In the business of medical device manufacturing, validating the cleaning process of products is a top priority. You must always ask yourself the two most important questions: will the device be safe for the patient, and will it continue to function properly? If it is not cleaned thoroughly during its production, it could be an issue. Consider these useful tips for validating your cleaning process to help ensure your medical device products will be safe and effective.

Identifying and Understanding the Effects of Potential Residuals

Because you understand your manufacturing process well, you know what products, machines, and chemicals are used to create all applicable medical devices. Make sure that you know each step of the process and which might create an issue, whether through machines creating loose particles or chemicals coming into contact with the device.

Then, when you know all of your potential residuals including those which come from outside sources, you can accurately identify which need to be eliminated and how. Not all residuals are completely dangerous or will wear out the product, so set realistic limits on the cleaning process and what needs to be done. Understanding how the product is to be used is also key. For example, whether or not a device will touch a person, or if a device is going to be used for a long time.

Conduct Tests and Analyze

Either your team or an outside company will want to conduct analytical tests in order to discover just how much of an issue contamination is. Often there is more than one residual or contaminant of which you must be aware. These tests are so important because variables and other issues must be taken into account.

Some of your potential testing methods are:

• A specific method in which Contaminant A is identified and measured for its presence on the product
• A specific method in which Contaminants A, B, C… are identified and measured separately for their presence on the product
• A specific method in which Contaminants A, B, C… are identified and measured during one testing session for their presence on the product
• A non-specific method in which the product is analyzed for the presence of chemicals, but their individual amounts are not measured and instead thought of as equal across the board with all other contaminants

The final method is common in cleaning validations and is less expensive while other specific methods are more expensive and time-consuming but more accurate. You can also create a melding of both a specific and non-specific test, depending on what is necessary for your product.

Either way, the testing must be repeated before it can be valid itself. If you are constantly getting different results or if you only test it once, there is no accuracy to your method. A good testing method must be repeatable and able to provide consistent results so that you can know which:

• Residuals/contaminants are major issues
• Need to be focused on in the cleaning process
• Area(s) of the device are likely to collect the most residuals/contaminants

Test the Cleaning Process Itself

Now that you have tested the device and its likelihood to carry or pick up contaminants during the manufacturing process, you must test the cleaning process itself. You can either test newly manufactured devices that have gone through the cleaning process or devices that have been specifically spiked with contaminants before going through the regular cleaning process.

If you have the ability, you may want to test the process both ways. It should effectively help you conclude the validity of your cleaning process, especially if you have followed the tips above.

Validating the cleaning process as part of medical device manufacturing is necessary, but it does not have to be difficult. Create your own method and take it step-by-step, allowing yourself to understand all possible issues and to solve them one at a time. The FDA asks, “How clean is clean enough?” The answer is of course when your product is safe, effective, and its cleaning process is sufficiently validated.