Originally Published IVD Technology October 2005
In this section
1. Adhesives, coatings, and solvents companies offer a wide range of such materials for use in product assembly. New adhesives and coatings are constantly being developed to improve product performance. Recent advances in cyanoacrylates and UV or visible-light curing adhesives make them worth consideration.
2. Automation/custom systems suppliers can design and fabricate equipment for converting, assembly, inspection, and packaging of diagnostic products. Such systems are built in strict adherence to FDA quality systems requirements, and can be furnished with state-of-the-art machine control and software for statistical process control.
3. Bioreactors, biochemical processors, tanks, and vessels can be key components of a manufacturer’s bioprocessing operations. The companies listed in this subcategory offer a wide range of such equipment in sizes suitable for R&D, pilot production, and scale-up to full production.
4. Component assembly equipment includes ultrasonic sealers and welders, laser welders, UV spot-curing machines, motion control products, and related electronic components. Suppliers in this subcategory may also offer custom products (see subcategory 2).
5. Fluid-handling equipment, dispensers, and fillers are offered by firms specializing in products for bulk fluid transfer, spraying, coating, pattern dispensing, and precise reagent dosing. Included are manual dispensers, automated dispensers, and both volumetric and nonvolumetric systems. In addition, these suppliers can provide a variety of fittings, reservoirs, and tubing types, as well as sophisticated dispensing nozzles for demanding applications. Suppliers in this subcategory may also offer custom products (see subcategory 2).
6. Laminating equipment enables manufacturers of immunoassays to bond antibody-coated membranes and other microporous materials to substrates that can add strength and stability or improve handling characteristics during assembly or use.
7. Lyophilization equipment is critical for manufacturers of liquid-state biochemicals and reagents that are heat-sensitive, react to oxygen, or lose potency over time. Freeze-drying—the removal of water from the product—can increase the stability and reconstitution properties of such products.
8. Materials-coating equipment can include systems using advanced technologies such as plasma polymerization, vapor deposition, and other proprietary surface treatment or modification techniques, as well as traditional coating of web stock with adhesives.
9. Packaging, labeling, and bar coding equipment suppliers offer the materials and systems needed to package a finished IVD product. Marking systems using laser technology have come to offer significant advantages over traditional labels and label applicators, and are key components in today’s automated processing systems.
10. Plastics-forming and -sealing equipment includes machines for injection, vacuum/pressure, and blow molding of device enclosures, as well as form-fill-seal systems for packaging end products.
11. Process-control equipment suppliers furnish complete closed-loop control systems for running manufacturing processes. Software for continuous monitoring of process parameters and statistical process control can also be supplied.
12. Product design, prototyping, and testing equipment includes rapid prototyping technologies such as stereolithography, selective laser sintering, and urethane casting. IVD firms are making use of such technologies to verify product designs more quickly, thereby reducing time to market.
13. Slitters come in a variety of sizes and configurations, from small manual units to large automated systems with high throughput. They are essential equipment for IVD firms that manufacture membrane-based immunoassays such as home-use pregnancy test kits.
14. Sterile processing and cleanroom equipment includes companies that provide contract sterilization of medical products, as well as related equipment and monitoring systems and services. Sterilization methods include ethylene oxide, gamma and E-beam radiation, and steam or autoclaving. Cleanroom equipment includes environmental monitoring and control enclosures, air filters, laminar-flow hoods, and floor coverings and mats. Such equipment is essential to proper manufacturing of many IVD products, or to proper terminal sterilization of instrumentation and related disposables.
15. Surface-modification equipment includes device coatings and treatments such as corona discharge, plasma spray, and other specialized surface-property modifiers. Surface modifications are intended to enhance specific properties of base materials and include treatments for lubricity and wettability, antimicrobial coatings, and biomolecule immobilization.
16. Contract manufacturers often provide consulting services, facilities, and equipment for IVD manufacturing processes. The range of services includes consultation about equipment for product design as well as for product assembly, converting, and packaging.
17. Stock items suppliers offer standard equipment for general use by IVD manufacturers, and may also offer custom-designed systems (see subcategory 2).
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