Our client Medartis, headquartered in Basel, is specialized in high-precision implant systems for bone fractures and bone malpositions. The anatomically precisely adapted titanium plates and titanium screws are used to fix the bones during surgical procedures. Especially in the case of hand and foot fractures, the patented technology facilitates patient mobility and regeneration through the freely pivoting and finely adjustable positioning of the screws.
The growing company has now invested in a 600 square meter CleanMediCell clean room to guarantee the safety standards for medical products. The titanium implants are cleaned in two washing units integrated into the clean room walls. After cleaning, the implants are individually packed and labelled before leaving the clean room. The clean room has different zones of the clean room classes ISO7 and ISO8. The material is introduced via two material airlocks, one of which is equipped with roller doors. The material transfer between the cleanrooms is done via two washing systems and 1m large material pass-throughs. Three personnel airlocks provide for a functional and safe inward transfer of employees into the different pure space zones. Two personnel airlocks are equipped with water dispensers, so that the employees do not have to lock themselves out completely.
78 filter fan units ensure the specified clean room conditions. Additional GMP monitoring and a final GMP qualification document the exact compliance with the specifications at all times. The clean room facility is temperature and humidity controlled.
