Be it contact lenses, intubation tubes, single-use syringes or cannulas, more than half of all medical products manufactured around the world are made of plastics. But even beyond these mass-produced articles, the prospects for polymer materials in medical technology look rosy. Market experts had the opportunity to track both the advances made and the growth of plastics in medical applications at K 2013. Subsequent to the market analysis some examples from K 2013 will follow.
Plastics are increasingly used in medical applications. (photo: Messe Düsseldorf)
Of the roughly 47 million tonnes of plastics processed in Europe, almost 40% are used for packagings, 21% for civil engineering and construction, 8.3% in the automotive industry, and 5.4% in the electrical and electronics industry. The rest is spread across such diverse areas as sport and leisure, toys, household goods, furniture, agricultural uses and medical technology. Regarding the latter, no exact percentages are available because of the blurred distinctions as to where medical technology starts and ends. But one thing is clear: only the technically sophisticated and high-quality plastic grades find their way into health care applications.
With a growth rate approaching 9% in 2010 and 6% in 2011, medical technology lies substantially above the figures for most domestic industries in Germany. Turnover by German enterprises in this market has been estimated at approximately €21billion for 2011 by Spectaris, the German industry association of businesses in the optical, medical and mechatronic technologies.
Plastics were already being used in medical technology even before synthetics began to write their commercial success story from the mid-20th century onwards. In 1936, William Feinbloom made the first contact lenses in the USA from polymethyl methacrylate (PMMA). From the mid-20th century, plastics were also being used increasingly to make artificial limbs. Currently, sophisticated composite constructions made of plastics reinforced with carbon fibres (CFRP) are being used to make such unusual prostheses.
Expectations are high on plastics for use in medical technology – and the demands are growing further. Novel creations in polymer chemistry, for instance, improved silicone elastomers, thermoplastics with antimicrobial finishes and the opportunities offered by nanotechnology are expanding the variety of applications, and more.
www.messe-duesseldorf.com
PVDF copolymer for minimally invasive medical catheters
Arkema introduced Kynar Rx 752 polyvinylidene fluoride (PVDF) copolymer for use in minimally invasive medical catheters that are exposed to bodily fluids for less than 30 days. The Kynar Rx 752 fluoropolymer was specifically developed for medical catheter applications and is readily melt processed using standard extrusion or injection moulding equipment similar to those used to process polyethylene (PE), polyvinylidene chloride (PVC) or polypropylene (PP). This allows for continuous coextrusion of multilayer constructions used in advanced catheter shaft designs. Additionally, Kynar Rx copolymer tubes and moulded components can be welded together using radio frequency (RF), direct heat contact, and ultrasonic methods to create consolidated catheter components.
Kynar Rx 752 copolymer is USP Class VI compliant and exhibits good resistance to chemicals and temperatures. This allows medical device components made from the material to be chemical, autoclave or irradiation sterilised. The material offers a flexural modulus of 50,000psi (345MPa) and dynamic coefficient of friction of 0.54, according to ASTM test methods. The new medical grade copolymer can be coextruded into multilayer tubing, providing device companies with an alternative to manually assembled shafts with PTFE liners.
www.kynar.com
Medical catheter application (photo: Arkema)
Medical tubing extrusion
Milacron Extrusion Systems showcased the Cincinnati Milacron PAK250 – 63.5mm single screw medical extruder along with the Multi Pass Tank specifically designed for medical extrusion. The most common product produced by this machine is flexible PVC for non-phthalate plasticisers.
www.milacron.com
High speed medical tubing extrusion line (video: Milacron)
Mini blow moulding machine
Dave Technical Services launched the Mini blow moulding machine model DI 100. The machine is said to offer fast production at low power consumption and to require very small space. It is available in 50, 100 and 200ml models and also in screw type models in 250ml, 500ml, 1, 2 and 3l capacities. Machines are suitable for processing polymers such as LDPE, LLDPE, HDPE, PP, PS, HIPS, EVA, etc. The mini model is capable of producing a wide product range to cater for various industry requirements simply by changing moulds as required on the same set up. The Mini blow machine caters for the requirement of various industries such as pharma, cosmetics, medical, chemicals, oral care, pesticides, agrochemicals, veterinary products and others.
www.davetechnical.com
Mini blow moulding machine (photo: Dave Technical Services)
High stability during sterilisation
Actega DS offers product solutions for the food, beverage, pharmaceutical, medical technology and cosmetic industries. Sustainable and PVC-free manufacturing have priority. One key focus, therefore, is on TPE materials which allow individual modifications and maximum areas of application.
