SPECIALIST FACILITY DESIGN
Creating an ‘in-house’ drug preparation facility
Gavin Statham, Southern Regional director at BES, a specialist in the design and construction of cleanrooms, aseptic facilities, and other sophisticated environments, discusses the demanding requirements for hospital aseptic facilities, and how the healthcare sector can benefit from the experience of the pharmaceutical industry.
High-specification, specialist facilities for the preparation of aseptically-prepared drugs need to provide a sterile environment that safeguards the purity and accuracy of the formulation. Such facilities are frequently built into pharmaceutical manufacturing environments, where GMP (Good Manufacturing Practice) guidelines ensure compliance to recognised standards. As treatments become more advanced, aseptic facilities are an increasingly common addition to hospital estates too, driven by a need for preparation of patient-specific drug formulations on site. This includes patient-centred prescriptive aseptic manufacture for chemotherapy preparation, along with Parental Nutrition (PN), Advanced Therapy Medical Products (ATMP), Central Intravenous Additives (CIVAs), and Monoclonal Antibodies (MAbs).
More aseptic suites in prospect Several NHS Trusts have already invested in adding an aseptic facility to their oncology or pharmacy departments. Indeed, BES is currently delivering a design and build project for a new pharmacy and aseptic suite at Weston Park Hospital in Sheffield. Over the next few years, there are likely to be many more aseptic suites built within hospitals. The need to plan aseptic facilities into acute care hospital development programmes has been clearly identified as a growing trend. In his 2016 report, Operational productivity and performance in English NHS acute hospitals: Unwanted variations, Lord Patrick Carter of Coles, chairman of the review panel examining the future of NHS pathology, identified the need for NHS aseptic facilities to enable a ‘future- ready, resilient, high quality, safe and efficient’ service. The report pointed to year-on-year growth in demand for aseptically-prepared treatments, indicating urgent and significant demand for the specialist expertise required to design, specify, construct, and validate such facilities.
Layout planning demands specialist expertise in cleanroom and aseptic facilities.
Meeting the aseptic challenge The challenge for healthcare estates managers is to ensure that the increased need for aseptic production within hospitals is met by utilising the appropriate level of project design and delivery expertise. Only then can NHS Trusts and private hospital operators be assured of accurate and safe preparation of these specialist treatments.
Aseptic production is carried out within a cleanroom facility, which can be defined as a specially constructed, environmentally controlled, enclosed space. Different drug preparations and processes require varying cleanroom classifications and compliance criteria.
The production area should be designed and constructed with an expert eye for detail that ensures that airborne particulates, temperature, humidity, air pressure, airflow patterns, vibration, noise, and lighting, can be controlled in compliance with the appropriate standards. It’s also important to take into account end-user workflows, material flows, staffing levels, specialised manufacturing equipment, and production capability; all of which adds up to a highly complex project.
Finding the right supply chain partner
As the design and specification of aseptic suites is relatively new to the NHS, there is a risk that the existing healthcare supply chain and procurement network does not include proven, competent, specialist contractors who are familiar with cleanroom and aseptic production. Identifying a supply chain partner that can provide specific expertise in the design, construction, and validation of aseptic environments is essential to avoid any delays in completing these new hospital facilities.
There is also a risk that an
inexperienced and disconnected supply chain may not be able to deliver aseptic facility projects to the exacting requirements of the Medicines and Healthcare products Regulatory Agency (MHRA). Where these high standards are not met, the facility will not achieve validation, leading to a costly re-design and modification process, and delays in beginning drug production at the hospital. As a result, the hospital’s spend could be much larger than planned, and operational targets – including
January 2020 Health Estate Journal 71
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