Factoring the uncertainties in cleanroom design

Align your furniture selection to company culture, SOP and continuous improvement if you plan to make your cleanroom fit for purpose, says Sue Springett of Teknomek

The pharmaceuticals industry is rife with acronyms so let’s start with two that should be at the forefront of your mind for cleanroom design: GMP and SOP.

All furniture and equipment chosen for the cleanroom must facilitate good manufacturing practice (GMP); in other words, it must stand up to thorough cleaning and maintenance. However, the hygienic design qualities of furniture are as significant as build quality in terms of the standard operating procedure (SOP). It’s these that dictate clean downtime. Therefore, the final design must be informed by the SOP.

Grand design… or not?

The SOP must align with your company culture and the intended lifetime use for the cleanroom. If it doesn’t, at worst you’ll be left with a costly white elephant and/or a situation in which the total cost of ownership (TCO) is way over budget.

If a business has a very clear outlook on the long-term use for the cleanroom, then a fixed ‘showroom’ design could be employed. While aesthetics cannot take precedence over function, a cleanroom that wouldn’t look out of place in a science fiction film is worth considering if you need to wow customers or investors.

However, besides being hugely expensive, this may limit function. A bespoke approach will usually incorporate integrated equipment and see fittings permanently fixed to the wall or floor. There’s little doubt it will look great, but makes it harder to change the layout or swap out kit if required down the line.

Known unknowns, and just the unknowns

If a business can afford to go for the wow factor, it’s a statement of confidence, but there is also some (financial) risk. ‘Uncertainty’ is a word that we’ve become very familiar with of late. The current geopolitical situation suggests it would be very reasonable to leave your options open.

While it’s understandable you might want your cleanroom to look space age, you don’t want the functionality to be stuck in the jet age! By its very nature, this isn’t a particularly fast-changing industry. However, it is worth noting trends in other sectors that are led by science and tech. For these, typically it's been those most agile that come to dominate.

It is worth noting trends in other sectors that are led by science and tech. For these, typically it's been those most agile that come to dominate.

Not even the biggest players can say the use scenario of a cleanroom won’t change. Companies must be prepared to pivot in line with market developments. A cleanroom will be one of the biggest single investments a business is likely to make, other than perhaps M&A. As such, you want to be sure it will remain fit for purpose over its lifespan and meet the needs of all potential users.

Reflecting on flex

Unless you can afford to operate multiple cleanrooms, it makes sense to make the most of what you do have. This is where the benefits of a flexible approach become clear.

A modular design takes a core standard (using a common working height or features to support air flow, for example), but offers flexibility on floorplan. The use of lightweight, free-standing furniture allows a space to be reconfigured as required. The strategy also facilitates ‘hoteling’, a popular option for communal working spaces that are shared between teams, ensuring minimal downtime.

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A modular approach also makes it much easier to address any immediate issues and implement continuous improvement cycles.

Power to the people

Regardless of intended uses, cleanroom design is simply too important to only consult the senior management and consultants, rather than the daily users. Getting it right means bowing to the wisdom of the crowd, from the project leads, to the compliance and cleaning staff.

This is a really useful way to identify easily missed issues and factor out previous problems.

Once you have analysed the feedback, the next step is to integrate the findings into the SOP with the practicalities of the clean down at the heart of the planning process. This means considering the most obvious factors such as the chosen sterilisation option to the minutiae of factors like furniture height.

SOP in the spotlight

Working backwards from the SOP, conduct a time analysis on cleaning to identify time drains.

In the most basic terms, each item that is fiddly, or each area that is hard to access, not only increases risk but also adds to running costs. Finally, look for simple solutions to reduce that expenditure without incurring additional risks.

Photo credit: Oxford Biomedica

Root cause analysis of swab testing almost always reveals design flaws in furniture as posing the most significant risk for contamination, so pay attention to harbourage points. Access and portability should also be key considerations to bear in mind when selecting the furniture, as it’s vital that teams are able to clean all the floors and the walls. Something as simple as a desk blocking access to a wall can present a significant risk.

Be the difficult customer

Buying in haste should be avoided at all costs. When possible, it really is worth spending as much time as necessary to be sure every item meets your hygiene requirements and fits SOP. Don’t be afraid to ask difficult questions, request photographs, and closely examine individual samples before committing to buying in bulk.

In short, be awkward.

Tables, cupboards and trolleys may not be the most exciting things to consider, but the most innocuous items can become the greatest time stealers. Research and specialist furniture may actually pay for themselves over time.

Get the balance right

Teknomek’s mantra, ‘the devil is in the detail’, should be yours’ too. It’s not complicated but there are many factors too easy to overlook.

In terms of GMP, it’s imperative that businesses choose furniture that is suited to their sterilisation option.

If you’re using chemical options such as hydrogen peroxide, opt for 316-grade stainless steel as it is most resistant to chlorides and can withstand chloride content of up to 500 mg/l. The 304-grade is suitable for mechanical (e.g. high bar pressure), thermal and chemical sterilisation processes for chloride content of up to 200 mg/l.

Sterilisation isn’t the only factor that will take a toll on how long furniture lasts though. Over specifying the strength of cleaning products can end up being just as costly as under specifying. It’s worthwhile considering using non-corrosive cleaning agents for the daily routine.

A substantial part of your team’s daily routine will be spent on risk management, swab testing and keeping up hygiene standards. Your procurement choices will dictate how much time will be used up reworking or conducting further investigation.

By definition, the success or failure of a cleanroom comes down to how simple and cost-effective it is to maintain in line with contamination prevention and control standards. Time is money and your SOP is the most important tool at your disposal in guiding the procurement process to ensure the cleanroom remains fit for purpose.

N.B. This article is featured in the May 2019 issue of Cleanroom Technology. The digital edition is available online.

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