Bespoke or modular: which approach is best for your cleanroom scenario?

From concept to construction, designing a cleanroom can take years; it’s an expensive, laborious and, at times, a fraught exercise

It goes without saying that the primary consideration will always be to ensure that the design complies with contamination prevention and control standards, as dictated by the MHRA. However, what’s equally significant is to consider how the long-term value will be derived from the space … and this should be reflected in the design.

There are two options; the first is to build bespoke cleanroom furniture. Although this offers a “showroom” finish and clearly demonstrates a commitment to quality and control, the downside is that it offers less flexibility should the business need to pivot. The alternative is to take a modular approach such that the space can be reconfigured to suit different scenarios with minimal downtime.

A design for life?

If your cleanroom is intended for use as a “shop window” to your operation for stakeholders such as investors and customers, then a fully bespoke design will offer a quality finish that is sure to impress. Given that this approach often entails fittings being permanently fixed to the wall or floor to mitigate risk and/or maximise operational efficiencies, there’s little opportunity to modify the layout or swap out integrated equipment without a complete refit.

However, it does lend itself to hygiene-controlled scenarios in which the application is unlikely to change. As the premium option, it can be a risky proposition if there’s even the slightest possibility that the use-case for the space may need to change in the short to mid-term. It’s for that reason that there has been a growing trend towards more flexible designs in recent years. The modular option will typically build on a core standard, such as a common working height and the essential clean design principles, but also allows for a greater degree of flexibility regarding where furniture is placed. It is undoubtedly a safer option for businesses that may need to factor in new processes or equipment to support growth and product development.

Modular also aligns to the growth of “hoteling,” whereby spaces are shared by multiple teams. Positioning the cleanroom as a communal resource means the design needs to allow for reconfiguration — whilst minimising the amount of time spent out of operation.

Plan big, think small

Whichever option you ultimately decide is right for you, the intelligent, hygienic design of the furniture you choose can reduce risk as well as operating costs, and this should be factored into the development from the earliest planning stages. A sensible starting place is to work backwards from the practicalities of the clean down standard operating procedure (SOP). This means that sterilisation should be your number one consideration, once you’ve decided on which option is right for your scenario — steam (autoclave), UV light or chemical (such as VHP) etc. — then you’re ready to make an informed decision regarding what equipment and furniture is best for you.

All furniture should support good manufacturing practice (GMP) and your procurement should be dictated by the designated sterilisation process. Primarily, the furniture must be robust enough to withstand your chosen option. Although the hygienic qualities of stainless steel make it the go-to material for cleanroom applications, it’s important to understand certain nuances: 304 grade stainless steel is tough enough for thermal (high temperature), mechanical (high bar pressure) and chemical (detergent) sterilisation, but 316 grade steel should be employed if you intend to use chemical options such as VHP.

Also, consider the practicalities; if you’re using an autoclave, can you disassemble the furniture, or if you opt for VHP would it obstruct vapour flow? The wrong decisions can increase contamination risk with all the associated consequences.

Access all areas

Accessibility is a key concern in terms of supporting a thorough clean down, and the manoeuvrability of furniture is key. Free-standing options are by far the most practical solution, especially for modular cleanrooms. Therefore, furniture that can be moved easily to enable efficient wall and floorspace cleaning is worth investing in. Do consider the practicalities though; although you want furniture to be as mobile as possible, cleaning some castors can be particularly time-consuming ... so interrogate the design.

Root cause analysis of swab testing reveals that furniture is a major problem area when it comes to harbouring or concealing contaminants. All too often it’s poor design that allows microbial life to gain a toehold within a sterile environment; we always preach that the devil’s in the detail, so look out for dirt traps such as ledges, gaps, raised welds, etc. Taking time to assess the hygienic qualities before reaching a purchase decision is time well spent, so don’t be afraid to request specific photographs or ask “difficult” technical questions. After all, it’s better to get it right first time than face the consequences.

Although clean down isn’t perhaps the most exciting element of developing a cleanroom, it is a significant part of the SOP — whether viewed from a risk management perspective or time invested. Once equipment and furniture are installed — and regardless of whether it’s bespoke or modular — a significant portion of your staff’s daily routine will be invested in testing and managing hygiene standards. Minimising risk through considered procurement choices has a knock-on benefit in that it means staff can avoid rework or further investigation, and frees teams up to focus on other areas of risk management.

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