Find out more
Where a process cannot be 100% verified, it must be validated to a suitable confidence level to ensure that the output matches the requirements intended.
Where ultrasonic cleaning is required prior to final packaging of product, a validation should be considered to ascertain the cleanliness of the device/product in question. This validation is always bespoke, but typically follows the OQ/PQ approach listed above with a cleanliness specification being generated against the final end user requirement. Testing is conducted to establish to an agreed sample plan that will provide objective evidence that the process is capable of cleaning products that meet these requirements.
Once the process is established we can offer an ongoing verification test plan to show onging compliance.