Medical Device Cleanroom Services
Cleanrooms offer specifically engineered environments that control and minimize contaminants such as dust, airborne microbes, and aerosol particles to ensure the highest standards of safety, efficacy, and regulatory compliance when manufacturing medical devices. Primo Medical Group is a trusted contract manufacturer for medical devices, providing ISO 7 cleanrooms, ISO 13485 certification, FDA registration, and over 40 years of cleanroom experience.
With cleanroom manufacturing for medical devices integrated into catheter manufacturing, precision machining workflows, electromechanical assemblies, and other stages of our full-service process, we can manage production projects from design through fulfillment to deliver high-performance, superior medical components and critical assemblies.
Want to know how Primo Medical Group’s ISO 7 cleanroom manufacturing for medical devices can support your production projects? Contact us today to discuss your project requirements.
Cleanroom Manufacturing for Medical Devices
ISO 7 cleanrooms provide highly controlled environments that support the production and assembly of critical medical devices and components. They prevent medical product contamination by maintaining specified standards for air quality and particulate control:
- Maximum of 10,000 Particles (≥0.5µm) per Cubic Foot
- Filtration System Coverage of 15–25%
- 30–60 Air Changes per Hour
- Standard Air Flow Rate of 9–16 CFM per Square Foot
Cleanroom Capabilities for Medical Device Manufacturing and Assembly
Primo Medical Group operates over 47,000 sq. ft. of ISO 7 cleanroom environments to support medical device manufacturers with complete solutions. With a staff trained in documented, client-approved processes for both disposable and reusable devices, we provide the following medical device cleanroom services:
- Controlled Assembly
- Cleaning
- Testing
- Packaging
As part of our full-service production processes, our cleanroom capabilities support components from catheter manufacturing and CNC machining workflows, leveraging vertical integration to streamline end-to-end medical device manufacturing with precision, consistency, and contamination prevention.
How Do ISO 7 Cleanrooms Support Medical Device Manufacturing?
For medical device manufacturing, ISO 7 cleanrooms are required to provide a highly controlled environment with limited airborne particles, microbes, and contaminants that could cause infection, device failure, or impact the performance of medical components. Our cleanroom services ensure patient safety and regulatory compliance when manufacturing medical devices that contact the body or have critical functions, and they offer efficiency benefits to improve throughput.
Medical Device Cleanroom Services and Assembly from Primo Medical Group
We offer several medical device cleanroom services, including assembly and packaging for implants, surgical tools, electromechanical devices, and catheter systems. With all work performed by trained personnel following approved documentation, our core capabilities for ISO 7 cleanroom services include essential processes such as:
- Adhesive/Solvent Bonding
- Ultrasonic Welding
- Laser Marking/Welding
- Tensile and Leak Testing
- Anionic Washing
- Tyvek Sealing
Dehydrogenated Ultrasonic Cleaning
To precision-clean medical and aerospace components with complex geometries, we provide dehydrogenated ultrasonic cleaning. This process removes particulate contamination and residues before assembly or packaging, using a dehydrogenated process to avoid hydrogen embrittlement that protects stainless steel, titanium, cobalt chrome, and other exotic materials while supporting cleanliness and performance requirements for regulated devices.
Catheter Manufacturing and Cleanroom Processes
Cleanroom services are designed to support catheter manufacturing and assembly, micro-components, coil winding, braiding, laminating, and tip forming, as well as other critical medical device production processes. We leverage the controlled environment of ISO 7 cleanrooms to maintain catheter quality and performance, offering capabilities including but not limited to:
- Pull-Wire Assemblies
- Flexible Shaft Construction
- Tight-Tolerance Coil Production
Contact Us for Precision Medical Device Cleanroom Manufacturing and Assembly Services
With over seven decades of medical manufacturing expertise, Primo Medical Group provides cleanroom manufacturing for medical devices to support critical applications with high-quality components. Our full-service production processes are vertically integrated to monitor and manage each step of your project—from development to machining, cleaning, assembly, packaging, and logistics—to ensure the quality and performance of medical devices. Through ISO 13485 and FDA-registered processes, we deliver proven performance, reliability, and consistency in regulated industries.
Contact Primo Medical Group for more information about our program-level support or request a quote today.