ABSTRACT

Effective cleaning and disinfection of manufacturing facilities are crucial to the achievement and maintenance of the high-quality standards required of medicines and medical devices. The range of operations in pharmaceutical manufacturing is so large that it is not possible to specify a cleaning and disinfection protocol which is universally applicable, and so the strategy adopted for this chapter is one of identifying the factors to be considered and the procedures likely to be applicable in the most critical scenario, i.e. the aseptic manufacture of a medicine or device from individual sterile components, and then identifying the less rigorous practices which might be acceptable in other circumstances.