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