Strict hygiene standards regulated under DIN EN ISO 13485 (for non-implantable medical devices) must be observed when manufacturing medical technology components. We specialize in plastic injection molding within ISO class 8 and 7 clean-room environments (ISO class 7 equivalent to GMP class C), and have been clean-room qualified since 2005 per ISO 14644-1 standards. What began with simple injection-molded parts for lancing devices has evolved at RKT to include complex microfluidic test carrier systems requiring an analyte-free environment.
Injection Molding in or next to the Clean Room
We injection mold inside cleanrooms, but also at times locate the injection molding machine just outside the clean room utilizing a containment and protection system for transfer of the parts into the cleanroom environment. This provides protection for the parts while reducing the potential for contamination from auxiliary activities such as injection mold machine maintenance.