For the Vascular Graft Weaving Line – weaving the polyethylene fabric tubes that make up a vascular graft… I believe that the IQ, OQ and PQ will be as following:

IQ- The machine weaving the polyethylene fabric has been installed under proper electrical configuration according to its installation SOP. The environmental area and conditions in which the machine has been installed is suitable for optimal performance. Safety features are under OSHA compliance. Equipment testing is being performed like calibration and ensuring that motors turn in the right direction.

OQ- The process control limits of the machine has been established to be capable of producing the optimal polyethylene weaving. Proper operational training has been conducted. Software V&V has been performed for intended use.

PQ- The machine has demonstrated a repeatable and long term stable process for producing an acceptable weaving by simulating the actual manufacturing conditions with all necessary raw material.