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VELOX GmbH, one of Europe’s leading solution providers of raw material specialities for the plastics, composites, additives and paint & coatings industries, and its long-term partner SK Chemicals Co., Ltd. (South Korea) are presenting Skyplete, a new plastics material range with some unique products for the 3D industry. VELOX has been chosen as distribution partner in Europe by SK Chemicals.

“We are excited to be working together with our long-term partner, VELOX, in developing the 3D printing industry in Europe. We believe that VELOX is the most suitable partner to meet our strategic objective to expand the market share in Europe because they have experience in 3D printing industry as well as technical knowledge on SK Chemicals products”, commented Brian Oh,  business development team leader at SK Chemicals.

“3D printing or additive manufacturing (AM) has become indispensable for design and manufacturing in different industries. Its widespread use is creating the need for specialised materials like the Skyplete range by SK Chemicals”, says François Minec, General Manager at VELOX.

Specialities to be highlighted within the Skyplete products are e.g. the EN100, a PLA-based biodegradable type with a heat resistance (HDT) of 100°C, that is up to twice as high as the HDT of competitive products on the market. But also the Skyplete E-Series, bio-copolyester types with higher impact and temperature resistance than the widely used ABS and PLA materials, as well as copolyester types that combine the advantages of PLA and ABS – e. g. food approval, low-odour, easy to print on, good adhesion of the individual layers – are to be emphasised.

“The Skyplete range is one of the most innovative 3D printing materials in our portfolio and an excellent choice for filament manufacturers looking for enhancement of temperature resistance for easy-to-print materials and the refinement of common compounds to improve impact resistance and engineering performance”, comments Manuel Delgado, 3D printing market manager at VELOX.

VELOX’ target group for the new Skyplete range are filament producers and compounders looking for innovative and specialised 3D printing materials with a great range of properties. VELOX provides the new product range in all European countries.

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Ashland today announced it has appointed VELOX as its new main composites distributor for France. The new distribution agreement, which is effective July 1, 2018, includes all Ashland unsaturated polyester resin, gel coat, low-profile additives products and epoxy vinyl ester resins, including Derakane™. All activities previously managed by Quimidroga, will transfer to VELOX France SAS per July 1, 2018.

“We are excited to have VELOX representing us in the French market," said Alessandro Lago, sales director, Composites, EMEA. "The VELOX team has considerable commercial experience in the composites business and the right technical expertise to support Ashland’s growth in the French market.”

“We are delighted that Ashland have selected VELOX as their main representative for composite products in France and trust in our expertise. We look forward to a very successful cooperation”, commented François Minec, General Manager at VELOX.

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Focus on newest antimicrobials, halogen-free flame retardants and bio-based materials

VELOX GmbH, one of Europe’s leading solutions providers of raw material specialities for the plastics, composites and additives industries, will be showcasing at the Compounding World Expo 2018 in Essen, Germany on 27th to 28th June 2018. At booth 100 VELOX and its co-exhibitors Polyram Plastic Industries LTD and Völpker Spezialprodukte GmbH will be presenting new and proven additive solutions for the plastics compounding industry.

“With its specific focus on the compounding market the Compounding World Expo is a highly relevant and promising exhibition for VELOX. We are looking forward to insightful discussions and exchange on current developments in the industry. Together with our partners we will be presenting  our extended additives portfolio”, states Nadia Kursawe, Business Unit Manager, Additives at VELOX.

Polyram will take the opportunity of the Expo to introduce a new impact modifier called Bondyram 7105. This grade is a MAH modified ethylene/octane copolymer elastomer for improving PA66 compounds.

Völpker will be showcasing its Montan waxes and special wax blends that are often the key to solving complex processing problems in the plastics and plastic recycling industry allowing to create compounds with significantly better characteristic value profiles.

Besides Polyram and Völpker, VELOX’ newest partner for antimicrobial additives, Life Material Technologies, will also be present at the booth. VELOX is the exclusive distributor of Life’s antimicrobial additives and treatments in most of Europe.

In addition to its antimicrobials portfolio, VELOX will be showcasing its broad flame retardant range. “With the new and stricter requirements for flame retardancy for various applications in electronics, construction or the public sector in Europe, halogen-free flame retardants are in increasing demand. VELOX has a wide range of halogen-free additives to offer”, highlights Kursawe.

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VELOX GmbH, one of Europe’s leading solutions providers of raw material specialities for the plastics, composites, additives, rubber and paints & coatings industries, will be showcasing its comprehensive rubber and rubber additives portfolio at the German Rubber Conference DKT, taking place in Nuremberg from 2nd until 5th July. In Hall 12, booth 338 VELOX’ long-standing partners Avanzare, Axalta Polymer Powders and Nitriflex, as well as the company’s new partner Himadri from India, a carbon black specialist, will co-exhibit.

