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Quality ensures bio-compatibility

Quality ensures bio-compatibility

METAV 2016 to showcase all the facets of production processes for medical technology

 

Frankfurt am Main, 18th December 2015. – Both of them are perpetually innovation-driven: medical technology and production technology will be interactively on show in the Medical Area at the METAV 2016 in Düsseldorf from 23 to 27 February. New machining technologies in the field of medical equipment necessitate new measures in terms of quality assurance. This applies particularly in the context of the patient-compatibility of the products being machined. The METAV will be showcasing the entire spectrum of options for production equipment in the field of medical technology.

The specific challenges entailed by quality assurance in the field of medical technology in comparison to other sectors, such as automaking, says Dr. Dagmar Martin, Project Manager Medical Technology at the Scientific and Medical Institute of Tübingen University (NMI) in Reutlingen, consist of “guaranteeing the bio-compatibility of the materials being used”. The NMI is one of the partners supporting the Medical Area at the METAV 2016 and as a member of the Medical Technology Working Group in the German Engineering Federation (VDMA) is also an exhibitor at the METAV 2016.

Quality assurance has to guarantee bio-compatibility

Medical technology poses similarly stringent requirements to the automotive industry. This applies particularly to dimensional stability, functionality and durability. And there’s also the problem of bio-compatibility. To quote Dagmar Martin: “The material must not cause any damage inside the human body. Particles originating inside a car’s engine must not result in any functional impairment. With an implant, in a hip, for example, particles must not lead to an infection, which in extreme cases may result in an explantation.”

At the same time, she adds, there are no specified limit values in medical technology regarding cleanliness. The introduction of limit values, she continues, is very difficult, due to the disparate products and applications involved: “The quantitatively identical proportion of carbon in the form of hydrocarbon has no toxic effect. In the form of cyanides, however, it is highly toxic. Even the tiniest of particles may have catastrophic consequences in heart pumps.” This is why a risk-based approach is adopted. This procedure is regulated in Annex I to Directive 93/42/EEC. The fundamental principle involved is this: “A medical product must not cause any damage to the patient.”

The NMI has for years now been using surface-sensitive processes like photo-electron spectroscopy or scanning electron microscopy for chemical characterisation of the surface of medical-technology products in accordance with DIN EN ISO10993-18. “The advantage of these direct processes,” says Dagmar Martin, “in comparison to extractive processes, is that you obtain information on the surface and the soiling, and not only on the dirt detached”. Preceding process steps like machining with cooling lubricants may lead to an unwanted coating on the surface, for example. The bio-compatible material of the volume is no longer present at the surface. But this surface comes into in direct contact with the tissue.

For the integration behaviour of implants, the topography (e.g. roughness) of the surface also plays a major role. Infections of the surrounding tissue may have their causes here. This information, too, is obtained through surface analytics. These processes are used for validating cleaning procedures. For daily process monitoring, it is important to obtain as much information as possible about the process, explains Project Manager Dagmar Martin: “This includes, in the case of cleaning systems, for instance, temperature, dwell time in the bath, cleaning agent concentration, and the bath’s degree of soiling. It’s best if these processes are already integrated in the system concerned, and documented there as well.”

This is what Dagmar Martin is expecting from the METAV 2016: “Interesting conversations with and suggestions from equipment manufacturers and users of medical equipment, which we can incorporate in new projects. At the METAV, we shall be showcasing options for surface analytics, and for assessing surfaces in regard to their bio-compatibility, and for evaluating the quality of individual process steps. One major focus here is on reliable bonding processes. In this context, we shall be presenting the results of our study on ‘Dependable bonding – challenges in practical bonding technology’. In addition, the NMI is involved in the ‘Clean Med’ cooperative network, and is presenting the initial results”.

Documented quality coupled with high individualisation

Jimmy Tjandra, Sectoral Manager Medical Technology at Jenoptik Industrial Metrology Germany GmbH, Villingen-Schwenningen, summarises quality assurance in the field of medical technology in these words: “Thanks to high-quality medical products, we nowadays enjoy longer and better lives. Medical equipment for diagnostics and therapy has to function flawlessly, and supply dependable results. When direct contact with human tissue is involved, particularly, or for prostheses that execute the function of body parts, the quality of the products concerned is crucial to the patient’s wellbeing. Thanks to modern-day metrological equipment, medical products can be rigorously tested. This improves their quality, manufacturing defects are detected in good time, and production processes are optimised.” At the Medical Area of the METAV 2016, he is looking forward to “establishing contacts with new customers, especially as our products are already being used very successfully at manufacturers of medical technology”.

