RT Journal Article
SR Electronic
T1 Validation of the Total Organic Carbon (TOC) Swab Sampling and Test Method
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 284
OP 290
VO 60
IS 5
A1 Chris Glover
YR 2006
UL http://journal.pda.org/content/60/5/284.abstract
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.