“VELOX is well established in the rubber and additive industry with a wide product portfolio for 25 years”, says Robert Zeppelin, Business Unit Manager CASE (Coatings, Adhesives, Sealants and Elastomers) at VELOX. “We are pleased to be represented again this year together with strong partners and a broad range of specialties."

Furthermore, Avanzare will present novel additives on the subject of "Thermal and Electrical Conductive Materials to Avoid H&S problems " at the daily Poster Sessions.

This year, VELOX is celebrating its 25th anniversary. The Group is operating 21 offices across Europe as well as in China, Russia and Turkey.

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PENTAC and VELOX at CEP Auto 2018 in Spain

VELOX GmbH, one of Europe’s leading solutions providers of raw material specialities for the plastics, composites, additives and paint & coatings industries, and its long-term partner PENTAC Polymer GmbH will be participating at the International Conference on Automotive Plastics, CEP Auto that will be held in Barcelona, Spain, from 27th to 28th June 2018.

The focus of PENTAC and VELOX will be lightweighting in automotive engineering. Dr. Georg Kirschbaum, Business Development Manager at PENTAC, will be holding a lecture on dealing with the different possibilities to reduce the weight of reinforced polyamide compounds, with solutions that allow to save up to 40 % of the weight compared with parts injected in "normal" nylon. Through the combined use of different base polymers with reduced density reinforcements and fillers weight savings of 30 % or more have already been achieved.

For example, savings of several 100 gr weight could be achieved by using dense-optimised material formulations compared to typical, previously used polymer compounds for motor covers. As part of a general concept for weight reduction in the automotive industry, it is already possible to significantly contribute to the overall goal achievement at this point, without affecting the function of the component.

„We are looking forward to an intense and fruitful exchange on cutting-edge technical developments in the industry at CEP Auto”, says Albert Kirchner, Country Manager Spain and Portugal at VELOX.

CEP Auto is organised by the “Centro Español de Plásticos”. For more information click the following link: https://www.cep-auto.com/

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VELOX announces distribution of Asahi Kasei’s DuranolTM W8011

VELOX GmbH, a leading pan-European distributor of raw material specialities and solutions provider for the plastics, composites, additives, rubber and paints & coatings industries, is now offering customers across Europe a new, unique additive developed by its long-term partner Asahi Kasei Corporation. The polycarbonate diol DuranolTM W8011 is easily dispersible in water. It improves the chemical as well as scratch resistance and the adhesion, softness and self-healing of coatings.

“DuranolTM W8011 is a high-quality water dispersible polycarbonate diol which can be used as poylol or additive in a wide range of applications. It is especially designed for the use in aqueous industrial coatings as well as wood, plastics, glass and furniture coatings”, states Olaf Knispel, Product Manager CASE (Coatings, Adhesives, Sealants and Elastomers) at VELOX.

DuranolTM W8011 is a polycarbonate diol developed by Asahi Kasei and is perfectly suitable as speciality additive for water-based 2K acrylate binder systems (2KPU). It improves adhesion on different substrates, especially aluminum and various plastics. It also provides increased scratch resistance (also "self-healing") and chemical resistance of coatings. Moreover, W8011 can be used for the polyol component of soft-feel coatings and gives excellent sunscreen lotion resistance.

VELOX will be introducing DuranolTM W8011 at Surfex, taking place in Coventry, UK, from 22nd to 23rd May 2018. Asahi Kasei will be co-exhibitor sharing VELOX’ booth 112.

Grade

Appearance

Molecular weight (Mn)

Viscosity (mPa. s/50°C)

OH value (mgKOH/g)

Solid content

DuranolTM W8011

Liquid or Wax-like solid

    1,000

800 ~ 1,800

110

100%

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VELOX GmbH, one of Europe’s leading distributors of raw material specialties and solutions provider for the plastics, composites, additives, rubber and paints & coatings industries, will exhibit at PLAST 2018, the international exhibition for the plastics and rubber industries, taking place in Milan, Italy from 29 May to 1 June 2018.

In Hall 9, booth 81, aisle A, VELOX and its partners will be showcasing among others new materials like bio-plasticizers for TPU/PLA and other polymers, special hydrolysis stabilizers, new flame retardant additives and high-temperature purging compound grades. Furthermore, VELOX will present a wide range of proven solutions for food, medical and pharma, TPUs for cable & wire and many other markets, materials for metal replacement like LCP, PEEK, PPA and carbon fiber reinforced polymers.

