do not require any maintenance effort (e.g. for chain lubrication).

Another method to prevent abrasion is to reduce conveyor speed to the minimum needed for the individual task. Here it is particularly suitable to use clock timers to make the conveyor run only when the production machine is running. This method of control has the additional positive side effect of saving energy and avoiding wearout.

Sometimes, conveyors and injection moulding machines are positioned outside the cleanroom, when the machine is equipped with a laminar flow module and the parts have to be conveyed by a capsuled conveyor into the cleanroom. In order to protect the conveyor against any environmental influences, MTF Technik applies ‘easy-to-clean’ coverings made from polycarbonate, aluminium or stainless steel.

CONTACTS UK Tim Peet Director UK PLASTICS MACHINERY LIMITED Solihull, West Midlands B90 1PX Likewise, it is ensured that the connection to the cleanroom is airtight.

If the customer requires special materials for any parts in contact with the product, the conveyor profiles can be provided with a FDA-approved coating.

Alternatively, the inner parts of the conveyor can be lined with stainless steel or the belt covers equipped with guidings made from FDA-approved materials, for example, side walls or longitudinal guides.

These guidings have the advantage to prevent relative movements of the conveyed parts to fixed lateral supports and therefore minimise abrasion and avoid damages to the parts.

Especially in the plastics industry, it is furthermore necessary to divert electrostatic charges from the products in order to avoid dust adherence. Here, next to antistatic belt covers, add-ons like ionisation devices play an important role.

Tel: +44 (0)1564 822172 Fax: +44 (0) 8700 941988 Email: tim.peet@ukplasticsmachinery.co.uk www.ukplasticsmachinery.co.uk These can be mounted on the polycarbonate coverings and be equipped with additional fans or air supplys, if necessary. This brings us full circle with regard to the drive units, as a slower belt speed ensures a longer dwell time of the ionisation and therefore delivers better results.

This range of illustrated options shows that there is no “one best solution” in conveyor engineering for cleanroom applications. In fact, according to the individual customer requirements, a reasonable equipment has to be configured in detail.

Germany MTF TECHNIK HARDY SCHÜRFELD GMBH & CO. KG Stadionstraße 8, D-51702 Bergneustadt Germany Telefon: +49 (0) 2261 / 9431-0 Telefax: +49 (0) 2261 / 9431-31 Email: info@mtf-technik.de www.mtf-technik.de

MARCH | APRIL 2012 / MPN /49

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CHINAPLAS PREVIEW Preview | CHINAPLAS

Asia's Largest Plastics Trade Fair Expects 100,000 visitors Pre-registered Visitors Enjoy Special Admission Arrangement CHINAPLAS 2012, Asia's number 1 and the world's number 2 plastics and rubber trade fair, will grandly return to As Chinaplas 2012 approaches Shanghai from its final countdown, a series of April 18 to 21, promotional activities have staging at been carried out in full swing Shanghai New International by the organiser. With its Expo Centre. To great influence in the plastics maximise the and rubber industries, exposure of this together with the flourishing mega show, the development of the organiser has application industries and also been showing up in various the green policy promotion of relevant Chinaâ&#x20AC;&#x2122;s 12th Five-Year Plan, international CHINAPLAS 2012 has become exhibitions over the focal point of the global the past few industries. It is expected that months, including the number of visitors this South Korea, India, Japan, year will hit 100,000, Russia, Thailand refreshing another new height and Turkey. in addition to the records of These initiatives exhibition scale and the have successfully number of exhibitors. brought the firsthand show news to the visitors there and recruited a large number of overseas trade buyers to pre-register as visitors of CHINAPLAS 2012. The organiser's tremendous promotional effort together with the staunch support from overseas media and travel agents will help to boost the number of overseas visitors to a large extent.

In order to strengthen the relevancy of CHINAPLAS with its application industries and to introduce relevant exhibits and exhibitors applied in each different industry,

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<< The number of visitors of CHINAPLAS 2012 is expected to break the record and exceed 100,000. >>

the organiser has put together a user industry conference in Shanghai in November 2011, in which over 100 representatives from plastics industry associations, user trade associations and end-user enterprises from various application sectors had demonstrated their support to CHINAPLAS 2012. Due to the overwhelming response, the organiser will hold two additional conferences in Fuzhou and Guangzhou in the coming month to meet end user associations and local key buyers from various industries. In addition, CHINAPLAS also showed its presence in over 20 activities in the past few months, such as annual meetings, seminars and forums held by different industries' media and associations, covering sectors of automotive, plastic profiles and windows, plastic pipes, chemical construction material, plastic pallet, new materials, casting films, medical equipment and automotive electronic technologies. This not only enabled the organiser to know more about the demand of users from different industries, but also allowed buyers to receive the most updated show information and relevant technologies.

