Cleaning Validation-The Cleaning Validation Program

 

Cleaning Validation

The Cleaning Validation Program

Frequently, the basis of cleaning validation programs is the establishment of a plan which describes
the overall validation approach. The rationale for any grouping philosophies utilized and the
validation program to be implemented should be identified.
After the determination has been made of which product(s) and piece(s) of equipment are to be
utilized in the validation study, the validation trials may commence. If the product is to be coated on
equipment surfaces to form a trial for cleaning validation, care must be taken that the product
coverage used for validation is appropriate to simulate the level of contamination that would be
present in an actual manufacturing situation.
Care should also be taken in the simulation of the production methods utilized. For example, a piece
of equipment that is utilized first thing in the morning may sit, contaminated with product, until the
second shift starts. Having the product "dry" on the equipment, therefore, may be the worst case.