For more information about the adhesive application systems, dispensing equipment,and ordering information, please contact your local specialist Loctite support group.
“Loctite” is a registered trademark of Loctite Corporation
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Medical Adhesive Technology
Loctite Industrial
www.loctite.com
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Loctite® Adhesives for Medical DeviceManufacturing
Henkel Loctite offers instant, structural and light cure adhesives along with flexible adhesives and sealants to the medical device industry. Whether your medical device assembly requires an adhesive that is biocompatible and sterilisable – or one that meets a host of other performance characteristics – Henkel Loctite has the right adhesive for your application.
The Henkel Loctite expertise in speciality adhesives for the assembly of medical devices is now revealed by the introduction of the complete high technology range.
�Improved productivity
�ISO 10993 USP or Class VI approvals. Safe and non-toxic
�Fast cure, room temperature or UV cure. No heat curing required
�Consistent bond strength after the sterilisation processes(ETO, gamma radiation or steam)
�Proprietary priming agents that improve the bond capabilities of instant adhesives to low surface energy plastics(E.g. polyethylene, polypropylene, Santoprene, EPDM, etc.)
�Suitable for manual or automated production
Benefits provided by our new medical device adhesives range include:
� Non-toxic
� Ability to bond dissimilar and
difficult to bond substrates
� Structural bonds
� Convenient, fast assembly
� Excellent adhesion and gap filling capability
� Very good resistance to sterilisation processes
The Loctite® Medical Device Adhesives Family includes:
Type of Adhesive Cure mechanism Viscosity
Modified Light Curing UV / Visible Light 100-10,000 mPa.s
Instant Surface Moisture 1 mPa.s - gel
Speciality Flexible UV / Moisture 50,000 mPa.s
Adhesion Promoters N / A 0.5 mPa.s
Light Curing Instant UV / Surface Moisture 20-900 mPa.s
Structural Two Part 6,000-37,000 mPa.s
These Loctite® speciality adhesives and primers have been developed for the assembly ofthe following types of medical devices:
Needles Syringes, lancets, hypodermics, injectors, introducer catheters, and blood collection sets.
Tubesets IV sets, blood and drug delivery sets and suction tubes.
Masks Anaesthesia and face masks.
Polycarbonate Blood oxygenators, stopcocks, filters, blood pressure transducers,Devices arteriograph manifolds, cardiotomy reservoirs and heat exchangers.
Application Areas
Certificates of Compilance to ISO 10993 or USP Class VI approvals (Acute Systemic, Muscle Implantation, and Intracutaneous,Cytotoxicity and Hemolysis) are available through Loctite’s Quality Engineering Department.
These products are not recommended or endorsed for permanent or long term (> 3 days) implantable devices.
Loctite® Medical Device Adhesives Range
The Loctite® one-component instant curing adhesives are available in viscosities ranging from water-thin liquids to thixotropicgels. Instant adhesives are formulated to polymerise rapidly in thin films between two surfaces to form rigid thermoplastics.They offer excellent adhesion to a wide variety of substrates and are ideal for joining plastics such as ABS, PVC, latex, polycarbonate, styrene, acrylic and thermoset plastics. By using Polyolefin Primer 7701, even difficult to bond materials suchas polypropylene, polyethylene and other low energy rubbers and plastics can be bonded to obtain maximum adhesion.These solvent-free products are easy to dispense in automated systems.
Instant Adhesives
Typical Applications
Bond balloon
to multi-lumen
tubes in
angioplasty,
thermo
dilution, foley
and high
pressure
catheters.
Bond needle
to tubing
in winged
infusion sets
and fistulas.
Product
4011Surface
Insensitive
4013
4014
4031Low OdourLow Bloom
4061
4081Low OdourLow Bloom
4161
4541Surface
Insensitive
4601Low OdourLow Bloom
4981
PackSize
20 g454 g
20 g454 g
20 g454 g
20 g454 g
20 g454 g
20 g454 g
20 g454 g
10 g200 g
20 g454 g
20 g454 g
Viscosity(m.Pa.s.)
