4. Hygiene design of equipment
A review of the hygienic design of the equipment must be carried out. The primary purpose of this step is to determine the areas of the equipment that are most difficult to clean as this will be helpful in determining the worst-case scenario and additional steps or processes that need to be carried out to ensure that as possible risks are addressed. These areas will be assessed for cleanability during the validation process. This may require additional engineering support to dismantle and reassemble equipment's.
