Abstract
For cleaning validation purposes, the combination of swab sampling and the total organic carbon (TOC) test method provides a useful mechanism to monitor the cleanliness of equipment surfaces. The TOC test method is an ideal choice for monitoring carbon-containing residuals. Sample and test method validation “TOC Swabbing Method Validation” BV-000-BC-078-01, Bayer Healthcare, proved quantifiable recovery of albumin down to 25 μg. The validation characteristics included accuracy, repeatability and intermediate precision, specificity, linearity, assay range, detection and quantitation limit, and robustness.
Footnotes
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