Total Organic Carbon (TOC)
Total Organic Carbon (TOC) is used in the pharmaceutical/biopharmaceutical industry as a quick, accurate and inexpensive screening protocol for contamination validation of small molecule drugs, peptides, proteins, and cleaning detergents. It can be utilised in conjunction with both CIP (cleaning in place) and COP (cleaning out of place).
The amount of carbon-containing contamination is seen as the worst case scenario i.e. where all the carbon content is designated the ‘active’ ingredient, even if this is not the case. Thus, rapid detection can be used to ‘salvage’ expensive production runs. If the TOC count is higher than acceptable, the contaminant(s) can be identified and quantified using SGS M-Scan’s extensive range of chromatography/mass spectrometry equipment – see detergents and surfactants, extractables and leachables.
Application areas for aqueous based samples typically include:- ultrapure water (water for injection- (WFI)) sample analysis (<20ppb), pharmaceutical applications (<500ppb), and drinking water (<5ppm).
TOC can be used with all relevant standard sampling methods such as swabs, wipes, rinse, and immersion techniques though the most consistent results are obtained by using a single method. TOC can be operated under full GLP protocols if required.
In environmental analysis Total Organic Carbon Analysis is also extensively used as a screening tool for the determination of carbon content of sediments and water samples both freshwater and marine. If the TOC count is higher than acceptable, the contaminant(s) can be identified and quantified typically using GC-MS or GC-FID.