I am currently trying to develop a Design Specification verification of a 15,000 cleaning cycles and no degredation test. In other words after 15,000 cleaning cycles of a Class II Medical Device component (PMA required), will it still operate as designed for its intended use environment. Any help, theoretical verifications, or alternatives to a custom PLC or other hardware fixture to provide actual physical evidence. Thanks in advance for helping a once manufacturing guy now in quality assurance.

One of the options that you can use is adopting section #4.1.3 (page 122) in the attached document (GMP and inspection), please take a look at line 18 and you will understand why I recommend you to use this section (the number of cleaning cycles to be performed…)

Thank you Nissam. My struggle is if there is an alternate to building a mechanical scrubber, i.e. a white paper on silicon surface and glass fiber robust characteristics. We have a probe which a person lays their arm on (see veralight.com). The probe surface is silicon and glass fiber ends. We should be able to argue a materials vs. benign cleaning agent and arm contact somehow. Again thanks for you input I will store the useful GMP guidelines. Fair well!