The critical role of modular cleanrooms in pharmaceutical production
In the pharmaceutical industry, maintaining strict control over manufacturing environments is crucial to producing safe and effective health products. Cleanrooms – specialized environments that help prevent contamination during drug production – are essential to this goal.
Historically, cleanrooms have relied on traditional stick-built construction. However, with ever-evolving regulations and market demands, modular cleanrooms have emerged as an essential solution for modern pharmaceutical manufacturing. In early 2025, industry players have even predicted that modular and prefabricated cleanroom solutions will be one of the most prominent trends in cleanroom construction for the year, especially in rapidly growing sectors like nanotechnology and gene therapy.
Whether you’re in the biopharmaceutical, biotechnology, medical device manufacturing or any other related industry, and you’re looking to set up a cleanroom, we, at PodTech™, highly recommend that you opt for a modular cleanroom. Not only does modularity offer unparalleled benefits in terms of production efficiency, but it also shortens your timelines and lowers your CAPEX.
If you’re new to the world of cleanrooms and/or modular systems in high-cleanliness manufacturing, this post will help you understand why you should go the modular or prefab route.
Understanding cleanroom classifications.
The level of air cleanliness, specifically the number of airborne particles allowed per cubic meter, determines the category of the cleanroom. This classification system, provided by the International Organization for Standardization (ISO), spans from ISO 1, which represents the cleanest environment, to ISO 9. Different pharmaceutical products require specific levels of cleanliness to ensure safety and effectiveness, so determining the appropriate cleanroom classification is critical for manufacturers.
Airflow systems are vital to controlling cleanliness. For example, higher-class environments use laminar airflow to ensure uniform, contaminant-free air distribution. In less demanding cleanroom classes, one may use turbulent airflow systems which, while less stringent, still help control contamination to an acceptable degree.
Why certification and compliance matter.
Pharmaceutical facilities must meet stringent regulatory standards, such as those set by the United States Food and Drug Administration (US FDA) or the European Medicines Agency (EMA), to ensure compliance. Certification of cleanrooms is a critical step in demonstrating that the environment meets necessary cleanliness and safety standards. This includes rigorous testing for particle counts, air velocity, and airflow patterns. Periodic audits and recertifications help ensure ongoing compliance, providing reassurance that the facility maintains its operational integrity and adheres to the highest safety standards.
The benefits of modular cleanrooms in biopharma manufacturing.
Streamlined construction process. Constructing a traditional cleanroom can be both time-consuming and heavy on the pocket. Modular cleanrooms simplify the process by utilising pre-engineered components, which allow for faster installation and lower on-site labour requirements. This means that pharmaceutical facilities can maintain production schedules with minimal disruption. Moreover, modular systems are an economical choice as they reduce the need for extensive site preparation and minimise material waste.
Modular cleanroom systems are also versatile — prefabricated units can be relocated or repurposed, offering long-term value and flexibility for not only pharma manufacturers but also those involved in healthcare delivery. Even health sector stakeholders who eventually build traditional facilities find modular cleanrooms particularly valuable when testing new production processes before committing to permanent infrastructure changes.
Adaptable design for evolving needs. One of the major advantages of modular cleanrooms is their flexibility. Unlike traditional cleanroom setups, which can be complex and costly to modify, modular cleanrooms can be easily reconfigured to meet changing production requirements. Whether you’re expanding capacity, incorporating new equipment or upgrading existing systems, modular designs offer the ability to adapt quickly without extensive downtime.
Additionally, with a partner like PodTech™, you can customise your modular cleanrooms to allow for the inclusion of specific equipment, such as isolators and biosafety cabinets. This enables you to optimise every aspect of your cleanroom environment for your facility’s specific production needs.
Precision environmental control. Biopharmaceutical manufacturing demands precise control over airflow, temperature, humidity, particulate matter concentration in the air, and other environmental factors. Modular cleanrooms, like the ones we make at PodTech™, are equipped with integrated air handling and HVAC systems designed to meet your specific environmental requirements. These systems ensure consistent airflow, temperature, and humidity levels, which are essential for the stability of both the products and testing processes.
Advanced filtration systems, including HEPA and ULPA filters, are also integral to maintaining cleanroom standards. These filters are capable of capturing particles as small as 0.3 microns, creating a contaminant-free environment critical for pharmaceutical production. Most importantly, for sustainable operations in a time of climate change and energy transition, efficient air filtration and circulation contribute to energy savings by minimising unnecessary air recirculation.
Ongoing monitoring and maintenance. Certification is not a one-time process — it requires ongoing monitoring to ensure that cleanrooms continue to meet the necessary standards. Regular particle count analysis, air quality assessments, and filtration checks are essential for maintaining a clean environment. Automated monitoring and quality assurance systems are increasingly used in modern cleanrooms to provide real-time data on air as well as product quality, enabling quick adjustments when needed. Many PodTech™ systems are built with integrated quality assurance mechanisms to ensure the integrity of every step in your production process.
The role of your process engineering partner.
Effective project management is a key factor in successful cleanroom construction. Working with experienced process engineers ensures that all aspects of the cleanroom – from the walls and the HVAC system to the insulation and waste management mechanism – meet stringent compliance standards. It also ensures that you have access to networks and information which can help you reduce your time to market.
Through effective designs and systems, your process engineering partner also plays an important role in validation and compliance with good manufacturing practices (GMP). Validation is an ongoing process in pharmaceutical cleanroom management. It involves comprehensive testing to ensure that the cleanroom environment is functioning as intended and maintaining its designated classification. This process includes airflow and filter tests, particle count evaluations, and other critical assessments.
Compliance with GMP is essential for ensuring that pharmaceutical products are consistently produced in a controlled, sterile environment. To achieve this, it is important that biopharma manufacturers collaborate with their engineering partners in training staff on the importance of cleanroom protocols; this helps reduce the risks of contamination, safety risks, and product recalls. Moreover, continuous validation guarantees that pharmaceutical facilities remain in full compliance with industry standards.
Achieve international standards with PodTech™’s cleanroom solutions.
At PodTech™, we specialize in modular cleanroom solutions that are designed to meet the unique needs of the biopharmaceutical industry. With a focus on highly efficient cleanroom design, HVAC systems, fire suppression, double insulation, weatherproof construction, and environmental controls, we create customisable cleanroom environments that help pharmaceutical companies ensure compliance with the most stringent regulations.
Our expert team is dedicated to delivering efficient, cost-effective, and high-quality cleanroom solutions. Whether you’re looking to build a new cleanroom, upgrade existing systems, or ensure regulatory compliance, PodTech™ has the expertise to support your project, from start to finish.
For support on your next cleanroom project, contact us today. You’ll find that we can help you maintain the highest standards in pharmaceutical manufacturing.