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Diagnostic Slide Kit Assembly & Production Success Story

A world leader in Clinical Chemistry Diagnostics approached ATS to develop a high speed, batch driven automation solution to match a quickly rising market demand.

flat panel display with a barcode that has red light across it background

CHALLENGE

A leader in chemical diagnostic slide kits wanted to implement a high speed, high precision assembly and packaging automation solution for diagnostic slides to meet an escalating market demand. The client required a turnkey automation solution from MES management to final packaging and shipping. The system required 21 CFR 11 compliance and flawless product traceability verified through full regulatory compliant validation documentation. The clients user environment required common easy-to-use controls and maintenance Interfaces.

APPROACH

We worked collaboratively with our customers staff to fully understand the required processes and historical lessons learned. With that knowledge in hand we then custom designed a turnkey solution to fulfill the defined requirements. The solution included:

  • Precision high speed product processing and assembly automation.
  • Multi vendor management
  • Third party equipment packaging equipment was integrated.
    • Controls written by ATS for common functionality as well as look and feel.
  • Fully expandable controls strategy to allow for future capacity expansion.
  • Custom MES and recipe management application.
  • Full product traceability.
  • Custom database and reporting software for paperless batch and production records.
  • Full testing and validation documentation and execution.
  • Embedded on site resources
  • Ramp up support

RESULT

The final result was the on-time launch of an automation platform that achieved all of the design goals and requirements.

The customer has since further expanded production capacity by commissioning a second system into service.