“PLAST is one of the biggest trade shows for the plastics industry in Europe and VELOX has been successfully participating since 1997. Therefore, we are looking forward to the fair and are pleased to announce that VELOX will be exhibiting a wide portfolio, representing our long-standing partners”, comments Carlo Iori, Country Manager VELOX Italy.

VELOX will represent Arkema, Asahi Kasei, Avanzare, FRX Polymers, Lubrizol, Polyram, Potters, Schäfer Additivsysteme, Shekoy, Struktol, Sumitomo Chemical, Tolsa, TOPAS Advanced Polymers, Völpker Spezialprodukte and ZOLTEK.

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TPU for the cable market

VELOX GmbH, one of Europe’s leading solutions providers of raw material specialties for the plastics, composites, additives, and paints & coatings industries, will exhibit at Plastpol from 22nd to 25th May 2018 in Kielce, Poland at booth 53, hall E. Co-exhibitor will be VELOX’ long-term partner Lubrizol. VELOX is intensifying its activities in Eastern Europe and Russia with a range of solutions especially adapted to the needs of the growing region.

“VELOX will present a broad offering of thermoplastics, polymers, additives and composites, as well as paints and coatings products designed for a wide range of applications”, says Guillaume Fromont, Product Manager Engineering Plastics. “In particular, the speciality thermoplastic polyurethane (TPU) products from our principal Lubrizol, under globally recognised trade names including Estane®, Pearlthane™ and Pearlbond™ TPU are of great interest for injection moulding, extrusion, adhesive and compounding applications. These are valued for their durability and mechanical properties in hose and tube, cable and medical device end uses.”

One key focus of VELOX at Plastpol will be the cable market. The company offers specialised products for extrusion applications for different industries, e. g. the automotive industry, electronics, the energy sector and more. Especially the Estane® flame retardant (halogenated and halogen-free) TPU’s that are able to pass the norms FT-1 and FT-2 at low thickness as well as to fulfill the norm IEC 60332-1 or -2 will be highlighted by VELOX. “The cable market in Eastern Europe is steadily growing and we are pleased to be able to offer materials for a very broad range of applications”, says Guillaume Fromont.

VELOX has been present in Eastern Europe for more than 10 years and is strengthening its activities in these important markets even further. The company operates local offices and sales networks in Poland, the Czech Republic, Romania, Slovakia and Hungary, and has established its Russian office in Moscow just in April 2017. From here, VELOX also serves the markets in Belarus and Ukraine.

“We are looking forward to propelling our sales in Eastern Europe and Russia, which are important markets for plastics and composites”, comments François Minec, General Manager at VELOX. “Our local teams have an extensive experience in the chemical industry and a very good knowledge of the respective markets. We are looking forward to supporting our Eastern European customers with our high-quality solutions especially customised to their needs.”

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Why a clarification would benefit both material suppliers and device manufacturers

The healthcare and medical device industry is heavily regulated to ensure quality, sustainability and most importantly safety of human life. Hence, device development is a long and complex undertaking, with strict compliance regulations, long-term tests, quality checks and certifications. Nonetheless, one seemingly simple question has not been answered yet:  What is a “medical grade” polymer? The Association of German Engineers, VDI, has embarked on defining a standard. First draft is expected in April 2018.
Siobhan Bastiansen, Market Manager Medical Plastics at VELOX GmbH, depicts the current situation and explains why material suppliers as well as device manufacturers would benefit from a clarification. She also shows how specialised medical polymer producers have risen to the challenge to create indispensable value for processors and OEMs.

From orthopedic and surgical instruments to diagnostic equipment, drug-delivery systems and implants to vision aids, polymers have been used in the healthcare and medical industry for decades. Meeting constantly new requirements like weight and size reduction, easier processing, flexibility, biocompatibility, stricter sanitation or the need for single-use instruments would be practically impossible without the use of polymers. Hence, it comes as no surprise, that an estimated 50 percent of all materials used in medical device manufacturing consist of plastics.
However, when it comes to  the right polymer choice for a specific medical or pharmaceutical application, things can get complicated. Despite strict international and national regulations as well as demanding requirements for medical polymers, one extra difficulty in this choice is the fact that there has been no universally accepted definition of “medical-grade” polymers so far.

The challenges of the past
In recent years, the so-called “PIP scandal”, where the French implant device manufacturer  Poly Implant Prothèse (PIP) used industrial silicone instead of surgical-grade silicone for breast implants, has been affecting the medical industry, with far-reaching financial, judicial and personal consequences for PIP, the material suppliers, Notified Bodies and for the patients. The scandal came to light in 2010 after high rates of rupturing were reported. To this day, this case keeps the courts busy. Only in February 2017, the European Union Court of Justice decided in the case of TÜV Rheinland that whilst Notified Bodies do have to protect end users of medical devices, they are not legally liable.

