How to develop and validate a total organic carbon method for cleaning applications

PDA Journal of Pharmaceutical Science and Technology

Volumn 55, Issue 5, 2001, Pages 290-294

  Clark, K ^a  

^a Anatel Instrument Corporation   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ENDOTOXIN; EXCIPIENT; SUCROSE; TRITON X 100; VANCOMYCIN; WATER;

ACCURACY; ANALYTIC METHOD; ARTICLE; CLEANING; GOOD MANUFACTURING PRACTICE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SENSITIVITY AND SPECIFICITY; TOTAL ORGANIC CARBON; ULTRAVIOLET SPECTROSCOPY; VALIDATION PROCESS;

CARBON; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG INDUSTRY; REPRODUCIBILITY OF RESULTS; SPECTROPHOTOMETRY, ULTRAVIOLET;

EID: 0034784748     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. A total organic carbon analysis method for validating cleaning between products in biopharmaceutical manufacturing
2. Application of total organic carbon analysis to cleaning validation
3. Total organic carbon analysis of swab samples for the cleaning validation of bioprocess fermentation equipment
4. Application of total organic carbon analysis for cleaning validation in pharmaceutical manufacturing
5. Using TOC analysis for cleaning validation