J
jhnichols
I have a question on common practices for validating injection molding processes across several molding machines. It is viable to perform an OQ study to define a process window on one machine, then move to PQ and apply the nominal setting to multiple identical machines to check for conformance to CpK requirements?
I have been informed by a purported expert that the best molders in the world typically use multiple similar (not identical- may have slightly different screw, barrel, etc.) machines without specifically running parts in them provided the OQ and PQ has been completed on a single machine. This seems somewhat unlikely for sensitive parts used in medical and pharma applications, so I am looking for confirmation of the general practices in use. Is requiring separate PQ runs on multiple machines common to approve those machines for production?
How do you typically go about qualifying multiple presses?
Jeremy
I have been informed by a purported expert that the best molders in the world typically use multiple similar (not identical- may have slightly different screw, barrel, etc.) machines without specifically running parts in them provided the OQ and PQ has been completed on a single machine. This seems somewhat unlikely for sensitive parts used in medical and pharma applications, so I am looking for confirmation of the general practices in use. Is requiring separate PQ runs on multiple machines common to approve those machines for production?
How do you typically go about qualifying multiple presses?
Jeremy