New GMP-compliant cell and gene therapy cleanroom suites

Clean Room Construction (CRC) was appointed by MeiraGTx to design and build a £14 million suite of GMP-compliant cleanrooms for the pioneering London-based gene therapy company.

The fully validated state-of-the-art facility will be used for all manufacturing aspects and in-house process development. The 2,000 sq.m facility includes multiple suites, clean change areas, material and personnel air locks, plus associated support and circulation spaces. It also features the facility for automated vaporised hydrogen peroxide (VHP) sterilisation of individual process areas, while leaving other areas operational.

The cleanrooms and associated HVAC services were installed into a new building. CRC was involved early in the design process, enabling architectural elements of the design to be influenced by the spatial requirements for the HVAC and process services to support the cleanroom. As part of the client’s design and delivery team, CRC fast-tracked the delivery of the project working within COVID-19 restrictions. Working overseas, CRC provided, installed and commissioned the following features:

  • High specification cleanroom partitioning system with double flush windows, doors and accessories
  • Walk-on ceilings, with services distribution over the rooms; durable, fully coved and welded sheet vinyl flooring
  • Multiple zone and fully integrated air conditioning and filtration systems to provide the specified conditions of temperature, humidity, pressure, cleanliness and noise, including single point of failure protection
  • An environmental monitoring system and dedicated HVAC BMS control systems
  • Electrically interlocked trolley and pass through hatches, MALs and PALs, all with time delay functions
  • Inflatable seal doors and dedicated HVAC systems allowing VHP sterilisation (surrounding suites operational)
  • Technical service panels for process services distribution and POU outlets
  • Process transfer ports; Gas tight service penetrations with air tightness test verification
  • Power, data and electrical distribution systems; LED lighting with automatic ‘switchless’ controls.

Contract value: Circa £14 million (across multiple phases of the project)

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