Critical Cleaning - Alconox, Inc.: Pharma Cleaning Validation

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General Cleaner Info: Pharmaceutical Cleaning Validation CAP Residue Detection Methods
Catalog	Users Manual

Tuesday, September 23, 2008

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Pharma Cleaning Validation - Residue Detection Method Selection

Question:
What are the residue detection methods that can be used for cleaners? Does Alconox provide pharmaceutical validation information?

Answer:
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 prefers specific methods, but will accept non-specific methods with adequate rationales for their use. For investigations of failures or action levels, a specific method is usually preferable. The later section of this document lists references to several methods for each cleaner brand.

Yes, Alconox, Inc. has compiled a directory of residue detection methods for all Alconox brand detergents and pharmaceutical cleaning validation information. To access this information, visit http://www.alconox.com/static/section_top/gen_cleanval.asp.

(Pharma Cleaning Validation - Residue Detection Method Selection)