A high level of cleanliness is required in clean areas. Frequent, thorough cleaning of areas necessary according to a written program should be done.

Regular monitoring to detect resistant strains of micro-organisms should be done. A program for chemical disinfection and corresponding records should be available. Manufacturers also have to monitor disinfectants and detergents for effectiveness.

Preparation of dilutions should be done in accordance with a program and SOP - and records should be available. Disinfectants should be kept in clean containers and stored only for defined periods of time. These should be sterilized before use, when used in Grade A or B areas