A few minutes from the site of our GMP manufacturing centre, currently under construction in Stevenage, is an access storage facility. Inside one of the storage lockers, behind a blue door, is a 5m2 room. The room is full of pipes, plugs and other pieces of technology and to an outside observer, it’s probably a strange use of a storage locker, but the room has an important purpose. It is a mock up of a clean room that’s been built based on the new manufacturing centre design. It’s there to show the fixtures, fittings and clean surfaces future collaborators can expect when they occupy one of the 100m2 of clean room modules, giving them the assurance they need of the quality of the facility.
The Cell and Gene Therapy GMP manufacturing centre, will initially contain six of these flexible clean room production modules. The centre will provide the UK with the manufacturing facilities needed for later-stage cell and gene therapy clinical studies and commercialisation.
Details that can be seen in the mock up are:
Ventilation outlets including ceiling mounted air diffusers supplying HEPA filtered air into the module and a low level extract grilles with built in HEPA filters. Environmental services are accessible from outside the module either via the interstitial ceiling or technical corridor.
Utility plates, of which each module will contain six, with an additional plate in the cell culture area. The flush mounted stainless steel plates include pre-assembled outlets for;
- Power (normal 240v essential and non-essential)
- Power 3 phase outlets
- Data outlets with RJ 45 terminations
- Medical gases outlets for quick connections
These outlets will allow a high degree of internal equipment configurations within each module and there is also provision to install additional outlets for equipment with non-standard connections. The utility plate can also be accessed from the technical corridor to which access is strictly controlled by CGT Catapult staff.
Constructed by Ardmac Ltd, the cleanroom facility has been constructed to high quality Class B standard enclosures. The room contains flush mounted doors and frames, all silicone sealed and suitable for appropriate cleaning materials.
The centre is due to open in 2017. If you are interested in visiting the mock up or finding out more about the manufacturing centre please contact us.