Medical Device: Assembly Solutions

MEDICAL DEVICE
ASSEMBLY SOLUTIONS
185 Bluegrass Valley Pkwy, Alpharetta, GA 30005

+1 770.664.6624 | chemence.com | KRYLEX.com
A
ABOUT
CHEMENCE
Since its founding in 1984 in the UK, Chemence® has continued to grow by identifying and
innovating in niche specialty chemical segments. Up to this date our company is still privately
owned by the Cooke family and many of the family members are actively involved in the
daily operations.
Over the years we have grown organically and via acquisition and spread our reach over three continents.
We have manufacturing sites in North America and Europe and sales offices in North America,
Europe and Asia.
Chemence’s® adhesives and resins provide solutions to customers in a variety of markets. Our range
of products can be found in use everywhere from operating rooms to living rooms, from automotive
manufacturers to toy manufacturers, and anywhere in between.
Over the years we’ve gained valuable experience servicing many Global 500 organizations as well as
small startups. Our key customers have included major automotive OEMs, market leading consumer
electronics companies, some of the finest medical organizations around the world and have even sent
rockets into space.
For more information about Chemence® and our products,

visit www.chemence.com.
IMPORTANT: It is the user’s responsibility to test and determine the suitability of a product for the user’s intended use. Any product
samples provided for testing are provided in accordance with standard limited warranties as stated on our technical data sheets.
MEDICAL DEVICE
ASSEMBLY ADHESIVES
Table of Contents Chemence® has become a world leader in the medical device arena
since its beginning in 1983. A global manufacturer of Class II and
Medical Device III tissue adhesives, we proudly bring you our latest innovation:
Assembly Adhesives 1 KRYLEX® adhesives for medical device assembly.
Products 3 STRONG RELATIONSHIPS BUILD QUALITY DEVICES
Better Than Chemence’s® focus is always on connecting our innovative product

Fasteners & Welding 4 developmentwithwhatmatterstoourcustomers’medicalapplications.
Our strong technical knowhow and extensive application experience
enable our customers to work with our technical teams to bring
diverse new ideas to reality.
We encourage solid partnerships with industry leaders at all stages

of device design from prototyping to manufacturing to ensure that
together we can deliver the highest quality medical devices.

1
LEVERAGING EXPERIENCE FAST, STRONG, AND
THAT FEW HAVE SOLVENT FREE
With over 25 years of experience in developing Also leveraging Chemence’s® strong history in
and manufacturing Class II and Class III medical developing Industrial adhesives, we’ve developed
devices ourselves, we know what Medical Device our products to provide fast, strong and reliable
Manufacturers are looking for in a design partner. bonding. Our Cyanoacrylates and UV-curable
Our team is not only familiar with the rigorous adhesives cure almost instantly forming tack free
standards that your medical devices need to meet, bonds allowing our manufacturers to optimize their
we always meet those standards ourselves when production throughput. Our adhesives stand up to
developing and manufacturing our topical skin the rigors of sterilization such as ETO and gamma
adhesives for many of the largest medical centers as well as many other environmental aging tests
around the global as well. such as temperature extremes, high humidity and
submersion in various chemicals.
ISO 10993 BIOCOMPATIBLY ISO 13485 CERTIFICATION MEANS

FOR ADHESIVES QUALITY MANUFACTURING
Most of our medical device assembly adhesives At Chemence® we know medical manufacturers
has passed ISO 10993 testing for cytotoxicity rely on their suppliers for consistent and reliable
as a baseline. Depending on the application materials – we understand that adhesive failure
requiring an adhesive solution, many of our in a medical device could mean the difference
products also have passed ISO 10993 testing between life and death. Our Alpharetta, Georgia
for skin sensitization and irritation as well. If you facilities are ISO 13485 and 9001 certified, ensuring
are looking for more subsections of ISO 10993 that our products are made consistently and
testing, we regularly work with our customers to that they will conform to Medical Device Quality
develop custom products that could meet other Management Standards. We’re one of the few
subsection of the standard as well such as toxicity adhesive manufacturers in the world that can claim
and hemocompatibility. that robust quality certification.
2
PRODUCTS
KRYLEX® adhesives can meet your performance requirements to deliver exceptional results. Our
products have been used around the world for over three decades, enabling diverse new ideas,
accelerating innovation and improving manufacturing efficiencies.
Micro Needle Bonding Catheter Assembly Needle Bonding

