Suez Total Organic Carbon - March 2020 - 5

cleaning validation from HPLC to TOC:
three factors to consider
Total Organic Carbon (TOC) analysis is often preferred over traditional, product-specific methods for

cleaning validation due to its speed, simplicity, and ability to enhance process understanding.

HPLC vs. TOC
TOC analysis offers several benefits over HPLC, including:
* Better process understanding
* Faster sample analysis
* Simpler method development

* Greater productivity
* Opportunity for at-line and online efficiency gains
* Lower operating costs

Here are 3 factors to consider to help you get started with TOC:

1

Cleaning process/sample compatibility
Does the existing cleaning cycle use a final aqueous rinse?
Understanding your current process will help determine if an aqueous final rinse is possible.

2

Cleaning limit acceptance criteria
Is the acceptance criteria limit within the linear dynamic range of the TOC analyzer?
Convert existing specific product limits to TOC limits using the percent carbon in the chemical formula
to determine if they are within the range of the instrument.

3

Product recovery/solubility
Are your compounds soluble enough for TOC?
Even traditionally insoluble or difficult-to-solubilize compounds such as ibuprofen, starch, and
lidocaine can often be recovered by TOC with little or no pretreatment.

TOC may be a great match for your CV program.

To learn more, visit www.suezwatertechnologies.com/applications/cleaning-validation

http://www.suezwatertechnologies.com/applications/cleaning-validation

Suez Total Organic Carbon - March 2020

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