Clean Room Design Guidance
Compliant. Controlled. Ready for FDA.
At Operon Strategist, we help US-based medical device manufacturers build, validate, and maintain clean rooms that meet FDA and ISO standards. Whether you’re setting up your first clean room or upgrading an existing facility, our experts deliver turnkey consulting tailored to your product, process, and compliance needs.
What Is a Clean Room in Medical Device Manufacturing?
A clean room is a controlled environment where airborne particles, microbes, humidity, and temperature are regulated to prevent contamination. These rooms are essential for manufacturing medical devices safely and in compliance with strict quality standards.
In the USA, medical device clean rooms must comply with ISO 14644 classifications and support the requirements of FDA 21 CFR Part 820 and ISO 13485.
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Why Medical Device Manufacturers in the USA Need Clean Rooms
Clean rooms are critical to protecting product integrity and ensuring patient safety. Even microscopic contaminants can lead to product failure or regulatory rejection. That’s why FDA requires certain devices—especially Class II and Class III—to be manufactured in controlled environments.
Our consulting ensures your clean room:
US Regulatory Requirements for Clean Rooms
Medical device manufacturers in the USA are subject to stringent federal regulations. Operon Strategist helps you align with:
- FDA 21 CFR Part 820 (QSR)
- ISO 13485:2016
- ISO 14644-1: Clean Room Classification
We also ensure your clean room design supports 510(k), PMA, or MDSAP certification goals.
Our Clean Room Consulting Services Include:
- Site Layout & Room Design – AutoCAD-supported planning for airflow, zoning, personnel/material flow
- Clean Room Classification (ISO 7, 8, etc.) – Based on device risk class and production needs
- Validation & Documentation – Support for URS, DQ, IQ, OQ, PQ as per FDA & ISO 13485
- Environmental Control Setup – HVAC system guidance, temperature/humidity control, pressure differentials
- Gowning & Entry Protocols – SOPs to maintain contamination-free operations
- Audit & Inspection Readiness – Ensure you’re always prepared for an FDA inspection or notified body audit
Why Choose Operon Strategist?
- 15+ years of global regulatory expertise
- Proven success with clean room projects for US startups and OEMs
- Turnkey planning – from concept to validation
- Engineering + regulatory insight in one team
- Custom solutions tailored to product risk class and volume
Let’s Build Your Clean Room—The Right Way
Whether you’re launching a new manufacturing facility or updating an existing setup to meet US compliance standards, Operon Strategist is your clean room consulting partner.
Contact Us today for a consultation to begin clean room planning.