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"I want to know whether TOC analysis is better than HPLC for cleaning validation?"
"The use of Total Organic Carbon (TOC) as an analytical test for cleaning validation has increased rapidly in recent years. This is due to a number of factors including:
- It is very easy to use;
- The actual testing can be carried out very quickly;
- TOC testing requires very little method development and is easy to validate;
- One method can be used for all cleaning samples; and
- It is a cost effective analytical technique.
To use TOC for cleaning analysis, you need to establish that the contaminating material is organic and contains carbon that can be oxidised under the TOC test conditions; some organic compounds cannot be reliably detected using TOC. Use of TOC requires that the contaminant is at least slightly soluble in water.
As to which is better, TOC or HPLC, it will depend on the contaminating substances you are testing for. The advantages of TOC make it preferable but there are times when it will not be suitable, in which case HPLC may provide a better option. The effort involved in validation of cleaning means that it is not usually beneficial to switch established processes from HPLC to TOC. However for new processes TOC may provide a good solution.”