From immunoassays to hematology analyzers, medical analytical instruments demand the highest levels of accuracy, reliability and purity.
Tony Gaglio, EmersonThe correct fluid-handling technologies are critical to medical sample purity and patient safety. In addition to controlling the flow of blood, chemical reagents and other aggressive media, the right valve prevents media cross-contamination and minimizes external factors that could influence the biological material, thus improving the performance of your analytical device.
To reap these benefits, it’s important to partner with a knowledgeable supplier who understands the requirements of today’s medtech market and can design a complete fluidic assembly that addresses these demands up front.
Here are five ways the right valve can improve your analytical process:
An estimated 70% of healthcare decisions regarding disease diagnosis or treatment involve a laboratory analytical instrument investigation. Since the fluidic systems involved in these sensitive applications handle and dose samples in very low volumes, small variations have a significant impact. Repeatability and accuracy are key. Although each analytical process is different, many involve volumes between 1 and 50 µl. Selecting valves with fast response times will enable actuation without significant delay to ensure precise media control in these low-volume applications.
A fluidic system typically has a lifespan of seven to 10 years, so fluidic valves must be able to withstand millions of actuations. To avoid premature valve failure, a fluidic system supplier should design the system with the lowest number of fluid connections to minimize the risk of leakage and ensure all valves within the assembly are quality tested.
The reliability of an analytical system also depends on sample purity. Look for valves with designs that specifically target and minimize contamination. For example, high-quality pinch or isolation valves will operate upon the tubing that contains the fluid, or hermetically separate the control mechanism from the fluid, respectively. This prevents friction-induced particulate contamination between moving parts.
3. Fast time to market
The timeline for new product development in in-vitro diagnostic instruments is highly compressed. Any delay in the design, engineering and procurement of a fluidic system can prevent you from meeting time-to-market goals. A fluidic system supplier must be able to respond to customers’ changing needs while providing fast turnaround on complex, high-performing fluidic systems.
4. Smaller footprint
Smaller, more affordable machines are in demand. As the instruments shrink, the components inside them need to shrink, too. For valves and other fluid-handling components, this relationship isn’t linear, requiring engineers to address new design challenges related to flow, power and heat transfer. As a result, it’s becoming increasingly difficult to design and develop a complete fluidic system that is precise and reliable, reduces system complexity and adds value to your manufacturing process, all while meeting smaller size requirements.
Look for a supplier that has extensive experience within in-vitro diagnostic, point-of-care and bioinstrumentation applications. Their technical expertise is critical to delivering appropriately sized, high-performing components and systems, including valves with reduced footprints for smaller instruments.
New and next-generation in-vitro diagnostic systems increasingly require custom fluid-handling components for today’s market. But even small changes to a valve can have profound effects on an instrument’s analytical performance. For example, even milliseconds of difference in a valve’s response time or slight alterations to its fluidic path can dramatically affect machine throughput and productivity.
To ensure optimal instrument performance and analytical results, a supplier should have technical expertise in the following areas related to fluidic design:
● Chemical resistance. While many valves can handle acids, alcohols, bases, solvents and corrosive gases and liquids, modified or special designs may be required, depending on the particular fluid or application.
● Heat dissipation. Managing heat is a balancing act. Valves require the right amount of power to accomplish the task at hand while minimizing heat transfer to thermally sensitive media.
● Fluidic path. Optimizing a valve’s fluidic path improves instrument efficiency. Look for designs that reduce the valve’s internal volume as much as possible while eliminating dead volume.
● Compliance. As a testament to their quality and safety in critical medical device applications, valves must meet all relevant CE directives and comply with Restriction of Hazardous Substances (RoHS) regulations. They should also be manufactured in a cleanroom environment to reduce any potential for contamination.
Tony Gaglio is the product marketing manager, Americas, for ASCO Analytical & Medical at Emerson. He has over 20 years of experience in the in-vitro diagnostic industry and has held positions as a senior chemist and strategic marketing manager for in-vitro diagnostic reagent manufacturers.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.