Total Organic Carbon (TOC) analysis is demanded by both the US Pharmacopeia (USP) and the European Pharmacopeia (EP) for testing Purified Water, Water for Injection (WFI) and cleaning validation samples.
The Food and Drug Administration (FDA) also considers TOC analysis as an acceptable cleaning validation method. Many pharmaceutical companies have adopted TOC over other traditional methods, due to the ease-of-use, accuracy in analyzing residues of organic contaminants, faster response times and cost-efficiency.
Skalar has automated the analysis of TOC according to the USP (Rev. 26, method <643>) and EP (method 2.2.44) on the SAN++ Automatic Wet-Chemistry Analyzer.
The SAN++ Analyzer consists of an auto sampler for automatic sampling, a TOC chemistry unit based on UV-persulphate digestion, Infra Red (IR) detection and data handling.
The water samples are offered to the SAN++ Analyzer by the Skalar SA1074 auto sampler. To avoid any contamination from the lab environment, the samples are being analyzed from certified EPA/VOA TOC vials.
After sampling the inorganic carbon is first removed from the sample by acidification. The sample is then mixed with a potassium persulphate reagent and introduced into a quartz coil which is radiated by UV light. The organic carbon in the sample is converted to carbonate. After acidification and sparging, the TOC is measured as carbon dioxide (CO2) by non-dispersive infra red detection.
In this configuration the SAN++ Analyzer performs according USP/EP requirements, which is illustrated in the table below.
The Skalar SAN++ Analyzer can furthermore be equipped with additional cartridges to analyze a wide range of complementary parameters, which increases the versatility and flexibility for the pharmaceutical industry. An example configuration is shown in the figure below.
The easy-to-use FlowAccessÂ® software controlling the SAN++ Analyzer is fully compliant with the requirements of pharmaceutical laboratories such as data security according to FDA 21 CFR part 11, standard operating procedures (SOP) and IQ/OQ/PQ validation protocols.