According to the organizer, a large number of end user associations, key buyers and trade media have shown a keen interest in organising delegation to visit CHINAPLAS 2012, including Shanghai Plastics Industry Association, Ningbo Plastics Industry Association, Shantou Plastics Industry Association, Suzhou Plastics Industry Association, Hunan Plastics Industry Association, XinJiang Plastics Industry Association, Yunan Plastics Industry Association, China Electronics Chamber of Commerce,

<< The organiser has just participated at Plastindia 2012 and recruited many overseas visitors to preregister as CHINAPLAS 2012 visitors >>

Suzhou Integrated Circuit Industry Association, Danyang Automobile Component Industry Association, Medical Plastic Professional Committee of China Plastic Processing Industrial Association, Wuxi Die & Mould Industry Association, Cixi Mould Association, and many more.

Meanwhile, a number of overseas trade associations from Egypt, India, Jordan, Philippines, the UK, Ukraine and Vietnam have also expressed their interests in organising buyer groups. Such a strong response greatly reveals that CHINAPLAS 2012 has been well recognised by the industry and supported by numerous trade associations over the world.

As the exhibition scale is ever expanding together with the number of overseas visitors, the organiser has actively cooperated with many travel agencies from all over the world as stragetic partners, including Algeria, Brazil, Canada, Colombia, Finland, India, Indonesia, Iran, New Zealand, Philippines, Russia, South Korea, Taiwan, Turkey, USA, UK and Vietnam, to promote CHINAPLAS 2012 and provide all around transport and hotel services for overseas exhibitors and visitors. Till now, travel agents from Brazil, India, Indonesia and Turkey have already confirmed to organise delegation to visit the show.

Overseas visitors from over 120 countries or regions have already pre-registered online, with the top 10 countries or regions being India, Taiwan, Pakistan, Indonesia, Hong Kong, Malaysia, Iran, US, the Philippines continued on page 54 >> MARCH | APRIL 2012 / MPN /53

CHINAPLAS PREVIEW Preview | CHINAPLAS continued... and Brazil. A number of famous leading enterprises, for example, Hangzhou Wahaha, Philips, Tyco Electronics, BYD, Qingdao Hongda, Panasonic, Inner Mongolia Yili, BMW, Rexam, Honda, 3M, Parker Hannifin, Mitsui Plastics, Schneider Electric and Mitsubishi, have already registered to visit this international industry event.

The total exhibition area is expected to hit a new record high of 200,000 square metres. Over 2,600 exhibitors from 35 countries and regions together with 13 country/region pavilions from Austria, Canada, France, Germany, Italy, Japan, Korea, PR China, Taiwan, Thailand, Turkey, UK and USA will gather under the same roof to showcase their diversified chemicals and raw materials and over 2,500 sets of machines. A number of prestigious enterprises have already confirmed their large exhibition areas. They include: chemicals and raw materials suppliers like Du Pont, SABIC, Borouge, BASF, Bayer, Dow, ExxonMobil and LANXESS; machinery suppliers like Haitian, Chen Hsong, Husky, Borch, SHI, EDI, Fangli, Liansu, Jwell, Jinhai, Dailian Totani, Demark, Akei, Matsui, Kawata, Wu Xi Yang Ming, Tongyu, Zerma, Avian and Conair; and mould and die suppliers like MoldMasters and Yudo. Through this platform, every exhibitor will unveil its latest research and development achievements, ranging from new materials processing technologies to final applications.

In order to ease the endless stream of visitors, crowd control will be implemented at Entrance Hall 1. Only online pre-registered visitors, badge holders and visitors by invitation are allowed to register or enter Entrance Hall 1 on April 18 and 19 from 9:00 am to 11:00 am.

Visitors not of these categories have to register or enter either at Entrance Hall 1 after 11:00 am or Entrance Hall 2 and 3. To enjoy this special admission arrangement, free admission and a free coupon to redeem the exhibition catalogue (worth RMB100), please pre-register now at www.ChinaplasOnline.com.

