Pharmaceutical Cleaning Validation – Residue Detection Method Selection

Q. What are the residue detection methods that can be used for cleaners? Does Alconox provide pharmaceutical cleaning validation information?

A. A pharmaceutical cleaning validation involves residue detection method selection. Residue detection method selection for cleaners can involve specific methods for specific cleaner ingredients such as; high performance liquid chromatography (HPLC), ion selective electrodes, flame photometry, derivative UV spectroscopy, enzymatic detection and titration, or it can involve non-specific methods that detect the presence of a blend of ingredients such as: total organic carbon, pH, and conductivity.

The FDA has approved both methods.  Specific methods seem to be more robust and possibly preferred, but we know non-specific methods with adequate rationales for their use have also been widely accepted. For investigations of failures or action levels, a specific method is usually preferable.

Yes, Alconox, Inc. has compiled a directory of residue detection methods for all Alconox brand detergents and pharmaceutical cleaning validation information. You can access whitepapers regarding pharma cleaning and residue detection at your convenience.

To request any Alconox, Inc. detergent for free, please complete the questionnaire at Get Sample. For more information about any one of our Alconox, Inc. detergents, consult the technical bulletin for each product. Or click here to access each of our detergent’s  Safety Data Sheets.

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