The PIP scandal from 2010 is only the most recent of the failures that took place in the past decades causing great outcry throughout the industry. It once again showed the extent of unresolved questions and uncertainties on all sides.

In the 1990s, many polymer suppliers decided to withdraw from the medical market as a consequence of similar affairs. To stop the drying-up of the market in the United States, the US Congress passed “The Biomaterials Access Assurance Act of 1998”, which stipulated that raw material suppliers were not to be held liable for any product failure as long as they “meet applicable contractual requirements or specifications” . Since then, medical device manufacturers have had to invest heavily to make sure their products comply with regulatory requirements and are safe for the intended application.
However, a national or international definition of “medical-grade” polymer or plastic is yet to be put into place.

Application restrictions as self-protection for polymer suppliers
Following several high-profile and costly litigations in the '90s, companies that actively market their polymers for medical applications typically have developed policies regarding restricted or permitted applications. “There is a wide variety of ‘rules’ from polymer producers concerning which applications are allowed. Often the restrictions may not be related to expected performance of the polymer in the target application, but rather reflect the corporate environment and legal department’s decisions. The restrictions can have much more to do with perceived risk exposure to litigation down the line”, says Siobhan Bastiansen

Some examples of guidelines are:

• not permitted to be used in medical applications
• skin contact only
• no direct contact with fluids entering the blood stream
• maximum 24 hours inside the body
• maximum 29 days inside the body

Of course, it is very challenging for medical device manufacturers and OEMs, especially the specialised small and medium-sized businesses, to keep track of all the different and complex policies and disclaimers. “As a specialist medical polymer distributor, we see our role as the critical bridge between our polymer principals and our customers, the device manufacturers, to make the right polymer choice process a safe, successful, sustainable and convenient one.”

For instance, currently, there are very few polymer choices for medical device manufacturers designing products to remain in the body longer than 30 days, and where the customer wants the confidence and support of the raw material supplier. “Our partner Lubrizol LifeSciences is one of the very few polymer suppliers who do not restrict the use of their TPUs to 30 day implants but instead have a disclaimer reminding that the choice of polymer is up to the device manufacturer. Medical device designers are free to select from a wide TPU portfolio the most suitable grades to be tested and considered for each specific application”, explains Bastiansen. “On the other hand, if we have a customer who has very low volume of demands for a coloured material for a non-invasive device, we can offer a range of options advising MOQs of coloured resins direct from the producer, or assist in finding a long-term sustainable solution with our medical compounding partner IPC”.

MDR and its impact for medical device manufacturers
While polymer producers have determined their own individual set of characteristics to define what a medical grade is, medical device manufacturers have been theoretically free to choose any polymer, as long as they followed existing regulations, while carrying the risks involved with product liability. Many device manufacturers have relied on compliance with applicable standards such as USP Class VI and ISO 10993, with regard to biocompatibility when choosing the material for their application.

The new European Union Medical Device Regulation 2017/745 (MDR), which came into force on 25th May 2017 and will be mandatory from 26th May 2020, places a strong emphasis on risk management and safety. Compared with previous medical device guidelines as MDD 93/42/EEC, that the new MDR will replace, it comprises 100 additional articles and two more appendices, new classification rules as well as extra surveillance and safety reports. It also reinforces the position of notified bodies, “with regard to their right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to ensure continuous compliance by manufacturers after receipt of the original certification.”
“Especially for many small and medium-sized medical device manufacturers, the new, more demanding law may sound the death knell, as it will make the market entry for their products extremely difficult and expensive”, Bastiansen comments.

Still, when it comes to an industry-wide, standard definition for medical-grade polymer, the new MDR, like MDD before, remains silent. Hence, there is no compulsory use of medical polymers for medical applications, as long as conformity with existing regulations is given.

First step towards binding definition of medical grades
In Germany, things are moving. In December 2016, the Association of German Engineers, VDI, has implemented a committee for defining a standard for medical-grade polymers. As VDI stated, “The aim is to define the requirements for the polymers for use in medical devices and thus to develop a standard that can be used as a guideline for raw material producers and manufacturers of medical devices. The directive covers development, logistics, procurement and purchasing equally.”  It is expected that VDI will present a first draft of the guideline at the VDI symposium “Plastics in Medical Technology”, taking place from 10 to 11 April in Friedrichshafen, Germany.

