Simplifying Failure Analysis For Select Medical Device Adhesives - Part 1

Introduction
Troubleshooting a failure in an adhesive bonded joint can be a daunting task due to the wide variety of processing and performance variables
that can affect joint performance. The adhesive families most commonly used for bonding plastics on medical devices are cyanoacrylates and
light cure acrylics. When examining a failed adhesive joint, one of three failure modes will usually present itself:
1) the adhesive is still liquid or partially cured, 2) the adhesive has failed to one surface and, 3) the joint is incompletely filled with adhesive.

The Medical Device Adhesives Light Curing Acrylics

Considered Cyanoacrylates
are one-part, room temperature-curing adhesives available in
viscosities ranging from water-thin liquids to thixotropic gels. When
a cyanoacrylate comes in contact with a weak base, such as moisture
present on most surfaces, acidic stabilizers in the adhesive are
neutralized and the cyanoacrylate hardens rapidly to form a rigid
thermoplastic that adheres to most substrates.
are one-part adhesives that cure via a free radical cure mechanism
upon exposure to light of proper wavelength and intensity to form
thermoset plastics with good bond strength to a wide variety of
substrates. Products may respond to ultraviolet light, visible light
or both. The sensitivity to visible light is particularly helpful when
working with substrates that transmit UV light poorly, such as
plastics that contain UV stabilizers.

Bond Failures: Causes & Solutions

No/Poor Cure
When a light cure product is incompletely cured, it will remain liquid or tacky. Stress cracking of the plastic part may result due to excessive
exposure to the liquid adhesive. Uncured cyanoacrylate can show similar symptoms but may also leave a white residue around the bond area.
This results because cyanoacrylates have a high vapor pressure and will tend to evaporate over time. When the evaporating vapor settles
around the bondline, it cures to form a white powder known as “blooming”.

Cyanoacrylate: Causes and Solutions

A. Potential Cause: Surface is too dry or acidic.
Cyanoacrylates are stabilized with acidic species. They cure when
the acidic species are neutralized by basic species (i.e. moisture) on
a substrate surface. If a surface is acidic, or has very little moisture
present, it can lead to slower cure of the cyanoacrylate.
A. Solution:
1. Use a “surface insensitive” grade of cyanoacrylate. This family
of cyanoacrylates will cure more consistently than standard
cyanoacrylates, particularly on dry and acidic surfaces.
2. Apply an accelerator to one of the surfaces being bonded. An
accelerator consists of a basic species dispersed in a solvent. The
accelerator is applied to the surface and leaves behind the basic
species that neutralizes the acidic stabilizer to initiate cure of the
cyanoacrylate. Be aware that some solvents used in accelerators
can cause stress cracking of some plastics. In addition, the
accelerator will have a limited on-part life once it is applied to the
surface, so be sure that this processing variable is controlled.
3. Consider the use of a light cure cyanoacrylate if the joint design
allows for it. Exposing the adhesive to light of the proper
wavelength and intensity will rapidly initiate the cure of the
cyanoacrylate.
4. Expose the parts to an environment with humidity of at least
40% RH prior to the bonding operation. This should be done
long enough prior to the bonding operation to allow the moisture
in the air to come into equilibrium with the surface. If the parts
have already been assembled, exposure to a moist environment
will offer minimal benefit, as the moisture must permeate into
the bonded joint to have any effect on the cure speed of the
cyanoacrylate.
B. Potential Cause: Bondline gap is large.
The cure of cyanoacrylates initiates at the substrate surfaces. If the
gap between the two substrates is greater than 0.010", it may be
difficult to gain complete cure through the gap.
B. Solution:
1. Redesign the part, or tighten manufacturing tolerances on
assemblies, to reduce the gap. Generally with cyanoacrylates,
the smaller the gap, the faster the adhesive will develop fixture
strength and completely cure.
2. Apply an accelerator to both surfaces being bonded. The presence
of accelerator on both substrates will help drive the cure reaction
through a larger gap. Be aware that even this approach will have
limited success if the gap gets much larger than 0.015". If both
substrates are treated with an accelerator, “activated” surfaces
will be present. Hence, the cyanoacrylate will begin curing upon
contact with the surfaces, making it necessary to mate them as
quickly as possible. The potential for clogging dispense needles
is also increased when cyanoacrylate is dispensed directly onto
“activated” surfaces.
3. Consider the use of a light cure cyanoacrylate if the joint design
allows. Exposing the adhesive to light of the proper wavelength
and intensity will rapidly cure the adhesive through gaps of 0.125"
or greater.

