2024 Emerging Trends In Cleanroom Technologies

By Damini Pawar, senior associate – healthcare, MarketsandMarkets

As we all know, cleanrooms are specialized environments with controlled levels of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. In the pharmaceutical and biotechnology industries, they are essential for maintaining the sterility and integrity of the research and production process. Cleanrooms are defined by their cleanliness classification, which is determined by the number of particles per cubic meter at a specified particle size. In this article, I share key findings from our recent market research report on cleanroom technologies.

4 Cleanroom Technology Trends Expected To Shake Up The Industry Landscape

1. Automated Operational Processes

Automation is transforming cleanroom operations with smooth processes and the need for fewer people for manual work. This technological progress uses robotics, intelligent control, and automation to increase efficiencies and preciseness.

Robotic arms have applications in delicate handling of parts that are sensitive in nature to ensure accuracy with minimal chances of contamination. Automation in manufacturing and systems of material handling reduces logistics time, leading to directed goods movement with minimal idle times.

Faster processes and reduced cycle times lead to improved efficiency. This, in turn, increases productivity and cuts costs. Automation of processes also prevents human-made errors and elevates the quality of products.

2. Advanced Sensors And IoT Devices

Real-time data visibility is important within a controlled environment, such as a cleanroom, for detecting any deviations from the ideal condition and acting promptly. Monitoring the key parameters of the process in real time opens the ability to react immediately to deviations, decreasing the risks of contamination and producing better-quality products.

The recent technologies available in data monitoring, such as sensors and IoT devices, have changed the manner of data collection within cleanrooms. The various critical factors, like particle levels apart from the temperature and humidity, can be very precisely monitored with sensors. The advanced IoT devices make data analysis easier, and predictive maintenance can drive continuous improvement.

3. Dehumidifiers And Desiccant Systems

Cleanrooms require very fine environmental settings — for instance, humidity — to ensure that operations run perfectly for the best quality products. Too high a level of moisture can induce mold growth, equipment rusting, and poor-quality products. Dehumidifiers play an essential role in such respects, keeping at bay such dangers through proper regulation of the levels of humidity, thereby assuring a stable and constant atmosphere for the operation of the cleanrooms.

Modern dehumidifiers are made from energy-efficient components, which efficiently and economically control humidity in cleanrooms. Designs for these dehumidifiers use available energy efficiently through variable-speed compressors and smart humidity sensors, plus other customized settings to maximize the energy efficiency for highly accurate control over humidity levels.

4. Energy-Saving Technologies

Cleanroom applications are slowly drifting toward more sustainability and energy efficiency, both to limit environmental impact and reduce operational costs. Among some of the energy-efficient technologies applied in cleanrooms are LED lighting and state-of-the-art HVAC systems.

Two primary benefits of LED lighting, an alternative to traditional lighting methods, are reduced energy consumption and prolonged service life. Intelligent control in HVAC systems keeps conditions at the optimum while being considerate of energy usage to maximize energy efficiency.

Characteristics And Needs Of Cleanroom Technologies In Pharma Vs. Biotech

Pharmaceutical Industry

Cleanrooms are environments with controlled parameters such as temperature and pressure, humidity and air filtration, where tests and/or product manufacturing are carried out. Thus, the insertion, generation, and retention of particles and the contamination of people and products are minimized as much as possible. In the pharmaceutical industry, cleanrooms are of fundamental importance because they prevent particles present in the air from altering the microbiological and physical qualities of inputs and medicines.

Cleanrooms, therefore, must ensure maximum cleanliness and minimum contamination in the air in products, equipment, and even on surfaces such as walls, ceilings, and floors, which must avoid the accumulation of dirt and be easy to clean and maintain. The fundamental technical requirements for a cleanroom made for pharmaceutical use include the cleanliness criteria established by the classes in the ISO 14644 standard (ISO 1 to ISO 9), as well as operating parameters such as the number of particles per m³, temperature, pressure, and humidity.

Biotechnology Industry

Biotech cleanrooms enable biotechnology research by maintaining highly controlled environments. Biotech cleanrooms frequently need to adhere to strict cleanroom classifications as well as follow industry-specific regulations for product quality and process.

Most biotech cleanrooms must comply with the ISO 14644-1 cleanroom classifications of Class 5 or less. (As the classes descend from 9 to 1, the cleanroom must be more and more “clean”, with ISO Class 1 being the strictest standard with the cleanest possible environment.)

