Originally Published IVD Technology October 2001
In this section
1. Bioprocessing services prepare and purify the biochemicals and chemical reagents used in IVDs, many of which are particularly hard to culture and grow in laboratory settings. Suppliers use advanced chemical, physical, and biological processes to recover and purify products from dilute process streams.
2. Converters supply industry with die-cut parts, adhesion of liners to pressure-sensitive products, and multilaminated packaging materials in sheet or roll form.
3. Dispensing and filling (liquid or powder) suppliers provide the essential service of applying reagents to substrates for immunochromatographic assays, and packaging assay-related biochemicals and reagents, often under controlled-environment conditions.
4. Lyophilization may be required since many liquid-state biological products are heat sensitive, react to oxygen, or lose potency over time. Freeze-drying—the removal of water from the product—is one of the safest ways to preserve the immunogenicity of such products as diagnostic controls, sera, plasma, conjugates, and peptides.
5. Machining services manufacture custom components and subassemblies using techniques such as laser cutting and welding, stamping, and coining.
6. Microfabrication refers to the technology of making very small devices using a variety of techniques (photolithography, for example). Using processes very similar to those used for fabricating integrated circuits, it is possible to create ultraminiaturized motors, actuators, pumps, gears, pistons, and other mechanical components. Miniaturization of IVDs is a hot and exciting technology.
7. Packaging and labeling vendors can help firms meet regulatory requirements, minimize materials use, protect sensitive products, and optimize consumer appeal. See also Section 6: Packaging and labeling materials and components.
8. Plastics and rubber-forming services use customer-specified and commodity resins to supply the diagnostic industry with rigid and semirigid tubing and assemblies. Tubing products with exact tolerances are their domain, along with the abilities to provide secondary and finishing processes such as sealing, counting, bundling, bending, bonding, and coating.
9. Product assembly sources provide OEM products and services including private labeling arrangements, system development (R&D), and contract manufacturing.
10. Product testing services are offered to ensure that products and materials meet established quality standards. The scope of testing is diverse, and includes physical, chemical, biological, environmental, and facility-related testing. Physical and chemical tests include materials characterization, solubility, and moisture testing. Biological and microbiological testing involves tests for safety, preservative action, sterility, and viral contaminants. CE marking requires testing that is provided by vendors in this subcategory.
11. R&D, design, and prototyping services can supplement a manufacturer's in-house staff or provide economical design services to start-up companies.
12. Sterilization companies provide contract sterilization via several methods, including ethylene oxide, steam, gamma irradiation, and E-beam irradiation. Some sterilization vendors also provide assembly, packaging, and microbiology and analytical chemistry testing.
13. Surface modification and coating consist of the development and manufacture of product-delivery systems. Customers include those involved in bioseparation media, controlled-release devices, biosensors, and cell-growth supports. Technologies are often handled as proprietary manufacturing arrangements.
14. Welding and sealing are often major parts of product assembly; firms in this category provide services for both metals and plastics.
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