Medical Device Manufacturing Innovation

The Question

Our client, a medical device manufacturer, required a latex component delivered on rolls for automatic dispensing. The diaphragm, however, did not require adhesive. How would the diaphragm stay on the liner without adhesive?

The Answer

Our AWT experts searched for an ultra-removable adhesive that contained a high differential release (one side of the adhesive or liner could be removed more easily than the other side). This differential release is most often controlled by the silicone content applied to the release liner. In this case, an ultra-removable adhesive allowed the part to be removed from the carrier without any adhesive residue. The tight release between the adhesive and the liner allowed the adhesive to stay on the liner after the part was removed.

The Challenge

Tolerances remained tight. The part has a 0.003 tolerance in the x, y and z dimensions. Maintaining this while working with the elastic properties of natural rubber and ensuring compliance within the lot was a considerable challenge.

Our Solution

AWT made certain the rubber was under the least amount of tension possible – its own weight. After converting, a sample population was measured. That data was then used to statistically calculate the mean, standard deviation and upper and lower control limits. Because the mean (plus or minus three times the standard deviation) was within the upper and lower specification limits, we had a 99.8% assurance that all parts will fall within this range. Understanding our customer’s requirements allowed us to succeed together and reach a common goal!

 

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Cold Chain Labeling

The study and engineering of healthcare remedies began long before the mid 1800’s, but it’s around that time organic compounds like morphine became available commercially as a source of pain relief. The first rudimentary clinical trials occurred during the 1500’s, but it wasn’t until 1943 in the UK when the first double blind, regulated clinical trial took place. Since then, discoveries and breakthroughs in drug remedies have been occurring more frequently, and with greater complexity when it comes to molecular structure.

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The Question

Our client, a medical device manufacturer, required a latex component delivered on rolls for automatic dispensing. The diaphragm, however, did not require adhesive. How would the diaphragm stay on the liner without adhesive?

The Answer

Our AWT experts searched for an ultra-removable adhesive that contained a high differential release (one side of the adhesive or liner could be removed more easily than the other side). This differential release is most often controlled by the silicone content applied to the release liner. In this case, an ultra-removable adhesive allowed the part to be removed from the carrier without any adhesive residue. The tight release between the adhesive and the liner allowed the adhesive to stay on the liner after the part was removed.

The Challenge

Tolerances remained tight. The part has a 0.003 tolerance in the x, y and z dimensions. Maintaining this while working with the elastic properties of natural rubber and ensuring compliance within the lot was a considerable challenge.

Our Solution

AWT made certain the rubber was under the least amount of tension possible – its own weight. After converting, a sample population was measured. That data was then used to statistically calculate the mean, standard deviation and upper and lower control limits. Because the mean (plus or minus three times the standard deviation) was within the upper and lower specification limits, we had a 99.8% assurance that all parts will fall within this range. Understanding our customer’s requirements allowed us to succeed together and reach a common goal!