Application of total organic carbon analysis to cleaning validation

PDA Journal of Pharmaceutical Science and Technology

Volumn 50, Issue 1, 1996, Pages 6-15

  Jenkins, K M ^a   Vanderwielen, A J ^a,b   Armstrong, J A ^a,c   Leonard, L M ^a   Murphy, G P ^a,c   Piros, N A ^a,c  

^a PFIZER INC   (United States)

^b WESTERN MICHIGAN UNIVERSITY   (United States)

^c ILLINOIS STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; RADIOPHARMACEUTICAL AGENT; STEROID;

ANALYTIC METHOD; ARTICLE; CLEANING; CONTAMINATION; FILTRATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; NONHUMAN; RESIDUE ANALYSIS; SPECTROPHOTOMETRY; TOTAL ORGANIC CARBON;

CARBON; DRUG CONTAMINATION; DRUG INDUSTRY; PHARMACEUTICAL PREPARATIONS;

EID: 0030063429     PISSN: 1076397X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. R. Baffi, et al., "A total organic carbon analysis method for validating cleaning between products in biopharmaceutical manufacturing," Journal of Parenteral Science & Technology, 45(1), 13-19 (1991).
2. R. W. Matthews, M. Abdullah, and G. K. -C. Low, "Photocatalytic oxidation for total organic carbon analysis," Analytica Chimica Acta, 233, 171-179 (1990).
3. ASTM Method D4 129-82, "Determination of Dissolved Organic Carbon." ASTM Book of Standards, Philadelphia, Pa. (1984).
4. Y. Sugimura, Y. Suzuki, "A high temperature catalytic oxidation method for the determination of non-volatile dissolved organic carbon in seawater by direct injection of a liquid sample," Marine Chemistry 24, 105-131 (1988).
5. FDA, "Guide to Inspection of Validation of Cleaning Processes," (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs. July 1993).
6. J. K. Taylor, "Quality Assurance of Chemical Measurements," Lewis Publishers, Chelsea, MI, p. 78-84, 1987.
7. Lowry, et al., Journal of Biol. Chem., 1951, (193), p. 265-275.