100
500
3
1,300
20
5
1,500
Gel
50
500
SterilisationMethods
ETOGamma Radiation
ETOGamma Radiation
ETOGamma Radiation
ETOGamma Radiation
ETOGamma Radiation
ETOGamma Radiation
ETOGamma Radiation
ETOGamma Radiation
ETOGamma Radiation
ETOGamma Radiation
Max.Gap
0.1mm
0.2 mm
0.05 mm
0.25 mm
0.1mm
0.05 mm
0.25 mm
0.5 mm
0.1mm
0.2 mm
Adhesive Properties
Colour: ClearLow Viscosity
Colour: ClearMedium Viscosity
Colour: ClearLow ViscosityWicking Grade
Colour: ClearHigh Viscosity
Low Odour, Low Bloom
Colour: ClearLow Viscosity
Colour: Clear, Low ViscosityWicking Grade
Low Odour, Low Bloom
Colour: ClearHigh Viscosity
Colour: ClearNon migrating Gel
Colour: ClearLow Viscosity
Low Odour, Low Bloom
Colour: ClearMedium Viscosity
Suitable Substrates
Rubber, urethane, foam,porous and other difficult
to bond substrates
Rubber, Plastics, Metals
Rubber, Plastics, Metals
Rubber, Plastics, Metals
Rubber, urethane, foam,porous and other difficultto bond substrates
Rubber, Plastics, Metals
Rubber Plastics, Metals
Rubber, urethane, foam,porous and other difficultto bond substrates
Rubber, Plastics, Metals
Resists thermal cycling.Rubber, Plastics, Metals.
Light Curing Instant Adhesives Loctite® light curing instant adhesives combine the advantages of the cure on demand UV-technology with the features ofinstant adhesives. This benefit is especially useful for applications where a secondary moisture cure is required, allowing theadhesive to cure completely in shadowed areas (where light cannot reach). Exposure to low intensity UV or visible light provides tack-free surfaces in less than five seconds. These adhesives eliminate the need for solvent-borne acceleratorsand minimise stress cracking and blooming, due to their „instant“ light fixturing.
Typical Applications Product Pack Viscosity Stersilation Cure Adhesive Suitable SubstratesSize (m.Pa.S.) Methods Depth Properties
ETO colour4304 20 Gamma 4 mm* light amber Rubber, Plastics, Metals
Radiation
ETO colour4305 900 Gamma 4 mm* light amber Rubber, Plastics, Metals
Radiation
* max. gap in shadow areas: 0.1 mm
Typical Applications
Priming low energy rubberand plastics to obtain maximum adhesion withInstant Adhesive.
Product
7701
PackSize
35 g300 g
Viscosity(m.Pa.S.)
1.25
StersilationMethods
N/A
Max.Gap
N/A
AdhesiveProperties
Low ViscosityLiquid
Suitable Substrates
Polyolefins e.g. Polyethylene, Polypropylene, Santoprene and other difficult to bond
substrates.
Primers
Typical Applications
Product
713
PackSize
40 g
Viscosity(m.Pa.S.)
1
StersilationMethods
N/A
Max.Gap
N/A
Adhesive Properties
Very fast fixture,Low Viscosity,
Liquid
Suitable Substrates
Accelerates the fixturing time with
all Instant Adhesives.
Activators
Surface Preparation
Accelerates the fixturing time with
all Instant Adhesives.
Fast fixture,Low Viscosity,
Liquid
Speed fixture time with InstantAdhesive 7451 40 g
360 g3 N/A N/A
Join stainless steel cannulae to non transparenthubs and syringes,bond catheters, bond oxygen concentrators, bond blood gas analysersand filters
7701 is best suited to 4061 but can be used with any of the instant adhesives
28.3 g454 g
28.3 g454 g
These one-component, solvent-free Loctite® adhesives can be applied to a variety of different substrates.They areavailable in a wide viscosity range (100 to 10,000 mPa.s) and cure rapidly (on demand) to form a tough thermosetpolymer. The products are specially designed for automated dispensing and curing in applications where highstrength, clear bondlines and a 100% seal are required.
Ultraviolet and Visible Light Curing Adhesives
AdhesiveProperties
Colour: Clear, Low Viscosity,
FluorescentColour: ClearLow Viscosity
Colour: ClearMedium Viscosity
Colour: ClearHigh Viscosity
Colour: ClearHigh Viscosity
Colour: ClearLow Viscosity
Colour: ClearLow Viscosity
Colour: ClearHigh Viscosity
Colour: ClearMedium Viscosity
Fluorescent
Colour: ClearMedium Viscosity
Suitable Substrates
Stainless steel, thermoset and thermoplastics. Plasma etching or corona discharge increases bond strength of polypropylene.
