Cleaning validation using the Sievers TOC meter.

The use of TOC in cleaning validation is gaining attention.

TOC is an effective tool for cleaning validation of pharmaceuticals, cosmetics, and medical devices. By using TOC for cleaning validation, improvements in quality, risk reduction, and efficient operations can be achieved. TOC is a simple analytical method that rapidly detects low concentrations of organic compounds and can identify degradation products and contaminants that HPLC cannot detect. Compared to HPLC, which is a specific analytical method that detects only specific components, TOC, being a non-specific analytical method, can comprehensively confirm that excipients, degradation products, and cleaning agents are adequately cleaned. Furthermore, TOC simplifies method development and minimizes equipment downtime, leading to increased efficiency. By using TOC, not only can the cleaning process be evaluated quickly, but it also reduces the workload, maintenance costs, and running costs compared to HPLC.

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