| 13 March 2006 E-mail for further details: enquiries@thermal-transfer.co.uk |
| Return to news summary |
TT’s Swindon office had total responsibility for the design, build and validation of a Pharmaceuticals Production Suite (PPS) within the new £52 million Pharmacy and Pathology Building constructed by Laing O’Rourke.
The existing PPS, in the basement at St. Barts in the City of London, serves two further hospitals in the Trust, as well as providing specialist products to over 85 other hospitals.
“It is over 20 years old and pharmacy standards have moved on since it was completed. The facility has also reached the limit of its capacity” explains Mike Lillywhite, director of pharmaceutical technical services.
The specification for the new 828 square metre suite, which is located on the first floor of this six storey self contained building, features clean rooms to EC GMP grade B and grade D standards, together with built-in grade A LAF units and pharmaceutical isolators. TT also provided the laboratory furniture, all the associated mechanical, electrical and medical gas services, specialist environmental monitoring and fumigation systems.
The cleanroom suite is divided into several zones with different levels of cleanliness, different pressure regimes and workstations, depending on the scale and type of process, the need for sterility and the hazardous nature of the materials being handled. All the zones are fed with HEPA filtered air at high level and extracted, for critical B rooms at low level. Room pressures are maintained by the use of air locks, through which all materials and people enter and exit. Air from rooms and cabinets handling hazardous materials is extracted to the outside environment, to avoid the risks of cross-contamination.
TT also handled the validation process in-house, which provided full testing and documentation qualification to meet MHRA approval. The challenges posed by validation had a major influence over the way the suite was constructed and in many cases standards have been set that go beyond the minimum requirements.
The facility will be fully operational in the spring of 2006.