There’s an (in)famous British Army acronym – the 7 Ps: proper planning and preparation prevents p**s poor performance. The version used in the business world is slightly less fruity, but the message remains the same (proper planning and preparation prevents particularly poor performance). The statement applies to all areas of pharma, from business operations, right down to technical aspects, such as facility design and manufacturing activities.
The 7 Ps are memorable and I like to use them a lot in my role when discussing cleanrooms. A cleanroom is a huge investment and it needs to remain fit for purpose over the years, as well as meeting the needs of all that will use it. To get the investment right, proper planning is a must because there is no one-size-fits-all cleanroom, or even clean down processes. Changing areas and packing will also differ between cleanrooms, so you need to carefully consider your needs and plan effectively.
The first stage of planning is to consult with all stakeholders. The wisdom of the crowd is a really useful way to identify issues that might be missed at a purely conceptual level, so discussions should be had with senior management as well as project managers and everybody who uses the cleanroom on a day-to-day basis, as they will have the deepest insight into what can help or hinder their productivity. In practice, this approach can help factor out previous problems, which in turn has the potential to reduce risk; for example, simple positioning of furniture may offer better access for improved clean down.
Next, consider how the usage of the cleanroom could change over time. I’ve seen many companies opt for a fixed “showroom” finish, but this could be a costly mistake if the business has to pivot. The only thing we can be certain of? There are no certainties! The industry as a whole is being rocked by waves of technology-led disruption, while global finance and geo-politics remain in a parlous state. In short, it pays to play it safe, so flexibility is key. Working backwards from the SOP, a modular approach takes a core standard – for example, using a common working height or designs to support air flow – and can offer greater flexibility on where furniture is placed. The space can be quickly reconfigured to support growth, new processes, or integrate new equipment in line with changes in product development. Such a strategy also plays into the trend for “hoteling,” whereby spaces are shared by multiple teams. With that goal in mind, cleanrooms need to be updated as quickly as possible and on an ongoing basis. By far the easiest way to support such communal working spaces is through the use of lightweight, free-standing furniture.
A further benefit inherent in this model comes down to the practicalities of the cleaning process. The manoeuvrability of the furniture is key in terms of accessing all areas for thorough clean down. It’s important to remember microbial contaminants, such as bacteria, won’t just take up residence on the item of furniture itself. It’s hugely important to be able to clean all of surrounding areas. It’s easy to overlook the obvious; something as simple as providing easier cleaning access can have a significant impact on swab test results. Aside from surrounding areas, swab testing almost always reveals design flaws in furniture that pose a significant risk for microbial contamination.
Be certain the furniture you choose is not at risk of deteriorating from detergents or disinfectants and is also suitable for your chosen sterilization processes. In the latter case, if you’re using chemicals, such as VHP, furniture needs to be robust enough – ideally 316 grade stainless steel – so it won’t degrade over time. If you are using an autoclave, you also need to consider the practicalities – can each item be easily disassembled and reassembled, for example?
Tables, trolleys and shelving aren’t perhaps the most thrilling considerations when planning a cleanroom. However, when you’re spending so much time and money on a project it really does pay to spend some time focusing on the minutiae. In my view, you can never be too thorough when it comes to planning the design of your cleanroom – and that includes the furniture.
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