Our production areas for medical devices in Germany are ISO 7 clean rooms according to DIN EN ISO 14644-1. Furthermore, there are two Class C clean rooms according to the GMP guidelines.
Our production area is divided into three distinct areas:
- An ISO 7 clean room for balloon production only, using different technologies depending on balloon dimensions and mechanical properties
- An ISO 7 clean room for catheter assembly, 100% quality inspection and packaging
- Two Class C GMP clean rooms for handling cytotoxic agents and the drug coating of balloons
All of these areas are equipped to the highest standards with all the necessary equipment such as additional laminar flow benches or safety workbenches.