Template 2 Standort Seiten Detail

Template 2 Standort Seiten

INTRO Text Location

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Get to know our GMP sites in Location XY

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The close cooperation of the three medical locations in Germany guarantees optimal customer care from consultation to construction to production and packaging, in order to produce the optimal product for each customer, customised to their wishes. Reliability and an awareness of the health responsibility towards humans and animals form the basis of our activities. This means that a low-germ process is essential in the manufacture of all our products. For this purpose, we manufacture at our Brensbach site in 2 clean rooms (GMP Class C & D and ISO 8) on a total of 2,000 m² of floor space.

Statement

"With a production and floor space of 6,100 m², Röchling Medical Brensbach stands for great professional know-how in the areas of injection moulding, assembly and toolmaking for the manufacture of products in the fields of drug delivery systems, primary packaging, diagnostics and life science."

Joachim Lehmann, Director BU Medical Europe

Production methods

currently 30 injection moulding machines (capacity can be expanded to up to 70 injection moulding machines and 6-8 assembly lines after expansion)
fully automated assembly automated inline quality control
(leak test, visual inspection, optical measurement, pressure test, process-controlled defect prevention)
In-house toolmaking with state-of-the-art equipment for the production of precision tools

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TEXT 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

Download Certifications

Facts & Figures

INTRO TEXT Competences

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Product Design & Development

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Toolmaking

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