How to choose the right modular clean room design partner
Let’s be honest: the cleanroom market is crowded. From traditional vendors offering stick-built cleanroom solutions to others offering basic softwall enclosures and yet other vendors offering fully integrated solutions. Even within the world of modular cleanroom systems, the options are many. But not all modular clean room designs are equal and neither are all modular cleanroom partners. So, how do you choose the right modular clean room design and build partner?
Selecting the right company is about understanding the factors that distinguish a true partner from a company that is a contractor, equipment reseller, or generic solutions provider. Finding the right modular clean room design and build partner is a strategic advantage, one that will help you ensure that your investment stands the test of time and sets you up for long-term success.
This guide is designed to help you understand the landscape of modular cleanroom systems. How should you evaluate your options? What is the gold standard when it comes to modular clean room design? What is non-negotiable? And what sets the best-in-class modular cleanroom suppliers apart from the rest?
Turnkey prefabricated and modular cleanroom systems are quickly becoming very common across regulated industries. So, whether you’re expanding capacity, upgrading old infrastructure, or kicking off a whole new greenfield project, you must understand how to select the right modular clean room design and partner. It’s the only way to have a cleanroom design and installation process that is high-quality, safe, compliant, and that yields a high-performance controlled environment.
Why the right modular clean room design and build matters.
With advancements in manufacturing and building design and infrastructure, modular cleanroom systems can and do offer flexibility, speed and environmental control at par with, if not better than, conventional cleanroom construction. But should you go for a cleanroom just because it’s modular? Of course not.
Regardless of the type of cleanroom build, you must do your due diligence to ensure that the controlled environment you are investing in offers the conditions required for you to carry out your operations safely and effectively.
So why does the right modular clean room design and installation matter? Because your cleanroom is more than just walls and machines. It is an ecosystem, a safe space within which precision operations can be carried out without risk. Essentially, your cleanroom is about eliminating risk as much as possible.
In regulated industries that require cleanroom use, the most important things for you to consider when it comes to clean room design and build are compliance, contamination control, temperature and humidity management, and energy efficiency. Get these right, and you’re on the path to success in your cleanroom operations. Get them wrong, and you risk the health of your consumers and the sustainability of your business.
Why the right partner matters.
When it comes to your cleanroom, it’s not just the design, build, or installation that matters. Who your cleanroom partner is matters just as much.
Your cleanroom supplier isn’t just a vendor. Given the critical environments they are responsible for supplying to you, in an ideal situation, they are a strategic partner.
Your modular cleanroom supplier must be your partner because the work they do helps you meet and maintain strict technical and regulatory requirements. From design, fabrication and installation to validation and maintenance support, the work of your turnkey cleanroom partners spans a wide array of expertise. They work closely with architects, engineers, quality teams as well as facility owners to ensure that every element of your cleanroom meets the standards you and your industry require.
So, what does it mean to have the right modular clean room design partner? It means having a reliable expert team that ensures they deliver a cleanroom compliant with GMP and ISO standards. It means having a technically-sound partner who provides ongoing maintenance and operational support, documentation, and integration expertise when needed.
The very best modular clean room design and build partners also provide solutions that are factory-tested and validated. This includes all the systems in the cleanroom, from the building management system (BMS) and environmental monitoring system to other utility systems and automation platforms. To support validation and keep your cleanroom ready for audits, the ideal modular clean room design and build partner will also take responsibility for all the relevant documentation, including installation, operational and performance qualification (IQ, OQ and PQ).
Continuity is the cornerstone of a fruitful relationship between you and your modular cleanroom design and build partner. This continuity doesn’t concern just the sale; it extends beyond, to the entire life cycle of your modular cleanroom system. It extends to routine maintenance, system upgrades, spare parts availability, and ongoing quality assurance. This is very important when it comes to cleanrooms because compliance failures at any point can cause your operations to face recalls, shutdowns, reputational damage, and/or financial damage. A reliable cleanroom partner will be responsive to regulatory changes, helping you manage risks, remain compliant, and enjoy operational success through the entire lifecycle of your cleanroom.
