Implementing Total Organic Carbon Analysis for Cleaning Validation

Pharmaceutical Technology

Volumn 28, Issue SUPPL., 2004, Pages 40-43

  Wallace, Brian ^a   Stevens, Robert ^a   Purcell, Mike ^a  

^a Teledyne Instruments   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLEANING; ORGANIC COMPOUNDS;

CLEANING VALIDATION;

DRUG PRODUCTS;

DETERGENT; DRUG RESIDUE; ORGANIC CARBON;

ACCURACY; CLEANING; DRUG INDUSTRY; MICROBIAL CONTAMINATION; OXIDATION; PROCESS DEVELOPMENT; PROCESS TECHNOLOGY; PRODUCTIVITY; REVIEW; VALIDATION PROCESS;

EID: 2442542165     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (7)

1. "Current Good Manufacturing Practice Regulations," Code of Federal Regulations, Title 21, Food and Drugs (General Services Administration, Washington, D.C., 1 April 1973), Part 211.67.
2. FDA, "Guide to Inspections Validation of Cleaning Processes," (FDA, Rockville, MD, July 1993).
3. K.M. Jenkins et al., "Application of Total Organic Carbon Analysis to Cleaning Validation, "PDA J. Pharm. Sci. & Tech. 50 (1), 6-15 (1996).
4. M.A. Strege et al., "Total Organic Carbon Analysis of Swab Samples for the Cleaning Validation of Bioprocess Fermentation Equipment," BioPharm 9 (4), 42-45 (1996).
5. 2 Dissolved in Ultrapure Water From 0 to 100 °C," presented at the 209th American Chemical Society National Meeting, Anaheim, CA, 2-6 April 1995.
6. A. C. Bevilacqua, "The Effect of Temperature, Temperature Error, and Impurities on Compensated Conductivity Measurements," presented at the 16th Annual Semiconductor Pure Water and Chemicals Conference, Santa Clara, CA, 3-6 March 1997.
7. Brian Wallace and Joe Furlong, "Cleaning Validation by Total Organic Carbon Analysis: Instrumental Technology Considerations," Application Note, Teledyne Tekmar (2000).