Banking on a modular approach

Clean Modules, a leader in modular prefabricated cleanrooms, has completed a major new facility for the UK Stem Cell Bank (UKSCB) at the National Institute for Biological Standards and Control (NIBSC) in Hertfordshire.

This impressive new facility, which is of international importance to the UK as a leader in the field of bioscientific research, complies with EU GMP and has been accredited by the MHRA under the DOH Code of Practice for Tissue Banks. Clean Modules' specialisation in the use of cutting edge modular construction techniques meant that the project could be completed quickly, with minimal disruption to other NIBSC activities and to a cost-effective budget. An additional benefit, especially for this rapidly developing new research field, is the adaptability of the modules to cope with changing demands and the potential for expansion by extending the facility.

Off-site construction The building comprises three modules, which were constructed off-site and transported to NIBSC for installation and final fitting out. Meanwhile the site was prepared to receive the modules and the necessary services were installed. Managing the project this way ensured contractors could be supervised and required access to the site for only a limited period of time. The finished cleanroom suite consists of three Grade B (ISO Class 5) laboratories, each connected by a special folding stainless steel transfer hatch and change areas to a Grade C (ISO Class 7) common service area. A HEPA filtered Grade C stainless steel transfer hatch links this to the liquid nitrogen storage area and autoclave. An outer corridor links the cleanrooms to associated office, storage and plant areas and the NIBSC main building. To meet the stringent demands of the UKSCB, Clean Modules had to design and install five separate air systems, complete with an uninterruptible power supply, which could all be controlled independently. The three laboratories each has its own dedicated air handling, as does the liquid nitrogen storage area, and there is an extra system to provide additional peak airflow requirements to meet safety requirements. Within the Grade B laboratory cleanrooms, the Grade A air environment necessary to produce GMP compliant cell lines is maintained within Class II microbiological cabinets. The independent air handling for each of the clean laboratories has three modes, including normal operation for the production of cell banks for therapeutic use and cell lines for research. A fumigation mode is employed to sterilise the facility, followed by a carefully controlled ventilation mode to complete a 24-hour cycle and ensure all the formaldehyde is removed safely. In view of the significance of the work of the UKSCB, it was necessary for Clean Modules to incorporate a complete facility monitoring system (FMS) into the project. The cleanroom laboratories and storage area have sophisticated computer-controlled data acquisition and monitoring, which continuously checks room pressures, temperature and humidity. "The UKSCB is the world's first public cell line banking facility of its type and has received many visitors from the UK, Europe and around the world," said Dr Glyn Stacey, head of the UK Stem Cell Bank. "The laboratories are capable of producing well-characterised quality controlled cell banks of the highest quality to enhance clinical research and support the development of new therapeutic treatments for a number of serious medical conditions." To meet the latest Annex 1 and EU GMP requirements, each laboratory has been equipped with separate continuous particle counting in the Grade A cabinets and Grade B environments. The FMS system also provides a comprehensive continuous monitor and record of room pressures and temperature, as well as the liquid nitrogen storage system, refrigerators and other process equipment. The supporting FMS software has been validated to GAMP4 and 21 CFR part 11. The system is operated from the facility office, with a direct link to the main site computer network for monitoring and alarm functions, with a capability of off-site upgrades when required. This is something that Clean Modules is now seeing incorporated into many of the new project specifications it is currently building. As a result of the extensive computer control systems, the UKSCB can electronically match the pedigree of cell lines to the conditions in which they were produced and stored and print hard copy for inclusion in the complete Quality Record. Safety is a key feature for the UKSCB and this is built into the unit with oxygen levels being checked continuously for depletion at all operational stages of the process. The staff are protected by CCTV and 'lone worker' monitoring, while each laboratory has an individual panic alarm. The inclusion of an autoclave within the unit means all waste can be sterilised prior to safe disposal. Following the success of this project, Clean Modules is already working on other related cleanroom applications such as tissue banks in healthcare and research institutions; it has also recently completed a gene therapy laboratory for a UK NHS Hospital Trust. "We have been impressed with Clean Modules' response and adaptability," said Steve Murray, head of operations. "The high standard achieved has made a major contribution to a successful accreditation by the MHRA, thereby enabling us to offer a first class service to stem cell research and therapy worldwide."