We have recently bought a new sterile tube welder from a new company. This particular company doesn't offer customers a sterile weld integrity kit. ( basically, it's a kit where you weld wet to wet tubing and dry to wet tubing. You send the welds to the company, who examines the weld strength and integrity) Should I be concerned about this? How am I going to test the integrity of the welds. We do examine the weld after each use, but our previous company detected the welds strength and integrity. Is checking the weld after each use enough?

thanks

stephanie

I sure hope that checking the weld is good enough, Stephanie. That's all we do.

BC

We do the weld check and that is all.

We only use the weld integrity kit because it's available. If it were not a vailable we would do like everyone else, give the line a little squeeze and see if it leaks and look to make sure both sides of the weld are lined up. Not much more you can do.

We do the weld integrity kit because it's required in our SCD operator's manual. If the operator's manual for you new SCD doesn't require it, I don't think you need to worry.

We just do a visual inspection of each weld, and this has satisfied our regulatory agencies.

WHen we got our sterile docker, I did a validation which included suspending various weights from the tubing to determine the strength of the weld. I did not allow the weight to drop and jerk the weld as part of the validation, but I did suspend the weight from the tubing for a few minutes and then checked the weld visually and with a dry paper towel to detect any fluid leaks. Our routine operation only includes a check of the weld like everyone else has stated.

We use Terumo's SCD and TSCD devices, and we have never used a Weld Integrity Kit in the almost 10 years that I have been there. We validate each device upon receipt or after repair, then inspect every weld that is made.

The Technical Manual suggests a weld check each use and an annual function check. If your manufacturer does not offer some sort of a weld test/kit, what type of function check do you perform?