When it comes to a controlled environment, where the complexity of engineering, layout and performance is so vital to preventing contamination and protecting process and yield, the fundamental building blocks of a project simply cannot be ignored.
Guardtech
It’s one of the reasons the Guardtech Group have invested so heavily in bolstering their Design Team over the past four years, with the Suffolk contamination control experts quadrupling their numbers from three permanent cleanroom design specialists to 12.
With three highly experienced Directors also involved in the Design process, it gives the Guardtech Group, and its subsidiary cleanroom construction brands Cleanroom Solutions, Guardtech Cleanrooms, Cleancube, Isopod and Isoblok, a robust team with a wide-ranging wealth of structural, mechanical and electrical cleanroom design knowhow with which to tackle even the most complex of facility specifications.
Commercial director, Mark Wheeler, lends 25 years of cleanroom construction experience – and he’s used everything he’s learned over a hefty bank of successful previous projects to put together a useful guide for applications looking to undertake a build of their own, both in new facilities and within existing premises.
“There are many key design considerations to cover when you’re trying to implement a successful framework for a new cleanroom construction project,” he said.
“It’s critical that your plan is clear from the offset – and that means defining the reason for needing a cleanroom, which ultimately lies with your process and asking a series of important questions.
“What is your Process Flow going to look like? You need to outline clearly what happens in the space and how it happens – how do people enter and leave? How do they move around the process? How do raw materials enter the space? What is the route for finished goods? How is waste collected? How are all of these things done in a manner that minimises cross contamination opportunity?”
Wheeler and the team then collaborate with clients to consider which tools they might use to minimise risk, such as transfer hatches, trolleys, HEPA-filtered goods lifts and cranes.
“This all needs planning and documenting within process flow diagrams and all of our decisions need to be focussed on reducing movement and restricting entry to our most highly classified zones,” he said.
Next up is the Equipment Register – which lists the equipment that an application is using and how it is laid out, the equipment dimensions and how it transfers into and through the space.
“Clients need to consider things like turning circles and access points, the maintenance access that is required for the kit and the clear space needed to surround the equipment.”
Following on from the Equipment Register, it’s vital to define a full Utility Schedule for each piece of equipment – including the power required and whether gas services like nitrogen, compressed air, vacuum or extraction are needed.
As a result, associated flow rates will need to be noted, and whether or not water or drainage is required.
“This then leads us to interrogate the likely heat output,” Wheeler said, “so we can factor this into the air conditioning design to compensate for the heat gains and meet the room condition.”
As with any controlled environment process, personnel – and their impact on the space – is one of the most important factors to consider.
Wheeler asked: “Who are the people required to run the process in your application? You need to determine the occupancy for each process room and outline likely shift patterns – this will then help you to decide on the space required for the change area, facilitate occupancy levels and consider the shift ‘switch-over’ of your operators.”
But a beautifully well-oiled cleanroom operation isn’t just about the people involved – it’s also about the product they’re dealing with.
Clients need to consider the environmental conditions that their product requires whilst in production and during storage.
Is it sensitive to changes in temperature or to low or high humidity conditions? Do vibration levels need to be considered, lighting levels in terms of luminance or wavelength, is the product vulnerable to or does it generate a static charge?
And on top of that, comes Regulatory Compliance – is your product regulated by a governing body such as the MHRA, the FDA, World Health Organisation or NADCAP?
If so, you’ll need to consider what guidance you need to review, understand, consider or follow – such as EU GMP guidelines like those in EudraLex Volume 4 Annex 1 – or those provided by the full range of the ISO 14644 standards and how that governs your brief.
What, perhaps, underpins thoughts on Personnel, Product and Regulation however is the actual building itself – and the construction principles you wish to adopt.
“It’s important to think about how you want your facility to be built,” said Wheeler. “Would you rather a more traditional stick-built approach of onsite construction or are you tempted to adopt a more modern approach with offsite pre-constructed pods or modules that are delivered to site in a more plug-and-play fashion?”
The Guardtech Group cover all bases with their holistic ‘total cleanroom package’ approach, with large-scale facilities taken care of by Cleanroom Solutions, smaller more modest modulars delivered by Guardtech Cleanrooms and even smaller pod systems catered to by Isopod Rapid Cleanrooms.
The pre-fabricated plug-and-play cleanroom module options are provided by shipping container business Cleancube Mobile Cleanrooms, while the Group hopes to grow fledgling brand Isoblok significantly in 2025 – a system that utilises bespoke steel-portal frame pods that will offer even more flexibility and versatility than Cleancube currently does.
Whatever set-up an application has and whatever the process requirements, it’s clear that the host building requires a particularly stringent pre-evaluation.
“What limitations or restrictions are you presented with by the selection of the host building,” asked Wheeler, “and are they limitations that need to be accommodated or overcome?”
The floor space available and internal height of the building will determine whether it is single or multi-storey.
And then there’s the need for potential plant space above the cleanroom ceiling, which is usually a minimum of 800mm.
Wheeler said: “Will the building structure form part of the support strategy for the cleanroom and its infrastructure? Does it need to be a free-standing environment with independent steel portal frame to suspend from – or indeed a mezzanine serving the same purpose whilst providing additional space for potential utilisation above?”
Ultimately though, any good project starts with an incredibly clear, well considered and appropriately challenged brief.
“One industry leads the way as an example of best practice for this approach,” said Wheeler, “the Pharmaceutical industry.
“Pharmaceutical environments start their life as a URS or User Requirement Specification, which is a document that that clearly identifies all your requirements and desires which can be used to form the contract deliverables.
“Room data sheets can help to form your plan of action, taking into account performance specification, room dimensions, heights, classification, temperature & humidity with specified tolerances and lux levels.
“This part of the brief needs to be fleshed out in as much detail as possible so that you achieve the environment you want to achieve in each of the specified zones.
“By working with specialists like those we have here at the Guardtech Group, in an open, collaborative process, you’ll be part of a detailed, thorough and robust design process that ensures no key steps are missed – and that you end up with exactly the right facility to meet your specific requirements.
“A facility that not only meets your needs today – but is also future-proofed to grow with you as your operation expands.”