Cleanroom & Laboratory for Diagnostic Device

The client

Our client has developed a point of care and high throughput diagnostics device that tests for a range of pathogens and delivers results in under 30 minutes.

The device development has been accelerated to market as it can detect COVID-19 and common flu within 14-30 minutes and is being shortlisted for the Bionow Digital Awards 2021.

Certain processes, such as reagent preparation and laser routing are incredibly susceptible to contamination so our client required new laboratory facilities including controlled environments. The art-deco style building gave a unique diamond shaped floorplan in which to house the new facility.

The project

Acting as Principal Contractor, C2C collaborated with Engie, the onsite Business Energy & Services contractors, to deliver a purpose-built facility of 10 fully-fitted laboratory zones, including 2 cleanrooms:

  • Microbiology lab
  • Post-amplification lab
  • Pre-amplification lab
  • Tissue culture lab 1
  • Tissue culture lab 2
  • ISO 7 prep and lyophilization
  • ISO 7 microfluidic cartridge laser welding
  • 4-Axis CNC micromachining
  • 3D printing lab and laser micro matching lab
  • Prototype Integration and testing lab

The two cleanrooms provide a primary classification of ISO 14644-1:2015 Class 7, as built, to protect the microfluidic cartridge laser welding and reagent preparation and lyophilisation processes. A further four service zones, includes a classified change area.

Using a 3D scan survey, our technical design team created a bespoke layout to maximise the laboratory footprint and verify the accuracy of the design. In addition to delivering ISO-compliant performance with a process-led design, the fresh and modern design complements the prestigious building in which it is housed.

Integrated cleanroom services

As an integrated cleanroom service provider, we provided a full furniture fit-out service, coordinated with the cleanroom installation to reduce overall project lead times and benefitting our client with the opportunity to use a single point of supply.

Sealwise laboratory benching was used to create antimicrobial and durable workstations.

On completing the cleanroom installation, our specialist team completed a full validation covering airflows, room pressures and particle counts from representative sample locations as defined within ISO14644-1:2015.

An interim report was issued immediately and the full report to meet the needs of regulatory bodies was issued in just 2 days.

What's right for your project?

The quickest way to move forward is to consult one of our specialists. That way you'll quickly find out which solution fits your project, and get an indication of the investment and timeline.