Customer scenario

An Algerian medical-device manufacturer scaling production of dynamic blood‑glucose test strips needed a fast, low‑risk way to validate reagent dispensing before committing valves to the production line. Key requirements were micro‑volume control to preserve costly enzyme reagents, uniform coating for consistent sensor response, a gentle fluid path to protect bioactivity, and a reliable prediction of production behavior to avoid costly rework during ramp‑up.

Challenge 

On‑line qualification often reveals mismatches: nozzle geometry that creates irregular dots, pulse settings that cause satellite droplets, or pressure/temperature windows that change viscosity and flow. Discovering these issues after valve installation increases downtime, reagent waste and commissioning costs—critical problems when enzyme stability and material cost are primary concerns.

Mingseal FATP + KPS2000 solution

Mingseal supplied the FATP (Factory Acceptance Test Pack) built around the KPS2000 piezo jetting valve as a bench‑validation kit tailored to the Algerian customer’s enzyme reagent. The pack includes a KPS2000‑compatible valve, matched piezo actuator, three nozzle sizes, mounting flange and quick‑start guide—enabling practical, hands‑on qualification of droplet formation, repeatability and basic tuning before line installation.

Key technical fit

• Sub‑nanoliter dosing and high frequency: KPS2000 supports jetting down to 0.5 nL and up to 1200 Hz, allowing the customer to test micro‑dosing recipes that reduce reagent use while maintaining sufficient film coverage for sensor chemistry.
• Wide viscosity and chemical compatibility: The valve supports viscous fluids and resists common solvents, weak acids and bases, making it suitable for glucose assay formulations and stabilizers used in strip reagents.
• Bench evaluation of nozzle options: The FATP includes three nozzle sizes so engineers can compare edge shape, dot spread and satellite formation on real substrate types used for the strips.
• Controlled temperature and pressure windows: Using the pack, the team identifies stable pulse timing and pressure ranges at working temperatures (10–50°C) so on‑line settings are predictable and repeatable.

Process workflow used in validation

1. Fluid characterization: Teams run short tests on the bench to record droplet mass, spread and evaporation behavior for the enzyme formulation across the three nozzle sizes.
2. Pulse and pressure mapping: Operators sweep drive timing and supply pressure to find the narrow window that gives single‑drop formation without satellites at target throughput.
3. Thermal sensitivity checks: Small temperature shifts are applied to check viscosity sensitivity and to lock in the controller temperature window for production.
4. Wear and cleaning trials: Short continuous runs estimate nozzle fouling and define cleaning/purge schedules to preserve enzyme activity and minimize downtime.

Production outcomes and value

• Microvolume control and cost containment: Bench‑proven sub‑nanoliter dispensing recipes reduced reagent consumption per strip and lowered per‑unit materials cost during scale‑up.
• Uniform coating and accuracy: Validated nozzle/pulse combinations produced consistent dot geometry and film uniformity, tightening QC distribution and improving lot‑to‑lot sensor reproducibility.
• Gentle fluid handling preserves bioactivity: Non‑contact piezo jetting with identified low‑shear pulse profiles minimized enzyme degradation compared with trial-and-error on‑line tuning.
• Faster, lower‑risk commissioning: By resolving nozzle, pressure and temperature variables before installation, the customer shortened setup time, avoided rework and achieved stable production performance from first‑pass validation.

Conclusion 

For Algerian makers of blood‑glucose test strips, the FATP test pack with the KPS2000 valve offers a pragmatic, low‑cost path to validate micro‑dispensing recipes, reduce reagent waste, and lock production parameters before line deployment. The bench kit ensures uniform, enzyme‑friendly coating and predictable integration—helping manufacturers meet accuracy, cost and reliability targets for clinical diagnostic strips. Contact Mingseal to schedule an on‑site FATP evaluation with your reagent and substrate.