There are a variety of rules and regulations that must be followed for any country or region in which a device maker wishes to market a product. While a cleaning validation is just one aspect of the process, it can directly impact patient safety and, therefore, must be addressed vigorously. Further complicating the matter is potential changes to ISO 19227, which is going through an update.

As this complicated process is so critical to the success of a medical device, manufacturers need to partner with companies that have a thorough understanding of the ISO standard and have established best practices for its implementation. In addition, keeping track of all aspects of the touchpoints that can impact a cleaning validation presents further challenges. Again, with close interaction with a company maintaining this expertise will help ensure a smooth pathway to compliance.

Fortunately, a representative from one such company—Matthew Homuth, Sr. Validation Engineer at Cretex Medical | QTS—took time to answer a number of questions around cleaning validation. In the following Q&A, Homuth explains what a cleaning validation is, the impact ISO 19227 has, and where companies often come up short on their own cleaning validations.

Sean Fenske: Can you please explain what a cleaning validation is and what the difference is between cleaning and sterilization?

Matthew Homuth: Cleaning validation (CV) is a data-driven process validation with the final intent of ensuring consistent final residues prior to final packaging and sterilization. Cleaning validation is also a critical input to the…