Stefan Staab, Product Manager Coordinate Measuring Instruments at Wenzel Group GmbH & Co. KG, Wiesthal, is more specific: “In the case of implants and the associated tools, in particular, we’re talking about individualised data and dimensions, precisely matched to the patient concerned. Durability is of maximum importance, since replacement or maintenance of the parts is not often possible.” Moreover, implants have to cope with the very complex movement sequences of a human body, and compensate for any changes in it. Thus for quality assurance in the field of medical technology, particularly, an even higher degree of documentation and individualisation is required.

Typical applications in the pharmaceutical sector include the dimensional stability testing of implants (titanium, PEEK) or structural examinations of 3D porously printed implants. Here, says Staab, “we find what is manifestly the best interface to bio-compatibility. If the dirt exhibits a sufficiently higher density than the material of the object being measured, then soiling phenomena can also be detected. In regard to testing sterility, it should be noted that you can certainly check whether a package has a hole – but it’s impossible to say whether a sample is contaminated,” explains the expert.

Product Manager Staab cites a project of applications-engineering interest that involved “scanning components in sterile packages without breaking the seal. We have successfully created other solutions, too, in the field of hearing aids, for example, and insulin injectors”.

At the METAV 2016, Wenzel will be showcasing “numerous innovative
solutions from the fields of coordinate metrology and industrial computer tomography. The focus here will be on optical solutions that in ever-shorter cycles generate measurements of high precision”. The relevant applications for industrial computer tomography lie in metrological and testing equipment for small to medium-size components, where 3D data of complex internal and external structures are required.

Production metrology and microscopic analysis

For Andrzej Grzesiak, Head of Metrology Systems at Carl Zeiss Industrielle Messtechnik GmbH, Oberkochen, metrological equipment is a fixed constituent of quality testing in sectors with stringent quality requirements, like medical technology: “We’re talking here about both the geometrical requirements and the surface quality, technical cleanliness and material characteristics. Thus here the field of production metrology is growing closer to microscopic analyses.”

The paramount task involved, he says, “is to restore to the patient a missing function – and to do it fast and painlessly”. Quality from the patients’ viewpoint, he adds, may look different, but poses equally stringent requirements for the quality of the manufacturing process. That is why implants are increasingly selected and fitted by digital methods. This is mostly accomplished using CAD data for the implants from the patient’s CT data. Here, the “perceived comfort” is a very important criterion for the patients concerned. The crucial factors involved include the geometrical characteristics and surfaces. Patients’ comfort is also significantly influenced, says Andrzej Grzesiak, by the long-term functions like abrasion and fracture properties.

Besides the acquisition of geometrical data using metrological equipment, the characterisation of engineered functional surfaces is gaining steadily in perceived importance. To quote Andrzej Grzesiak: “Our microscopic methods, too, consist of data acquisition and processing steps: monitoring the samples, image acquisition, image processing and analysis all the way through to archival and documentation.” At the METAV 2016, Zeiss will be showcasing “its metrological portfolio for microscopic analysis and above all the Pi-Web software package, a quality management system for harmonised evaluation and analysis of measured and process data”.

 

Author: Walter Frick, specialist journalist from Weikersheim

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Background

METAV 2016 in Düsseldorf

The METAV 2016 – the 19th International Exhibition for Metalworking Technologies – will be held in Düsseldorf from 23 to 27 February. It will be showcasing the entire spectrum of production technology. The principal focuses are machine tools, production systems, high-precision tools, automated material flows, computer technology, industrial electronics, and accessories, complemented by the new themes of Moulding, Medical, Additive Manufacturing and Quality, which are now permanently anchored in what are called “areas” with their own nomenclature in the METAV’s exhibition programme. The METAV’s target group for visitors includes all branches of industry that work metal, particularly machinery and plant manufacturers, the automotive industry and its component suppliers, aerospace, the electrical engineering industry, energy and medical technologies, tool and mould-making, plus metalworking and the craft sector.

Further information under www.metav.de

 

Scientific and Medical Institute at Tübingen University (NMI), Tübingen

The NMI conducts application-driven research at the interface between bio- and material sciences. An interdisciplinary team of scientists explores and develops new technologies for companies and public-sector research sponsors in the fields of pharmaceutical and bio-technology, bio-medical technology plus surface and material technologies. Since being founded in 1985, the NMI has evolved into a stable bridge between the academic and business communities. Its portfolio of capabilities also encompasses part-projects and one-off services like consultancy, technology assessment, funding applications, project conception and/or coordination. The NMI performs pre-competition research for companies in the medical technology sector, and supports them in their production and quality assurance operations.

