Procedure for Incoming Inspection of Adhesives including Shelf Life

[Davey]

I am seeking assistance in developing an appropriate procedure for the incoming inspection of adhesives. These adhesives are used in a medical device.

I am hoping to use the following approach:

1. Obtain results of testing of the adhesive from the supplier (demonstrating it can meet the requirements for strength, etc). This should demonstrate the adhesive meets my company's requirements.

2. Obtain evidence of the supplier's final product inspection. This shoud demonstrate the adhesive is inspected and (hopefully) describe a process for testing lots or batches before they leave the supplier's facility.

3. Ensure the supplier provides a Certificate of Conformance (C of C) demonstrating the adhesive I receive meets the stated specification.

4. At incoming inspection, review of the C of C to ensure the product meets the stated specifications, including the supplier's final testing.

Parts that are held together by adhesive are tested (during the manufacturing process) to ensure the bond is satisfactory.

Therefore, I expect that testing of the adhesive at my company, while perhaps desirable, is not essential.

Determining whether or not the adhesive is appropriate for use is made by the design engineering group. For now, please assume that the adhesive is appropriate, it has been demonstrated to work in its intended application and its use has been validated.

Any comments or suggestions on my approach to the development of an incoming inspection procedure for adhesives would be useful.

Thanks,

Davey.

I can't comment directly, but there is a test for adhesives that can be used with different substraights. I forget the name of the machine but it works as follows.

You put the substraight on the bottom holder and top holder and measure the total resistence of the top separating from the bottom. This is ususlly read in PPI but it can be adjusted for other types of measurement.

It looks like a type of tinsil tester but can be modified.

It's not a Shore reading, and it is not conducted in a very controlled environment It as about 2" x 2" by 6' tall and has a digital reading if the pressure pulled on whatever substrate required.

We used to use it as a method of measuring the breaking point of a foam resin. The gage insides looked like a black accordian and the outside had the readings. For what it's worth, it was a type of pull tester!!!!!

[Alf Gulford]

Davey-

This looks like a well-reasoned approach to me (but I come from an FDA Class 1 perspective). Assuming all of the surrounding details are taken care of (Design has documented the required specs, the supplier has been qualified, etc., etc.) the only question I'd have is in point number 2.

Unless you're walking some kind of thin line I would think that one of the Purchasing requirements could be that the supplier provide details of how they test their product before shipment. Shouldn't be any 'hopefully' about it. How else could you make an informed decision about testing adequacy?

Looks like you're off to a great start.

Alf