Validation of the total organic carbon (TOC) swab sampling and test method
Glover, C.
PDA Journal of Pharmaceutical Science and Technology 60(5): 284-290
2006
ISSN/ISBN: 1079-7440 PMID: 17089697 Document Number: 605169
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 microg. The validation characteristics included accuracy, repeatability and intermediate precision, specificity, linearity, assay range, detection and quantitation limit, and robustness.
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