Diagnostic Reagent Manufacturing

Diagnostic reagent kits contain all of the major components necessary to perform designated diagnostic tests or procedures. With surging demand for at-home virus testing, laboratory test strips, and other industrial or commercial diagnostic reagent kits, incorporating precision fluid metering pumps into your production has never been more important. However, investing in quality pumps is essential, as minor errors or manufacturing inefficiencies can lead to inaccurate results and critical consequences for end users.

Diagnostic Reagent Kits Manufactured to Your Industry’s Requirements

Diagnostic reagent manufacturing impacts an extensive range of applications as these kits are used widely across industries. They can be used in a laboratory, at the point of care (POC), or for personal use in cases like pregnancy tests, glucose strips, or at-home DNA ancestry tests, as well as many other uses:

• In vitro and molecular diagnostics
• Biomarkers
• Clinical chemistry
• Diabetes
• Polymerase chain reaction (PCR)
• Test strips
• Illicit drug testing
• And much more!

Whether you’re manufacturing diagnostic, predictive, presymptomatic, pharmacogenomic, or other diagnostic reagent kits, your products must be compliant with standards set by the US Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), and other federal or local regulatory bodies specific to your industry and production.

Common Challenges in Diagnostic Reagent Manufacturing

Diagnostic reagent manufacturing usually involves dispensing very small and precise amounts of fluid of varying chemical makeup, such as liquid enzymes, buffers, diluents, standards, calibrators, and controls. Each of these fluids presents unique challenges for manufacturing lines, and all parts and components must be kept clean and free of contamination. Additionally, the amount or volume of each reagent presents varying demands for your production, and maintaining repeatability and precision can be difficult as you balance multiple programs without compromising accuracy or output. Finally, comprehensive quality control during packaging is of the utmost importance as creating a tight, leak-proof seal is critical when dealing with complex chemicals and precise fluid measurements.
 

How Precision Metering Pumps Improve Your Diagnostic Reagent Manufacturing Line

The best way to mitigate these differing needs is to integrate electronic adjustment fluid metering pumps into your diagnostic reagent manufacturing line, such as the eVmP line from Zaxis, including the eVmP Micro Pump. These fluid metering pump systems deliver nanoliter, microliter, and milliliter amounts with better than 1% accuracy, making them ideal for integrated, turnkey, or laboratory applications. Features include:

 

• Patented design utilizes two precision stepper motors, integrated controller, and drivers
• Dynamically changes dispense volume and flow rate
• Ceramic internals, valveless construction, and synchronous rotation and reciprocation keep pumping motion simple and inert
• Dispenses neatly and without drips by creating a dynamic suck-back to improve uptime and keep nozzles clean, even with the most demanding isotonic buffers
• Stores up to 100 programs and has immediate run controls that include speed, volume, and pumping direction
• Advanced controls, including suck-back, fine adjustment, acceleration, deceleration, and linking of programs
• PLC and CPU communication over Ethernet/IP or RS485
• Intuitive Touch Screen Interface, allowing access to up to 32 pumps with one screen

As your full-service manufacturing partner, Zaxis also offers air leak testing solutions for packaging finished diagnostic reagent kits. A chamber test and vacuum decay test performed on the reagent kit packaging with the Isaac HD leak tester will ensure quality and repeatability in the manufacturing process.

Zaxis Customizes Solutions for Your Diagnostic Reagent Manufacturing Line

From providing fast turnarounds on initial quotes to delivering USA-made air leak testing and fluid metering pump solutions tailored to your production line, Zaxis is dedicated to improving your operations and streamlining your processes. For over 25 years, we have worked with OEMs and manufacturers like you to increase efficiency and precision, allowing you to better serve your customers.

Contact us to learn more about how our family of products can maximize your production. Request a quote to get started.