Clean Room Assembly
Certified ISO Class 7 environments validated to ISO 14644 standards. Over 1,300 sq. ft. of GMP-compliantmanufacturing space in the UK, dedicated to the precision assembly of medical devices and sensitive instruments.
Clean Room Assembly for Medical Devices
Meeting criticial demands in healthcare
Class 7 Certified
Validated to ISO 14644:2015 standards to ultra-low particulate counts.
GMP Compliance
Operated under strict protocols for regular rigour in medical device assembly.
Continuous monitoring
Real-time tracking of air cleanliness, pressure, and temperature.
Full Traceability
MaPS enables us to measure and monitor Key Performance Indicators to drive continuous improvement
Ideal for medical consumables and sensitive instrumentation
Each of our class 7 clean rooms offer 60m² (660sq ft) of manufacturing area. They are validated to the ISO 14644:2015 standard for air cleanliness. The clean rooms are operated in accordance with strict protocols and operator training. Routine monitoring provides evidence of cleanroom performance, by measurement of air cleanliness and air pressure.
Our Class 7 Clean Rooms are able to meet even the most demanding requirements and are ideal for the manufacture of consumables or highly sensitive instruments. Whether your device manufacture demands this level of purity or if you are interested in accessing this space for your own product development team to hire then please talk to your account manager today to discuss your project with us.
Need your own clean room space?
Innovation often requires a controlled environment before full-scale manufacturing begins. Cogent Technology offers access to our Class 7 clean rooms for your own product development teams. Access our pioneering facility in Felixstowe to accelerate your R&D in a validated, sterile setting.
Their commitment to quality in the clean room environment has been instrumental in our product's regulatory success.
Head of Manufacturing, Cancer Diagnostics
Ready to start your clean room project?
What classification are Cogent’s clean rooms, and what does this mean for my product?
Cogent Technology operates two dedicated ISO Class 7 (Class 10,000) clean rooms, validated to ISO 14644-1:2015 standards. This means we maintain a controlled environment where airborne particulate levels are strictly limited, making it the ideal standard for manufacturing Class II and Class III medical devices, diagnostics, and sensitive electronic instrumentation.
Can Cogent manage the full "turnkey" journey from PCB assembly to clean room final build?
Absolutely. This is our core strength. We can manufacture your PCBs in our main facility and then transfer them directly into our ISO Class 7 clean rooms for final assembly, testing, and sterile-ready packaging. This "all-under-one-roof" approach reduces lead times, simplifies your supply chain, and minimizes the risk of external contamination during transit.
Do you offer clean room space for hire for external engineering teams?
Yes. Uniquely, we offer Clean Room Space Hire at our Felixstowe facility. This is designed for R&D teams and product designers who need a validated, sterile environment to build prototypes or conduct early-stage product development without the massive overhead of building their own facility. You get access to our Class 7 space and our expertise.
How do you monitor and maintain environmental stability? Our clean rooms feature real-time environmental monitoring systems.
We continuously track air cleanliness (particulate count), positive air pressure, temperature, and humidity. This data is logged and integrated into our quality management system, providing you with the objective evidence required for regulatory audits and "Genuine Care" assurance.
Is the facility suitable for high-volume medical consumables?
Yes. Our 1,320 sq. ft. of GMP-compliant space is specifically configured to handle both complex low-volume instruments and high-volume medical consumables. We have the infrastructure for rapid assembly, secondary operations, and primary packaging of single-use devices, ensuring they are ready for sterilization or direct-to-market distribution.
How is traceability managed within the clean room environment?
Every project in our clean room is managed through our proprietary MaPs (Material and Process) system. This provides total traceability at the component level. In the event of an audit, we can tell you exactly which batch of materials was used, which operator performed the assembly, and the specific environmental conditions during the time of manufacture.