Now that we’ve established how important it is to have the right partner with you in your modular cleanroom design and build journey, let’s move on to some foundational concepts in the world of modular cleanroom systems.
In part two of this guide to modular clean room design, we’re examining all things modular cleanroom. Cleanroom classifications, design aspects, contamination control, timelines, testing, compliance, and beyond. Stay tuned.
In this part of our guide to choosing the right modular clean room design partner, we’re going beyond what to look for in your partner. Instead, we’re focusing on the foundational concepts of clean room design that you should be familiar with as a buyer. Understanding these concepts yourself will help you make an informed decision as you assess different players in the industry and evaluate their offerings.
Design aspects, layout, and contamination control in modular clean room design.
The best modular clean room designs prioritise contamination control, airflow management, and efficient workflows. Each of these is an umbrella concept, encompassing multiple systems and processes like personnel movement, air filtration systems, and the like. Let’s explore some of these in more detail.
HVAC systems. Good quality HVAC systems are non-negotiable in modular clean room design. In prefabricated or modular cleanrooms, the HVAC system is usually integrated and so it is the responsibility of your cleanroom partner to ensure that it meets your operational and compliance requirements.
The HVAC system in any cleanroom, be it conventional or modular, must incorporate HEPA or ULPA filters to achieve the required levels of air quality by preventing polluting particles from entering the facility. Your HVAC system is also necessary to help you control other aspects of the internal environment of your cleanroom, including humidity and temperature.
Air handling systems are also an integral part of your modular clean room design. Advanced airflow systems not only remove contaminants but they also maintain a positive pressure in critical zones of your facility. This prevents the ingress of contaminants from adjacent spaces inside or outside your facility.
The walls, flooring, equipment and other surfaces must be smooth. The lack of textures and crevices makes cleaning easy, minimising the risk of bacterial growth and ensuring that your cleanroom can meet the required cleanliness standards. Insulated PUF (Polyurethane Foam) panels can be used to provide airtight sealing of the facility as well as thermal insulation; this is important because energy is expensive, and passive methods of maintaining internal conditions can help reduce energy consumption and costs on HVAC.
Documentation, validation, and compliance.
Your modular clean room design and build must comply with the relevant industry regulatory standards. Typically, these are ISO 14644-5, FDA 21 CFR Part 11, EU GMP Annex 1, or USP 797/800. The right clean room design and installation partner will demonstrate knowledge of these global regulatory standards. They will also possess a deep understanding of how these regulatory standards impact every aspect of the modular cleanroom system, from material flow and HVAC design to air exchange rates and materials of construction.
The ideal modular clean room design partner will be able to provide full qualification packages, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. They must be able to supply validation data as well as all the digital records needed for compliance with industry and regulatory body expectations. Having audit-ready documentation as soon as possible helps you accelerate your time to market, enabling rapid facility management and long-term traceability.
Despite being factory-manufactured, modular cleanroom systems are not automatically compliant. Compliance is a continuous process that must be maintained through the lifecycle of the cleanroom. Compliance is not generic. Compliance depends on the modular clean room design, build, validation, and operation within the context of a specific manufacturing process.
On the whole, the right partner for you will support you through this complex process, supporting you through documentation, audits and regulatory walkthroughs, helping you streamline the processes of qualification and audits.
Timelines for the construction of modular cleanroom systems.
When it comes to traditional brick-and-mortar cleanroom construction, the timeline can be fairly long: anywhere between 12 and 24 months, sometimes even longer.
On the other hand, modular cleanroom systems boast of much shorter timelines. Since cleanroom panels are manufactured off-site in a factory, most systems are integrated, on-site construction time is minimal, and documentation and quality assurance don’t have to be held up until after the build, your time to market gets a lot shorter. From the design stage to operational readiness, your modular cleanroom system can be delivered and installed in as little as three to six months, depending on the complexity of your project and the speed of your modular cleanroom manufacturer.
