The clean room ISO 7 T.S.T. S.r.l. is an environment inspected and certified according to the UNI EN ISO 13485: 2016 in which the presence of contaminants in the air is controlled and reduced. Compliance with the procedures in the clean room is strictly binding and subject to audits, as the respect of contaminations is a sine qua non to provide products in compliance with the medical certification.
The access to the production department is regulated by donning procedures and personnel behavior in compliance with strickly regulations. The main aim is to ensure the quality of the product.
Inside the clean room we produce components for hemodialysis, holders for chardiosurgery, valves, fluid control components, connectors, filters and cosmetic parts.
The clean room is equipped with:
- N. 2 mono-electric injection molding machines, 28 and 100 Tons, enslaved with robots;
- N. 1 mono-injection molding machine, 35 Tons., Sumitomo;
- N. 1 bi-injection molding machine, 110 Tons., Engel, enslaved with robot;
- N. 3 assembly and testing lines.