Pharmacy / Biotechnology

Due to the high requirements in the case of these fields of applications, the product is manufactured exclusively from a specific raw material that corresponds to the FDA regulation 21 CFR 177.1550.

Tests for plastics were performed, pursuant to USP Class VI - 121°C:

USP <87> Biological Reactivity - In VITRO 

USP <88> Biological Reactivity - In VIVO 

as well as pursuant to the ISO-Standards 10993-5, -6, -10 and -11.

Furthermore, an extractables study was conducted. 

A corresponding validation package is available on request from TECNO PLAST.