Excellent for glass and optical applications.
Polycarbonate, acrylic and other thermoplastics where a flexible joint is desired.
Polycarbonate, acrylic and other thermoplastics where a flexible joint is desired.
Best on rigid and flexible PVC, giving a flexible joint.
Best on rigid and flexible PVC, giving a flexible joint.
Best on rigid and flexible PVC, giving a flexible joint.
Best on highly plastisied PVC, giving a flexible joint.
Bond glass to metal.
TypicalApplications Product
PackSize
Viscosity(m.Pa.s.)
SterilisationMethods
CureDepth
Cannulae/hubs
Cannulae/hubs
Glass assemblies andoptical instruments
Bond subassembliesin blood pressuretransducers, arterio-graph manifolds,stopcocks, fittings,adapters and arterialfilters
Bond and seal anaesthesia, surgical and other masks. Bonding tubing to fittings in IV sets, gas inlet and arterial outletconnections on membrane oxygenators
Insulin glass syringes to metalneedles
3001 1ltr 100 ETO 3 mmGamma Radiation
3011 1ltr 100 ETO 4 mmGamma Radiation
3051 1 ltr 1,100 ETO 4 mmGamma Radiation
3201 25 ml 4,000 ETO 13+ mm1 ltr Gamma Radiation
Steam
3211 25 ml 10,000 ETO 13+ mm1 ltr Gamma Radiation
Steam
3301 25 ml 150 ETO 13+ mm1 ltr Gamma Radiation
Steam
3311 25 ml 300 ETO 13+ mm1 ltr Gamma Radiation
Steam
3321 25 ml 5,000 ETO 13+ mm1 ltr Gamma Radiation
Steam
3341 25 ml 450 ETO 13+ mm1 ltr Gamma Radiation
Steam
3345 250 ml 1,500 ETO 4 mm1 ltr Gamma Radiation
Steam
Loctite® high-performance structural adhesives provide high peel and shear strength on a widevariety of plastics, metals and glass. When cured, these thermoset plastics offer superior thermal and chemical resistance, as well as high cohesive strength and minimalshrinkage. Loctite® two-part epoxies are packaged in side-by-side cartridges, allowing them to be dispensed as easily as any one-partsystem.
Structural Adhesives
Typical Applications Product Pack Viscosity Stersilation Max Adhesive Suitable SubstratesSize (mPa.S.) Methods Gap Properties
M-21HP 1 mm
M-31CL 0.5 mm
M-121HP 1 mm
50 ml200 ml
50 ml200 ml
50 ml200 ml
ETOGamma
RadiationSteam
ETOGamma
RadiationSteam
ETOGamma
RadiationSteam
Toughoff-white
ClearLow Viscosity
AmberPeel resistant
Metals, ceramics, glass, rigid plastics
Metals, ceramics, glass, rigid plastics
Metals, ceramics, glass, rigid plastics
Bond/seal endoscopes,
Bond/seal catheters,
Bond/seal artherectomy devices,
Bond/seal blood heat exchangers,
Bond/seal syringes anddental instruments, surgical and orthopedic handheld tools, poweredinstruments
Depth of cure is dependent upon spectral output of lamp, radiation intensity, distance of parts from light source, transmittance of substrates and bonding gap and geometry.
37,000(mixed)
6,000(mixed)
11,000(mixed)
Speciality Flexible Adhesive
Typical Applications
Bond and seal extruded siliconeparts in colostomy, ileostomyand urostomy bags and appliances. Bond and seal the cuff and tube assembliesin endotracheal, tracheostomy,gastrostomy devices, foleycatheters and other fabricatedsilicone parts.
ProductPackSize
Viscosity(m.Pa.S.)
SterilisationMethods
ETOGamma
RadiationSteam
CureDepth
AdhesiveProperties
Colour: Clear/Translucent
Flowable
SuitableSubstrates
Extrudable and
mouldable silicones,
stainless steel,glass and
aluminium.
