Introduction
A medical diagnostic company developed a revolutionary system for point-of-care testing.
The technology platform enables the development of next-generation point-of-care diagnostics and monitoring systems. The finger-prick tests provide lab-quality measurement of disease markers and drugs in whole-blood in less than ten minutes, but must be manufactured in an ISO 7 cleanroom in accordance with GMP regulations.
Clean Air Technologies successfully delivered the design and construction on time and on programme for this critical environment.
We provided a complete service from design review through to the production of operational procedures to ensure a facility’s readiness for regulatory inspections and approval.
Project Overview
- Design of cleanroom and associated mechanical and electrical services
- Selection and procurement of all plant through our established supply chain
- Installation of Cleanroom Envelope, Mechanical and Electrical Services
- Construction of Laboratory envelopes, Lobbies, and Corridors utilising PIR panel system
- Dedicated Air Handling Unit, Condensing Units / Heat Pumps and Trend Control System contained within new Plant Area
- Lab and Lobby pressures monitored on Magnehelic gauge panel
- New cleanroom furniture including benching, cupboards and sink vanity units
- Laboratory commissioned, cleaned and validated to ISO 14644 Class 7
