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.