Veolia Water Technologies & Solutions

Cleaning Validation and Verification with Sievers TOC

Validation of cleaning processes is critical for determining whether equipment used in pharmaceutical manufacturing has been sufficiently cleaned of contaminants and residues. TOC analysis is a fast and simple analytical method to confidently detect low levels of organic compounds, including degradants and contamination not possible with specific analytical methods such as HPLC. TOC offers simpler method development and a faster time-to-result to aid in cleaning validation and verification applications. A comprehensive analysis of cleanliness is achieved with TOC because it can  detect API, degradants, cleaning agents, and excipients.

TOC’s versatility, small footprint, and ability to provide gains in quality and efficiency support process analytical technology (PAT) applications. With shifts 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 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

Validation of cleaning processes is critical for determining whether equipment used in pharmaceutical manufacturing has been sufficiently cleaned of contaminants and residues. TOC analysis is a fast and simple analytical method to confidently detect low levels of organic compounds, including degradants and contamination not possible with specific analytical methods such as HPLC. TOC offers simpler method development and a faster time-to-result to aid in cleaning validation and verification applications. A comprehensive analysis of cleanliness is achieved with TOC because it can  detect API, degradants, cleaning agents, and excipients.

TOC’s versatility, small footprint, and ability to provide gains in quality and efficiency support process analytical technology (PAT) applications. With shifts 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 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

Total organic carbon (TOC) analysis is a simple and highly effective analytical tool commonly used to validate the effective cleaning of manufacturing equipment in  industries such as pharmaceuticals, biopharmaceuticals, cosmetics/personal care, food & beverage, and medical devices. Cleaning validation involves demonstrating that the documented cleaning process effectively removes contaminants to a pre-defined, suitable level to prevent the possibility of cross-contamination during manufacturing. TOC is often the method of choice for cleaning validation and cleaning process control,  enabling 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 

 

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 analytical methods such as HPLC or UV-vis (i.e., specific methods) to non-specific methods such as TOC for cleaning validation practices

Resources to get you started:

Sievers Laboratory TOC portfolio and consumables

At-line 

 

At-line TOC testing for cleaning validation can greatly increase process efficiency, particularly in a cleaning program with time constraints. At-line deployment uses a portable TOC analyzer located directly next to the equipment or process to be monitored. Once the cleaning process is complete, required samples are taken and analyzed promptly. Traditional lab testing relies on the coordination of QC activities, sampling, analysis, and release of data, often leaving  equipment sitting idle for periods of time. In contrast, at-line analysis can turn around equipment faster following cleaning by allowing for 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.

Resources to get you started:

Sievers TOC portfolio and consumables for at-line cleaning validation

Online

 

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 is automatically exported to the site data host. 

Online cleaning validation with TOC 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

Resources to get you started:

Sievers TOC portfolio for online cleaning validation

 

Products & Services

Products and services for cleaning validation

Membrane Conductometric Technology

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.

 

Resources

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