Cleanroom manufacturing
The entire process chain for med-tech components takes place under segregated and controlled conditions: KH has aligned its production accordingly, offering customers the high level of product safety required for items used on or inside the human body. The infrastructure comprises a dedicated medical injection molding facility, Class 7 and 8 cleanrooms with continuous particle monitoring and airlocks for personnel and incoming components. Ongoing training ensures constant awareness.
Capacities in accordance with EN ISO 13485
We currently have cleanroom facilities at our manufacturing sites in Germany, the Czech Republic and China. In the medium term, we also plan to establish facilities in Mexico in order to supply the NAFTA region from there.
| DE + CZ | CN | |
| ISO 7/8 cleanroom with GMP compliance | 940 m² | 120 m² |
| ISO 7/8 cleanroom (non-GMP) | 950 m² | 1200 m² |
GMP Biomonitoring
Independently verified: the air purity in our cleanrooms. In accordance with the European cleanroom standard ISO 14644, air purity must be continuously monitored through regular particle measurements. Measurements are taken in cubic meters (m³), with three measurement cycles per minute at multiple sampling points.
The determination of airborne and surface microbial counts is also governed by the GMP guidelines (Annex 1). For the test, the air sampler draws in 1 m³ of air and forces it onto a pre-inserted nutrient plate. A certified laboratory subsequently analyzes the plate.