SUEZ Water Technologies & Solutions

Cleaning Validation and Verification with Sievers TOC

Increase efficiency, process understanding, and confidence throughout the lifecycle of your cleaning validation or verification program. TOC analysis is a fast and simple analytical method for detecting low levels of organic compounds and allows for detection of degradants and contamination not possible via HPLC. Compared to specific methods such as HPLC, TOC offers simpler method development and allows you to test not only for product removal, but also removal of excipients, degradants, and cleaning agents.

Cleaning Validation and Verification with Sievers TOC

Increase efficiency, process understanding, and confidence throughout the lifecycle of your cleaning validation or verification program. TOC analysis is a fast and simple analytical method for detecting low levels of organic compounds and allows for detection of degradants and contamination not possible via HPLC. Compared to specific methods such as HPLC, TOC offers simpler method development and allows you to test not only for product removal, but also removal of excipients, degradants, and cleaning agents.

Accurately measure organics in samples without background interference

Sievers TOC Analyzers use our unique membrane conductometric technology to accurately measure organics in rinse and online samples without interference from background substances. We help make method development and running cleaning samples as simple as possible. You can use the Autoreagent feature to ensure complete oxidation when the TOC concentration of your sample is not known, and our time-tested technology ensures superior sensitivity and recovery.

Portfolio

Sievers TOC Analyzers for Cleaning Validation

Total organic carbon (TOC) analysis is a simple and highly effective tool for cleaning validation, verification, and process control in industries such as pharmaceuticals, cosmetics, food & beverage, and medical devices. Using TOC for cleaning verification ultimately enables companies to operate more efficiently, reduce risks, and improve quality control.

Testing can occur in the lab, on the manufacturing floor (at-line), or in a slip stream from the final rinse (online) of an automated cleaning cycle (attached to CIP skid). With Sievers M9 Lab, Portable, and On-Line TOC Analyzers, you can design your cleaning program around your manufacturing processes and needs. Develop methods faster with Autoreagent mode, and decrease analysis time from two minutes to four seconds with Turbo mode.

Products & Services

Products and services for cleaning validation

Membrane Conductometric TOC

Unmatched performance and ease-of-use

While all TOC analyzers oxidize organic carbon and measure CO2, different technologies and methods of detection can have a substantial effect on accuracy, thus affecting your cleaning validation testing process. The combination of UV persulfate oxidation with a unique, selective CO2 membrane technology that minimizes background interferences is one of the many factors differentiating Sievers TOC Analyzers from more conventional TOC technologies.

Sievers TOC Analyzers are known for producing consistent, accurate results and are designed for ease-of-use and compliance in the pharmaceutical industry. For cleaning validation, the TOC concentrations of samples are not always known, making optimal analysis conditions difficult to achieve. The following differentiating factors ensure unsurpassed analytical results with Sievers technologies:

  • Autoreagent feature for complete oxidation
  • Non-catalytic combustion method
  • Absence of NDIR detector
  • No use of carrier gasses
  • Superior sensitivity and recovery
  • Membrane selectivity eliminates interferences

HPLC vs TOC

Why choose TOC Analysis over HPLC for cleaning validation?

With simpler method development and less downtime compared to product-specific methods, TOC analysis allows you to increase efficiency and reduce your analytical method footprint. In addition to faster release of production equipment with TOC analysis, you can save money on instrument maintenance, labor, and consumables compared to HPLC.

 

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