In regulated industries such as pharmaceuticals, biotechnology, and advanced manufacturing, a standard cleanroom is rarely sufficient. Every process has unique contamination risks, space constraints, equipment layouts, and personnel workflows. Custom cleanroom projects address these complexities by aligning environmental control with specific operational needs—from the earliest design stages to final validation.
How to define user requirements and URS documents
The foundation of any custom cleanroom projects lies in a well-structured User Requirement Specification (URS). This document captures all client-specific expectations regarding cleanliness classification, process flow, occupancy rates, air change per hour (ACH), pressure differentials, and material/personnel access.
Drafting a clear and comprehensive URS is critical. It involves collaboration between cleanroom engineers, quality assurance professionals, facility managers, and end-users. The URS not only informs the cleanroom’s design but also guides risk assessments and regulatory alignment. It helps stakeholders identify non-negotiable elements—such as compliance with GMP Annex 1, ISO 14644-1, or USP <800>—and define boundaries for customization.
Often, the URS will also include operational constraints like ceiling height, HVAC integration with existing systems, budget considerations, or required scalability for future expansion. The earlier these parameters are defined, the smoother the design process becomes.
Moreover, the URS serves as a contractual and validation reference point throughout the lifecycle of the project. It supports traceability during design qualification (DQ), installation qualification (IQ), and operational qualification (OQ), ensuring that every decision made during execution can be justified and audited. In regulated environments, a well-documented URS is not just good practice—it is often a prerequisite for inspection readiness.
Design and engineering of tailored solutions
Once the URS is finalized and approved, the cleanroom design process moves into the engineering phase. At this stage, architectural layouts, mechanical systems, environmental controls, and utility interfaces are developed in detail to meet the project’s functional and regulatory goals.
Zoning and Layout are essential for maintaining controlled environments. Rooms are organized into classified and non-classified zones based on their function and required cleanliness level. Pressure differentials are planned to create pressure cascades, allowing air to flow from cleaner to less clean areas. This includes incorporating airlocks, changing rooms, and transfer hatches to minimize particulate migration between zones.
HVAC and Air Filtration Systems are engineered according to ISO class targets, occupancy levels, and thermal loads from equipment. Airflow rates, air changes per hour (ACH), and filtration efficiency are calculated to achieve and maintain ISO 14644-compliant air cleanliness. HEPA (High-Efficiency Particulate Air) or ULPA (Ultra-Low Penetration Air) filters are selected based on the particle size and retention required for the intended process.
Material Selection and Construction Methods are defined to ensure durability, cleanability, and compliance with hygiene standards. Surfaces must be smooth, non-shedding, and resistant to repeated cleaning cycles. Modular panel systems—often composed of coated steel, HPL, or stainless steel—enable rapid assembly and easy integration of wall-mounted equipment or utilities.
Utilities and Equipment Integration involves planning the placement and connectivity of critical systems such as lighting, control panels, intercoms, emergency alarms, fan filter units (FFUs), and monitoring sensors. Electrical, plumbing, and HVAC interfaces are coordinated to support a seamless and efficient workflow inside the cleanroom.
To minimize design errors and ensure coordination among trades, advanced tools like BIM (Building Information Modeling) and 3D CAD software are commonly used. These tools help visualize spatial relationships, detect clashes, and simulate airflow dynamics—facilitating a more efficient installation phase and reducing rework on site.
This detailed and collaborative design approach ensures that the resulting cleanroom not only meets operational and compliance requirements but also supports long-term performance and maintainability.
GMP and ISO certification for custom equipment
In regulated industries such as pharmaceuticals, biotechnology, and healthcare manufacturing, cleanroom environments must comply with internationally recognized quality and safety standards. Designing and building a custom cleanroom projects therefore entails rigorous attention to certification requirements and validation protocols.
The most relevant regulatory references include:
GMP (Good Manufacturing Practice): These guidelines, including EU GMP Annex 1, outline requirements for cleanroom construction and operation to safeguard product quality and patient safety. Key topics include airflow directionality, microbial and particulate monitoring, environmental control, and qualification of HVAC systems.
ISO 14644 Series: This standard governs cleanroom classification by airborne particulate cleanliness. ISO 14644-1 defines cleanliness classes based on particle concentration per cubic meter, while ISO 14644-2 specifies the monitoring protocols and frequency to maintain compliance. Together, they establish the foundation for environmental control in a cleanroom setting.
