I would agree with many that have commented in regards to the syringe filling process, vascular weaving line, antibiotic releasing hip stem manufacturing line, and wound healing growth factor and delivery device manufacturing line.

Syringe Filling Process:

IQ: Since the medical device is mechanically operated. the IQ would test the device if the outputs of the device meets the specs. An SOP or Work Instructions would need to be filled out to test the device for limitations, tolerances and calibrations. Another aspect is if the device needs to be maintenanced and how often does it need to be.
OP: Would test if the process of this device’s action is reproducible, and can perform to spec and providing controlled limitations and how it performs in these limitations. In this case, the syringe is filled with a bone filler substance to a certain level at each time with a specific amount needed depending on the application. The rate of which the filling takes place will be tested if it meets the specs along with the consistency of the output ensuring there isn’t any complications or incosistencies such as not being uniform.
PQ: Would show that the process can be done again and again the same way, ensuring that the variability is within the intended spec, we would call this consistency. A batch of syringes would be extracted and tested each with the same parameters such as volume, content color, extrusion rate, filling rate etc are the same for each. The performance of these would be tested to ensure that statistically it meets the acceptable range.

Vascular Graft Weaving Line:
IQ: The weaving process using polyethylene fabric tubes would be tested with an SOP or Work Instructions would need to be filled out to test the device for limitations, tolerances and calibrations. Another aspect is if the device needs to be maintenanced and how often does it need to be.
OQ: The rate of weaving time and device parameters will be tested to ensure which are the optimal parameters that the device must be set too, in addition the quality of the output of the product will be tested for durability, tensile strength and flexibility.
PQ: The processes of the output will be tested such as the size and consistency of quality of the output product will be tested to ensure that with each batch it fits within production acceptable range.

Antibiotic Releasing Hip stem Manufacturing Line:
IQ: The process of creating a hip-stem outline of the patient would require an SOP or Work Instructions would need to be filled out to test the device for limitations, tolerances and calibrations. Another aspect is if the device needs to be maintenanced and how often does it need to be.
OQ: The device would be tested for optimal parameters such as temperature, release rate of antibiotic, biocompatibility, and application rate will be tested to ensure it meets to specs.
PQ: The process of which the liquid growth factor that sits on the bottle will be tested to ensure that no complications are found or large variability. This would also include the production of these batches to ensure that they are not within acceptable ranges of acceptance.