HPLC and UV/Vis are classified as specific methods that identify and measure appropriate active and substances.

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A sodium persulfate oxidant is then added to the sample, and in the presence of UV radiation, the remaining carbon is oxidized to CO2.

The amount of CO2 generated is then measured by the NDIR to determine the amount of TOC originally present in the water.

For equipment cleaning validation there are two types of TOC sampling techniques.

One is the direct surface sampling of the equipment using a swab.

It builds on and updates previous PDA publications, including the 1998 Technical Report No. The report uses a life-cycle approach to biotechnology cleaning validation that encompasses design and development, process qualification, and ongoing control of effectiveness. In particular, this technical report addresses unique features of biotechnology cleaning validation, including the way in which limits are established for bulk biotechnology manufacture.

The report also considers the effect of degradation of the active on cleaning-validation practices and the widespread use of nonspecific methods, such as total organic carbon (TOC) and total protein, for measuring residues of actives.

USP TOC methods are standard for Water for Injection and Purified Water, 7 and simple modifications of these methods can be used for cleaning validation.

Click on any image for a larger view TOC analysis involves the oxidation of carbon and the detection of the resulting carbon dioxide.

A number of different oxidation techniques exist including photocatalytic oxidation, chemical oxidation, and high-temperature combustion.

In this study, a TOC Analyzer, equipped with an autosampler, was used.

Table I provides a list of the major topics covered in Technical Report No. This article is the twenty-second in the "Elements of Biopharmaceutical Production" series and will discuss the various issues to consider when designing a cleaning-validation program.