In addition, by using the online function of myChinaplas, pre-registered visitors can search exhibitor profiles, plan their visiting route, personalise their own visitor guides and join the online business matching service. Visitors who visit CHINAPLAS on April 18â&#x20AC;&#x201C;20, before 3:00 pm will have the chance to win an iPad2 or digital camera. For details, please visit www.ChinaplasOnline.com/luckydraw.

The CHINAPLAS mobile website has been launched.

Visitors can access latest show updates, transport and accommodation information and conference details anytime at their fingertips. They can also pre-register online by simply clicking the icon on the phone. For more enquiries, please visit www.ChinaplasOnline.com

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ENGEL at Chinaplas 2012 in Shanghai Booth No: E2D01 ‘Meet the experts’ is the word at the ENGEL trade fair booth at Chinaplas 2012 in the Shanghai New International Expo Centre. Five leading edge topics will be presented in Expert Corners. On top of this, three production cells will demonstrate how application and industry-specific state-ofthe-art technologies can improve productivity, efficiency and sustainability in injection moulding operations.

Chinaplas 2012 sees ENGEL present a new exhibition concept in. Five leading edge topics will be presented with videos and sample parts. “Additionally, we have experts from ENGEL China and from the business units at ENGEL’s headquarters in Austria on site to talk to trade fair visitors about their challenges,” said Gero Willmeroth, ENGEL’s President Sales and Service in Shanghai. The focus will be on the trend topics lightweight construction, automation, LSR processing, process monitoring and glazing. ENGEL implemented the Expert Corner Glazing in cooperation with Bayer MaterialScience.

Three production cells at the ENGEL trade fair booth add a hands-on touch. They cover a wide range of the major growth drivers in China, from automobile manufacturing, through the teletronics industry, to medical technology.

Chinaplas Asia: Leading in Performance and Quality Booth No: N1S01 This is the slogan used by KRAIBURG TPE at Chinaplas 2012. Visitors will be invited to take a closer look at the new products such as the drinking water series and a wide range of adhesion compounds. KRAIBURG TPE’s thermoplastic elastomers offer optimal adhesion properties on materials such as PA (nylon), ABS or ABS/PC and ensure excellent elastic recovery. Additionally, through the application of TPE, manufacturers benefit not only from improved production conditions for injection moulding, but also from an extended complex functionality, even at extreme heat or low temperatures. Furthermore, the application of a timeand money-saving multi-component process ensures simplified logistics as well as safe and more hygienic products compared with assembly processes. The new DW compounds (drinking water series) are to be exhibited in Asia for the first time. Their special formulation means that they satisfy the most important European drinking water standards. Due to their smooth, dirt- and limescale-repellent surface, TPEs are suitable for use particularly in the sanitary and drinking water sector.

LS5 Materials Testing Machine Booth No: W1TBC The new LS5 single column materials testing machine from Lloyd Instruments is on show for the first time at Chinaplas 2012. The LS5 provides enhanced travel, accuracy and flexibility for plastics, rubber and packaging materials testing applications under 5kN force with a crosshead speed range of 0.01–1016 mm/min. Other instruments on show from the company’s comprehensive range of materials testing machines will include the LS1 single column machine and the LR10KPlus twin column materials tester, together with Davenport polymer test equipment and Chatillon force measuring equipment.

Designed for routine QC testing or complex multi-stage tests, the new LS5 can perform a comprehensive range of tests, including tensile strength, compression, flexural, peel, shear, static and kinetic coefficient of friction and many more. Load accuracy of ±0.5% down to 1% of load cell value provides high dynamic range, reducing the number of load cells required.

Available in 800 mm (5kN) and 1400 mm (2.5kN) travel versions, the LS5 will be shown equipped with an EX800Plus contacting extensometer.

A wide throat depth (140 mm) provides a large sample working area. PC control is provided through Lloyd’s own materials testing software. Handheld controllers and integrated consoles are also available.

LPKF Laser-Plastic Welding – fast, secure, reliable Booth No: E1C45 Laser plastic welding scores because the technique is extremely hygienic, particle-free and safe. LPKF, a leading supplier for laser plastic welding systems, will be showcasing the LQ-Vario at Chinaplas 2012.

The LQ-Vario is a flexible and compact laser welding system specially designed for the economical processing of small and medium-sized batches. In the RT version, an integrated rotary indexing table speeds up mechanical loading and makes the machine much more productive. A special version of this stand-alone-system, the LQ-Vario MF, enables even complex welding contours, such as those in microfluidic components and clear-clear-parts, due to a high performance fibre laser.

