Manufacturing & Processing Technologies
Manufacturing and Processing Go High-Tech
As manufacturing technologies become more sophisticated and advanced, IVD companies find challenges in sourcing materials and dealing with globalization. Outsourcing continues to be one method for easing these challenges, as does streamlining documentation and finding new IT solutions.  To learn more about manufacturing and processing technologies in the IVD realm, IVD Technology editor Richard Park spoke with Ray DeGrella, vice president, advanced supply chain, Beckman Coulter. In this...
Pressure-sensitive adhesive tapes for IVD applications
IVD test strips and biosensors are used in a range of modern diagnostic applications such as blood glucose monitoring, pregnancy and fertility tests, and infectious disease detection. Such test strips are normally composed of several layers. The state-of-the-art assembly of bonding the different layers is accomplished by either printing heat-seal adhesives or using pressure-sensitive adhesive (PSA) tapes. One single test strip often contains various layers of tapes for laminating and marking....
Introduction to manufacturing equipment and supplies
      Equipment availability, overall performance, longevity of a system, and consistency of quality are all factors in the true total cost of ownership. The lowest up-front cost may not equal the longest lasting or most durable revenue stream. Despite recent economic uncertainties, the IVD industry remains healthy and competitive. Rising diabetes rates, evolving or mutating flu viruses, and continuing corporate need for employee drug screening combine to create...
Introduction to packaging and labeling materials and components
      The Advanced Desiccant Polymer by Sud-Chemie Performance Packaging (Belen, NM) is used in the blue cap to protect reagents from moisture degradation and eliminate the need for an extraneous desiccant. A common refrain heard in IVD manufacturing is, “Oh—packaging. We'll deal with that issue later.” Although scientists and engineers may be excited about the development of a new IVD, they tend to be less enthusiastic about dealing with the...
Examining the processes in polymer laminate technology
              Figure 1. The edge view of a fluidic card designed and built for autonomous cell culture experiments for NASA's GeneSat program. The first part of this article (IVD Technology, June 2009, page 37) gave an overview of polymer laminate technology, a microfabrication platform for rapid prototyping of single use, lab-on-a-chip devices. This method offers the ability to form enclosed three-dimensional channels, complex and closely spaced...
IVD Manufacturing and Processing
              Jorgine Ellerbrock is senior vice president, operations, Gen-Probe Inc. (San Diego). She previously served as vice president, operations, for Invitrogen Corp., most recently for its molecular biology business. Before joining Invitrogen, Ellerbrock held positions with GE Healthcare Biosciences and Roche Molecular Systems. She can be reached at jorginee@gen-probe.com. While IVD manufacturing and processing technologies pose some...
Applying polymer laminate technology to developing IVDs
              Designing and developing molecular and immunoassay-based diagnostic products requires extensive empirical testing and repeated evaluation of functional elements. While prototyping should ideally be rapid in order to shorten the time-to-market, the traditional techniques can be slow and cumbersome. Among the more traditional approaches, injection molding offers rapid prototyping but only for the simplest designs.   Other prototyping...
The impact of water quality on IVD testing
              IVD tests are used today in many different ways for various purposes. For example, several types of biological techniques have been adopted for performing sensitive IVDs, such as biochemistry, microbiology, immunoassays, immunohistochemistry, and molecular biology. Such IVD tests are used for both clinical and industrial applications by hospital laboratories, biomedical research laboratories, blood banks, transfusion centers, and...
Introduction to packaging and labeling materials and components
      High-barrier laminate films by Perfecseal are used to package IVD devices. (Photo courtesy Perfecseal) It should not come as a surprise to those involved in the purchasing of medical device and diagnostics packaging components that a philosophy of packaging does exist. Packaging must efficiently protect, contain, and describe the kits they enclose, whether they are sent around the globe or to the local drug retailer. Protecting IVD kits during their...
Packaging and labeling materials and components: In this section
      1. Ampules, bottles, jars, vials are primary containers for reagents in both liquid and dry-powder forms. With the increasing market for automated laboratory systems, the need for ready-to-use liquid reagents is also growing. 2. Clamshells, blisters are often the preferred packag­ing systems for diagnostic kits, enabling manufacturers to package sterile components together in an easy-to-open container. 3. Closures, lidding, caps, stoppers are available in a wide...