Volume Manufacturing

‘One-stop-shop’ for Scale-up Needs

ALine simplifies your transition from a cartridge designed, built and tested in the hundreds, to pilot production of thousands of devices suitable for Beta-testing or clinical trials.

We support your volume production needs, providing contacts to build out your supply chain to transition to volumes >1 million annually. We also serve as a second-source manufacturer and a trusted partner for the development of the next generation product.

Eliminate long lead times to prepare for volume production:

  • In-house production of laminates
  • In-house assembly of injection molded components using a programmable pick and place robot
  • 100% QC inspection for incoming components
  • 100% QC inspection for outgoing assemblies.

We transition our customers smoothly from early design concepts to a final proof of principle cartridge that can be quickly scaled for production into tens of thousands of units per month.

We work with you to:

  • Integrate reagent storage
  • Identify and source the correct packaging and QC procedures
  • Establish simple, and cost-effective QA inspection protocols

Our facilities and equipment:

  • Industrial CO2 lasers, with capability for roll to roll cutting
  • 30 ton thermal press
  • Laminators with heated rollers
  • Programmable UV glue dispenser and a UV cure conveyor
  • SCARA robot pick and place

Well-characterized Batch Manufacturing Processes

We’ve invested over 13 years to develop our bubble-free, defect-free batch production processes. Years of data verify our yields of >95% for multilayer laminate production in volumes of tens of thousands per month.

Quality Assurance

Document Control from the First Design

We start from the first design concept, implementing our well-documented design rules and fabrication processes into the design, ensuring functional performance in the first batch delivered. Every batch of parts, starting from the first build, includes:

  • Design & revision control documentation
  • Material lot numbers
  • Lot numbers on any customer supplied components
  • Equipment parameters
  • In process QC

Final assembled parts are delivered to you with packaging that captures: date, quantity, lot number and part number.

Final assembled parts are shipped with a test report that captures three levels of QC evaluation on 100% of the parts:

  1. Visual inspection up to 7x to scrap parts with particulates, debris or other defects
  2. Measurement on an optical comparator up to 20x for critical alignment tolerances and to verify dimensions
  3. Non-destructive functional testing with pressure or vacuum
  4. Destructive testing with fluids with video recording, accessible via a unique customer link.

What’s Unique about Our Processes?

ALine integrates a rigorous post-cutting cleaning process to reduce debris and residuals on laser cut or machined parts before they are laminated together. Components processed in sheets are protected during singulation and cleaned before being assembled to other components.

Clean, dry compressed air is used to dry the parts which are then stored in a class 7 cleanroom and staged for further assembly step.

Upon request, substrate materials can be plasma treated, silanized, or treated with a customer-specific protocol to eliminate, for example, RNAases.

Proof of Principle to Product Launch

Contact us today to start your project.

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