Thanks to decades of experience with polymer extrusion, the high-pressure tubing manufactured by RAUMEDIC combines quite contradictory requirements: - Pressure-resistance of at least 1,200 psi (83 bar) - Extremely kink-resistant - Flexible material properties - High degree of transparency - For common connectors - Economic processing - High-quality raw materials
Helmbrechts –Raumedic AG is introducing a new IT-based quality-assurance and production-control system as a way of raising its high quality standards and further boosting the efficiency of its production process. Under the companys plan, the system will be installed in all Raumedic production locations in Germany and the United States by 2019. The medical technology manufacturer reached an agreement on this goal with the software provider Guardus Solutions, the company that in October will design the machine link for both existing machinery of Raumedic and for future investments.
Increased transparency thanks to digitalized production
The manufacturing execution system (MES) is designed to take the transparency of the production operation of the international polymer processor to the next level. With the help of the new system, the status of machinery, production data and necessary work documents will be available at all times on a single platform. MES can help reduce potential sources of error, identify savings potential and increase it. The solution also offers standardized, cross-location performance figures as well as reporting and analysis data in real time.
Step by step, MES will eliminate decentralized island systems, Excel lists and paper documents in a way that will simplify the lives of production employees in particular. Digitalized, paperless processes are designed to perfect manufacturing.
Quality and customer benefits are critical
The solution will also make significant improvements in quality management: Individual products cannot just be tracked all the way back to the raw material. They can also be digitalized, cross-linked, managed and documented from the time of their development to their delivery. The MES covers the entire product cycle. In addition, integrated training and qualification systems ensure that employees have the very latest knowledge at their disposal.
“The use of digitalized processes will not just open up undreamed of possibilities. Above all, it will boost the value that we can and will generate for our customers,” said Martin Schenkel, Head of Operations at Raumedic.
The basis for sustainability and competitiveness
“Medical technology and pharmaceuticals are sensitive business areas that have extremely high quality requirements,” CEO Martin Bayer said. Bayer noted that not only the companys customers, but also government regulators place strict demands on the documentation of product and process data. As a result, a central standardized data management system will create significant improvements, he added.
Florian Pöhner, Head of IT at Raumedic, is overseeing the implementation of the IT solution. “The system creates an optimal link between our quality control and production units,” Pöhner said. “The MES is a consequential step for us and will enable us to take on future projects in terms of Industry 4.0.” He added that the company selected Guardus Solutions because the IT provider had an excellent reputation in the area of medical technology and offered a solution with a high level of usability.
Human health is at the core of RAUMEDIC Group's business. The company specializes in processing medical-grade thermoplastic polymers and silicones at five production sites in Germany and the United States.
As a partner of the international medical technology and pharmaceutical industry, the polymer specialist develops and produces customized components for customers, including tubing, catheters and molded parts as well as complex groups of components and systems for diagnostic and therapeutic uses. For the clinical areas of neuro-monitoring and traumatology, RAUMEDIC produces high-precision pressure-measuring systems with microchip technology. In doing so, it plays a key role in safe patient care around the world.
With nearly 70 years of experience in the areas of extrusion, injection molding and assembly, the company with a global workforce of 700 people turns customer ideas into mature products. The foundation of this work is formed by a quality management system based on ISO 13485 and clean room manufacturing on an area of 107,000 square feet (10,000 square meters) based on ISO 14644 (class 7).
Its global sales network and its own distribution companies in core markets ensure that medical and pharmaceutical customers as well as end users in hospitals and doctors offices have a high level of product availability at all times.