Modular Cleanroom
A modular cleanroom for pharmaceutical applications is a controlled environment built using prefabricated panels and integrated air handling systems to meet defined cleanliness standards. It enables faster installation and flexibility compared to conventional construction.
These systems are designed for pharmaceutical manufacturing and laboratory environments, meeting ISO 14644 Class 5–8 requirements and supporting GMP-compliant operations.
Key Features
- Prefabricated modular panel construction
- Faster installation with minimal disruption
- Designed to ISO Class 5, 6, 7, and 8 standards
- Scalable and reconfigurable layout
- Suitable for pharma and controlled environments
Related products
Frequently Asked Questions
A modular cleanroom is a pre-engineered, factory-built controlled environment assembled from standardised panels, framing, HVAC, and filtration components. Designed for pharmaceutical manufacturing, it achieves ISO 5 to ISO 8 and GMP Grade A–D classifications, offering faster installation, lower construction risk, and easier reconfiguration than traditional stick-built cleanrooms.
Modular cleanrooms can be designed and validated to achieve ISO Class 5 through ISO Class 8, corresponding to EU GMP Grades A, B, C, and D. The specific classification depends on HEPA filter coverage, air change rates, pressure differentials, and HVAC design—all engineered to meet FDA, EU GMP Annex 1, and ISO 14644-1 requirements.
Modular cleanrooms typically reduce installation time by 40–60% compared to traditional construction. Factory-fabricated panels, pre-wired electrical systems, and pre-plumbed utilities are assembled on-site in weeks rather than months. Factory acceptance testing (FAT) before delivery further accelerates site qualification, reducing overall time-to-GMP-compliance for pharmaceutical manufacturers.
Yes. Pharmaceutical modular cleanrooms are engineered to comply with FDA 21 CFR Part 211, EU GMP Annex 1, and ISO 14644-1. They include validated HVAC systems, HEPA filtration, pressure cascade control, epoxy-sealed coved joints, and full IQ/OQ/PQ documentation packages to support regulatory submissions and site inspections worldwide.
Pharmaceutical modular cleanrooms use GMP-grade panels with smooth, non-shedding, chemical-resistant surfaces—typically powder-coated steel, aluminium, or fibreglass-reinforced polymer. Coved internal corners prevent particle accumulation. All surfaces must be cleanable with pharmaceutical-grade disinfectants, meeting EU GMP Annex 1 construction material requirements for contamination control.
Yes. Modular cleanrooms are specifically designed for future flexibility. Panels and framing can be disassembled and reconfigured to expand capacity, change room layout, or relocate the entire facility. This adaptability makes modular cleanrooms a cost-effective long-term solution for pharmaceutical companies with evolving production requirements or multiple manufacturing sites.
Pharmaceutical modular cleanrooms use dedicated HVAC systems with HEPA or ULPA terminal filters achieving 99.995% particle capture at ≥0.3 µm. Air change rates range from 20 ACH (Grade D) to 600+ ACH (Grade A). Positive pressure cascades, validated ductwork, and differential pressure monitoring maintain cleanroom classification and prevent cross-contamination between zones.
GMP modular cleanrooms require continuous environmental monitoring including airborne particle counting (ISO 14644-1), viable microbial monitoring (settle plates, active air sampling, surface contact plates), temperature and humidity recording, and differential pressure trending. EU GMP Annex 1 mandates a defined monitoring programme with alert and action limits for each cleanroom grade.
Yes, all our products are designed and sourced to meet international regulatory standards, including GMP, USFDA, EU-GMP, WHO, and other relevant compliance requirements.
Absolutely. Our solutions are engineered for seamless integration with existing systems, ensuring minimal disruption and optimal performance within your current setup.
Yes, our team offers technical consultation to help you choose the most suitable product based on your process requirements, facility design, and compliance needs.
Yes, all our products are aligned with our turnkey execution approach, ensuring compatibility with overall facility design, engineering, and operational requirements.
Yes, we provide customised solutions tailored to your process, capacity, and regulatory requirements to ensure optimal performance and efficiency.
Our products are used across pharmaceutical manufacturing, biotechnology, nutraceuticals, research laboratories, and regulated healthcare environments.
We follow strict quality standards and work with trusted technologies and manufacturing processes to ensure consistent performance, durability, and compliance.
Yes, we offer ongoing technical support to ensure smooth operation, performance optimisation, and long-term reliability of all supplied systems and components.
