Committed to Cleanliness

Plastics Processing in the Field of Medical Technology

May 22, 2015

Company

Although designing plastic products in the areas of medical technology and pharmacology often appears to be very simple, the devil is usually in the details of the manufacturing process. In an interview with Dr. Ralf Ziembinski and Frank Richter we shed light on the company RAUMEDIC AG and their role as a plastics processor.

Extensive approval processes, a complete and detailed documentation and the traceability of precursors and intermediate products for patients as well as other quality assurance measures may easily become a big challenge for the plastics processor. This is why some processors, such as RAUMEDIC AG from Helmbrechts, have specialized in processing plastics for the medical technology and pharmaceutical sectors. With a staff of currently 600 employees worldwide RAUMEDIC have already become a major player in this industry. Presently the company are investing millions of dollars for the extension of their headquarters in Germany and the establishment of a new location in North America.

  • Frank Richter

Dr. Ralf Ziembinski is the director for the Extrusion/ Tubing business unit at RAUMEDIC AG. Along with Frank Richter, Head of Communications and Customer Service, he faced questions from the editorial team of Kunststoffe.de regarding "Plastics Processing in Medical Technology".

  • Dr. Ralf Ziembinski

Kunststoffe.de: What is the product portfolio of RAUMEDIC composed of? Do you mainly manufacture goods in large quantities or do you also produce customized products?

Frank Richter: The product portfolio of RAUMEDIC is based on two pillars. On the one hand we are developers and manufacturers of polymer components and systems for the medical and pharmaceutical industry. These can be produced thanks to our expertise in the areas of extrusion, injection molding and assembly. The scope of polymer based products manufactured and customized for customers therefore ranges from individually manufactured single catheters to the automated large-scale production of medical tubes or pharmaceutical molding components – all of which are of course certified in accordance with ISO 13485 and manufactured under clean room conditions in accordance with ISO 14644, class 7.

On the other hand we provide diagnostic systems for the measurement of diverse physiological parameters in human bodies such as pressure, temperature and oxygen. These contribute to restoring the health of diseased patients in clinics all over the world. In addition to the polymer component we here use our knowledge of integrating electronic parts such as electrodes, microchips, storage elements or the smallest camera systems.

We manufacture our products at three locations in Germany. In addition to the nearly completed expansion of our headquarters in Helmbrechts our new North American operating- development- and production center is currently being constructed in North Carolina. Thus we are answering the call of our international customers to have a presence in the largest medical market.

Kunststoffe.de: How and in which areas are RAUMEDIC involved in the development process from the initial idea to the manufactured and packaged medical product made of plastic?

  • This neurosurgical device for intracranial pressure (ICP) detection on mobile patients was developed in collaboration with RAUMEDIC

Frank Richter: Ideally, we are involved throughout the development process from conceptualization to the continual improvement of the product within the implementation of our own series. Therefore, our research often starts before receiving a customer inquiry. So we help pave the way for new ideas for new medical applications, technologies or polymer materials until they are practically applied, e.g. for our neurosurgical telemetric system for measuring intracranial pressure in mobile patients. Another example is primary packaging material in the area of injection, inhalation or drug delivery. These are manufactured and certified with immediate effect in accordance with DIN EN ISO 15378. It is not only the knowledge of the relationship between the product and the manufacturing concept, but also economic and ecological factors that play an important role for our customers when developing new medical products made of plastic.

Kunststoffe.de: Which processing methods do you implement and which proportion of the overall production does each of them cover?

Frank Richter: RAUMEDIC have over 60 years of experience in the classical fields of extrusion, injection and molding as well as expertise in advanced technologies that are necessary for the production of technologically high-quality products. These include, for example, micro-extrusion with an internal diameter of 0.1 and several layers in the walls of the tubes including X-ray contrast stripes, multi- component injection molding with hard/soft combinations, film blowing or fully automated assembly including a 100% control with corresponding camera systems. Based on our long-term chemical and raw material expertise we also process in addition to all common thermoplastics and silicones approved for medical technology our own compounds and high temperature polymers such as PEEK, FEP or PTFE that is to be processed thermoplastically.

Kunststoffe.de: How is the production of medical products arranged and how important are the aspects of clean room technology and automation hereby?

  • At RAUMEDIC, the production of medical or pharmaceutical products takes place exclusively in the clean room

Dr. Ralf Ziembinski: The production of medical technology products or pharmaceutical products – whether tubes, molded parts or components – is carried out at RAUMEDIC exclusively under certified clean room conditions. We currently have over 6,000 square meters of production areas in the clean room, and we will add approximately another 50% at locations in Germany and the US in the upcoming months. All machines, tools and processes must be aligned with the controlled work environment. The use of specialized materials at production facilities, such as easy-to-clean stainless steel, is only one of many aspects. Our personnel must wear special clothing and must be trained to work in the clean room. This includes of course the knowledge of regulatory requirements and how to put them into practice.

In principal, the employees must have an awareness for the topic of medical products and the fact that they are manufacturing products that help to save lives. This is why process validitation or tool qualification are the tools of their trade as are the documentation and tracing of all processes and their results.

Kunststoffe.de: In which areas and to what extent do requirements and regulations pertain to you as a processor within the manufacturing process, for example for the moisture content of the granules or other processing and machine parameters?

