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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
September 2013
I am trying to understand the trend, if there is one, away from the use of solvents in the assembly of medical devices, specifically as it is used for coating ends of PVC tube sets and catheters.
< 1 min reading time

As originally asked by Nancy Gleason.

Are more medical device manufacturers using UV and even cyanoacrylates for this type bonding? Any insight from members of this group would be most appreciated.


Alfredo REYES
Chief Financial Officer / Strategy and Operations Partner / Interim Management
Are you looking for Biocompatible / Bioabsorbable Drug-Eluting Polymers having broad applications in the medical device coating and fabrication industries? If you are I can put you in contact with a manufacturer.

George Purtell
Senior NPD Engineer at NextPhase Medical Devices
For high volume applications of extremely low cost products such as tube sets I believe that Robert is correct. But in the world of catheters which tend to be much more expensive devices these other technogies are far more widespread. So the short answer to the original question is, It depends on your application.

Nate Tran
Senior Principal R&D Engineer at Rotation Medical
I have designed and developed disposable devices for use in laparoscopy, endoscopy, and even CABG anastomosis site clearance that all contained large amounts of PVC tubing for gas and/or fluid transport. Cyclohexanone is the ideal bonding agent as long as the mating features that attach to the tubing are appropriately designed and the solvent application process is validated. Cost is a huge factor here as ISO 10993 compliant cyanoacrylates and UV adhesives are significantly more expensive. In addition, the administration of UV or LED curable adhesives typically require specialized equipment for administration and curing. UV stations also require a larger clean room footprint as appropriate shielding measures must be in place per OSHA. Make no mistake, cyanoacrylates and UV/LED curables are incredibly useful and versatile, but for bonding PVC tubing, solvents are hard to beat.

ROBERT W. ANASTASIA
SENIOR CONSULTANT at R. W. Anastasia Consultants and R.A.Q.A. Associates, Inc.
I disagree that solvent bonds are not widely used. When I was making blood tubing sets for hemodialysis we were producing over 25 million tubing sets yearly, each with approximately 25 bonds (since then the yearly volume has tripled). Tubing sets sold for less than $5.00 and our total complaint rate, for all causes, was less than 3 per million. Can you do that with new adhesive technologies? I submit that in the total medical device industry, solvent bonds account for 90% of all bonds. The high volume, lower cost segments still employ solvent bonding.

George Purtell
Senior NPD Engineer at NextPhase Medical Devices
I have been in the device industry for several decades now. Back in the day cyanoacrylates were the primary adhesive that I have seen used in device assembly. However, over the last 15 years or so UV adhesives have come along way and whenever possible they are my adhesive of choice. Cyanoacrylates, because they act instantly can be a problem. If the adhesive is not well distributed It can set in place even though the bond may not have as much adhesive around it as you may like. This makes the proper use of cyanoacrylates very technique dependent. Also cyanoacrylate bonds are extremely rigid and sometimes bending can cause the joint to crack. UV adhesives offer many advantages. The joint can be worked and manipulated as much as desired until you are ready to cure it. UV adhesives are also very flexible , so for a tubing application they are far less likely to be damaged with manipulation. Recently I have heard a lot about adhesives that are cured with an LED lamp, but I do not have personal experience with that . In short I do not believe that the solvent bonding is very widely used these days due to the advancements in these other adhesive technologies.

Robert Houghland
CEO at Hanover Pen Corp., Hanover, PA
Robert Houghland-as a contract manufacturer we see all types of bonding issues in a wide variety of devices and with various materials. We use solvents, cyanoacrylates and UV curable adhesives depending on the circumstances. Personally, I think the trend away from solvents is due to the hazardous nature of the chemicals, the fixturing time and drying time when compared to the other methods, not to mention the offensive smell.

ROBERT W. ANASTASIA
SENIOR CONSULTANT at R. W. Anastasia Consultants and R.A.Q.A. Associates, Inc.
My background is blood tubing sets for hemodialysis. Using cyclohexanone solvent for PVC to PVC bonds yields a bond that is stronger than the tubing. As with any other process the bonding must be a controlled and validated process.

Shelly Staat
Marketing / Commercial Operations / Business Development
Nancy, this is an interesting question. My experience is with tubing sets and single use disposables for the cellular therapy and transfusion medicine markets and we were not looking into alternative bonding agents. I’ll be interested to see replies from others.

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Posted by Joe Hage
Asked on September 15, 2013 1:25 pm
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