Further information under www.nmi.de

 

Jenoptik, Jena

As an integrated opto-electronic conglomerate, Jenoptik operates in five divisions: Laser and Material Machining, Optical Systems, Industrial Metrology, Traffic Safety, plus Defence & Civilian Systems. Its worldwide customers primarily include companies in the semiconductor and semiconductor equipment industries, the automotive industry and its component suppliers, the medical technology sector, security and defence engineering, plus the aviation industry. The company was created following German reunification in 1991 from the then state-owned firm VEB Carl Zeiss Jena. It is headquartered in Jena, Thuringia. Besides facilities in Germany, Jenoptik has production plants in almost 70 different countries. Jenoptik employs around 3,550 people, and in 2014 achieved a turnover of about 590 million euros.

Further information under www.jenoptik.com/messtechnik

 

Wenzel Group GmbH & Co. KG, Wiesthal

Wenzel Group GmbH & Co. KG claims to rank among the market leaders in the field of metrological equipment. Its principal customer groupings include the automotive industry, aerospace manufacturers and the mechanical engineering sector. The company owns subsidiaries all over the world, and possesses a network of service and sales partners in more than 50 different countries. The Wenzel Group employs around 630 people. The name of Wenzel is frequently regarded as synonymous with maximised precision and innovation in the fields of coordinate measuring technology, gearing metrology, metrological software, high-speed measuring and digitising systems, reverse engineering and computer tomography.

Further information under www.wenzel-group.com

 

Carl Zeiss AG, Oberkochen

Zeiss is a globally operating technology conglomerate in the optical and opto-electronic industries. The group is divided into six divisions: Industrial Metrology, Microscopy, Medical Technology, Vision Care, Consumer Optics and Semiconductor Manufacturing Technology. Zeiss operates around 30 production facilities in more than 40 different countries, complemented by over 50 sales and service facilities and about 25 research and development facilities all over the world. In the 2013/2014 business year, the group was employing just under 25,000 people for a turnover of around 4.3 billion euros. Founded in Jena in 1846, the company is headquartered in Oberkochen. Carl Zeiss AG heads the Zeiss Group as a strategic management holding company. The company’s sole owner is the Carl-Zeiss Foundation.

Further information under www.zeiss.de/industrial-metrology/de

 

Your contact persons

VDW (German Machine Tool Builders’ Association)

Sylke Becker

Press and Public Relations

Corneliusstrasse 4

60325 Frankfurt am Main

GERMANY

Tel. +49 69 756081-33

s.becker@vdw.de

www.vdw.de

 

NMI Scientific and Medical Institute at Tübingen University

Dr. Dagmar Martin

Project Manager Medical Technology

Markwiesenstr. 55

72770 Reutlingen

GERMANY

Tel. +49 7121 51530-863

dagmar.martin@nmi.de

www.nmi.de

 

Jenoptik Industrial Metrology Germany GmbH

Marco Lachenmaier

Marketing Specialist

Alte Tuttlinger Strasse 20

78056 Villingen-Schwenningen

GERMANY

Tel. +49 7720 602-198

Fax +49 7720 602-123

marco.lachenmaier@jenoptik.com

www.jenoptik.com

 

Wenzel Group GmbH & Co. KG

Steffen Hochrein

Press & PR Manager

Werner-Wenzel-Strasse

97859 Wiesthal

GERMANY

Tel. +49 6020 201-6114

steffen.hochrein@wenzel-group.com

www.wenzel-group.com

 

Carl Zeiss Industrielle Messtechnik GmbH

Andrzej Grzesiak

Business Unit Metrology Systems

Senior Director Systems

Carl-Zeiss-Strasse 22

73447 Oberkochen

GERMANY

Tel. +49 7364 20-9846

andrzej.grzesiak@zeiss.com

www.zeiss.de/imt

 

Editorial Office Frick

Walter Frick

Hölderlinstr. 2

97990 Weikersheim

GERMANY

Tel. +49 7934 990021

redaktionsbuero@walter-frick.com

 

You will find texts and pictures about the METAV 2016 on the internet under www.metav.dein the Press Service section. You can also visit the METAV through our social media channels:

http://twitter.com/METAVonline

http://facebook.com/METAV.fanpage

http://www.youtube.com/metaltradefair

https://de.industryarena.com/metav

Responsible for the content of this press release: Verein Deutscher Werkzeugmaschinenfabriken e.V.

Contact

Verein Deutscher Werkzeugmaschinenfabriken e.V.
Corneliusstraße 4
60325 Frankfurt am Main
Germany
+49 69 756081-33
+49 69 756081-11

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