Developed for the area of medical technology, the ProvaMed compounds cover a wide mechanical range comprising flexible and elastic (shore hardness A20, E-Modul under 2MPa) to resistant, harder and non-abrasive compounds (shore hardness A80, E-Modul 30 MPa). They have been designed to display high stability during standard sterilisation procedures such as gamma radiation and gassing with ethylene oxide.
www.actega.de/ds
ProvaMed compounds for medical applications (photo: Actega)
Transparent PA grade for steam sterilisation
Essen, Germany-based Evonik Industries developed a highly transparent polyamide (PA) on the basis of monomers that can withstand higher temperatures. PA Trogamid RS6121 is said to improve the performance of the Trogamid CX product family and allows for applications that used to be reserved for other polymers such as polysulphones because of temperature resistance requirements.
The highly transparent Trogamid CX PAs are plastics made of asymmetrical polymer components that reduce the customary crystalline polyamide morphology or form micro-crystalline structures that have no influence on transparency. The new grade, Trogamid RS6121, has a number of additional characteristics that make it especially suited for applications with higher temperature requirements. According to Evonik, the (dry) glass transition temperature of Trogamid RS6121 is approximately 30°C higher than in Trogamid CX7323, which results in a higher maximum continuous use temperature. They say that due to the reduced water absorption of below 2%, the glass transition temperature does not fall below 134°C, even when saturated and components made of Trogamid RS6121 can therefore be steam-sterilised at 134°C and 2bar without any impact on mechanical properties. Alternative sterilisation methods rely on gamma radiation or ethylene oxide. Additionally, Trogamid RS6121 is said to be approximately 20% less dense than, for example, PSU. The combination of these properties opens up a multitude of new application fields for the new product in medical technology, the electrical industry, as well as automotive and mechanical engineering.
www.evonik.com
Sealing solutions
Chemical and pharmaceutical manufacturing environments can be challenging due to advanced technologies and strict environmental and consumer protection regulations, so robust sealing solutions in these environments are a must. A diverse range of perfluoroelastomer (FFKM) sealing solutions from Dyneon, part of 3M Advanced Materials Division, are said to offer long-lasting sealing applications that can also improve productivity.
The full range includes 3M Dyneon Perfluoroelastomer PFE 90Z, a peroxide curable FFKM; 3M Dyneon Perfluoroelastomer PFE 7301BZ; HeatShield, a high-temperature, triazine cure material with superior temperature resistance (continuous at 316°C); the new enhanced 3M Dyneon Perfluoroelastomer E-21464 HeatShield (continuous at 316°C with further improved compression set); and 3M Dyneon Perfluoroelastomer PFE 7502BZ ChemShield, a grade with all around good chemical and thermal resistance (continuous at 275°C).
Perfluoroelastomer PFE 7502BZ ChemShield was developed to meet industry demand for a product that combines the benefits of excellent chemical resistance associated with peroxide curable FFKM technology and with higher continuous operating temperature resistance to improve productivity and the reliability of sealing solutions. It is suitable for use with solvents, acids, bases, amines, water and steam processes and in processes with continuous operating temperatures of up to 275°C. It is also USP VI-compliant, a specific requirement for the pharmaceutical industry.
www.dyneon.eu
O-rings (photo: Dyneon)
Reduced sterilisation time with soft PP
Borealis is extending its comprehensive family of Bormed polypropylene (PP) and polyethylene (PE) materials specifically tailored for healthcare packaging applications with the launch of Bormed SB815MO.
As a step change innovation in soft PP, Bormed SB815MO addresses some of the most pressing challenges in the healthcare industry today. Firstly, the material exhibits a new level of softness and is the softest PP grade yet within the Bormed portfolio. The use of the Borstar technology is also said to enable good transparency without the addition of clarifiers. Critically, Bormed SB815MO is said to enable sterilisation at 121°C and therefore makes a reduction of sterilisation time possible. This offers advantages for those production processes in which terminal sterilisation has become the rate determining step (RDS).
When compared to low density polyethelene (LDPE) that can be sterilised at 110°C, the sterilisation cycle may be completed in half the time, says Borealis. This is achieved with a material that is flexible enough to be easily self-collapsible without venting, thus avoiding contamination. Finally, quicker sterilisation times can potentially enhance sustainability, for example, by extending the lifetime of autoclaves.
www.borealisgroup.com
Bormed SB815MO PP is said to enable reduced sterilisation time whilst providing a new level of softness, good transparency without the addition of clarifiers and the ability to be self-collapsible without venting. (photo: Borealis)
