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!

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!

Hi Alongtain,

:bigwave: Welcome to the cove. :bigwave:

I am not familiarised in this field, but experts on the cove will be able to help you out. In the meantime you may browse the 'Validation Times' issued by High Beam here: http://www.highbeam.com/Search.aspx?q=Validation+of+Bone+screw+manufacturing+process

Have a good day.

Umang :D

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!

Hi alongtain,

Very true - the GHTF document is a genric one but using the concepts mentioned in that document, you could draft something meaningful for you.

You could start with identifying all the equipment that are involved in the process and perform Equipment Qualification (IQ, OQ and PQ).

Once the equipment qualification is successful, draft a Process Validation protocol and validate all your processes. The GHTF document gives very good guidance on both qualifications and validations.

Pl come back if you have specific queries. :)

Very good an example, just for you..cheers :agree1:

Very good an example, just for you..cheers :agree1:

Thanks for sharing - great document.

The primary focus in an OQ is testing the limits of your manufacturing process. In the case of the screw machine, you want to establish the range of variable parameters that can be set on the machine, ie, screw feed, spindle speed, feed rate, etc. You will want to establish which combination of variable parameter work well together and what the range is for each parameter to produce product to specification. Your in essence trying to find the right and wrong combination of parameters to ensure you are always confident you will produce good screws. Once you establich a range of values that produce good screws, then you will execute a PQ.

In PQ, you want to establish that your process can maintain the middle of the range of each parameter you tested over the long haul...current Good Manufacturing Processes dictate 3 separate manufacturing orders....This is where you want to ensure that you can maintain good product between separate operations, ie, shift changes, weekend shutdowns, Operators, etc.

Primary focus of a Validation is ensure that there is a plan, procedures are in place for the equipment and people are trained AND everyone involved in the validation is aware and trained in the validation plan. Keep training records.

Also, have a provision for deviations in your initial validation plan, because stuff always happens that you didn't expect, so you want to be sure you provide for a way to address deviations...but you address them in a logical manner and the corrective actions makes sense or you will need to do it all over again.

Hope this helps, and I'm sure I have missed some aspect of validation because there is also the factor of risk management and how to ensure you are addressing potential risk in manufacturing that could affect the device at the point of use(human body)...this is best done with risk analysis tools such as FTA and FMEA.

Jeff

Thank you very much!

Thanks alot, I'll check it out today and should be able to apply it to my situation.

Thanks to all of you! I've gotten some great feedback and the cleaning validation document is a real help. :thanx:

Great info here! I am also working on a similar validation project (actually several!) and having issues with the sampling plan to use for this type of process.
I have the general Process PQ essentially complete except my customer who owns the product design is waffling on the sampling justification they would like to see used.
I have seen several references to a Bayes formula but am having trouble interpreting it as I am definetly not a statistician. I can easily plug the 90%/90% into a calculator and come up with the 22 piece sample but need to explain my sample size rational in the PQ.
Any help anyone can give on this would be greatly appreciated.