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Cartridge & Consumable Assembly

Life Science Outsourcing provides comprehensive cartridge and consumable assembly services, ensuring precision, quality, and regulatory compliance for diagnostic devices and consumables.

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Diagnostic consumables used in point-of-care testing are filled with wet reagents and mounted on a microfluidic cartridge

Cartridge & Consumable Assembly
Precision You Can Trust

Reliable diagnostics start with precision-assembled components. From microfluidic cartridges to disposable consumables, our expert assembly ensures accuracy, sterility, and compliance—so your products perform exactly as intended. Scroll down to see how we make it happen.

What is Cartridge & Consumable Assembly?

Cartridge and consumable assembly involves the precise integration, handling, and assembly of diagnostic components, ensuring accurate performance in clinical and laboratory settings.

  • Microfluidic cartridge assembly: Precision manufacturing for lab-on-a-chip and diagnostic applications.
  • Disposable diagnostic consumables: Single-use components such as reagent cartridges and test cassettes.
  • Automated assembly solutions: High-throughput manufacturing to meet commercial demand.
A microfluidic diagnostic cartridge featuring multiple reagent blisters and intricate fluid pathways for automated testing.
Precision reagent packaging

Who Needs Cartridge & Consumable Assembly?

  • Diagnostic device manufacturers developing integrated testing systems.
  • Clinical laboratories requiring pre-assembled consumables.
  • Biotech startups scaling microfluidic or point-of-care diagnostic solutions.

How Does Cartridge & Consumable Assembly Work?

  1. Component Sourcing & Inspection: All materials and parts undergo strict quality checks to ensure compliance with regulatory and performance specifications.
  2. Microfluidic Transfer & Precision Molding: Utilizing cleanroom environments, LSO ensures that fluidic pathways, membranes, and reservoirs are accurately assembled.
  3. Automated & Manual Assembly Processes: Leveraging robotic automation for high-precision assembly while utilizing manual processes for specialized or low-volume requirements.
  4. Adhesive & Bonding Techniques: Employing advanced sealing technologies such as ultrasonic welding, thermal bonding, or medical-grade adhesives for airtight and contamination-free cartridges.
  5. Final Quality Assurance & Validation: Conducting leak testing, functional testing, and sterility verification to ensure that all consumables meet industry requirements before shipment.
Technicians in a cleanroom assembling and inspecting diagnostic devices in a controlled environment.
A laboratory technician in cleanroom attire conducts a quality control inspection with a clipboard and pen in a sterile facility.

What standards apply?

  • ISO 13485 – Medical device assembly quality management.
  • FDA 21 CFR Part 820 – Quality system regulations for diagnostic consumables.
  • ISO 14644 – Cleanroom classification for precision assembly.

Why LSO?

  • Microfluidic assembly expertise ensuring seamless integration and performance.
  • Regulatory-compliant processes maintaining sterility and traceability.
  • Automated and scalable solutions tailored for high-volume diagnostic applications.
Get Started with LSO

Full EtO Validation

Comprehensive packages for regulatory compliance.

Flexible Sterilization Cycles

From fractional to full cycles with EtO residual testing.

Robust Qualification

Secure with 2X qualification.

Choice of PCDs

Tailored to your sterilization needs.

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