But the rate at which technology advances means these controlled environments continually require reconfiguration or adaptation to support the process changes or allow for increased output.
Whether to meet changing ISO compliance regulations or increase capacity, manufacturers can future-proof elements of their cleanroom design from the outset to avoid repeated financial outlays.
Our Managing Director, Mark Davey, explores the factors that should inform the design stage to ensure long-term success.
Traditional large-scale cleanrooms are extremely expensive to build, and CapEX for the initial phases to get into production may not stretch to considering and providing for expansion in the future. This makes upgrades more difficult to implement down the line.
Concept and design workshops focusing on current and future needs will greatly assist in the decision-making process and help reduce costs when progressing to later phases in the facility’s lifecycle.
The type, classification and scale of the cleanroom should all be analysed at the earliest opportunity to provide the best-suited configuration for the customer’s product.
Depending on product type, a smaller-scale manufacturer may benefit from a much more bespoke and tailored solution. Modular cleanrooms use prefabricated wall systems and panelling, allowing quick expansions or layout adjustments, giving the small producer a cost-effective expansion route. Housing gas, power, and data connections within accessible conduits in the wall also makes future upgrades easier and less disruptive.
It’s not just the structure itself that needs to be scalable. Air Handling Units (AHUs) must have additional capacity at the point of installation if they are to adapt to stricter air quality regulations that may come into force. This becomes inefficient with cleanrooms of thousands of square meters, but is more simply achieved with a self-contained modular cleanroom with its own HVAC plant sized only for its environmental conditions.
Cleanroom environments require constant monitoring to maintain compliance. Emerging technologies like IoT sensors and AI-driven analytics are changing maintenance and operational efficiency for the better.
IoT sensors continuously track temperature, humidity, particle levels, and pressure to ensure adherence to particular ISO standards.
AI-driven analytics can also detect early warning signs of equipment failure, helping to prevent costly downtime and financial losses related to reduced manufacturing output.
Cleanrooms are among the most energy-intensive environments. For example, cleanrooms consume up to 25 times more energy in the UK than in non-classified rooms. HVAC systems account for 50-75% of electricity consumption due to high airflow requirements for specific ISO classes.
Industries where cleanrooms are commonplace will continue to be under increasing scrutiny when it comes to sustainability. Integrating energy-efficient solutions from the outset is crucial, and ISO 14644-16 focuses on best practice for cleanrooms and associated environments.
HEPA and ULPA filters with longer lifespans reduce maintenance costs and waste. Variable Frequency Drives (VFDs) can also optimise the performance of HVAC systems by adjusting air handling speeds based on real-time load demand.
Small improvements in a number of areas can make a big difference overall and help avoid costly improvements further down the line.
With today's high energy costs, renewable energy solutions, such as solar panels, have become more viable to reduce OpEX with the added attraction of lowering their carbon footprint further.
Automation is transforming cleanroom operations, reducing contamination risks, and enhancing efficiency. For example, Automated Material Handling Systems can transport materials without introducing human-borne contaminants. This improves cleanliness and efficiency.
Investing in Collaborative Robots (Cobots) to work alongside human operators also helps maintain strict cleanliness standards while assisting with repetitive tasks. However, this does introduce the need for overhead support structures.
Cleanroom compliance is a moving target. Evolving regulations demand continuous adaptation, and this has been the case since standards for cleanroom classification and monitoring were first established in 1963 via US Federal Standard 209E. It wasn’t until 1992 that ANSI and the Institute of Environmental Sciences and Technology (IEST) petitioned the International Organisation for Standardisation (ISO) for a new standard that could be used by companies globally.
Seven years in the making, ISO 14644-1 was the first international standard to deal with cleanliness classifications and was first published in 1999. By 2001, most nations had adopted the new standard, and the US declared FS209E ‘cancelled and superseded’ in November of that year.
This standard is now divided into 18 sections covering classification, specification, design, construction and start-up, test methods, operations, cleaning, equipment and materials selection, consumables and energy efficiency, to which users are expected to comply.
One way to minimise the impact of regulatory changes is to design cleanrooms to surpass current ISO standards, mitigating the need for frequent updates. If global product expansion is also in the pipeline, align with multiple regulatory bodies to ensure readiness for international markets.
Given the increasing scrutiny in pharmaceuticals and biotech, in particular, a proactive regulatory approach is essential to avoid costly disruptions.
As cleanroom technologies evolve, businesses that invest in future-proofing today will be better positioned to handle industry shifts with minimal disruptions. The bottom line? A well-designed cleanroom isn’t just an expense - it’s a long-term investment in operational excellence.
Finding an engineering firm, like Northern Engineering Solutions, that can strategically design a cleanroom with today's and tomorrow’s needs in mind is money well spent.
