Production facilities

From Research and Development to final shipping, all production activities are carried out under the same roof in an area of 6.000 m².

We produce a wide range of tubes, from standard IV set tubing to microbore coextruded tubing, both translucent and with light resistance properties, in a variety of materials such as DEHP-FREE PVC, PUR, EVA and PE.

In-house injection moulding takes place in our ISO 8 cleanroom with a surface of 3.500 m².

Final assembly is executed manually or automatically, depending on the type of product in an ISO 8 cleanroom.

Finished products are single packed with latest technology blister packaging machines, using medical grade porous paper and plastic film suitable for EO sterilization.
Ethylene Oxide Sterilization is electronically controlled and has been validated and revalidated to deliver the required sterility assurance level in conformity with the regulation ISO 11135.

Fully equipped laboratory to conduct all Quality Testing prior to lot release: Sterility test, bioburden test, biological indicators test, pyrogen test, as well as functionality test such as leakage, pull-test, flow regulation and residual ethylene oxide test.

Additionally, our partnership with reliable manufacturing partners in Europe allows us to offer short production runs under our license and design

 

All processes are executed under strict
Quality Assurance procedures in conformity
with ISO 13485.