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Total Organic Carbon (TOC) is measured by a special instrument called “Total Organic Carbon Analyzer,” which oxidizes the TOC in aqueous solution to carbon dioxide and measures its content. The correspondence of carbon content between carbon dioxide and total organic carbon is used so that the total organic carbon in aqueous solution can be quantitatively determined.
The TOC method consists of two processes: the oxidation of carbon and the detection of the carbon dioxide generated. Various oxidation techniques are available, including photocatalytic oxidation, chemical oxidation, and high-temperature cautery.
The operable cleaning method is determined according to the specific situation of the equipment. For equipment that can be easily wiped and the surface is flat, the cotton swab wiping method can be used. For the equipment and pipelines that are not easy to wipe to take samples should use the drenching method. To determine the limits of residual contaminants by measuring microbial limits and total organic carbon according to different cleaning methods.
The systematic applicability, linearity, accuracy, and repeatability of the analytical method were verified to confirm that the method is suitable for the testing requirements of equipment cleaning validation, and the sampling recovery rate verified the validity of the sampling method.
It applies to validating the TOC determination method for samples collected after cleaning the equipment related to the common line production of the medicine extraction workshop, medicine preparation workshop, etc.
For the TOC method, when organic substances are set as exclusive substances, it is possible to determine the presence of any residual substances, regardless of their source, whether they are products, cleaning agents, chemicals, solvents, or by-products or microbial contamination, and to perform this task well. As long as the molecular structure contains carbon, any active pharmaceutical ingredient or residual substance for cleaning can be detected. The detection result must be below the limit of the target compound, which improves the stringency of the cleaning verification.
The pharmaceutical industry has gradually accepted the TOC method, and the stringency of cleaning validation has been significantly improved throughout the industry and is increasingly in line with the overall requirements of the industry. The universality of the TOC method saves time and labor costs for pharmaceutical companies. The scientific, rational, and feasible cleaning validation process ensures the cleanliness required for the safe production of pharmaceuticals.
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Swabbing is the preferred method to validate critical cleaning within pharmaceutical manufacturing environments. The 1993 FDA Guide to Inspections states that direct surface sampling (e.g., wi...
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Cleaning validation usually employs two sampling methods: rinse sampling and wipe sampling. Rinse sampling is typically used to collect samples from large surfaces such as floors or wa...
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