CLEANROOM DESIGN
Managing the risks – getting it right first time
Gary Horrocks, Business Development manager at BES, a specialist in the design and construction of cleanrooms and sterile environments, discusses the importance of managing the financial and operational risk associated with hospital cleanroom and aseptic facilities, highlighting an example in the Middle East where a lack of specialist expertise in the original design led to costly and time-consuming re-design, strip out, and retrofit.
With advances in treatment, and an increasing focus on managing patient journeys within integrated healthcare environments, the need for aseptic and cleanroom environments within hospitals is growing. Here, bespoke chemotherapy and cell therapy treatments can be prepared to the highest pharmaceutical manufacturing standards to meet specific patients’ individual needs, and testing can be carried out on site without the risk of contamination.
Estates managers may be aware that the design, specification, and fit-out standards needed to achieve commissioning and validation for such specialist facilities are much higher than those seen within the existing hospital specification culture as far as reduced contamination risk and meticulous cleaning regimes are concerned. However, they may not realise that even engineers who routinely design high specification healthcare facilities, such as operating theatre suites, often lack the knowledge required to design EUgGMP- compliant clean room and aseptic facilities. Section 6 of HBN 14-01: Pharmacy and radiopharmacy facilities, states that ‘The design of aseptic preparation facilities should comply with the guidance laid down in the Medicines & Healthcare products Regulatory Agency’s Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017 (the so-called ‘Orange Guide’) and the Royal Pharmaceutical Society publication, Quality Assurance of Aseptic Preparation Services, and it is vital that engineers involved in designing these facilities are familiar with these standards and experienced in delivering them’.
A strictly documented process Compliance with those standards not only requires a highly specialist approach to design and fit-out, but also entails a strict and meticulously documented process of qualification throughout project delivery – including design qualification, installation qualification, operational qualification, and performance qualification, the last
The toxic compounding facility ‘Chemo Room’ with biosafety cabinets at the Middle East hospital where BES has recently worked.
of which is carried out by the end-user following completion. The new facility must undergo a typical commissioning process to ensure that all building services equipment is fully operational, delivered ‘to spec’, and fit for purpose; it must also pass a validation process, conducted by an independent validation engineer, to ensure that it complies with the relevant MHRA and/or FDA standard.
Need for ‘joined-up accountability’ This level of complexity is a clear indication that specialist expertise is required to design, engineer, and construct cleanroom and aseptic facilities, but often procurement processes put the responsibility for enlisting integrated expertise to design and deliver the project with a trusted healthcare contractor. NHS procurement processes are prescriptive, and do not always accommodate the specialist nature of projects of this kind,
‘‘
because framework and design and build models often lead to a fragmented supply chain. Consequently, the main contractor brings together various specialisms, and decisions are made based on what can be delivered within agreed cost and length- of-programme parameters, while still enabling acceptable profit margins. In other healthcare markets too, where procurement practices are less rigid, there is often an assumption that the main contractor can outsource specialist elements of the project to sub-contractors. While this may be driven by a strategy of assigning all accountability to a core supplier, it often results in a lack of cohesive, interdisciplinary expertise on the project. This, in turn, can lead to an increased risk of mistakes being made, or opportunities to improve the design being overlooked.
While a traditional main contractor/ subcontractor project design and delivery
This level of complexity is a clear indication that specialist expertise is required to design, engineer, and construct cleanroom and aseptic facilities
October 2018 Health Estate Journal 63
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116