Manufacturing & Processing Technologies
Reading Alpha Assays
Further expanding the Synergy microplate reader family, the Synergy 2 Alpha microplate reader provides high-performance Alpha detection for low- to medium-throughput laboratories. Synergy 2 Alpha comes preconfigured with the Alpha filter set, mirrors, software, and optical modules to read all Alpha assays, and it is upgradable with additional detection modes as the laboratory’s needs change. Synergy 2 Alpha’s sensitivity is on par with that of laser-based systems, the manufacturer...
Microfluidics
A microfluidics designer and manufacturer has introduced the Micro Droplet Systems, which enable rapid advances in droplet microfluidics and allow users to produce more than 10,000 monodispersed droplets per second. Built around Dolomite’s industry-leading microfluidic pumps, connectors, and chips, the Micro Droplet Systems benefit a wide range of applications including compartmentalized chemistry, high-throughput experimentation, and the formation of monodispersed emulsions or beads. The...
Enrichment and Mass Spectrometry
A phosphopeptide enrichment kit aids in processing protein digests and strong cation exchange fractions to selectively recover phosphopeptides for mass spectrometric analysis in less than 30 minutes. The Pierce Fe-NTA Phosphopeptide Enrichment Kit supplies high-capacity Fe-NTA spin columns and optimized buffer for analyzing 30 protein digests. The phosphopeptide-specific resin in each spin column will sufficiently enrich up to 150 micrograms of phosphopeptides. The spin columns complement other...
Quality Control in Molecular Diagnostics
New information on proficiency results and quality practices points to a continued gap in the standard of quality control (QC) practice between molecular diagnostic testing and that of other laboratory disciplines. Indications of quality issues have surfaced in several areas but most visibly in the direct-to-consumer (DTC) testing arena. A recent Government Accounting Office study, for example, showed evidence of inadequate quality of molecular testing following an analysis of the results of...
Enhancing IVD Packaging Efficiency
FDA’s Center for Drug Evaluation and Research (CDER) established Quality by Design (QbD) principles because manufacturing efficiencies in the pharmaceutical industry were not as state-of-the-art as in others. QbD seeks to increase quality and efficiency while decreasing waste and the need for intensive regulatory oversight. QbD is defined as the systematic design of product formulations and related manufacturing processes to ensure a predefined quality by understanding how the variables...
Introduction to Electronic and Mechanical Components and Software
Automated systems for the manufacture and quality control of IVDs consist of a combination of mechanical, electrical, and software components whose nature and mode of integration into a system must be specified in light of what the system will be expected to do. The manufacturer needs to thoroughly evaluate and define the tasks to be performed by the system and related process parameters. An automated microplate well coating system by Oyster Bay Pump Works (Hicksville, NY).  ...
Introduction to Manufacturing Equipment and Supplies
Before making decisions about any investment, decision makers try to compile, evaluate, and categorize as much relevant information as possible. But even in a relatively transparent market such as automated manufacturing investment goods for IVDs, there is a striking lack of symmetry in information. Every so often, decision makers see themselves at a disadvantage. In practice, certain strategies, at least to some degree, can assist in achieving reasonable judgments in investment decisions. The...
Introduction to Packaging and Labeling Materials and Components
IVD devices are an important part of healthcare. These devices typically contain a sample collection area on which chemical reagents or biologically active proteins react, sometimes electrochemically, with the sample to produce something that can be measured optically or photometrically. By virtue of their critical function in analyzing samples ranging from urine, saliva, and blood to swabs of cellular matter at home or in a laboratory, their reliability must remain intact. This integrity must...
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....