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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 with specific analytical methods. TOC offers simpler method development and a faster time to result to aid in cleaning validation and verification applications. TOC provides a measure of absolute cleanliness being able to detect API, degradants, cleaning agents, and excipients.

Because of TOC’s versatility and small footprint, it lends itself to process analytical technology (PAT) applications as well. With the industry shifting to continuous monitoring and real-time release practices using PAT instruments, TOC can be integrated into a clean-in–place (CIP) skid for your online cleaning validation needs. Online and at-line cleaning validation enhance PAT portfolios and mitigate or in some cases entirely eliminate equipment downtime. Ultimately, whether used in the lab, at-line, or online,? TOC for cleaning validation will optimize uptime and increase QC workflow efficiencies.

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 with specific analytical methods. TOC offers simpler method development and a faster time to result to aid in cleaning validation and verification applications. TOC provides a measure of absolute cleanliness being able to detect API, degradants, cleaning agents, and excipients.

Because of TOC’s versatility and small footprint, it lends itself to process analytical technology (PAT) applications as well. With the industry shifting to continuous monitoring and real-time release practices using PAT instruments, TOC can be integrated into a clean-in–place (CIP) skid for your online cleaning validation needs. Online and at-line cleaning validation enhance PAT portfolios and mitigate or in some cases entirely eliminate equipment downtime. Ultimately, whether used in the lab, at-line, or online,? TOC for cleaning validation will optimize uptime and increase QC workflow efficiencies.

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 continuous verification of cleaning samples as simple as possible. Our time-tested technology ensures superior sensitivity and recovery.

Portfolio

Sievers TOC Analyzers for Cleaning Validation

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, biopharmaceuticals, cosmetics/personal care, 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 slipstream from the final rinse (online) of an automated cleaning cycle (attached to CIP skid). With Sievers M9 Lab, Portable, and Online TOC Analyzers, you can design your cleaning program around your manufacturing processes and needs.?

Sievers TOC options for Cleaning Validation

Laboratory?

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TOC and conductivity analysis are routine tests that can be found in most Quality Control (QC) laboratories supporting cGMP operations. Benchtop TOC analyzers and software are available that allow users to stack protocols, run system protocols, run large volumes of samples at a time, manage data, and electronically sign and export data. Sievers experts can help support the start-up of a TOC analyzer in QC or the transition from specific to non-specific methods for cleaning validation practices.

For more information, see our applications expertise and product portfolio below:

At-line?

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At-line analysis can greatly increase process efficiency, particularly in a cleaning validation program with time constraints. At-line deployment uses a portable TOC analyzer located directly next to the process to be monitored. Once the cleaning process is complete, required samples are taken and analyzed. Coordinating activities with QC, sampling, analysis, and release of data can leave equipment sitting idle for periods of time. To turn around equipment faster following cleaning, at-line analysis allows samples to be taken and immediately analyzed on a portable TOC analyzer located within reach. At-line cleaning validation can reduce clean hold-times, translating to the reduction in unnecessary equipment downtime. Swab and rinse sample results can be generated and reviewed within minutes, ultimately avoiding any delays associated with QC workflow and reducing equipment hold times.

For more information, see our applications expertise and product portfolio below:

Online

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A pain point of cleaning validation is equipment downtime due to the work involved in sampling and sample analysis. Equipment downtime can be reduced from days to minutes with real-time release using data from a TOC analyzer integrated directly onto a Clean- In-Place (CIP) skid. Programmed automation diverts CIP rinse samples from the skid directly to the analyzer for analysis. The samples are analyzed, and data are automatically exported to the site data host.?

Online cleaning validation offers process understanding, process control, risk management, efficiency gains, and optimization that cannot be achieved with laboratory monitoring. Additionally, online cleaning validation can be used in multiple applications:

  • Characterization of cleaning residue
  • Optimization of the cleaning cycle by visualizing the rinse-down profile
  • Continuous cleaning verification programs

For more information, see our applications expertise and product portfolio below:

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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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