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comment_31642

We currently use the small metal clips and a crimper to seal off a unit after splitting it. I was told by the Quality department at the ARC that by placing two clips on each side of a cut, the unit would maintain sterility up to the expiration date on the bag. TRM.43650 states that there has to be procedures for maintaining sterility and the weld and maintenance of the closed system be assessed and documented after each weld. Does anyone else do this? If so, how do you document? What are you documenting? We only do this maybe once or twice a year as we are a small facility and we can not get a heat sealer. Any help is appreciated. Thanks!

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comment_31646

Are you sterile docking on a second bag or is it an attached bag? Or are you entering the unit with a satellite bag?

comment_31656

If you are using a sterile docker and follow validated protocols, there should be no problems. If you are entering the bag it is a different story . . . your procedure will need to be fairly specific about handling the "spike" prior to insertion. The FDA considers 2 seals to be adequate to maintain sterility - these can be annealed (sp) or with the metal clips.

comment_31658

I was taught that whenever you enter a bag with a spike it is only good for 24 hours. Having 2 clips on the tubing does not negate entering a bag does it?

comment_31661

And we wonder why the ARC has so many problems. Do yourself a favor and use a sterile dock and a heat welder to close off the system thereby maintaining sterility

comment_31665

If what you are referring to in TRM.43650 is the "NOTE: If a sterile connecting device is used, the integrity of the weld and maintenance of the closed system must be assessed and documented after each weld." and you are not using a sterile connecting device, then this note does not apply. Facilities that use a sterile connecting device do examine and document the appearance and integrity of each weld. If you are not using a sterile connecting device then you are not performing "welds" so you need to have defined procedures for maintaining sterility (which is appears you have by using 2 clips) and evidence that this is followed.

comment_31682

Probably can't justify a $10K docker for twice a year. If you are sealing from a satellite bag that came connected to the main bag, then what the ARC says certainly fits with many years of practice I have seen. I agree with SMW above for having a policy and following it--and viewing TRM.43650 as non-applicable.

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comment_31758

If what you are referring to in TRM.43650 is the "NOTE: If a sterile connecting device is used, the integrity of the weld and maintenance of the closed system must be assessed and documented after each weld." and you are not using a sterile connecting device, then this note does not apply.

Great! Thanks for clearing that up for me!! I just needed another point of view.

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