ENGINEERING
classified clean room areas and the ancillary rooms, while HEPA filters will clean the extracted air before this is released into the atmosphere. In addition to the general extract, Local Extract Ventilation (LEV) exhaust systems have been designed into the facility where sporicidal and alcohol spraying occur, with the CT and ATMP Isolator room LEVs being filtered through safe change HEPA units before being discharged to atmosphere.
Strict temperature and humidity control
Across all cleanroom-classified areas of the new Chemotherapy Aseptic Suite and CT/ATMP Aseptic Facilities, the environment will have a strict tolerance of the temperature control, as well as upper humidity limits being maintained for occupancy comfort. The Grade C areas are maintained at 19˚C to ±2˚C, while the Grade D rooms are maintained at 19.5˚C to ±1.5˚C, and both areas are controlled with an upper limit of 55% relative humidity. To ensure that these conditions are met consistently, a new building energy management system has been installed specifically for the Chemotherapy Aseptic Suite and CT/ATMP Aseptic Facilities. This will constantly monitor temperature, humidity, and the various air pressure cascades between the different grades (C, D and CNC+) of the rooms. Temperature sensors installed in the return ductwork from each room will monitor the temperature of the air leaving the location, enabling automated temperature adjustments by the BMS in line with real-time conditions. In this way, the environment will consistently meet temperature and humidity parameters, regardless of occupancy levels, equipment use, or outdoor temperatures.
Ease of maintenance
The BES team worked with the client to consider the logistical and maintenance implications of AHU specification. Often facilities of this kind are specified with some level of redundancy in the AHU installation, as standby provision for the controlled environment. The challenges of locating additional standby AHU capacity in the limited seventh floor plant room location, however, led to an alternative approach to resilience. Fault monitoring has been built into the BMS to ensure that fans are repaired or filters are changed before a developing fault can begin to affect the performance of the air-handling system.
Indeed, ease of maintenance, and the need to ensure that the environment remains fit for purpose, have influenced all aspects of the design, including the choice of materials and finishes. The inner support and isolator areas are fully vinylled across the walls, floors, and
26 Health Estate Journal July 2021 ‘‘
Ease of maintenance, and the need to ensure that the environment remains fit for purpose, have influenced all aspects of the design, including the choice of materials and finishes
ceilings, creating a robust and easy-to- clean environment with no crevices where particles can collect. All workbenches and desks have been fabricated using Corian – a smooth, impervious material compatible with cleaning agents and regimes. The workstations and benches have smooth, rounded edges to ensure that there are no awkward corners, with every effort made to enable faster, easier, and more effective cleaning.
Commissioning and validation Validation of the new facilities has been embedded in the project design and construction process from the outset. Design reviews commissioned by the Trust were documented to enable design qualification, which considers the validity of the design against the URS and compliance requirements. Further detailed documentation has also been compiled by the BES team during the construction phase to ensure the Installation Qualification carried out by the Trust cross-references with the ‘as-built’ information, detailed design, and the URS. The BES team is also responsible for commissioning the new facilities, and for ensuring that accurate information is available for future maintenance or modifications.
Operational and performance qualification of the facilities will be undertaken by the hospital’s Chemotherapy aseptic dispensing team, with the support of BES, following completion of each build phase. BES also carried out airborne particle cleanliness classification tests, recovery (clean-up) tests, and airflow (smoke) visualisation studies. Because the BES team is familiar with the validation process, all validation requirements have been built into to the design and construction process at every stage. This has reduced validation risk, and ensures that all design, installation, and compliance documentation, is available.
Pioneering facilities The new Chemotherapy aseptic dispensing unit has now been completed without disruption to the normal working of the hospital. The BES team has completed the installation qualification process in preparation for the client to carry out the operational qualification and finalise the validation.
Construction will begin on the aseptic facility as soon as the old pharmacy has been vacated, with BES continuing
to provide both design and construction services, within social distancing guidelines, during the COVID-19 pandemic.
The co-ordination of architectural design, building services engineering, and construction across the multidisciplinary BES team will result in a best-in-class facility that supports the hospital’s reputation for excellence in cancer treatment, and creates a template for future gene therapy preparation facilities for other NHS Trusts.
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JonathanMorton
Jonathan Morton, Engineering director at BES, has a BEng in Building Services from the University of Central Lancashire (UCLan), and more than 30 years’ experience in designing sophisticated environments for the pharmaceutical and life sciences sectors. A member of the BES team for over 16 years, he has been Engineering director since 2017. Working with BES’ in-house multidisciplinary team, he oversees all aspects of programme, design, technical, and commercial considerations, ensuring that each project outcome ‘benefits from exceptional, design, value, quality, and safety’. His expertise includes design, management, SHE, validation, and GMP.
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