Total Organic Carbon (TOC) analysis

Our total organic carbon (TOC) testing provides rapid indication of residual contamination, ensuring your purified or sterile water is up to required standards.

 

At RSSL, we recognise the critical role Total Organic Carbon (TOC) analysis plays in pharmaceutical manufacturing. Whether for water purity testing, cleaning validation or regulatory compliance, our highly sensitive TOC analysis ensures your processes meet the highest industry standards.

 

TOC testing is essential within the pharmaceutical industry in verifying purified and sterile water as well as ensuring Water For Injection (WFI) meet strict regulatory limits of ≤500 ppb carbon.

 

The testing is also vital for cleaning validation, confirming the presence of active pharmaceutical ingredient (API) residues, detergents, and other organic contaminants. By analysing waste, wash or rinse waters, we provide a rapid indication of residual contamination from previous API or finished product manufacture. 

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Additionally, TOC testing enables quick contamination detection by identifying organic impurities in cleaning processes helping to prevent cross-contamination. Since both detergents and APIs contain carbon, the analysis provides a non-specific yet highly sensitive measure of contamination. The results can even be used to estimate API levels, offering worst-case detection.


With our expertise in TOC testing, RSSL supports pharmaceutical manufacturers in maintaining compliance, product integrity and safety.

Pharma Chem RSSL 23 R2 1775 HR (35) TOC Colour Corrected R5 1393 HR

 

Why Choose RSSL for TOC Analysis?

 

Fast & reliable results - High-throughput instruments for quick turnaround times.

 

Regulatory compliance - Fully aligned with EP, USP, and JP pharmacopeial standards including;

  • European Pharmacopoeia (EP 2.2.44)
  • United States Pharmacopoeia (USP <643>)
  • Japanese Pharmacopoeia (JP 2.59)

 

Industry-leading expertise - Award winning, trusted partner for pharmaceutical companies worldwide.

 

Comprehensive testing solutions - Supporting cleaning in place (CIP), cleaning out of place (COP), swab testing and rinse water analysis.

 

 

Advanced TOC technology


RSSL’s state-of-the-art Beckman Coulter QbD 1200 provides not only high-throughput testing, capable of analysing over 40 samples per day, but also precision and accuracy. Each sample processed through the instrument is tested in triplicate to ensure reliable and repeatable results.

 

The Beckman Coulter also provides the additional benefit of dual-component detection. This means that both TOC and Total Inorganic Carbon (TIC) for a full water quality profile can be measured.

 

TOC analysis can also be carried out in conjunction with conductivity to determine both organic impurities (TOC) and in-organic impurities (conductivity) for pure water.

 

 

Get trusted TOC testing from RSSL

 

With decades of experience, state of the art equipment and a commitment to quality and compliance, RSSL is the go-to partner for TOC analysis in pharmaceutical manufacturing. Contact us today to discuss your testing needs.

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