DM-0018_CleanWorx™ CyClean™ 35_IOM_Rev1.2

5.5) Methods to Achieve a Repeatable Cleaning Process The CyClean uses Sanitation Carts designed to hold predetermined parts in specific locations. By using the same Wash Recipe with configured Setpoints, the CyClean is capable of repeatably and reliably cleaning these parts. While this functionality does not happen out-of-the-box and is not guaranteed, a repeatable, reliable clean may be achieved following these steps: 1. See section 5.4) Configuring a CyClean Wash Recipe to configure your CyClean Wash Recipe with parameters for your process, if known. Coupon studies from a chemical supplier may identify time, chemical type, chemical concentration, and temperature recommendations. 2. Identify a batch of worst-case scenario soiled parts from your process. 3. Place these parts in their respective location on a Sanitation Cart. 4. Follow the steps in section 5.1) Typical Operation Instructions , selecting a specific Wash Recipe (Short, Medium, or Long). 5. Once the Wash Recipe is complete, remove the Sanitation Cart. Inspect each part closely for any remaining contaminates and perform any analytical tests (i.e. ATP, Allergen) desired on a large sample of parts. If the parts are deemed clean and pass testing: 6. Repeat the steps above a minimum of 1-2 additional times. If the parts are continually clean and pass any testing done, the process is proven repeatable and reliable. This process should be documented and placed into a company-specific Sanitation SOP (SSOP) or other documentation. While this process has proven repeatable and reliable, due to variables that may change over time (i.e. your product, water quality, operator loading of parts), routine inspection and testing should be put in place to ensure the

cleaning process continues to remain effective and valid. It is recommended that this process be reconfirmed periodically.

If the parts remain dirty or fail to pass testing: 7. Review section 5.3) Understanding a Wash Recipe to determine what might need to change to the specific Wash Recipe used. Make the change to the Wash Recipe as indicated in section 5.4) Configuring a CyClean Wash Recipe . Once the change is made, repeat the steps listed above.

CleanWorx ™ CyClean ™ 35 IOM

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