Dr. Ralf Ziembinski: The provisions and standards for manufacturing medical products and their semi-finished products and raw materials are very high. Although they do not dictate the moisture content of the material, they require a process adjustment in order to obtain a high-quality and clean product. Therefore the standards above all pertain to the raw materials used and their substances. For example, biotoxicological tests are required in accordance with ISO 10993. Moreover, the products must comply with standards for cleanliness; in many cases this is only achievable in clean room production facilities. Clean rooms are required to have a reduced particle count for certification. Appropriate clean room technology, special clothing and adapted machines are necessary in order to achieve this.

After all, we talk about products that will be used on and inside human bodies. This begins with raw materials. RAUMEDIC only collaborate with suppliers who have all the necessary certificates and approvals for the use of their materials in the field of medicine. Therefore we only use plastics that have undergone the necessary biological and toxicological testing for their respective intended use. Recycled materials, which are very good from an environmental perspective, are here not used for the reason of cleanliness. The ability to retrace the entire process by using a corresponding batch system is also required.

Kunststoffe.de: Any change of materials or processing steps for the production of medical products must be approved. How extensive are these approvals and how often do they occur?

Dr. Ralf Ziembinski: Of course, both the product and the essential steps of the manufacturing process are specified together with our customers and thus form the basis for all of our deliveries. Changes can be made either by the customer, our pre-suppliers or by RAUMEDIC. Even regulatory specifications and framework conditions can change. The regulations are precisely manifested by our in-house management for project changes. Whatever the triggering factor, a clearly regulated procedure is thus specified for the notification, approval and implementation of any change.

Such modification processes do occur quite frequently – even when we as the manufacturer want to avoid changes, if possible, since the challenges and hurdles to overcome are already significant. This applies mainly to the areas of research and development, production, and of course, quality management. However, it happens time and again, for example, that raw material providers change some of the preliminary products, packaging materials are no longer available on the market, tools wear out or simply the location of a machine must be changed. It is thus important for our customers to collaborate with a partner who defines and implements clearly regulated and verifiable processes.

Kunststoffe.de: Where do you currently see the largest development steps in the production of medical products? (e.g. machine technology, clean room, automation, process technology, etc.)

  • The increasing number of minimally invasive surgeries requires that tools are constantly reduced in size. For this reason, micro-injection moldings are becoming increasingly important as processing procedures in medical technology

Dr. Ralf Ziembinski: The complexity of the products has continued to increase over the past years. This trend will not reverse itself in the next years. At the same time, the requirements for economic efficiency are increasing while maintaining consistent quality and functionality at the same level at least. RAUMEDIC manufacture their products in a near-customer fashion in Germany and will also do so in the US by the end of 2015. In order to stay competitive, RAUMEDIC are constantly looking for efficient ways to optimize production. And this already begins with product development, since it is exactly here where the foundation for the production concept is laid. We always emphasize this unity, since this is one of the reasons why we can operate in a high-wage country such as Germany. Automation is another important element, which does not only apply to the quantity of millions but also to concepts in the area of catheter assembly for smaller and middle-sized quantities, for example.

Miniaturization is certainly another advancing trend. Minimally invasive procedures in human bodies require smaller and smaller tools. Here we see a considerable development potential; therefore we have been focusing on technologies such as micro and multi-layer extrusion early on. RAUMEDIC will increasingly focus also on micro-injection molding in the future and develop their skills in this area. Due to multi-component injection molding technology, polymers with different levels of shore hardness can fulfill complex requirements in a component.

Kunststoffe.de: In your view, what role will generative production procedures play in relation to medical products made of plastic? Are these procedures a threat to classical processing procedures or rather a purposeful addition to the manufacturing of individual products?

Dr. Ralf Ziembinski: Generative procedures, such as 3D printing, have taken a giant step forward in recent years. This pertains to both, the geometries and characteristics of components as well as ecological aspects. The procedures are thus a very useful addition to the processing of polymers, especially for the purpose of custom-made products for patients or very small batches, such as those required in the area of prosthetics. Even in conjunction with the development process of new products and a faster time-to-market implementation, these processes offer amazing opportunities for prototyping. Currently, we do not regard the generative procedures as a "threat" to the processing procedures that we are applying. Many product requirements, that we are able to fulfil thanks to our raw material and processing skills, cannot be met due to the many limitations in the use of materials.

Kunststoffe.de: In your opinion, in which direction is the development of plastic medical products going? Is the trend more likely to go in the direction of complex products with a high degree of functional integration or are simpler components with a high degree of customization the focus for development?

Frank Richter: At RAUMEDIC, we think the trend is more likely to go towards system products with a very high degree of functionality. This does not automatically mean that a product is made from a great number of individual components. Rather, the contrary is true. We are then on the right path, when we succeed in reducing the number of necessary components within a unit and ideally compressing them into one single component. This requires a clever combination of suitable materials as well as technical and technological capabilities and the requirements for the medical product. Multicomponent-injection-molding, multilayer extrusion or a combination from thermoplastic and silicon can be the answer to this. As a result, various characteristics can be combined even in a minimum space; and the required functions can be produced efficiently in terms of economy.

  • Future system products will build upon the increased processing capabilities and require multi-component technology from the processor, for example

This article was published originally on www.kunststoffe.de