Application Note


Sanitization Of The Bio-Rad Process Chromatography Skid 00

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Tech Note: Sanitization Of The Bio-Rad Process Chromatography Skid 00

By Bio-Rad Laboratories, Inc.

Process chromatography equipment must provide a very high level of cleanability to meet the requirements of various regulatory agencies. The efficiency of the cleaning process must satisfy regulations, norms, and standards, such as cGMP,ISO 13408, U.S FDA 21 CFR ยง 211.67 regulations or USP 32 NF27.

Equipment used for the downstream processing of biopharmaceutical ingredients must be regularly cleaned in place, typically by using a 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.

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Tech Note: Sanitization Of The Bio-Rad Process Chromatography Skid 00

Bio-Rad Laboratories, Inc.

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