ABSTRACT
One of the key components of the microbiological control program is that of the sanitation program. Along with the certificate of analysis program and the product testing program, the sanitation program provides a chemical or mechanical pathway or some combination of both to eliminate the substrate needed for microbiological organisms to grow and thrive. In some form, this is a program that each and every company must have to eliminate risk of a contamination. Its importance is outlined in 21CFR110.35b.2d(1-3):
Although it is easy for a company to take the stance that it can just put things away at the end of the day and make the equipment and processing area look clean, to meet the preceding criteria, a significantly more structured approach must be taken. This includes determining the general method of cleanup, establishing a master cleaning schedule, designing and documenting the specific cleaning methods to be used, and establishing a sanitation inspection program.