All systems are equipped with integrated online process monitoring for an end-to-end “Tracking & Tracing”.

As a full service provider, LPKF not only supply systems, but also the associated technical knowhow about laser engineering, plastic technology and material processing, as well as a comprehensive process experience and competence.

Experts will be on hand to demonstrate and answer any specific questions.

MARCH | APRIL 2012 / MPN /55

DOCTOR’S NOTE

OrthoSensor’s intelligent device for knee replacement surgery leverages Bayer’s medical polycarbonate LEFT: OrthoSensor’s Knee Balancer provides real-time, quantitative feedback on soft tissue balancing to surgeons during total knee arthroplasty. Bayer MaterialScience LLC’s Makrolon Rx1851 plastic provided the necessary bio-compatibility and superior strength that this application required.

his intelligent device uses sensors and wireless technology to provide real-time, evidence-based data to the surgeon to optimise the positioning and balance of implants.

By giving surgeons the ability to quantify adjustments intraoperatively, the OrthoSensor Knee Balancer contributes to improved patient comfort and prosthetic longevity. OrthoSensor had several criteria for choosing a material for this innovative product, including biocompatibility, superior strength and support from the supplying company. Bayer MaterialScience LLC’s Makrolon Rx1851 polycarbonate fitted the bill. This medical grade of resin is compliant with FDA-modified 10993, Part 1. It also possesses desirable properties, such as improved flow,

Surgery requires precision.

OrthoSensor’s new Knee Balancer provides precise, quantitative intraoperative data on soft tissue balancing during total knee replacement surgery. Until now, surgeons had to subjectively determine the amount of pressure to apply to a knee implant.

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T

lubricity, easy release and strength. Bayer’s ability to provide custom colour formulations for its Makrolon polycarbonate solidified OrthoSensor’s choice.

The OrthoSensor Knee Balancer is available in four translucent colours — brown, green, blue and yellow — each indicating a specific surgical size. The devices can also be used with four shim sizes that correspond to these colours, which increase the thickness of the device allowing for variations in patient anatomy. The OrthoSensor Knee Balancer, which is the only device of its kind according to OrthoSensor, was launched in late 2011 and is commercially available in the United States.

“The OrthoSensor Knee Balancer is a revolutionary, intelligent orthopedic device, so using a high quality, reliable material was of paramount importance to us,” said Erik Herrmann, OrthoSensor’s Director of Product Development, Surgical Balancing. “Both the performance of the material and the support provided by Bayer have gone above and beyond our expectations.”

“We value all of our customer relationships and will work with our customers to help ensure satisfaction,” explained Bruce Fine, Market Segment Leader, Medical >>

and Consumer Products - Polycarbonates, Bayer MaterialScience LLC. “In the creation of OrthoSensor’s Knee Balancer, we worked with an adhesives formulator and moulder to safeguard the integrity of the material and assure that OrthoSensor’s high standards were met.”

Representatives from Bayer were on hand to discuss this application and other medical advances from Bayer at MD&M West, on February 14-16, in Anaheim, CA, USA.

The Clinical Drive

for Better Plastics in Open heart Surgery Polymers Progress Innovation in Cardiopulmonary Bypass (CPB) Systems Open heart surgery has been with us for over 50 years now. It has changed much in that time, but still relies on the use of a heart/lung or cardiopulmonary bypass (CPB) system to support the heart and lungs of the patient during the procedure. ver the past half century, much has changed in terms of the complexity and quality of the technologies used in constructing the CPB system. However, some elements have changed little in this time and it is fair to say that a clinician from the early pioneering days of CPB would still recognise the apparatus used today as being a heart/lung machine.

The CPB system relies upon polymeric materials for both the functional (membrane exchange surfaces) and containing (tubing and blood reservoir) elements of the system and a vast array of polymers have evolved for these purposes.

The use of PVC as a blood contacting surface remains controversial to this day.

In the early days of CPB, the PVC tubing employed in heart/lung systems was sourced from hardware stores in the form of garden hose of various sizes. This was an adequate short-term solution at a time when open heart surgery was both pioneering and risky and the medical polymer industry was very much in its infancy.

O

WORDS | PROF TERRY GOURLAY, BIOENGINEERING UNIT, UNIVERSITY OF STRATHCLYDE

In the ensuing years during which the risks associated with open heart surgery reduced due to improved diagnosis, intervention and materials, the importance of blood/material interaction became more apparent and assumed greater importance as high mortality and morbidity became unacceptable.

