Cleaning Validation-The Cleaning Validation Program

 

The cleaning of the equipment should proceed in accordance with the documented standard operating procedure for cleaning.

After the cleaning has been completed, an intensive sampling of the system
may begin. (See the section on Sampling Techniques and Analytical Methods.) Attention should be given to product contact areas, intricate areas, and critical sites.

As defined previously, critical sites are those locations in which a contaminant is in danger of affecting a single dose with a high level of contamination.
The number of trials to be performed for each system is another issue which is often debated.

Most cleaning validation programs demonstrate the reproducibility of a process by three (3) consecutive trials for a single product on a single piece of equipment.

If a firm chooses to pursue the grouping philosophies for the initiation of the cleaning program, it may be part of the plan to pursue the representative products and equipment with three (3) trials each.

After completion of the trials which were "representative" of the most challenging cleaning, it may be appropriate to reduce the number of trials for subsequent products which fit within the grouping baseline.

If reducing the number of trials to be performed, great care should be taken to identify the rationale for the product grouping and to demonstrate the equivalency of new findings to the initial results.