Pharmaceutical Clean – Detecting Residues In Cleaning Validation


When beginning cleaning validation, a company must identify the residues to be tested and then select the best detection method. Alconox Inc. is here to help. We provide validation service support and we also provide technical support via Free Downloadable Whitepapers. Here is an excerpt aboutIdentifying Residue and Selecting a Detection Method:

Before you start identifying residues, first you have to assemble a list of all the possible residues that could be left on critical manufacturing surfaces as a result of the cleaning process: including cleaners, primary ingredients, excipients, decomposition products, and preservatives. Once you have your list of residues, you need to have a detection method for those residues.

For cleaner residues, selecting the proper detection method involves choosing a specific or non-specific methodology. Specific methods test for an individual ingredient include high-performance liquid chromatography (HPLC); ion selective electrodes; flame photometry; derivative UV spectroscopy; enzymatic detection; and titration. On the other hand, non-specific methods such as total organic carbon (TOC), pH levels, and conductivity test for the presence of a blend of ingredients. While the FDA often prefers use of specific methods, non-specific methods may be accepted provided a scientific rationale for their use is determined.

Specific methods are also preferred when investigating failures or action levels. Sometimes a broad non-specific method is used for monitoring, and specific methods are used for investigating when the non-specific method exceeds acceptance criteria or internal action limits. Sometimes a specific method is used for an initial validation, and then correlated with a non-specific method which is then later used for retesting to maintain a validated state of manufacturing.

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