Industrial Aseptic Bag Heat Sealing Sampling and Qualification

Looking for some guidance. The company I work for manufactures industrial aseptic bags (300gallon). We are in the process of installing a new machine to manufacture our bags. I have been tasked to qualify the machine and than move further into qualifying parameters for each different bag type (different number of ply's , different material). We purchase our film and this machine will be responsible for installing and fill spout and sealing, and also running cross and side seals to form a "pillow" style bag. I have been tasked to qualify the temperature, pressure, and time settings for the seals of the bag to ensure our parameters produce the best seal. The sealing process is heat. Anyone have any good literature I can read or some examples on where I can start putting something together?

Thanks
Clint

Lots of views no comments - maybe my first post was a little jumbled, so I will try to explain what I am better trying to accomplish.

If I am running a bag on the new machine and want to get the limits established for good seals (Temperature, Dwell, Pressure) so that each time it is run we have parameters in place that have been qualified. The seals will be destruct tested to pass/fail these parameters. What would be a good initial system to begin qualifying the 3 main parameters.

Bags/Liners are 315 Gallon square (around 83" wide x 100" long), most are comprised of 2-4 ply's of material including PE and MetPet. We make all 4 seals using impulse control seal bars. Depending on the make up of the liner we will alter temperature, dwell time and pressure to get adequate seals. We use ASTM F88 as our testing process for our seals, we conduct our testing on an instron using the unsupported method. Our seal criteria is min 2" of elongation with no peel.

Thanks in advance for your suggestions

patience...you posted on Friday afternoon as most people were prepping for the weekend. May people will read the post then think about it and post a response the next business day. this should keep your post in the 'recent' posts thru Monday noon...

I have some suggestions but need time to formulate and type a full response for you...

Thanks Bev - I just though my initial request may have been to broad - I edited the details in my reply.

Just bear in mind that a "heat seal" may be strong enough and still leak. I prefer leak tests over pull tests.

Cheers,
Ronen.

A basic plan would typically involve making product at the various extreme allowed settings of each factor. This could get pretty large so many people use fractional factorials for this. You can also block or group factors together.
It's advisable that you perform the study across a couple of lots of raw materials to provide replication...

in this case, since you are qualifying a new machine I recommend pairing the same materials across both machines. this technique is called blocking or matched pairs...

A great resource for this is:
"Quality Improvement Through Planned Experimentation" by Ronald Moen and Thomas Nolan

Bev Thanks..

This is what I have been working on this week, hopefully I am working in the right direction - I am setting it up with attribute and variable data points to look at. Lot size will be 3201-10,000 and I was going to use general II inspection level.

Attributes being anything visually we currently inspect product for on our current equipment (ie. wrinkles, voids, debris, carbons/gels etc.) I am going to rate these as major defects, having an AQL of 2.5%, or minor defects having an AQL of 4.0%.

Than I was going to look at variable data for seal tests and consider this critical with an AQL of 1%. We would pull a sample of liners and test seals to determine if our settings (temp, pressure, dwell time) were accurate for the liner we were running. My question with this is can I use the same tables that I use for Attributes out of which essentially means at 1% AQL I wouldn't be allowed to have any seal failures.

I know this is more for sampling of finished products, and not qualification but my boss wanted to use similar guidelines and criteria for our new machine so we would have documented criteria and qualification steps.

Thanks
Clint