Loctite® light and moisture curing speciality flexible adhesive is a non-corrosive product to form a thermoset elastomer
resulting in excellent durability for medical device uses. Due to its UV cure mechanism, this product enables fast
fixturing which results in enhanced productivity. It is thixotropic and stays flexible at low temperatures. In addition, the
product withstands repeated steam sterilisations.
5248 300 ml 50,000 6 mm
Product/Substrate Selection Chart
Note: For further information refer to appropriate Technical Data Sheet.
Adhesive Group
■ = Instant Adhesives
● = Primer + Instant Adhesives
▲ = UV/Visible Light Curing Adhesive**
◆ = Light Curing Flexible Adhesives
■ = Light curing Instant Adhesives
✚ = Structural Adhesives
**One substrate has to be transparent or transluscent.
Substrate 2 Substrate 1
Stainless Glass Rubber PC PVC Silicone PE/PP Other thermo-Steel (poly- and other difficult plastics and
carbonate) to bond plastics thermosets
Stainless Steel ■ ■ ✚ ▲ ✚ ■ ▲ ■ ■ ✚ ▲ ■ ■ ✚ ◆ ● ● ▲ ■ ■ ✚
Glass ▲ ✚ ▲ ✚ ▲ ✚ ▲ ✚ ◆ ▲* ▲ ✚
Rubber ■ ■ ■ ■ ■ ■ ■ ■ ● ● ■ ■
PC (polycarbonate) ▲ ■ ■ ▲ ■ ■ ▲ ■ ■ ✚ ▲ ■ ■ ✚ ◆ ● ● ▲ ■ ■ ✚
PVC ▲ ■ ■ ▲ ■ ■ ▲ ■ ■ ▲ ■ ■ ◆ ● ● ▲ ■ ■ ✚
Silicone ◆ ● ◆ ● ◆ ● ◆ ● ◆ ● ● ◆ ●
PE/PP and other difficult ● ▲* ● ● ● ● ● ●
to bond plastics
Other thermoplasticsand thermosets ▲ ■ ■ ✚ ▲ ✚ ■ ■ ▲ ■ ■ ✚ ▲ ■ ■ ✚ ◆ ● ● ▲ ■ ■ ✚
Design ServiceHenkel Loctite Engineers can assist customers with the adhesive selection and thedesign of medical devices for optimum joint configuration, as well as engineering for accurate adhesive dispensing methods in manufacturing environments. Contactyour local Loctite Technical Centre for details.
*Corona or plasma pre-treatment of plastic required.
Henkel Loctite offers a comprehensive range of equipment for manual, semi-automatedand fully automated product dispensing. This range of equipment is especially designedto make application and use of Loctite® products fast, precise, clean and economical.
Loctite® Dispensing EquipmentThe lamp is the heart of the light curing system. Which lamp is right for the job is a matterof technical requirements and/or economic constraints. Loctite® light curing adhesives arecured by UVA light or UVA/visible light. Acceleration of surface (tack free) cure can beachieved with UVC light.
Loctite® Light Curing Equipment
Loctite® 97006 Digital syringe dispenser systemThis is a fully-integrated system that willdispense products from water-thin topaste-thick from 10 g and 25 ml plastic-syringes.
Loctite® 97113Stationary applicator valveSlim, lightweight and user-friendly valvewith a suck-back feature that eliminatesproduct dripping and stringing at theend of the dispense cycle.The DispenseValve applies products in dots, dropsand beads.
Loctite® 97035UVALOCCure system for manual loading of thecuring cabinet. Designed to emit UVA,UVC and visible light.
Loctite® 97033 High intensity spot curing system designed to emit UVA and visible light(blue light) for extremely fast curing.Ideal for high-volume production andshort cycle times.
Loctite® 97034 High intensity spot curing system designed to emit UVC light for fast surface cure as well as UVA and visiblelight (bluelight).
Loctite® 97134Dispensing Valve CAFor exact application of Loctite products. It shows no suckback, so it is specificallysuitable for CA´s. Used as a stationaryapplicator unit. It is mounted directly atthe dispensing position.
Loctite® 97008 2 litre Integrated Semi-automaticController (valve has to be selected and orderedseperatly)
Loctite® 970092 litre Integrated Semi-automaticController With low level sensor (valve has to beselected and ordered seperatly)