ABSTRACT

Cleaning validation ensures the implementation of an effi cient cleaning procedure, which excludes “cross-contamination” between different products or different batches of the same product.

Another defi nition of the concept of cleaning validation, which is controlled through a separate master plan, is a tool that provides documented evidence that a cleaning procedure is effective in reducing, to predefi ned maximum allowable limits, all kinds of contamination from an item of equipment or a manufacturing area following processing. The means of evaluating the effectiveness of cleaning will involve sampling cleaned and sanitized surfaces and verifying the absence of product residues, cleaning residues, and bacterial contamination.