Clinicians have engaged in studies designed to understand the clinical importance of “biocompatibility” in CPB systems more fully and this work led to an understanding of the underlying mechanisms and the importance of these materials in terms of clinical outcomes. In particular, the role of blood/biomaterial interactions in the development of clotting and inflammatory disorders associated with CPB was highlighted. PVC tubing, used to convey blood around the CPB system, was highlighted as being one of the major culprits in these inappropriate responses.

Studies carried out in the UK further confirmed that DEHP, used as a plasticiser in tubing for CPB systems, migrates to the surface of the material both before and during use and is in itself associated with inappropriate activation of inflammatory processes.

The clinical importance of these findings is significant. They have informed

both clinical and manufacturing practice over the past years. Three strategies have evolved in recent years to mitigate the problem of blood/PVC mediated activation of inflammatory processes, as follows: 1. develop smaller CPB systems with lower PVC contact surfaces; 2. develop surface coatings which prevent contact between the DEHP rich polymer surface and blood; and 3. avoid the use of CPB during open heart surgery by using an off-pump approach.

All of these strategies have offered some degree of resolution to the clinical problems of contact activation, but the problem persists, albeit to a lesser degree in modern clinical practice. The off-pump approach, carrying out heart surgery without CPB on a beating heart, is technically challenging and is only performed on a limited cohort of patients.

The use of CPB will continue into the future and clinicians continue to appeal to the polymer industry for an affordable solution to the blood/biomaterial contact challenge.

MARCH | APRIL 2012 / MPN /57

EVENTS medical plastics | DIARY 2012

Conference - Silicon Elastomers March 27 - 28, 2012 Berlin, Germany

Trade Show - Plastics April 18-21, 2012 Shanghai, China

Conference - Medical Plastics March 28-29, 2012 Friedrichshafen, Germany

Trade Show - Medical Devices May 22-24, 2012 Philadelphia, PA, USA

Trade Show - Plastics April 1-5, 2012 Orlando, FL, USA

Trade Show - Medical Plastics September 23 - 25, 2012 Birmingham, UK

Trade Show - Medical Devices November 14 - 16, 2012 Dusseldorf, Germany

Mediplas 2012 - Call for Papers Tattenhall, Cheshire, UK, February 29, 2012 â&#x20AC;&#x201D; Fresh from the news of its launch, Rapid News Communications Group is formally announcing the Call for Papers for the inaugural edition of Mediplas 2012.

The debut event, which is uniquely focused on the highly specialised area of manufacturing plastic parts for the medical industry, will co-locate alongside MM, MEMS & NANO Live UK and TCT Live. 2012 also sees a formal co-location with Sensing Technology 2012. This grouping of shows will provide a significant showcase of engineering and manufacturing technology in the UK with a projected attendance approaching 6,000.

In order to establish the world-class nature of this event, Rapid News Communications Group is now calling for outstanding abstract submissions for the following sessions: Medical Grade Polymers Materials Selection Design & Prototyping Efficient Manufacturing Advanced Processing Regulations & Legislations Any other relevant topics

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Confirmed Exhibitors Already Include:

BFA SOLUTIONS, CARVILLE, CLA SSIC INDUSTRIES, DALAU, DATA PLASTICS, DS BROOKES, DYNE TECHNOLOGY, ENGEL, ENSINGER, EWIKON, FIBRACON-IN SOLL, GREINER BIO-ONE, OGP UK, PREMIER MOULDING MAC HINERY, TELSONIC, TICONA UK, WILD ANALYSIS AND ZWICK TESTING MACHINES.

All submissions must be non-promotional in content and presented by companies or institutions that are utilising and/or researching technologies for an industrial application. Exhibitors are welcome to submit practical application-based case studies.

Interested parties are initially requested to submit an abstract of 300 words of their proposed paper on or before March 30, 2012. This should include the working title, all authors/contributors and their affiliations. All submissions will be reviewed to ensure that they meet the necessary and exacting requirements of the Mediplas Conference.

Mediplas will be held at the NEC Birmingham, September 25â&#x20AC;&#x201C;26, 2012, and anyone submitting a presentation must be available to present on any of these two days. Please submit abstracts to Colin Robinson via email: colin.r@rapidnews.com.

Mediplas, TCT Live, MM Live UK, MEMS Live UK, NANO Live UK and Sensing Technology will take place on September 25-26, 2012, Hall 3/3a, NEC, Birmingham, UK.