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FDA expects corporations to have written procedures (SOP’s) and descriptions of the cleansing processes used for various items of equipment. Suppose corporations have a cleaning procedure for cleaning between different batches of an equivalent product and use a unique method for cleaning product changes. In that case, we expect written procedures to deal with these different situations.
Generally only cleaning procedures for product contact surfaces need to be verified. Consideration shall be given to non-contact parts where product transfer is likely, such as mixing shafts, seals, flanges, fans and oven heating elements. Fluid bed dryer (FBD) bags are another example of a washable solids device and are usually dedicated to a select product.
When the cleaning process is used only within batches of the same product or among many of the same intermediate in a bulk process, such as a single product line, only visible cleanliness criteria should be met. After cleaning, equipment may be subject to disinfection and sanitation, which may support microbial growth.
