Application Note
Sanitization Of A Packed Bed In The Bio-Rad® InPlace™ Process Chromatography Column
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•Tech Note: Sanitization Of A Packed Bed In The Bio-Rad® InPlace™ Process Chromatography Column
By Bio-Rad Laboratories, Inc.
Process chromatography columns must provide a very high level of cleanability to meet the requirements of various regulatory agencies. The efficiency of the column cleaning process of must satisfy regulations, norms, and standards, such as cGMP, Norm ISO 13408, FDA 21-211.67, or USP 32 NF27.
Columns used for the downstream processing of biopharmaceutical ingredients must be regularly cleaned in place, typically by using sanitizing agent. Sodium hydroxide(NaOH) is a commonly used sanitizing agent because of its efficiency against all living organisms, low cost, availability, ease of use, and compatibility with most materials used on biopharmaceutical hardware.
In this application note, we show using the two different tests, that Bio-Rad's InPlace columns can be safely sanitized after bacterial contamination. A Bio-Rad InPlace column packed with Macro-Prep® High S chromatography media was contaminated with strains of Bacillus subtills and Serratia marcescens, then tested for sterility after sanitization with 1 N NaOH using a sensitive and accurate method.
Click Here To Download:•Tech Note: Sanitization Of A Packed Bed In The Bio-Rad® InPlace™ Process Chromatography Column
