Chromatography Forum

Chromatographers,
I'm posting to share an experience with a particular British column distributor to hoping to find whether I am receiving a typical degree of support. The situation relates to us attempting to get what we feel is a faulty column replaced as quickly as possible.

- Our US client develops an HPLC method, purchases an second equivalent column of different stat. phase batch and confirms the method 'works'.
- Client sends the newer column to us for method pre-val and utimately validation. We purchase a second equivalent column from the UK distributor. It's of different stat. phase batch.
- Chromatography on the UK column is immediately very poor; main peak elutes late, is split and tailing. US column on our system looks good; profile consistent with data supplied by the client.
- We contact and explain the problem to the UK distributor. They want our column back to test before drawing a conclusion. We have not run the test mix depicted on the column certificate.

Is it others' experience that this is the way of things? Are we reliant on the distributor confirming our poor column performance? We have here, and have also read, examples of confirming system suitability by just running the method. Do you think the delay would of been avoided if we had run the manufacturer test mix?

Thanks

Well,

I got once a column back from a customer, and it looked like he drove with a tank over the column and angry because his column was not working.

This is an extreme, but I understand the problem of your supplier in a certain extend. If their test mix shows splitted peaks, there went something wrong during packing, shipping or whatever. If you complain that your application is not working, it can be of several causes.

If you have a major column supplier and your a good customer, this will not happen. I agree.

We had a similar case in US and column was replaced within a week.
We got a method from our contract lab and had time reproducing it in the lab due to longer retention. It was traced to contract lab which managed to clip off part of the phase (at pH above 7). We always perform standard check before validating the method.
This is another reason why our company never asks about "demo" columns and usually buys two columns from different batches.

- Chromatography on the UK column is immediately very poor; main peak elutes late, is split and tailing. US column on our system looks good; profile consistent with data supplied by the client.
- We contact and explain the problem to the UK distributor. They want our column back to test before drawing a conclusion. We have not run the test mix depicted on the column certificate.

Is it others' experience that this is the way of things? Are we reliant on the distributor confirming our poor column performance? We have here, and have also read, examples of confirming system suitability by just running the method. Do you think the delay would of been avoided if we had run the manufacturer test mix?

Come on. Be fair to the column manufacturer, perform the evaluation using their test mix, as that's why you also get the certificate. If it passes ( which is very unlikely from what you say ), accept that your method uses properties that the manufacturer doesn't test for. If it fails they will probably replace it, depending on perceived use.

The obvious solution immediately is to get the US client to send you columns that work, and get a refund/replacement if the column fails the agreed manufacturer's performance test.

You can't reject columns because they fail your performance test, unless you asked the supplier to confirm their column performance to those criteria at the time of ordering.

As I just noted in another thread, obtaining identical values for plate counts is often difficult because the HPLCs and software used may be different, so be prepared for a little discussion about results.

Column manufacturers don't set out to deliver faulty columns, and it's how they respond to complaints that should define your future suppliers.

Bruce Hamilton

Well, here are some points from the column manufacturers angle. I apologize for the lengthy reply, I hope it makes sense.


• Here at Hamilton (like many other places) every individual column is being tested to meet a set of specifications prior to shipment. The test is intended to characterize the integrity of the stationary phase as well as the packing. It is obviously impossible to test a column for any conceivable application. .We urge users to run this test prior to putting the column into service but I have to admit that only very few actually do.
• There are several reasons why columns fail in the field: they could have been damaged during shipping, the column was dropped, the column has been contaminated within the first few injection of a customers sample. Once in a great while it happens that a customer application works on batch A of stationary phase but it doesn't work on batch B despite the fact that our internal QC does not show any differences between the two. This is why it is imperative that for method validation at least two different batches of stationary phase being used. If requested and if column volume allows we will adopt a customers QC procedure to test all columns for this particular customer/application. Since this constitutes a change in our process we have to issue a new part number, new QC- SOP etc. so it is somewhat of an effort.
• When a column fails and the customer needs to return it for a refund (exchange for new column, credit, monetary) we have to issue a "Return Goods Authorization" (RGA). This RGA triggers an investigation by the QA department to find out why the column did fail. For us it is of course very important to find out if the problem is a manufacturing issue (very bad news if being confirmed) or if the problem is confined to a specific application or user error or some mishap, like column was dropped etc.

Unfortunately once in a while we receive some columns back that “have never been used and failed right out of the boxâ€

I would recomend if you can to purchase direct from the column manufacturer. In most cases they will give you a refund or replacement whilst they investigate your complaint. There are so many unknown interactions happening in a separation, that even if the column passes the manufacturers test method, there may still be something different between the two columns you tried that no-one knows!