Medical device manufacturers face strict requirements for cleanliness, sterility, and quality control. At Filtration Technology Inc., we provide cleanroom environments that support the reliable production and inspection of medical devices under strict regulatory standards. Our team brings decades of experience delivering controlled environments for critical applications, including device assembly, sterile packaging, and testing.
As cleanroom manufacturers serving a wide range of industries since 1971, we understand the specific environmental needs of medical device facilities. Our services include cleanroom design, installation, certification, and ongoing support to help companies maintain compliance with evolving standards. We specialize in building ISO Class 7 cleanrooms and USP 797 cleanrooms that meet the strict environmental demands required for safe and consistent medical device production.
Cleanroom Compliance and Regulatory Standards
Medical device production must comply with stringent cleanliness standards to protect patient safety and product integrity. Cleanrooms play a central role in meeting FDA, ISO, and other international guidelines. Our cleanroom solutions are developed with these standards in mind, helping clients align with regulatory expectations.
The USP 797 cleanroom standard is particularly relevant for facilities involved in sterile compounding and aseptic processes. This standard outlines specific conditions such as air change rates, particle counts, and pressure differentials. Filtration Technology builds cleanrooms that meet or exceed these requirements, helping clients support clean handling and contamination control for sterile products.
In addition to USP guidelines, we build ISO Class 7 cleanrooms in accordance with ISO 14644-1 classifications. ISO Class 7 cleanrooms maintain no more than 352,000 particles per cubic meter of air at 0.5 microns and larger. These environments are suitable for various medical device processes, including sub assembly of sterile components, device testing, and packaging. Our cleanroom systems feature high-efficiency particulate air (HEPA) filtration, airflow control systems, and seamless construction techniques to reduce the risk of contamination.
Design and Construction of ISO Class 7 Cleanrooms
ISO Class 7 cleanrooms are often required for clean-critical medical device operations. At Filtration Technology Inc., we offer a range of cleanroom construction options, including modular, softwall, and stick-built designs. Each system is developed to maintain clean conditions and support efficient workflows within a controlled space.
Our modular cleanroom systems offer flexibility for growing medical device companies. These systems allow for easier installation and modifications to support changing production lines or new regulations. Softwall cleanrooms provide a cost-effective solution for operations that need controlled environments without permanent alterations to the facility. For more permanent installations, our hardwall and stick-built cleanrooms offer long-term durability and strict cleanliness control.
Whether the application requires sterile packaging, component assembly, or quality inspection, our cleanroom designs meet ISO Class 7 criteria and can be built to support USP 797 compliance. Clean zones, gowning areas, and airlocks are integrated into each design to help prevent cross-contamination and maintain directional airflow.
Support from Experienced Cleanroom Manufacturers
With more than 50 years of experience, Filtration Technology Inc. has become a trusted name among cleanroom manufacturers. Our team provides start-to-finish support, from conceptual layout and engineering to installation, testing, and certification. We help medical device companies meet deadlines, manage risk, and maintain clean environments that support regulatory compliance.
Our construction process includes site analysis, airflow modeling, equipment integration, and documentation support. We work closely with engineers and facility managers to deliver cleanrooms that meet functional goals while aligning with regulatory requirements. Our experience covers clean environments for a wide range of device types, including surgical tools, catheters, diagnostic equipment, and electronic components.
Modular Cleanrooms for Medical Device Manufacturing
Modular cleanrooms are an efficient way to create controlled spaces for medical device production. These systems are often chosen by manufacturers who require faster deployment and easier reconfiguration. Whether you’re launching a new production line or expanding an existing facility, modular cleanrooms provide the flexibility to adapt without extended downtime.
Our modular systems can be built to meet ISO Class 7 cleanroom standards and configured to align with USP 797 cleanroom requirements. Cleanroom panels, lighting, ceilings, and filtration systems are all selected based on the specific environmental needs of each facility. The result is a high-performance cleanroom that supports sterility and minimizes contamination risk.
Cleanroom environments for medical devices often include pass-through chambers, gowning rooms, air showers, and specialized workstations. We provide all the necessary components and structural elements to create a fully functional space that supports critical manufacturing and testing operations.
Cleanroom Equipment and Integration
In addition to cleanroom construction, we supply a complete line of equipment and furnishings required for cleanroom operations. This includes stainless steel tables and cabinets, laminar flow hoods, clean benches, and gowning furniture. These items are selected for compatibility with cleanroom environments and can be configured to support specific processes.
Lighting options include cleanroom-grade LED fixtures, teardrop lighting, and flo-thru lighting that maintain performance while reducing particle buildup. Each component is chosen to minimize contamination and support ease of cleaning. For facilities operating under USP 797 guidelines, we also offer cleanroom pass-throughs, carts, and shelving designed to support aseptic workflows.
Filtration Technology Inc. works with top manufacturers to integrate these components seamlessly into the cleanroom environment. Our attention to air circulation, workspace configuration, and equipment placement helps medical device manufacturers optimize both cleanliness and productivity.
Certification and Performance Testing
Once a cleanroom is installed, we provide thorough certification and testing services to verify performance and compliance. Cleanrooms are tested for particle counts, airflow patterns, pressure differentials, and HEPA filter integrity. We use calibrated instruments and established protocols to assess cleanroom function based on ISO 14644 and USP 797 standards.
Our services include:
- Particle count testing
- Airflow visualization
- Filter leak detection
- Temperature and humidity mapping
- Pressure balancing and verification
These tests provide assurance that the cleanroom meets the intended cleanliness level and supports product quality. We also offer routine maintenance testing to help facilities retain certification over time.
Why Choose Filtration Technology Inc.
Our experience, technical knowledge, and long history of delivering high-quality cleanrooms make us a reliable partner for medical device manufacturers. We understand the critical nature of clean environments in this field and apply that understanding to every project. Our cleanrooms meet industry standards, support regulatory compliance, and help protect patient safety.
From ISO Class 7 cleanroom design to USP 797 cleanroom certification, our team supports every step of the cleanroom lifecycle. We are based in Greensboro, North Carolina, and serve clients nationwide with engineering-driven solutions and dependable customer support.
To learn more or request a project consultation, please feel free to contact us.