Manufacturing Diagnostic Reagent Kits

Manufacturing Diagnostic Reagent Kits

The manufacturing of diagnostic reagent kits can be challenging. These reagent kits contain all of the major components necessary to perform designated diagnostic tests or procedures. Applications for these kits include in vitro and molecular diagnostics, biomarkers, clinical chemistry, diabetes, polymerase chain reaction (PCR), test strips, and illicit drug testing. 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.

The manufacturing of these reagent kits usually calls for the dispensing of very small–very precise amounts of fluid of varying chemical make-up. The eVmP Micro Pump is ideal for integrated, turnkey, or laboratory applications that require metering and dispensing of liquid enzymes, buffers, diluents, standards, calibrators, and controls used in diagnostic test kits.

The chemical make-up of each reagent can have its own unique challenges for pumps. The eVmP relies on ceramic internals, no-valves, and synchronous rotation and reciprocation to keep the pumping motion simple and inert. The lack of valves and synchronous motion allow the eVmP to dispense neatly, and without drips, by creating a dynamic suck back. This can improve precious up time and keep nozzles clean, even with the most demanding isotonic buffers.

The other challenge is the unique amount or volume of each reagent. The eVmP Micro Pump can be set up to deliver nanoliter, microliter and milliliters through our patented variable metering pump system, with better than 1% accuracy and precision. The eVmP’s patented design utilizes two precision stepper motors, integrated controller and drivers, and can dynamically change dispense volume and flow rate.

Each eVmP can store up to 100 programs, and has immediate run controls that include speed, volume, and pumping direction. Advanced controls include suck-back, fine adjustment, acceleration, deceleration and linking of programs. All of the run controls are accessed through the latest in PLC and CPU communication over Ethernet/IP, or RS485. The eVmP can also be controlled from our Touch Screen Interface, up to 32 pumps with one screen.

Using a chemically inert fluid path, high accuracy and precision dispensing technology, the ability to make high resolution adjustments dynamically, and offering the latest in factory automation controls, makes the eVmP ideal for manufacturing diagnostic kits.

Isaac HD Multi-Function Leak TesterOnce the diagnostic kit is created, packaging is of the upmost importance. Creating a tight, leak proof seal is especially important when dealing with complex chemicals and precise fluid measurements. A chamber test performed on the reagent kit packaging with the Isaac HD leak tester by Zaxis will ensure quality and repeatability in the manufacturing process. For more information on leak testing for diagnostic reagent kits, CLICK HERE.

For questions please contact a sales rep via email at sales@zaxisinc.com or phone at +1 (801) 264-1000, or CLICK HERE to request a quote.

Soft Gel Manufacturing

Soft Gel Manufacturing

Accuracy and Repeatability with the Zaxis Variable Metering Pump

Modern Soft Gel Manufacturing is an incredibly long, sophisticated process, which relies on many of the electro-mechanical and chemical technologies. For many years, the encapsulation and filling of the active pharmaceutical ingredients (API), relied on old mechanical technologies, that no longer can keep up with the industry demands. The Zaxis eVmP pump has been the choice to replace mechanical filling methods, with a dynamic, electronically controlled, positive displacement, ceramic piston pump.

Pump Head and Gel CapsulesIn addition to being very accurate, the patented eVmP pump relies on the repeatability of sapphire hard, ceramic internals, and no valves.  These wetted path parts are designed for millions of maintenance free cycles, because they resist wear.  The repeatability and accuracy are very important in the control of API fluids, but the eVmP offered much, much more.

The Sanitary Pump Head design is made of 316SS, and is easily disassembled for cleaning, which can take place after each batch or run of product.  Once cleaned, an eVmP pump head must return to the encapsulation area quickly, and without compromise to precious downtime.

With the modular design and electronic controls, including Ethernet IP, the pump is quickly getting back to another formulation and production run. Zaxis eVmP pumps can be configured in single OEM or Dual modules, including IP45, 316SS enclosures.

For the latest in API dispensing technology, used in soft gel encapsulation, please come see us at Booth 1365 at Interphex, in NYC, April 2-4,  where you can see the eVmP in action and talk to one of our application engineers.