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Cleaning Validation - List of Manufacturers, Suppliers, Companies and Products

Cleaning Validation Product List

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Online cleaning validation using TOC, IC, and conductivity.

Online cleaning validation using TOC, IC, and conductivity.

Application Note: Optimization of Cleaning Conditions Using an Online TOC Analyzer

Cleaning validation is an essential process in pharmaceutical manufacturing. However, traditional manual sampling and swab testing are time-consuming, carry a high risk of human error, and are costly. This is where Process Analytical Technology (PAT) comes into play. Based on guidance published by the FDA in 2004, this technology provides recommendations for understanding, controlling, and continuously verifying processes. By using PAT, it becomes possible to understand processes without manual sampling or analysis, leveraging real-time data. Utilizing real-time data on TOC, IC, and conductivity from online TOC analyzers enables comprehensive understanding of the cleaning process through online cleaning validation.

  • アットラインCV_M9P.jpg
  • アットラインCV_CIPからの排水.jpg
  • Analytical Equipment and Devices

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Cleaning validation using the Sievers TOC meter.

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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  • CIP.png
  • Other physicochemical equipment

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TOC-based lab/at-line/online cleaning validation

TOC-based lab/at-line/online cleaning validation

The Sievers TOC meter for cleaning validation is effective in various situations such as lab, at-line, and online, depending on the application.

TOC and conductivity are important analytical items that support cleaning validation, cleaning verification, and cleaning monitoring. TOC measurements can be performed in response to user requests in various settings, including laboratories, manufacturing sites (at-line), and online (final rinse water monitoring from CIP).

  • アットラインCV_M9P.jpg
  • オンラインCV.jpg
  • スワブ操作.png
  • Analytical Equipment and Devices

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