“We are fully supportive of the VDI aim, and think that a standard definition would bring more reliability, stability and long-term commitment for all sides. This is what polymer manufacturers and medical device producers alike need”, comments VELOX’ medical plastics expert Bastiansen.

Change management and long-term commitment as key differentiators
In the meantime, specialised medical polymer producers have already taken the opportunity to create indispensable value for medical plastics processors and OEMs.

To understand the peculiarity, one has to recall that only up to three percent of the worldwide polymer production ends up in medical and healthcare applications. “This is really a drop in the ocean”, says Bastiansen. For many polymer suppliers that serve diverse high-volume industries like automotive, food, packaging, construction etc., it may make no economic sense to invest in a market with such small potential volumes. However, several of these ‘industrial grade’ resins have made their way into products that are considered as medical devices and as such are subject to MDR or FDA conformity. For medical device manufacturers, on the other hand, this holds several risks and challenges; once they have carefully chosen and tested a material to comply with all the complex laws and guidelines for medical plastics, and to meet the requirements for their specific application, they need to rely on long-term supply and predictability. Sudden delivery stops or changes in the raw material production without notification of the device manufacturer, that are common in the industrial polymer sector, can be fatal as the medical device producers may have to repeat the whole complicated and expensive gauntlet of tests, qualification and certification processes that can take years.

“Polymer suppliers that develop and provide specialised polymers for medical applications have discovered a significant gap in this complicated situation to add value for the manufacturers”, highlights Bastiansen. “Suppliers like Repsol or Lubrizol LifeSciences that we have been cooperating with for many years have put transparent mechanisms into place to ease the process of change control for the OEMs and to also secure a long-term supply.”  This way, both parties benefit from a close cooperation with mutual insight and knowledge exchange and protect their business and products from expensive failures.

Therefore, it is important for these manufacturers to understand the “landscape” of typical polymer producers. Cristina Martinez from VELOX’ partner Repsol, Healthcare division, explains the challenge precisely: “The typical dynamic in chemical plants producing hundreds of thousands of tonnes such as we have for our PE, PP and EVA resins, is to strive for continuous improvement in efficiencies, quality, innovation and economics. By implication, things are always changing – new grades bring advantages and old grades become obsolete – which is great for our industrial customers but can be a nightmare for medical customers. The challenge in setting up our Repsol Healthcare® portfolio has not been of a technical nature in developing innovative new grades. The much bigger task has been to understand the needs of medical and pharma companies and to put the necessary product stewardship in place across all the stakeholders within the organisation. This means production, purchasing, logistics, R&D as well as sales and marketing.”

“So knowing your supplier and being sure that they know you and your application is the ideal scenario”, sums up Siobhan Bastiansen from VELOX. “They can give the right support, advise you and be there for the long term, which is crucial for success across the lifetime of the product. This is even more true with regard to the regulations of the new MDR.”

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Ixef® PARA distributed by VELOX for single-use medical instruments

VELOX to become European distributor of Solvay’s Ixef® PARA polyraylamide for medical applications. 

VELOX GmbH, one of Europe’s leading solution providers of raw material specialities for the plastics, composites, additives and paint & coatings industries, is pleased to announce a new distribution partnership with Solvay, a leading global supplier of specialty polymers, headquartered in Brussels. VELOX will be distributing the healthcare grades of Ixef® PARA, a special polyarylamide containing 50 % glass fibres and best-suited for the development of medical devices as single-use surgical tools.

“We are very pleased to have gained Solvay, a world-renowned company, as our partner and are looking forward to a very successful cooperation”, says François Minec, General Manager at VELOX. “With Ixef® PARA we have added a unique product to our medical plastics portfolio, complementing our already wide range of speciality products.”

“VELOX is very experienced in the medical and pharmaceutical plastics market in Europe and has established a versatile, sustainable network. We are full of trust in this partnership and are looking forward to it”, comments Daniel Stoecker, Channel Partners Manager EMEA,  at Solvay.

Ixef® PARA is best-suited for the development of complex parts requiring both strength and a smooth, beautiful surface. Even with glass loadings of 50 %, the material insures a high-gloss, glass-free finish. As a very high-flow resin, Ixef® PARA can fill walls as thin as 0.5 mm. “This unique product has great mechanical properties perfect for metal replacement, for instance in single-use instruments”, highlights Anja Flossbach, Product Manager for Ixef® PARA at VELOX. Operators can thereby eliminate central service costs associated with the sterilization of reusable instruments. Further benefits are weight reduction and accordingly cost savings as well as a great level of design freedom.

Ixef® PARA is biocompatible according to ISO 10993. VELOX offers the material in different gamma stabilised colours.

® Ixef is a registered trademark of Solvay.

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