Comparative TOC Rinse-Up Study Of Pharmaceutical Tubing

Total organic carbon (TOC) content provides a measure of the cleanliness of single-use materials and components considered for use in pharmaceutical manufacturing processes. A material’s cleanliness is a critical quality attribute to establish fitness for purpose in a variety of applications. For example, the selection of appropriate tubing can be assessed by determining TOC levels as a function of rinse-up volume using water. TOC measures the total amount of organic compounds containing carbon atoms that can be oxidized. TOC measurements do not differentiate among the contributing chemical organic species. TOC measurement is therefore considered a high level marker. In this technical bulletin, the results of a rinse up study to measure the TOC from four different tubing types is presented. BioFlex^® TPE, C-Flex^® 374, Colorite PVC, and Dow Corning^® Pharma 50 silicone tubing were each rinsed with deionized (DI) water, which was then sampled and analyzed off-line to determine the TOC content from each.