Control of Sterile Barriers made by the supplier


Starting to get Involved
Hello together. Hope all is well. I would like to get advice from you regarding what we have faced as an issue in a close time manner.

Normally, when a sterile pouch is changed with a new one in a product portfolio, first of all, CRS(Component requirement specification) is created to specify the material requirements. And then the initial sampling tests are performed. (Dimensional measurement, supplier seal seam check, etc.) When initial sampling is completed, the process validation is performed in order to specify the internal sealing parameters. The supplier seal, as well as the internal sealed seam, is tested in the scope of the design verification test. There is also QA/RA agreement that the supplier is qualified and also seals are validated according to ISO 11607-2. Therefore when the pouch is purchased and gets to the facility, only Receiving inspection is control the supplier seal according to the AQL level. There is no control point in the production in terms of seal width for the supplier seam. There is only checkpoint regarding internal sealed seams. But we had an issue that some pouches (tyvel reel) did not meet the requirement and it is noticed in the production. (Some seals were almost 4mm; normally it has to be greater than 6 mm.). Now, our quality department request checkpoint to the supplier seams.

How do you feel regarding this situation? Do we have to add checkpoints to the supplier seams even though our QA/RA agreement? (Supplier has to ensure that seal seams are higher than 6mm.). It does not make sense to me to add control points to the supplier seam in production. Maybe Receiving inspection department could increase the sample size but not for the production site. We have already lots of checkpoints and control forms.

Do you have any recommendations on how to solve the issue properly ?

Thanks in advance.


From my perspective, you do not need to add any control point in the production steps if you have an agreement with the supplier regarding ISO 11607-2. The supplier must be produced sterile bags according to your specifications and regulations. But to avoid the issue in production, you can add additional control points in the receiving inspection side i.e increase the AQL level or add the control point for the supplier seam.


Trusted Information Resource
As you say, this is a problem with the supplier, not with production. I would discuss it with the supplier first. You say it is checked on receipt according to an AQL, You should review the AQL to ensure it is appropriate now you know there is a potential issue and also look at the sampling regime to ensure it is random across the batch.


Starting to get Involved
Thank you guys for your recommendations. As a consequence, I will regret adding control points to the production site in regards to supplier seam if Quality department insists on this idea. I will reach out the supplier and make sure their process is stable and well controlled. And increase the AQL level (so increase the sample size) for the RI. Any further recommendations are appreciated :)
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