PT  - JOURNAL ARTICLE
AU  - Chris Glover
TI  - Validation of the Total Organic Carbon (TOC) Swab Sampling and Test Method
DP  - 2006 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 284--290
VI  - 60
IP  - 5
4099  - http://journal.pda.org/content/60/5/284.short
4100  - http://journal.pda.org/content/60/5/284.full
SO  - PDA J Pharm Sci Technol2006 Sep 01; 60
AB  - 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.