A
Hello,
I'm a contract manufacturer that specializes in swiss machining orthopaedic implants/instruments. We are working on our first bone screw project that requires validation.
These screws will be swiss turned complete, ultrasonically cleaned, finished & laser marked, then, bagged with an IFU and sealed with a label (They don't require sterilization, they just need to be cleaned).
My customer wants us to validate our swiss machining process, as it relates to this type of screw and also validate our ultrasonic cleaning process. They have supplied me with the GHTF Process Validation Guidance document and have been working with us to develop our validation system, but, the guidelines and information are so generic.
I was wondering if anyone out there has devised validation processes that are specific to swiss machining and ultrasonic cleaning? If so, would you mind supplying some sample documentation?
I've got a handle on the IQ stuff, but I'm having trouble figuring out how to apply the OQ and PQ aspects. I'm thinking for the swiss machining of the bone screw, I'll have to come up with a validation plan that's specific to the manufacture of that specific type of part. But for ultrasonic cleaning, it seems like I could validate on a broad general basis and apply the results to a variety of different parts that we might manufacture and clean.
Any help would be greatly appreciated!
I'm a contract manufacturer that specializes in swiss machining orthopaedic implants/instruments. We are working on our first bone screw project that requires validation.
These screws will be swiss turned complete, ultrasonically cleaned, finished & laser marked, then, bagged with an IFU and sealed with a label (They don't require sterilization, they just need to be cleaned).
My customer wants us to validate our swiss machining process, as it relates to this type of screw and also validate our ultrasonic cleaning process. They have supplied me with the GHTF Process Validation Guidance document and have been working with us to develop our validation system, but, the guidelines and information are so generic.
I was wondering if anyone out there has devised validation processes that are specific to swiss machining and ultrasonic cleaning? If so, would you mind supplying some sample documentation?
I've got a handle on the IQ stuff, but I'm having trouble figuring out how to apply the OQ and PQ aspects. I'm thinking for the swiss machining of the bone screw, I'll have to come up with a validation plan that's specific to the manufacture of that specific type of part. But for ultrasonic cleaning, it seems like I could validate on a broad general basis and apply the results to a variety of different parts that we might manufacture and clean.
Any help would be greatly appreciated!
Welcome to the cove. 