Sodium hydroxide is widely accepted for cleaning and sanitization of chromatography resins and systems. The benefits of its use include efficacy, low cost, and ease of detection, removal, and disposal. As with any sanitizing agents, certain precautions should be taken and compatibility with both chromatography resins and systems determined.
This application note examines these aspects of using sodium hydroxide as a cleaning and sanitizing agent. Many examples of particular interest to producers of recombinant proteins, monoclonal antibodies, and oligonucleotides are included, as designing and scaling up validatable cleaning processes are critical issues in the commercial manufacture of these products.