Cleaning Frequency

The frequency and rigor of cleaning is usually determined by the nature of the changeover process.
For example, the frequency will depend upon whether the manufacturing involves many different
products or several batches of the same product.

Between batches of different products
When equipment is changed over from one product to another, cleaning must take place to
prevent product cross-contamination.

Between batches of the same product (campaign)
The cleaning frequency within batches of the same product should be determined as part of
the process development. In some cases, it is possible to show that cleaning between batches
may be reduced or eliminated.

Validation should be accomplished to determine the number of lots of the same product that may be consecutively manufactured before a more rigorous cleaning is necessary.