All marks used are trademarks and/or registered trademarks of Henkel and its affiliates in the U.S. and elsewhere.
® = registered in the U.S. Patent and Trademark Office. © 2015 Henkel Corporation. All rights reserved. 12410/LT-8082 (4/15)
Light Cure Acrylic: Causes and Solutions
A. Potential Cause: Insufficient light energy due to light
source degradation.
A. Solution:
Check the output of the lamp/wand assembly using a calibrated
radiometer and compare this to values obtained when the product
cured properly and/or manufacturer’s recommended curing
conditions. Many light cure systems will drop in output over time
due to bulb degradation, material accumulating on the light cure
system reflectors and/or wand tips. Clean the system and replace
bulbs before the system output drops below minimum light output
values.
B. Potential Cause: Insufficient light energy due to change in
curing parameters.
B. Solution:
Consistent cure of the adhesive requires maintaining consistent cure
time and light irradiance at the adhesive joint. If the cure time has
been reduced, or irradiance reduced due to the distance from the
light source, unacceptable cure may result.
C. Potential Cause: Insufficient light energy at the proper
wavelength.
C. Solution:
If the surface of the adhesive is tacky, it may be due to insufficient
light energy at lower wavelengths (200 – 300 nm) that aid in surface
Insufficient Adhesive in the Joint
When a failed adhesive joint is inspected and found to have insufficient adhesive coverage, there are a number of potential causes and
solutions to consider.
Causes & Solutions Common to Both Adhesive Systems
A. Potential Cause: Insufficient/inconsistent amount of adhesive
being dispensed.
A. Solution:
Increase the amount of adhesive being dispensed. The use of
dispensing equipment can aid in consistently dispensing proper
amounts of adhesive and avoid problems associated with variance
in adhesive dispense amounts. A wide range of dispensing
equipment is available that works well with light cure and
cyanoacrylate adhesives.
B. Potential Cause: The adhesive being used is too low in
viscosity for the joint.
B. Solution:
If the gap in the joint is too large for the adhesive to bridge, poor
contact between the adhesive and the two surfaces being bonded
will result. If the gap between the two parts cannot be reduced, a
higher viscosity or more thixotropic adhesive may be required.
C. Potential Cause: The adhesive being used is too high in
viscosity and is being squeezed from the joint.
C. Solution:
This problem is often seen in cylindrical assemblies where adhesive
is applied to one part and then the two parts are slid over each other
as they are mated. If the gap between the two parts is too small, the
adhesive can be scraped from the surface as the parts are mated and
not reach into the joint. In this case, designing a taper to the
All marks used are trademarks and/or registered trademarks of Henkel and its affiliates in the U.S. and elsewhere.
® = registered in the U.S. Patent and Trademark Office. © 2015 Henkel Corporation. All rights reserved. 12410/LT-8082 (4/15)
cure. Consider a different light source or an adhesive that has
better tack-free curing characteristics. Blanketing the surface of the
adhesive with an inert gas such as argon or nitrogen during cure can
also eliminate this problem.
D. Potential Cause: Substrate inhibits UV transmission.
D. Solution:
There is a wide range of light curing acrylic adhesives that can
be cured with visible light. Consider the use of these products if
your substrate will not transmit UV light. If you have been using
a UV product and find that it is suddenly curing poorly, check the
UV transmission characteristics of your plastic to be sure that it
has not changed.
E. Potential Cause: Shadowing of the adhesive
E. Solution:
Light cure acrylic adhesives will only cure in areas that are directly
irradiated with light of the proper wavelength and intensity. Be
sure that no areas of the bondline are shadowed by features on the
assembly during the curing operation. Additional light sources or
reflectors may be required if this is the case.
joint can aid in getting adhesive flow into the joint. Other potential
solutions include providing a larger gap between the parts, and
using a lower viscosity adhesive that can be applied to the parts
after they have been mated.
D. Potential Cause: Excessive clamp load squeezing adhesive
from the joint.
D. Solution:
It is important to provide sufficient clamp load to attain intimate
contact between the adhesive and the substrate; however, excessive
clamp load that deforms the adhesive joint is undesirable. If clamp
load is great enough to cause deformation of the joint and then
removed prior to curing the adhesive, the part may return to its
original configuration and leave a joint starved of adhesive. If the
adhesive is cured while the part is deformed, the resulting joint will
have high amounts of residual stress that could lead to premature
joint failure. It is best to supply only the clamp force needed to
achieve intimate contact between the adhesive and the substrates.
E. Potential Cause: Not maintaining clamp load during
curing process.
E. Solution:
Movement of the parts after adhesive is dispensed but prior to
curing may result in gap formation. Maintaining part alignment
during cure without using excessive clamping force can prevent
this problem.