5 replies to this topic

[Pedro Vissotto]

Hi, I thought about creating this topic to have a place to see in what you guys are working with right now and how are you managing the development process on that. The idea is to create some database on methods of development and to create a good information exchange. So I will stars with my current work: Resume: In the company I work for, we are implementing 3 new syringe production lines, 3ml, 5ml and 10ml. They are low cost syringes, designed to fight the chinese products, that are hitting our market with a very competitive price. Me, as the packaging development analyst, have the job to develop primary and secondary packaging for these new syringes (primary packagin=blisters / secondary packaging = carton boxes). So, This is the machinery the company purchased to vacuumform the blisters: Dutch company, Sealpac - RE30 In this link you can see a .gif animation of the packaging system: http://www.sealpac-uk.com/RE30.htm#

The primary packaging follow this steps (LOOK AT "ATTACHMENT 1" TO A BETTER UNDERSTANDING)

1 - Formstation use heat, pressure and time to shape the cavities of the blister.

2 - The Syringes are fed by a parallel system (feeder), (but thats another stuff, live it alone)

3 - The paper roll enter the sistem and with the film, they are sealed together.

4 - Seal station use heat, pressure and seal time to find a good sealing.

5 - Then, blisters are cutted transversal and then longitudinal direction.

After that a conveyor bring the blisters to the secondary packaging, which is made manually.

Edited by Pedro Vissotto, 27 December 2011 - 05:44 PM.

[Pedro Vissotto]

last post was to heavy to add the attachmente, here goes the #1

Attached Files

•  image 1.jpg   857.24K   0 downloads

[Pedro Vissotto]

So, continuing...

There are some quality stardards we have to achieve to be able to release the product to marketing:

I work with the parameters (pressure, heat and time) of the machine to find a good forming and a good sealing.

By that throw some numbers to check how the machine will respond, for example:

Put 100º C on forming to check how it goes, then try 120º C, until you find a satisfiying quality blister. Same for pressure and time. By these studies you can have an idea of what will be the window of parameters you will go for.

To confirm that we run a test, called DOE (design of experiment), in here you combine the variations on tha parameters you worked on your studie, for example:

Temparature: 90ºC 95ºC 100ºC 105ºC 110ºC 115ºC 120ºC

Pressure: 2 bar, 2.5bar , 3bar , 3.5bar

Time: 0.5s 0.75s 1s 1.25s 1.5s

So, to combine all these variations you will make 112 runs:

example:

Run#1: 90ºC + 2bar + 0.5s

Run#2: 90ºC + 2bar + 0.75s

and so on...

in the end, you have samples that will be measured for:

- Film thickness

Can't be so thin, because the material has to pass a severe shipping test, if it gets too thin, we will have pinholes in the blister, will fail all the experiment.

If it gets too thick the plastic film will pressure the syringe against the paper, and cause paper rupture, will fail all the experiment.

- Seal force

Cant be weak enough to open easily, will compromise sterility.

cant be strong enough to rag the paper whan you open the blister, beacause a paper fiber may enter the syringe cylinder and be injected in a pacient, os a paper fiber can fall inside an open wound, and compromise a pacients recovery.

continues...

[Pedro Vissotto]

We use the data collected on the DOE to make a statistic study on which interval we will work:

lets suppose:
Temperature: 95 to 105 ºC

Press: 2,5 to 3bar

Time: 0.75 to 1.25 seconds.

This interval are supposed to cover the process variations, and keep producing with a satisfiyng quality standard.

Continues

[Pedro Vissotto]

Development of secondary packaging:

We define the quantity of parts per box, 100 , 200, 300 , 400...and so on...

find the best way to feed the syringes inside the box.

and go for shipping test, which will give green light to keep the development,

2000 parts packed with the higher parameters defined in the DOE and 2000 parts with lowest parameters.

The shipping test, as it says, has to simulate extreme transport conditions, so the boxes are sterilized at 90ºC with EtO (Ethilene Oxide), for 9 hours, 2 times. This is parte of the process for each box that goes to the final customer. The heat from sterilization shrinck the film, what makes it more sensitive. It increase possibilities of holes and rags.

After sterilization the material gos to the shiptest itself, boxes are dropped, in normal position, upside down, corner to floor. Then goes to shaking test for an hour. Then dropped in normal position again, but with twice the height.

To check the material integrity parts go to a carbon dust chamber, with a very fine carbon dust that will enter any hole that have ocurred during the test.

Statistical studies show that if we have at last 5 failures in 2000, we can proceed.

This video show the drop test (except that we use a machine for that hahahahahaha)



and this shows the shaking test



Suppose that all results are fine (which is very, very hard to get in the first tryout) we start developing tha graphic layouts for the carton boxes, labels, paper rolls.

[Pedro Vissotto]

I would like to post some images of the real thing...but its just agains the company rules...

How is development process in your company, office or even school projects???