Modular cleanroom system testing.
Cleanroom compliance, as we’ve discussed, is not a one-time process. It’s an ongoing requirement that must be met at installation and operational stages. So, naturally, cleanroom testing must also be a regularly repeated process.
To meet the performance requirements of the industry and regulatory agencies, cleanrooms must identify and comply with different class levels in different states: these levels are as-built, at-rest, and operational. The ISO 14644-3:2005 outlines specific test methods for each of these different stages.
When cleanroom systems are rated and sold, testing and classification is carried out for the as-built category. This means that testing is carried out in an empty room with the filter system running. However, there is no personnel or production equipment in the space.
This is different from testing during operation. When equipment and cleanroom personnel are added to the equation, they will usually introduce some level of contamination. So, a cleanroom rated ISO 6 at rest could be rated ISO 7 during operation.
If at any of these stages, the cleanroom does not meet the relevant standards, you must take corrective steps to meet compliance needs. Whether that involves testing air flow performance, examining production processes or assessing cleanroom personnel strength, your cleanroom design partner may be an active part of the redesign or correction process.
Air flow design and frequency of air changes are important metrics that help you ensure optimal cleanroom performance. Even cleanroom classifications are defined according to the number and size of particles permitted per volume of air in a specified amount of time.
Accordingly, there is a strong relationship between cleanroom class ratings and a cleanroom’s per hour air exchange rate. Essentially, the stricter a cleanroom rating, the more air exchanges become necessary.
As an example, generally, an ISO Class 7 cleanroom must have an air exchange rate of 60 to 150 air changes per hour. The stricter classification, ISO 6, must have more air changes per hour, anywhere between 150 and 240.
These air change rates should be somewhat similar in all the areas within the modular cleanroom system. This means that there shouldn’t be any spots where the air is stagnant and contamination can be allowed to build up.
A more even and vertical air flow is also useful in improving overall air quality in the cleanroom. Moreover, a positive pressure must be maintained in the cleanest areas to prevent the ingress of contaminants from less clean areas. Fan-filter modules (FFMs) are an effective way to upgrade air flow performance in your cleanroom.
What defines the best-in-class modular clean room design and build partner.
Once you have understood what goes into building best-in-class modular cleanroom systems, you can start to make a list of what to look for in a best-in-class cleanroom design partner.
Generally, the right modular clean room design and installation partner for your project will have experience and expertise in your industry. This is important because different industries like biopharmaceutical manufacturing, semiconductors, medical devices, data centres, and other regulated industries that require cleanrooms, have different customer and compliance requirements.
The right modular clean room design and installation partner will also have the design and engineering capability that a project of this scale and complexity requires. This includes multidisciplinary technical depth, like expertise in airflow modelling, automation, pressure cascade design, cleanroom architecture, contamination control, and more.
If you’re looking for a turnkey partner, as you should, you should assess their capabilities to execute the project end-to-end. This includes project management, validation and documentation support, and also after-sales maintenance support.
At the end of the day, your modular cleanroom system project is yours. So, the design and build partner you choose should be able to customise and modularise their offerings to meet the requirements of your specific project. Modular cleanroom systems make this a lot easier because of the flexibility they offer for expansion, upgrades, and relocation.
Meanwhile, your choice of modular clean room design partner can also dramatically improve your chances of long-term success. Because ultimately, setting up a clean room is a collaborative process.
Choosing the right cleanroom partner is not simply a procurement decision. It is a strategic decision that very directly affects your capacity to meet compliance requirements, protect product integrity, and ensure the long-term success and growth of your business.
The right modular clean room design partner does more than build walls and fill a room with equipment. The right partner, a trusted partner, delivers a system and support that aligns with your needs and enables you to focus on other aspects of your business. The right partner helps you build a robust foundation for the sustainable growth of your business.