SPECIALIST FACILITY DESIGN


As a specialist in cleanroom and aseptic facility design and construction, BES ensures that validation criteria are embedded throughout the design and installation process. This is essential when considering the critical path involved in taking an aseptic facility from concept to operational asset, because any validation failures could result in costly modifications and delays. Validation is an extensive qualitative and quantitative process that should involve both the design and construction team and the hospital, in accordance with GMP requirements. It should prove and document the quality, functionality, and performance of the process as a whole, as well as scrutinising individual pieces of equipment. For BES, this means that the multidisciplinary team involved in designing and building the facility works closely with the client to complete each stage of validation. This collaborative approach ensures that the aseptic facility both meets the hospital’s brief, and delivers the compliance standards demanded for its classification.


A four-stage process


Validation is divided into four stages, beginning at the design stage with the Design Qualification (DQ), which involves completing and documenting design reviews to illustrate that all the quality aspects for the aseptic facility have been fully considered. Establishing all requirements at the start of the project allows the finished facility to be measured against these detailed criteria when the construction work is complete. The next stage is Installation


Qualification (IQ), which involves checking that all components meet the approved specification, deliver the detail of the original design, and have been correctly installed. Detailed documentation is required to evidence the quality and accuracy of the installation, and this can then be used to support planning and management of future maintenance regimes or modification programmes. Operational Qualification (OQ) is the third stage of the validation process, and is designed to test that individual and combined systems function in line with agreed performance criteria, and have been installed to manufacturer requirements. It is vital that all tests are carried out using certified and traceable test equipment, so that all test results can be verified as accurate.


The final stage of the validation process is the Performance Qualification (PQ), which verifies that the aseptic facility will consistently deliver the desired outcome, aligned to the required classification. This is carried out to clearly defined parameters during the facility’s operational phase, and is summarised in a report which is a pre-requisite for GMP certification.


74 Health Estate Journal January 2020 Right first time


Design of the ventilation system is one of the key areas where specialist expertise must be applied to the facility’s specific physical, workflow, and operational conditions


Compliance and licensing Once construction and validation have been completed, the aseptic facility can become fully operational to serve the hospital’s pharmaceutical preparation requirements. To produce aseptically prepared drugs within an NHS hospital, however, the Trust must either choose to operate under a Section 10 exemption, or apply for a full MHRA Drugs Licence. Before embarking on a project to create an aseptic facility within a hospital campus, it is important to understand these two options. The purpose and capabilities of an on-site aseptic facility will influence which route is taken. If the funding model for the aseptic facility is based on using it for commercial drug preparation as a revenue stream, it is particularly important to understand the legislative obligations involved in producing aseptically prepared drugs for use beyond the hospital’s own patient community.


A Section 10 exemption is likely to apply for most hospital aseptic facilities. This provides an exemption from The Medicines Act 1968, which was introduced as a licensing system to regulate the manufacture, distribution, and importation of medicinal products. A hospital’s aseptic facility can gain an exemption if the medicinal product is prepared, assembled, or dispensed in the hospital by a pharmacist (or under their supervision), in accordance with a doctor’s prescription. The exemption can also be applied if a stock of medicinal products is being prepared in the hospital by or under the supervision of a pharmacist, with a view to dispensing them.


Any NHS Trusts that intend to use their facility to produce aseptically prepared drugs for commercial sale or to supply other hospitals outside of their own organisation will require an MHRA Licence. To gain this, the hospital will need to undergo a thorough inspection process, and may also be asked to provide additional documentation and samples of the aseptically prepared drugs for testing during the inspection.


The complexity of designing, installing, and validating an aseptic cleanroom for the manufacture of advanced medical treatments within a hospital requires a ‘right-first-time’ approach to ensure that the demands of financial due diligence, operational planning, and regulatory compliance, are met. Current advances and future growth in demand for personalised, gene-based medicines are driving a need for bespoke aseptic facilities within hospital campuses, tailored to hospital-specific clinical services and patient requirements. Such facilities must, therefore, be designed with the input of all stakeholders, and the expert guidance of specialists with proven experience of delivering highly specified pharmaceutical environments like these. Only then can the hospital be confident of a smooth project delivery, from initial concept through to detailed design, construction, and validation, which will support individual treatment plans, and help deliver improved patient outcomes.


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Gavin Statham


Gavin Statham is Southern Regional director at BES, a specialist in the design and construction of specialist environments for the healthcare and pharmaceutical sectors.


He has over 30 years’ experience working within construction and building services, specialising in healthcare and complex building engineering solutions. He is a member of the Chartered Institute of Building Services Engineers, a Fellow of the Chartered Institute of Plumbing & Heating Engineers, and an Associate with the Association for Project Management.


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