CLEANROOM DESIGN
The ‘Ante Room’ with step-over bench.
strategy may appear to offer better financial accountability and cost assurance, in fact, a disparate supply chain cannot add value with a holistic approach to design development on technically complex cleanroom or aseptic facility projects. Nor can a fragmented approach identify design conflicts or clashes that may only be apparent when the scheme is considered as a whole.
Dangers of ‘disconnected approach’ This ‘disconnected approach’ often also prevents the numerous niche providers involved from engaging directly with the facility’s end-users to really understand the requirement, as all client communication sits with the contractor and its design team. As a result, valuable suggestions to enhance the original specification may be missed, or design issues overlooked. Errors in design, compliance, or installation, could all lead to failure at validation stage, with serious financial implications for elements that need to be revised, and onerous operational implications relating to delays in availability of the facilities and disruption to other areas of the hospital. Indeed, depending on how far along the way a project is when errors in the specification are noticed, the hospital could even find itself paying for the same facility twice, because non- compliant specification would have to be stripped out, re-designed, and re-installed, before commissioning and validation could be completed.
This was the case at a recent BES project at a large new-build hospital in the Middle East, where the BES team was called in to redesign three facilities in the same hospital after compliance problems had been recognised at commissioning stage.
Re-designing to reach validation targets
The three specialist facilities that BES was called upon to redesign at a hospital in the Middle East were all part of a showpiece new hospital, and had been designed and built as part of the main programme,
64 Health Estate Journal October 2018
The IV ‘Prep Room’ with laminar flow cabinets.
without the involvement of a specialist in cleanroom and aseptic environments. Construction had gone to plan, and the completed compounding facilities for the preparation of chemotherapy treatments had been fitted out to specification. It was clear, however, that when the commissioning process began they would not meet the internationally-recognised USP (United States Pharmacopeia) guidance stipulated by the client for these areas of the hospital. Although the hospital as a whole had been designed and constructed to recognised healthcare standards, the two Non Toxic Sterile Compounding facilities and single Toxic Sterile Compounding facility were not compliant with the relevant standards (USP 797 and USP 800 respectively), and commissioning and validation could not be completed.
BES’s task
The task for BES was to examine the original specification, understand where it needed to be changed, and consider the wider effects of those changes to the hospital build programme and building services provision. The team could then develop a new design that would re-use as much of the existing building services infrastructure as possible, while replacing or upgrading underspecified elements to ensure that commissioning and validation could be achieved second time around. Each of the facilities is located in a different area of the hospital, and consists of a suite of rooms. As the USP guidance for the Toxic Sterile Compounding and Non Toxic Sterile Compounding facilities are different, the redesign challenges were distinct for each.
The biggest design flaw with the original design of the Toxic Sterile Compounding facility was that it did not have a full fresh air system. Unlike a conventional sterile hospital environment, where a recirculation system can re-use the air, the toxicity in this environment means that every air change needs to bring in new fresh air from outside the
building, while the extraction system needs to discharge its collected air directly to atmosphere.
Insufficient cooling
The knock-on effect of this specification error was that there was insufficient cooling in the system to maintain the temperature and humidity parameters required for compliance of the Toxic Sterile Compounding facility. This was particularly onerous due to the location of the hospital because the intake of outdoor air involves cooling air from a summer maximum outdoor temperature of 46˚C to provide a constant indoor temperature of 19˚C (+/–1˚C). The BES team was able to utilise the existing air-handling equipment with some modifications while introducing a full fresh air ventilation system and increasing the size of the cooling coil to double the cooling capacity in the Toxic Sterile Compounding facility. This also required spatial considerations to modify the layout of the facility to accommodate the larger coil. The lack of consideration given to the toxicity of the atmosphere in this facility also prompted the BES team to recommend HEPA filtration of the extract air before it entered the extract ductwork. This ensured that any toxicity in the air from an unexpected spillage is contained within the compounding room.
Operational issues with layout There were also operational issues with the layout of the original Toxic Compounding suite, which includes three compounding areas – one containing a robotic compounding machine and the other two, smaller areas, containing microbiological safety cabinets for small- scale drug preparation undertaken by hand. The original layout had not allowed sufficient space for the operational requirements of the robotic equipment, which meant the footprint of the Toxic Compounding facility had to be redesigned, with space re-allocated from the two smaller compounding areas.
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