Implementing Total Organic Carbon Analysis for Cleaning Validation

نویسندگان

  • Brian Wallace
  • Robert Stevens
  • Mike Purcell
چکیده

*To whom all correspondence should be addressed. otal organic carbon (TOC) analysis is a fast and effective analytical technique for cleaning validation in pharmaceutical manufacturing. This nonspecific method can be used to test for residues of previously manufactured products, cleaning detergents, chemicals, solvents, by-products, degradants, and microbial contaminants. However, many factors must be considered before implementing a TOC cleaning validation program, including detergent selection, establishing TOC acceptance criteria, and choosing from the variety of TOC technologies available.

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تاریخ انتشار 2004