ISO Class 5 is considered to be an extremely stringent classification standard. Most cleanrooms fall in ISO Classes 7 or 8, which require moderate control over particle count and size. They must routinely change the air to cleanse it for particulate matter and regulate other environmental factors like temperature and humidity. ISO Class 5 must do all these things to a higher degree. It allows a maximum of 3,520 particles of 5 µm or larger and the air must be changed a specified number of times per hour, with the constant flow described as the air velocity of 40 feet to 80 feet per minute.

Regional Trends In Adoption Of Cleanroom Technologies

Pharma and biotech companies in emerging economies such as India and China are expected to grow their adoption of cleanroom technologies in the coming years. The cost of cleanroom technologies is 30%–35% lower in India compared to the U.S. Similarly, in China, the cost of cleanroom technologies is 35%–40% lower than in the U.S. In addition to lower manufacturing costs, markets in developing countries are characterized by the presence of lenient and flexible environmental regulations related to cleanroom technologies’ production capacities. The industry can take advantage of this to scale up production, productivity, and efficiency. But in order to realize this potential, companies must use economies of scale.

In the U.S. and Canada, the effective regulatory systems in these two North American countries are major factors in driving the use of cleanrooms.

In Europe, tight regulatory requirements have accelerated the acceptance of state-of-the-art cleanroom solutions to deliver the contamination-free environment required during manufacturing and research activities. In this region, pharma and biotech companies are particularly looking to use modular cleanrooms coupled with the integration of digital monitoring systems.

Prominent Players And Recent Developments

The prominent players in the active pharmaceutical ingredient market include Azbil (Japan), Kimberly-Clark (U.S.), Ardmac (Ireland), Clean Air Products (U.S.), Labconco (U.S.), Dynarex (U.S.), DuPont de Nemours (U.S.), Illinois Tool Works (U.S.), Taikisha (Japan), Exyte AG (Germany), COLANDIS GmbH (Germany), ABN Cleanroom Technology (Belgium), Clean Rooms International (U.S.), Bouygues Group (France), Terra Universal (U.S.), Angstrom Technology (U.S.), Camfil (Sweden), OCTANORM-Vertriebs-GmbH (Germany), Parteco srl (Italy), Airtech Japan, (Japan), Berkshire (U.S.), AIRPLAN (Spain), Clean Air Technology (U.S.), Weiss Technik (Germany), and Atlas Environments (U.K.).

These players have adopted strategies such as agreements, collaborations, product launches, technology advancements, partnerships, acquisitions, and expansions to expand their global presence and increase their shares in the cleanroom technologies market. Some of their strategic initiatives are given below:

• In April 2024, Labconco was awarded a national group purchasing agreement for clinical and laboratory products with Premier.
• In March 2024, ABN Cleanroom Technology announced the launch of ABN Labs. This expansion maximizes its capabilities and enhances cleanroom technology offerings in controlled environments.
• In July 2023, Labconco announced the launch of the Nexus Horizontal Clean Bench, the first laminar flow hood of its kind with complete onboard intelligence.
• In May 2023, Camfil opened a new production plant in Taicang, near Shanghai, China, to meet the growing demand for air filtration solutions in China and the Asia-Pacific region.
• In April 2023, ABN Cleanroom Technology launched the first ready-to-use low dewpoint cleanroom solution in Europe.
• In October 2022, Bouygues Energies & Services, a subsidiary of Bouygues Construction, successfully delivered a manufacturing cleanroom facility to Novanta (U.S.) in Taunton, England.
• In October 2022, Labconco entered into an exclusive agreement with Erlab. Under this agreement, Labconco will enhance the effectiveness of its products by using Erlab’s filtration technology in fume hoods.
• In June 2022, ABN Technology launched the first off-the-shell cleanroom solution that can reach cleanliness classifications up to ISO Class 4 and cGMP grade B.
• In February 2022, Angstrom Technology acquired Specific Environments Limited (U.K.), a cleanroom company, to strengthen its presence in the European market and expand its product offerings.
• In January 2022, Angstrom Technology acquired Connect 2 Cleanrooms to strengthen its presence in the European market and expand its product offerings.
• In January 2022, Clean Rooms International launched Flow-Thru Light Troffer.

The cleanroom technologies market is estimated at $8.18 billion in 2023 and is projected to reach $11.39 billion by 2028 with a CAGR of 6.8%. The increasing demand for certified products, advancements in cleanroom technologies, growing prevalence of infectious diseases, and rising demand for sterilized pharmaceutical products are some of the factors driving the growth of the market.

About The Author:

Damini Pawar is a senior associate (healthcare) at MarketsandMarkets. She earned her master’s in biotechnology with a specialization in oncology. With expertise in market assessment, market sizing and forecasting, end user perception analysis, and opportunity analysis, she has worked on the growth engagements across the biotechnological industry, veterinary market, and contract research and manufacturing markets.