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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 ‘futureready, 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.

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