Validation of the total organic carbon (TOC) swab sampling and test method

PDA Journal of Pharmaceutical Science and Technology

Volumn 60, Issue 5, 2006, Pages 284-290

  Glover, Chris ^a  

^a BAYER CORPORATION   (United States)

Author keywords

Carbon; Recovery; Sampling; Swabs; TOC; Validation

Indexed keywords

HUMAN SERUM ALBUMIN;

ACCURACY; ARTICLE; BIOLOGICAL MONITORING; CHEMICAL ANALYSIS; CLEANING; DEVICE; DRUG INDUSTRY; DRUG MANUFACTURE; QUANTITATIVE ANALYSIS; REPRODUCIBILITY; SAMPLING; SENSITIVITY AND SPECIFICITY; TOTAL ORGANIC CARBON; VALIDATION PROCESS;

ALBUMINS; DOCUMENTATION; DRUG CONTAMINATION; ORGANIC CHEMICALS; REPRODUCIBILITY OF RESULTS;

EID: 33750362062     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (4)

1. Office of Regulatory Affairs, U.S. Food and Drug Administration. Guide to Inspections Validation of Cleaning Processes, IV. Evaluation of Cleaning Validation, 4. Sampling, USFDA, Washington, D.C. (2006).
2. Clark, K. How to develop and validate a total organic carbon method for cleaning applications. PDA J. Pharm. Sci. Technol., 55 (5), 290-294, (2001).
3. USP28 - N23 (643) Total Organic Carbon. United States Pharmacopeia, (2005); pp 2393-2394.
4. Glover, C. "TOC Swabbing Method Validation" BV-000-BC-078-01, Bayer Healthcare (2005).