ABSTRACT
Protein products used as therapeutics or diagnostics for health care as well as proteins used for many research projects must be highly purified. Consistently achieving high levels of purity requires that attention be paid to sanitization and cleaning of purification equipment, chromatography media, and filters. For health care products, regulatory agencies issue guidelines, points to consider, guidances, and other documents that delineate the requirements. This chapter addresses some of the regulatory documents that apply to protein purification with an emphasis on cleaning and sanitization. It also presents current issues related to cleaning and sanitization of protein recovery and purification operations.
