King's College London (Rayne Institute)
New GMP manufacturing cleanroom – Denmark Hill
Clean Room Construction (CRC) was chosen to design and build a new state-of-the-art GMP manufacturing suite as part of a production capacity expansion in the Rayne Institute at King’s College London.
The Rayne Institute is a specialist medical research facility within King's, conducting world-leading research. CRC was appointed to engineer this new GMP manufacturing facility for the Department of Haematological Medicine on the Denmark Hill campus.
With a floor area of 60m2, the new facility comprised two Grade D cleanrooms housing isolators, incubators and centrifuges for open and closed processing. It also incorporated a Grade D preparation room used to service the isolator rooms as well as an outer lobby separating the cleanrooms from the general corridor, and separate personnel airlocks between the preparation room and the isolator rooms. The cleanrooms were successfully validated to Grade D in accordance with MHRA guidelines, but they were designed to function as Grade C rooms should there be a requirement.
The specification included the installation of ventilated trolley and pass through hatches, with HEPA filter units in the ceilings of the hatches to maintain the pressure regime and cleanliness, a range of mobile and fixed laboratory benching and mechanically interlocking doors. Fully integrated air conditioning and filtration systems have been installed to provide the specified conditions of temperature, humidity, pressure, cleanliness and noise in line with the design parameters. A dedicated HVAC system, BMS control and a new fire alarm system were also provided alongside an independent environmental monitoring system. CRC supplied and installed the internal finishes, fixtures and fittings and completed the Installation Qualification and Operational Qualification for the client.
The facility is part of the Rayne Cell Therapy suite premises and is used for the production of cell and gene therapy-based investigational medicinal products. The new GMP manufacturing suite has helped to increase production capacity by 50 per cent.
Contract Value: Circa £900,000