KM9980-Series KM9900-series KM9970-series
Provide high pull strength on Ultra fast, tack-free cure. Reliable
the smallest gauge needles. Adhesive solutions optimized for cure even with light colored hubs.
Fluorescing formulas available. difficult to bond substrates.
Tube Set Assembly Medical Electronics Opaque Substrate

KM9900-series Assembly Bonding
KH-series, KU-series KM0100-series
Bonds rigid and soft substrates
with a strong bond that flexes. PUR hot melts and UV/dual- UV and moisture curing
LED cure optimized for improved cure adhesives for assembly of
cyanoacrylates for instant
processing efficiency. electronics and wearable devices.
fixture and moisture cure in
shadowed areas.

3
BETTER THAN
FASTENERS & WELDING
Bolted assemblies, rivets and other mechanical fasteners require introducing holes into your medical
device - causing points of weakness in the assembly. Heavy weight plastic assemblies can sometimes
withstand the additional stress on the insertion site but when designing small or delicate products,
mechanical fasteners are simply not an option. Ultrasonic welding is commonly used to assemble devices
but the process can lead to high gap variances in the bond line and while solvent welding reduces this
risk, the hazardous solvents come with a high risk of stress cracking delicate plastic substrates
Choosing KRYLEX® adhesives for assembling your medical devices is the more efficient, easier
alternative to the above traditional fastening method.
ADVANTAGES OF ADHESIVES FOR MEDICAL DEVICES

• Adhesives easily fill and cure in irregularly • Adhesives are normally colorless within the
shaped joints and assemblies providing a strong bondline, minimizing the aesthetic changes to
bond and robust seal in the bondline. the finished device.
• Adhesives distribute stresses evenly across the • Light cure adhesives cure on demand and
bondline of the assembly ensuring a strong cyanoacrylates cure within seconds to ensure
assembly. assembly processes are fast and efficient.
• Adhesives are designed to bond to a wide
variety of substrates including metals, glass,
ceramics, and most plastics.
CUSTOMIZED FORMULATIONS
Chemence’s® dynamic mix of engineers and chemists from the industrial adhesive and medical device
industries allows us to truly understand our customers’ needs and work with you to develop the perfect
product for your application. With hundreds of custom formulations already developed in our 30+ years
of existence, chances are we already have a starting point ready for your customized requirements.
Our wide range of in-house analytical and mechanical testing equipment allows us to ensure a
fast, thorough development process that will allow you to quickly go from design to validation to
manufacturing. Generally, we can complete ISO 10993-5 testing for cytotoxicity in a few short weeks
once a new formulation is locked in.
4
NOTES

5
CREATING BONDS THAT LAST
Chemence, Inc. | USA Chemence Ltd. | UK Chemence Commercial Ltd. | Shanghai
+1 770 664 6624 +44 (0)1536 402600 +86 21 3420 2686

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MEDICAL DEVICE

185 Bluegrass Valley Pkwy, Alpharetta, GA 30005

For more information about Chemence® and our products,

Products 3 STRONG RELATIONSHIPS BUILD QUALITY DEVICES

Better Than Chemence’s® focus is always on connecting our innovative product

We encourage solid partnerships with industry leaders at all stages

185 Bluegrass Valley Pkwy, Alpharetta, GA 30005

ISO 10993 BIOCOMPATIBLY ISO 13485 CERTIFICATION MEANS

Micro Needle Bonding Catheter Assembly Needle Bonding

Tube Set Assembly Medical Electronics Opaque Substrate

185 Bluegrass Valley Pkwy, Alpharetta, GA 30005

ADVANTAGES OF ADHESIVES FOR MEDICAL DEVICES

185 Bluegrass Valley Pkwy, Alpharetta, GA 30005

Chemence, Inc. | USA Chemence Ltd. | UK Chemence Commercial Ltd. | Shanghai

+1 770 664 6624 +44 (0)1536 402600 +86 21 3420 2686

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