Validation of the total organic carbon (TOC) swab sampling and test method.
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.
Glover
Chris
C
Quality Control Supervisor, Bayer Healthcare, Berkeley, CA, USA.
D000418:Albumins / Q000032:analysis; D004282:Documentation; D004340:Drug Contamination / Q000517:prevention & control*; D009930:Organic Chemicals / Q000032:analysis*; D015203:Reproducibility of Results
D000418:Albumins; D009930:Organic Chemicals