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Clean Room Technologies
Clean Room Technologies
In order to meet the respective high demands on the production environment in the pharmaceutical and medical technology sector, the companies of Röchling Medical have state-of-the-art clean rooms in addition to production areas under standard conditions. Individual parts, assemblies, and complete OEM products are manufactured under production conditions required with a broad spectrum of manufacturing and processing technologies - injection molding, extrusion, blow molding, printing, and downstream joining/assembly processes.
All production areas are subject to strict regulations, permanently monitored and re-audited internally and externally on a regular basis. Systematic training and further education programs ensure the manufacturing and assembly processes are always up-to-date in order to meet regulatory requirements. Monitoring as an essential element of quality assurance ensures operating parameters (including room pressure, particle concentration, temperature, etc.) can be continuously verified and documented in the batch documentation.
In addition to areas under normal conditions, Röchling Medical currently has more than 13,000 m² of clean room space that is used for injection molding, extrusion, blow molding, and downstream assembly processes. Specifically, the requirements and expectations of customers from various sub-segments of the pharmaceutical and medical technology sector are fulfilled.
We offer manufacturing processes according to the latest GMP and ISO standards under the following production conditions:
- Standard conditions
- GMP C
- GMP D
- ISO 7
- ISO 8
For special customer requirements, we also use higher purity classes such as ISO 5 to a limited extent. Please contact us.
