Cleaning Validation Terms & Definitions


Process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels.

The focus of cleaning validation is those cleaned surfaces, that, if inadequately cleaned could potentially contaminate the product subsequently manufactured in that same equipment.

Purpose of cleaning validation is to design and carry cleaning in a way that contamination is reduced to an acceptable level and to have a documented evidence that an approved cleaning procedure will provide clean equipment.