Hello, my company is required to conduct a cleaning validation on our ultrasonic cleaner which is used to clean smaller, product-contacting items such as stainless steel pickup tips, dispensing tips and various stainless steel connectors used to connect dispensing tubing. The items to be cleaned are used to formulate and dispense non-drug or hazardous products which include salt buffers at a variety of concentrations and sugar solutions upwards of 70% concentrations. We have done an extensive equipment qualification on the ultrasonic cleaner which included foil tests, pencil/glass slide test (mark a slide and clean in ultrasonic), soil test (using bath monitors) as well using swab kits to detect product residues on the equipment post-cleaning (the items were soiled with 50% glucose product, allowed to dry out on surface of items before cleaning). To now perform a cleaning validation, will values such as ADE, NOEL, NOAEL, MACO, ADI or Safety Based Limits need to be calculated for non-drug/no-active/non-hazardous products? What other aspects of the cleaning process will need to be addressed to complete a cleaning validation for this equipment/process? The cleaning agent we use is the Alconox powder detergent which is biodegradable, free rinsing and readily disposable. Thank you for help!
I should note, we only have the test methods of pH, conductivity and TOC analyses validated at the moment. Swab testing has not been validated and was used for the equipment qualification as only a compendial verification method.
I should note, we only have the test methods of pH, conductivity and TOC analyses validated at the moment. Swab testing has not been validated and was used for the equipment qualification as only a compendial verification method.
