Validation of Washing and Degreasing (Solvent Washer) for Precision Machine Parts

[Validation2011]

Hi All,

I work for a precision machining company and we are currently validating various pieces of equipment.

We have a Washing unit that we use for washing and Degreasing (Solvent washer) of our parts.

Our Customer has requested that we qualify/validate this piece of equipment.

We are trying to develop a performace qualification protocol to test the unit but the problem is that when we remove the parts from the machine all we do is look at them and verify that they are "Visually Clean". We have no other method of testing the parts.

The customer has suggested we look into Dyne Testing the parts, but im not sure how well this would work with our process.

Has anyone validated a similar process? or can anyone offer some advise?

Thanks

 

[Ka Pilo]

Re: Validation Help!!

I think all you have to show is that the right results are obtained.

 

[pkost]

Re: Validation Help!!

The question you have to ask, or more specifically your customer has to answer is "how clean do we want it to be" and as ka pilo suggested..."how sure do we want to be that the cleaning process worked".

Obviously considering that the more certain you are the more expensive it gets. We have in the past used XPS analysis to confirm identify an measure surface contamination, which is probably a little extreme if you believe visual inspection is sufficient

Depending on the size of your product, you could use gravimetric techniques to detect the change in mass resulting from the contamination being removed.

 

[bobdoering]

There are cleanliness standards in many industries - they generally refer to rinsing down a product in an appropriate solvent, drawing it through a vacuum filtration and observing the results on the filter paper with a criteria of how much and/or how large the remaining particles are. You really need to have that specified before you start.

However, you can do that once with a new system and fresh washing solution and pass the requirement - but the key is to run the process to the point of normal preventive maintenance, and check the product then to assure that over the "life" of the solution, filters, etc., the washing system is effective.

Otherwise, you are kidding everyone.

 

[automoto]

Hi All,

I work for a precision machining company and we are currently validating various pieces of equipment.

We have a Washing unit that we use for washing and Degreasing (Solvent washer) of our parts.

Our Customer has requested that we qualify/validate this piece of equipment.

We are trying to develop a performace qualification protocol to test the unit but the problem is that when we remove the parts from the machine all we do is look at them and verify that they are "Visually Clean". We have no other method of testing the parts.

The customer has suggested we look into Dyne Testing the parts, but im not sure how well this would work with our process.

Has anyone validated a similar process? or can anyone offer some advise?

Thanks

Hi,

You can do that with cleanliness test (see ISO 16232). Perform cleanliness test on part before degreasing and after degreasing. With that analysis you will found out how many particles are removed during washing.
If you want to validate only degreasing you can do that easily by testing the surface tension with test pen.

 

[Validation2011]

Thanks everyone

 

[Peterseb]

I have participated in a number of validations of washing procedures. In its simplest form, one way of determining whether the surface is sufficiently clean or not it to use "white glove test", which is actually mentioned in a standard for parts that come in contact with oxygen. Whether this method is acceptable or not of course depends on your client's requirements.

There are chemical methods to analyze the amount of carbon hydrogen contaminants per surface area available. But once. again, it depends on the requirement on cleanliness.

HTH,
Peter

 

[cosmobenz]

Hello, I'm also in a medical device company. We are 9001 13485 certified. We were asked to validate our cleaning process. Washing parts, degrease, ultrasonic clean etc.

How is the best way to perform this validation?

Thank you.
Cosmo

 

[cosmobenz]

Peterseb, we have not been given a requirement to meet on cleaning. Basically it should be free of grease , oil, dirt etc. I appreciate any help you can provide me.

 

[ScottK]

In my last company we had to clean parts for oxygen service.

I forgot the standard we had to comply with, but there are test labs that will test your parts for hydrocarbons and contamination after cleaninig.

The key, as many have pointed out, is you need a standard for cleanliness. From there you set up your process, define the validation protocol, and find a test lab to do the testing on cleaned parts to see if you comply.