ISO 7 Cleanroom Manufacturing, Assembly, and Packaging Services
Also known as Class 10,000 cleanrooms, ISO 7 cleanrooms provide controlled environments for medical manufacturing processes. Their strict environmental controls ensure product sterility and integrity, minimizing contamination to guarantee regulatory compliance with the necessary standards for manufacturing surgical tools, components, and other medical products. Supported by ISO 13485:2016 certification, Primo Medical Group offers comprehensive production, assembly, and testing of medical products in a cleanroom environment.
For more information on our cleanroom capabilities, contact us, and one of our representatives will be happy to answer any questions you may have.
What is an ISO Class 7 Cleanroom?
ISO 7 cleanrooms are controlled environments that limit airborne particles to no more than 10,000 per cubic foot. As a designated space with specific environmental parameters, such as temperature, humidity, lighting, and air pressure, that are regulated and kept within precise limits, they utilize HEPA filtration, airflow, and pressure control systems to maintain standards. Cleanrooms offer an ideal blend of cleanliness and manufacturing efficiency to produce compliant medical devices for a range of applications.
Our Cleanroom Capabilities and Services
With a cleanroom staff extensively trained in processing both disposable and reusable medical devices, we can perform a range of cleanroom assembly and packaging services to meet your needs. Each process is governed by product- and client-specific documentation, and clients must approve all processes before initial production begins, with any changes to assembly procedures also requiring pre-approval. Our selection of cleanroom assembly and packaging services includes:
Assembly Processes
- Full component assembly
- Sub-assembly
Joining Capabilities
- Ultrasonic welding
- Adhesive bonding
- Laser welding
Testing Procedures
- In-line tensile testing
- Leak testing
- Burst testing
Packaging Services
- Tyvek pouching
- Sealing
- Custom labeling
Contamination Control and Cleanroom Environment Specifications
To meet the strict environmental requirements of ISO 7 cleanrooms, various systems are in place to create the necessary controlled conditions. ISO 7 cleanrooms environmental specifications are as follows:
- HEPA or ULPA-filtered air supply with 30-60 air changes per hour
- Controlled airflow and positive air pressure maintenance to push out and prevent the entry of external contaminants
- Stable temperature and humidity levels to reduce the generation of particles and ensure a consistent environment
- Gowning procedures that include cleanroom suits, gloves, masks, head and shoe coverings, and other protective gear to minimize the introduction of contaminants from outside of the cleanroom
- Airlocks, typically ISO 8 anterooms or gowning rooms, to create buffer zones that maintain cleanliness, pressure differentials, and minimize particle transfer with controlled access
All procedures and systems work together to uphold the controlled environment requirements, making each factor crucial to the success of cleanroom operations.
Applications of ISO 7 Cleanroom Manufacturing Services
ISO 7 cleanroom manufacturing, assembly, and packaging services are designed to support the production of compliant medical devices and surgical components. Offering solutions for precise, contamination-sensitive products, they can also be used for applications in the following industries:
- Pharmaceuticals
- Electronics
- Aerospace
Why Use Cleanroom Manufacturing for Medical Devices?
Medical device cleanroom manufacturing is essential to the success and quality of medical products. These processes prevent contamination that can lead to product failure while ensuring regulatory compliance and improving product consistency and reliability. With cleanroom operations, we can support complex, high-precision assemblies with the environment they need to succeed.
Quality and Compliance with Primo Medical Group
Primo Medical Group is ISO 13485:2016 certified with adherence to GMP (good manufacturing practices) and regulatory standards, providing comprehensive cleanroom services for medical device manufacturing. Our services include documented, validated processes with client approvals at every stage to deliver strict quality control focused on consistency, traceability, and risk reduction for high-quality medical products. With over 47,000 sq. ft. of ISO 7 cleanroom space and 45+ years of experience in medical device manufacturing, our trained cleanroom staff follows controlled procedures and protocols to provide end-to-end capabilities that meet your needs.
Contact Us for ISO 7 Cleanroom Manufacturing, Assembly, and Packaging Today
With decades of experience in medical device development, Primo Medical Group provides contract manufacturing, advanced machining, and other capabilities to produce high-performance solutions. Our certifications, cleanroom capabilities, and comprehensive technology allow us to fulfill your project requirements with cleanroom manufacturing solutions that can consistently meet or exceed expectations across a range of applications and services. Contact Primo Medical Group to discuss your project today or request a quote to get started.