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The world’s leading provider of innovative rapid-curing assembly solutions. Agenda. Brief Dymax Review Chemistry Basics Advantages of Light Cure Typical Medical Applications Design Considerations New Technology Medical Selector Guide Review. DYMAX Corporation.
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The world’s leading provider of innovative rapid-curing assembly solutions
Agenda • Brief Dymax Review • Chemistry Basics • Advantages of Light Cure • Typical Medical Applications • Design Considerations • New Technology • Medical Selector Guide Review
DYMAX Corporation DYMAX is uniquely positioned as a: • Formulator of Light Curing Adhesives • Designer of Light Curing and Dispensing Equipment
The DYMAX EDGE Total solutions from DYMAX increase the efficiency of any manufacturing process.
Substrate Selection Adhesive Recommendation Design Consultation Automation Questions Dispensing Curing Recommendations QC Inspection Options Dymax Assists with…
Contacts • Jorge Lopez- Alenica • jo_lopez@alenica.com • Fabio Tarazona- Alenica • f_tarazona@alenica.com • Mario Chinchilla- Alenica • mchinchilla@alenica.com • John Kyger – Regional Sales Manager, Dymax • jkyger@dymax.com
Dymax Chemistries • Acrylated Urethanes (standard light curing materials) • Activator-Cured Acrylics • UV Epoxies • Moisture-Cure Materials (Dual-Cure) • Cyanoacrylates • Two-Part Epoxies • Heat-Curable Epoxies
Advantages of Light Curing Adhesives Cure in seconds ‘On Demand’ Cure with UV and Visible Light 100% solids, no volatiles or solvents Single part Gap filling Non flammable Non-toxic when fully cured and passes USP Class VI & ISO 10993 Typically 1 year shelf life at room temperature
Typical Medical Applications Single-use Devices: • Needles/ Syringes • Catheters • Airway ManagementDevices • Reservoirs • IV- Tube-Sets • Oxygenators • Blood-Pumps
Design Considerations • Substrates • Bond gaps • 0.002-0.006 inch gap preferred, typical • 0.001-0.003 inch gap preferred, needle/hub • UV Curing Systems • Required Approvals
Typical Substrates • PVC - strong bonds achievable. Caution with highly plasticized PVC • PC, PS, ABS, PUR - strong bonds achievable • TPE, SEBS, Pebax - selective adhesives • Silicone - requires surface treatment
Bond Gaps • 0.001-0.003 inch gap preferred, needle/hub 0.002”- 0.006” gap preferred for best adhesive strength
UV Curing Considerations • Oxygen Inhibition - The phenomenon where some adhesives have a wet film on the surface after cure • Oxygen interferes/slows down the cure on the outermost surface of the adhesive leaving the surface semi/uncured. • Techniques to overcome: • Higher intensity and/or longer UV exposure • Remove oxygen from bond line • Interfacial bond • Inert gas blanket (nitrogen) • Try a new adhesive
UV Curing Considerations cont. • Pulse curing • Not recommended for Dymax adhesives • Typically results in a tacky surface or not optimal cured properties • LED vs. Broad spectrum (UVA/BlueVis output) • Identify LED wavelength output – UVA or VIS? • Match output of the UV equipment with absorption of the adhesive
Required Approvals • Devices are FDA approved, not our adhesives • ISO testing
Dymax Adhesive Biocompatibility Tests ISO 10993-4: Selection of tests for interactions with blood (Hemolysis) ISO 10993-5: Tests for in vitro cytotoxicity (Cytotoxicity) ISO 10993-6: Tests for local effects after implantation (Muscle Implantation) ISO 10993-10: Tests for irritation and delayed-type hypersensitivity (Intracutaneous injection) ISO 10993-11: Tests for systemic toxicity (Systemic injection)
Sterilization Compatible with sterilization radiation (gamma or e-beam) chemical (ETO or other chemical sterrilants) autoclave (limited to 10-15 cycles max with correct adhesive, substrate and design)
New Technology • LED curing adhesives & equipment • Matching output with absorption • Ultra Red™ Fluorescing • Bond-line inspection • See Cure™ • Confirming complete cure
New LED Adhesive Technology! • Introducing: • 1120-M-UR • Plastic-to-Plastic Bonder Fully exploits the benefits of LED-Cure! • Lightening-fast, cooler cure • Tack-free surface • Ultra Red fluorescing • BlueWave LED Prime UVA
Inspection - Blue fluorescence Adhesive emits blue light at 435-465 nm upon absorption of 365-375 nm black light Detection used for QC bond line inspection automatically manually
Ultra-Red™ Ultra Red™ Fluorescing technology allows for faster, deeper depth of cure. www.ultraredadhesives.com
Ultra-Red™ Ultra-Red™ Fluorescing Technology Enables Accurate Bond-Line Inspection and Product Verification
Ultra-Red™ When do you utilize Ultra-Red? When the plastics fluoresce blue! • Enhances ease of bond line inspection against blue fluorescing plastics
New Technology: We answered 2 big questions: How do I know that I’ve dispensed a sufficient amount of adhesive in the prescribed area? How do I know when it is cured?
See-Cure™ A revolutionary new technology from DYMAX greatly enhances adhesive dispensing and in-line inspection processes for medical device manufacturing companies.
Safety Margin See-Cure™ Color Development Cure Color
New See-CureTM Adhesive Dymax 211-CTH-SC • Color Change Technology • LED-Curable (very fast) • Plastic bonding • Catheter Assembly • 100 mPa, Shore D70