Manufacturing Equipment
Most pieces of manufacturing equipment, especially for API manufacturing, are made of some type of steel. Steel is a metal alloy (mixture of elements with at least one being a metal) primarily composing of Iron. A big risk with steel is that it is susceptible to rust and corrosion, both of which are forms of oxidation. Choosing the proper materials for equipment protects the patient to ensure any rusting or corrosion doesn’t impact patient safety. It additionally protects the employees operating the equipment! When equipment rusts and corrodes, its mechanical integrity weakens, increasing the risk for a safety incident.
A cleaning validation is proof that the cleaning process removes all potential sources of contamination. It tests that all residues of the product that was manufactured prior and any cleaning agents used in the process have all been removed. Cleaning validation is critical to maintaining patient safety and mitigating cross contamination.