PT  - JOURNAL ARTICLE
AU  - Baffi, R.
AU  - Dolch, G.
AU  - Garnick, R.
AU  - Huang, Y. F.
AU  - Mar, B.
AU  - Matsuhiro, D.
AU  - Niepelt, B.
AU  - Parra, C.
AU  - Stephan, M.
TI  - A Total Organic Carbon Analysis Method for Validating Cleaning Between Products in Biopharmaceutical Manufacturing
DP  - 1991 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 13--19
VI  - 45
IP  - 1
4099  - http://journal.pda.org/content/45/1/13.short
4100  - http://journal.pda.org/content/45/1/13.full
SO  - PDA J Pharm Sci Technol1991 Jan 01; 45
AB  - The validation of cleaning procedures for biopharmaceutical products produced by recombinant DNA (rDNA) technology presents a diverse analytical challenge. This is because of the need for quantitation of a broad range of potential residual cellular components, including proteins, carbohydrates, and nucleic acids, as well as trace levels of detergents at various manufacturing stages. The validation of a Total Organic Carbon (TOC) analysis method for use in cleaning validation studies is presented. The method has a limit of detection of approximately 0.1 ppm, with a limit of quantitation of 0.5 ppm. TOC analysis has an accuracy of 50 to 70% or better in the 0.5- to 10-ppm range and demonstrates an overall variability of approximately 5%. The method is broadly applicable to a variety of impurities and contaminants that are likely to be encountered following the manufacture of rDNA products.