PDA CLEANING VALIDATION

Simple Equipment Train

Complex Equipment Train

An equipment train is generally recognized as a grouping of equipment or systems which

function as a unit during the production of a product. The complexity of the "equipment

train" is based on the number of discreet pieces along the train, the number of transfer or

process steps and the ability to sample the equipment train as discreet items (e.g., closed

systems). The complexity of the cleaning validation is directly proportional to the complexity

of the equipment train.