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Cleaning Validation Studies To CFR Title 21 Part 211.67: M-Scan 26 Years of Analytical Excellence 1979-2005
Cleaning Validation Studies To CFR Title 21 Part 211.67: M-Scan 26 Years of Analytical Excellence 1979-2005
TOC is 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).
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.
The amount of carbon containing contamination is seen as the worst case scenario i.e. where all the
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chromatography/mass spectrometry equipment.