Comparability Guide for Reinforced Silicone Tubing

This guide serves as a comparability document for two types of reinforced silicone tubing: Braided Tuflux® SIL from Sartorius and Sani-Tech® STHT®-R from Saint-Gobain. It outlines the physical properties, general features, biocompatibility, and physico-chemical properties of each tubing type. The document details the testing methods used to evaluate tensile strength, elongation at break, and pressure resistance, including results from gamma-irradiation and autoclave treatments. Additionally, it presents an evaluation of extractable profiles, highlighting the extraction protocols and analytical methods aligned with industry standards such as USP <665> and USP <1663>. The guide emphasizes the importance of these properties in the context of biopharmaceutical applications, where the tubing is utilized for various processes including buffer preparation, cell culture, and final formulation. The document concludes with a summary of the compliance of both tubing types with relevant biocompatibility tests and regulatory standards.