EN

Please select a language

 

Röchling Medical Brensbach

Our company has over 20 years’ experience of successfully operating on the global market for the manufacture of high-quality plastic products with trained, qualified and highly motivated employees, providing our customers with exceptional quality and expertise. We are able to achieve our high standards thanks to a strong project and industrialization team as well as our wide range of customized product solutions designed to meet the specific requirements of our customers.

Thanks to the closely coordinated efforts of the three medical sites in Germany, we are able to guarantee optimum customer support, from advice and design right through to manufacturing and packaging, in order to provide each and every customer with the perfect product tailored to meet their every need. Reliability and a strong sense of responsibility in terms of human and animal health provide a strong basis for our operations. As such, low-germ processes are essential in the manufacturing of all of our products. We therefore manufacture at the Brensbach site in 2 clean rooms (GMP class C & D and ISO 8) over a total useful floor space spanning 2,000 m².

“Boasting a production area and other usable floor space totaling 6,100 m², Röchling Medical Brensbach prides itself on its extensive expertise in the areas of injection molding, assembly and toolmaking for the manufacturing of products relating to the areas of drug delivery systems, primary packaging, diagnostics and life sciences.”

Joachim Lehmann, Director BU Medical Europe

Production methods

  • 30 injection molding machines (following expansion, capacity can be increased to up to 70 injection molding machines and 6-8 assembly systems)
  • Fully automated assembly
  • Automated inline quality control (leak test, visual inspection, optical measurement, pressure test, process-controlled error prevention)
  • Inhouse toolmaking with cutting-edge equipment for the manufacturing of precision tools

Our certifications

  • ISO 9001 Quality Management Systems – Requirements
  • ISO 15378 Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001, with reference to good manufacturing practice (GMP)
  • ISO 13485 Medical Devices – Quality management systems – Requirements for regulatory purposes
  • ISO 50001 Energy management systems – Requirements with guidance for use
  • ISO 14001 Environmental management systems – Requirements with guidance for use

Downloads

Facts and figures

 
Search
Contact

Share

Select Website

roe_medical_teaser.jpg
System solutions and components for Diagnostics, Fluid Management, Pharma and Surgery

Medical