KRYLEX® medical device assembly adhesives have been proven to help manufacturers of needle assemblies to improve manufacturing efficiencies and increase reliability and confidence in their finished devices. Whether assembling microneedles, pen needles, insulin delivery systems, prefilled syringes or any other type of assembly, Chemence’s line of needle bonders provide several key benefits:
- High adhesion to most substrates
- Excellent chemical and moisture resistance
- Ultra-fast fixturing and curing speeds
- Superior tensile properties
- Low total cost of ownership
- Reliable performance and quality
Speed of Cure
Light Curing Adhesives provide on cure demand of adhesives in high speed assembly lines. KRYLEX’s customized needle bonding adhesives provide ultra-fast cure allowing for manufacturers to increase their throughput and optimize manufacturing efficiency.
Our KRYLEX® line of medical device assembly adhesives is tested and certified to ISO 10993 and USP Class VI biocompatibility standards. Many of our products have been found to pass critical standards including:
- ISO10993-4: Hemolysis
- ISO10993-5: Cytotoxicity
- ISO10993-6: Implantation
- ISO10993-10: Intracutaneous Sensitization and Irritation
- ISO10993-11: Systemic Toxicity
Substrates and Adhesion
KRYLEX’s range of Needle Bonding Adhesives have excellent adherence to ABS, acrylic, Polycarbonate (PC), Polyethylene (PE), Polypropylene (PP), Polysulfone (PS), and Polyurethane (PU) among many other metal and glass substrates.
Sterilization and Environmental Resistance
Once assembled, needle assemblies must be sterilized. Sterilization procedures such as Gamma, Ethylene Oxide (EtO), and autoclave are industry standards. KRYLEX’s range of specialized needle bonding adhesives have excellent retention of strength after these procedures. KRYLEX’s range of adhesives also have excellent thermal stability and environmental resistance to water and cleaning chemicals.
Viscosity and Flow of Adhesive
Selecting the correct viscosity for needle bonding is a trade off between ensuring a fast-consistent fill of the hub/cannula assembly and ensuring the product does not migrate outside of the assembly. Adhesive that has too low viscosity can migrate outside of the needle assembly causing the product to fail quality inspections and create waste in the manufacturing process.
Adhesive that has too high viscosity can inconsistently fill hub and cannula assemblies causing scrap and quality issues. The KRYLEX® range of needle bonding adhesives comes in a wide variety of viscosities to ensure perfect fit into manufacturer’s production lines.
When an adhesive is manufactured, the viscosity of the adhesive can vary significantly based on manufacturing tolerances and raw material inputs. Chemence has implemented strict quality control and process engineering guidelines to ensure consistent and reliable products arrive at our customers’ manufacturing plant.
Chemence regularly works with manufacturers and engineers to modify and optimize adhesive formulations to precisely meet the requirements of their application. In some applications even slight modification of an adhesive formulation can solve production problems and ensure more reliable dispensing.