Total Organic Carbon Analysis of Swab Samples for the Cleaning Validation of Bioprocess Fermentation Equipment

نویسندگان

  • Mark A. Strege
  • Avinash L. Lagu
چکیده

ceutical manufacturing that processing equipment be cleaned using validated procedures to avoid cross contamination from material remaining from a previously manufactured product (1–3). Potential residues remaining on the surfaces of equipment following processing steps (fermentation, for example) include, in addition to the product itself, a multitude of organic cellular components such as nucleic acids, proteins, and carbohydrates. Together with appropriate surface sampling procedures, analytical techniques that can determine trace levels of

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تاریخ انتشار 2007