Medical Device Manufacture
Medical Device Manufacture encompasses a wide range of health care products that are used to diagnose, monitor or treat a disease or condition that affects humans. Medical technology extends and improves life. It can help alleviate pain, injury and handicap. The endless improvement of medical technology enhances the quality and effectiveness of care and is essential in the healthcare industry.
Hapco’s line of polyurethane plastics and rubbers are used in the development or in many cases, the final production of wheelchairs, pacemakers, MRI scanners, surgical instruments, implants, machines, mechanical devices, component parts and many more. In fact, today there are more than 500,000 medical products available.
The ease of processing and high strength of polyurethane elastomers makes them the material of choice for soft durometer applications, such as, instrument grips, gaskets, seals, implants, etc. Silicone, for example, another common polymer used in low durometer applications, is difficult to extrude and does not bond easily to other device components made of non-silicone materials. Polyurethanes eliminate the problems associated with other materials such as PVC, where the dangers of leachable plasticizers become a concern. Liquid rubbers also retain their elastomeric characteristics even at low temperatures where PVC becomes brittle.
Steralloy™ FDG Series has been specifically formulated with FDA recognized components and have many advantages over standard materials. Many users have required that their parts pass cytoxicity, biocompatibility, and USP Class VI testing and have had no problems when using Steralloy™. These products range in hardness from 25 Shore A to 84 Shore D, making them useful for a wide variety of medical devices and components. Steralloy™ isn’t the only material used in this the manufacture of medical devices. If the application does not require FDA approval, just about any Hapco product can be used. Here are a few products that have been used in this Industry:
Part Materials
Hapflex™ – Hybrid elastomeric polyurethanes ranging in hardness from 25A-72D.
Ultralloy™- General Purpose rigid casting compounds. All speeds.
S-RIM™ – Low viscosity, 1:1 casting resins that de-mold in less than 10 minutes.
Tuffalloy™ – Liquid Molding Compounds with thermoplastic properties. 4 speeds.
Ultraclear™ – Crystal clear, UV stable casting resins with gel times ranging from 5 to 900 minutes.
Castalloy™ – Low viscosity, 1:1 ratio casting resin that de-molds in less than 10 minutes.
Mold Materials
Steralloy™ FDG Elastomeric Series – Food & Drug Grade elastomers ranging in hardness from 25 to 90A.
Hapflex™ 500 Series - Flexible polyurethanes that will long outlast silicone.
Hapflex™ 600 Series - Rigid elastomers that wear like iron.
Hapcast™ - Aluminum, steel, and iron filled epoxies used for cast composite and production tooling.
Haprez™ 3744/63 - Glass filled epoxy laminating system for structural backups.
Fill-Its/Haprez™ Combo – Lightweight, low cost filler materials that will decrease shrinkage and mold cost.
Equipment
RAPIDFIL™ - LCD / computer controlled, 2 component, dispensing equipment.
MINIFIL™ - Low cost, 2 component, portable, dispensing equipment.
RAPIDSHOT™ – Handheld cartridge dispensing system for 1:1, 2:1, and 4:1 ratios.
X-11 Molding Chamber – Ergonomically designed pressure and curing chamber for parts and molds.