Cleanroom Medical Device Manufacturing
Excellence in Cleanroom Medical Device Manufacturing at RexMed
Cleanroom Medical Device Manufacturing
What is IT and why is it critical?
At RexMed, we take pride in our expertise in cleanroom manufacturing of medical devices that contribute to better patient care. Our cleanrooms are designed to maintain precise levels of cleanliness, controlling airborne particles, humidity, and temperature, in full alignment with regulatory requirements.
We operate with ISO Class 7 and Class 8 cleanroom environments and follow strict cleaning, hygiene, and air control protocols to support the production of high-quality devices in compliance with industry standards. Our infrastructure and processes ensure contamination is minimized and safety is upheld throughout the manufacturing workflow.
Key Benefits
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ISO 14644-1 Class 7 & 8 Environments
Airborne particle-controlled areas suitable for manufacturing, depending on product risk sensitivity -
Air Quality Management
Cleanrooms use HEPA/ULPA filtration, maintain positive pressure, and achieve the required air changes per hour (ACH) for their classification. -
Environmental Monitoring
Includes regular testing of temperature and humidity (typically 18°C–24°C and 30%–60% RH), surface sampling, and microbial control procedures. -
Cleaning Procedures
Use of approved non-toxic disinfectants, fiber-free materials, and defined SOPs to ensure surface cleanliness and prevent contamination. -
Personnel Hygiene and Gowning
Controlled gowning protocols including gloves, masks, shoe covers, and hairnets; personal hygiene standards are enforced to limit contamination.
Key Factors
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Compliance with Cleanroom Classifications
Facilities should be validated under ISO 14644-1 with procedures suited to the device's risk class. -
Air Handling and Filtration Standards
Proper use of HEPA/ULPA filters, pressure differentials, and required ACH levels per cleanroom class is essential. -
Documented Cleaning and Monitoring Practices
Providers must follow established SOPs and maintain records of environmental conditions and disinfection activities. -
Microbial Control Measures
Routine testing and surface sampling should be conducted to monitor biological contamination levels. -
Personnel Access and Hygiene Controls
Effective gowning, access procedures, and personal hygiene policies are critical to maintaining cleanroom integrity.
Certifications
RexMed's Competitive Edge
RexMed’s cleanroom manufacturing is grounded in robust process control and aligned with global standards such as ISO 13485, FDA regulations (21 CFR 820), and Good Manufacturing Practices. We maintain validated cleanroom environments supported by defined operational protocols, routine environmental monitoring, and cleaning procedures designed to maintain air and surface quality throughout the manufacturing cycle.
Ready to scale your cleanroom production with traceability and dual compliance?
We’ll provide a tailored quote based on your regulatory and operational needs.