USP <800>: Applicable primarily in healthcare and compounding environments, this U.S.-based guideline mandates engineering controls for handling hazardous drugs. It specifies containment strategies such as the use of negative pressure rooms, externally vented exhaust systems, and closed-system transfer devices to minimize exposure risk.
To meet these standards, all cleanroom equipment—such as air showers, isolators, laminar flow hoods, and filtration systems—must undergo documented validation. This includes Factory Acceptance Testing (FAT) to verify system functionality before shipment, followed by Site Acceptance Testing (SAT) once the equipment is installed on-site. These steps precede Installation Qualification (IQ), Operational Qualification (OQ), and, where required, Performance Qualification (PQ)—each supported by technical documentation and traceable test data.
Integrating compliance from the early design phase reduces risk during inspections and ensures that the facility is ready for production from day one.
Project Workflow and client support
The successful execution of a custom cleanroom projects requires a clearly defined workflow that aligns technical, regulatory, and logistical components. Whether intended for pharmaceutical, research, or industrial use, cleanroom implementation typically unfolds across several key stages:
- Needs Assessment: The process begins with gathering information on the intended processes, required cleanliness class, pressure zoning, utility needs, and available space. Budget constraints and future scalability are also considered.
- Conceptual Design: Based on the input from stakeholders, an initial layout is developed. This includes room classifications, personnel and material flow diagrams, HVAC zoning, and pressure differentials. Attention is given to process segregation, contamination control, and ease of operation.
- Detailed Engineering: Technical drawings, equipment specifications, and integration plans are created. Coordination with HVAC designers, electrical contractors, and automation specialists ensures compatibility across all systems.
- Manufacturing and Assembly: Modular panels, equipment, and supporting systems are prefabricated off-site where possible. Pre-installation testing—including leak checks and mechanical fit assessments—helps reduce errors and delays during final installation.
- Installation and Validation: Cleanroom components are assembled on-site, followed by IQ/OQ testing and environmental monitoring. Final documentation is prepared to support regulatory submissions and inspections. Operational staff are trained to ensure proper handling and maintenance of the facility.
Post-installation support plays a critical role in maintaining cleanroom performance. This includes access to user manuals, requalification services, remote diagnostics, preventive maintenance schedules, and the availability of spare parts. A comprehensive lifecycle approach ensures that cleanroom environments remain compliant and efficient over time.
Case Histories in biotech and advanced therapies
Custom cleanrooms projects are essential in biotechnology and advanced therapy applications, where manufacturing processes are complex, sensitive to contamination, and subject to evolving regulatory scrutiny. Each project presents unique challenges that must be addressed through careful planning and customization.
Gene Therapy Facilities often require high-grade environments, such as Grade A/B clean zones, for activities like viral vector production and aseptic filling. These facilities typically feature unidirectional airflow, high-efficiency HEPA filtration, and robust segregation between upstream and downstream operations to maintain biosafety.
Cell Therapy Laboratories demand flexible, modular configurations that can adapt to changing clinical protocols or process innovations. The integration of single-use bioprocessing systems, cleanroom isolators, and biosafety cabinets helps ensure sterility while supporting ease of reconfiguration. These setups must also support compliance with both GMP and ATMP (Advanced Therapy Medicinal Product) guidelines.
Vaccine Production Sites frequently operate under accelerated timelines, especially during public health emergencies. As such, cleanroom facilities must be fast to deploy while ensuring high-throughput capability and contamination control. These may include negative pressure rooms for attenuated virus handling or dedicated zones for fill-finish operations with high-volume output.
Across these use cases, tailored cleanroom design provides the flexibility, safety, and performance required for successful technology transfer, process scalability, and consistent product quality. A well-engineered solution supports compliance, reduces operational risk, and enhances production efficiency—key priorities in highly innovative and competitive sectors.
Conclusion: building Cleanrooms that fit your process, not the other way around
Custom cleanroom projects are essential when off-the-shelf solutions fall short of regulatory or operational needs. From defining detailed URS documents to navigating complex GMP and ISO standards, every phase must be tailored with precision. The design, engineering, and validation of these environments require a multidisciplinary approach that combines technical expertise with regulatory insight.
Whether the goal is to support advanced therapies, scale up biopharmaceutical production, or manage hazardous compounds safely, a custom-built cleanroom provides the foundation for long-term success. Investing in a solution designed around your specific processes ensures not only compliance—but also efficiency, safety, and adaptability for future innovation.
