Medical Device Cleanroom Construction
Precision, compliance, and contamination control are essential when manufacturing medical devices. At Ultrapure Technology, we specialize in medical device cleanroom construction that meets ISO 14644, GMP, and FDA standards — ensuring every product is manufactured in a controlled, validated environment.
Our cleanroom solutions are designed to support all stages of medical device production — from prototyping and assembly to testing and packaging. We integrate modular wall systems, HEPA/ULPA filtration, and environmental controls to maintain consistent air quality, temperature, and humidity.
Whether you’re producing implants, surgical instruments, diagnostic tools, or electronic devices, Ultrapure ensures your cleanroom meets the exact regulatory requirements for Class I, II, and III medical devices. Every project is built for long-term performance, easy maintenance, and audit-ready documentation.
Ultrapure Technology helps medical device manufacturers build cleaner, safer, and more efficient production environments — enabling innovation with confidence and compliance.
Building Medical Device Cleanrooms That Protect Quality and Patient Safety
The medical device industry operates with zero room for error — every product you make must be clean, precise, and fully compliant. At Ultrapure Technology, we build medical device cleanrooms that meet the strictest requirements of FDA, ISO 14644, and GMP regulations.
Our cleanrooms support the entire lifecycle of medical device production — from design and assembly to packaging and sterilization. Whether you need a compact Class 8 assembly space or a large ISO 5 production area, our team delivers facilities that combine reliability, efficiency, and long-term value.
Medical Device Cleanrooms Built Around How You Work
No two medical device manufacturers operate the same way. That’s why we design each cleanroom around your workflow, equipment layout, and regulatory goals.
We start by learning what you build — implants, diagnostic tools, tubing, or surgical components — and then design a controlled environment that keeps every product safe and compliant.
Our projects follow global standards, including:
- ISO 14644-1 for cleanroom classification
- FDA 21 CFR Part 820 for device manufacturing controls
- ISO 13485 for quality management systems
- EU GMP Annex 1 for sterile operations
You get a space engineered not just to pass inspections — but to make day-to-day work smoother and safer.
Our End-to-End Medical Device Cleanroom Construction Services
We take care of every stage — from early design through validation — so you can focus on your core production.
Planning and Design
Before we build, we design your cleanroom layout around product flow, gowning areas, and sterilization zones.
We consider:
- Airflow direction and pressure balance
- Utility and equipment placement
- Personnel and material movement paths
- Expansion plans for future production
Our design team blends technical expertise with practical insight, creating cleanrooms that work as efficiently as they are compliant.
Modular Construction Systems
We use high-performance modular wall and ceiling systems that are durable, easy to clean, and customizable for different ISO classes.
- Non-porous, smooth surfaces for easy sanitization
- Flush windows and sealed junctions to prevent contamination
- Wall finishes that resist impact and chemicals
- Rapid installation to minimize downtime
Modular cleanrooms also make upgrades and relocations simple — saving time and cost in the long run.
Environmental and Air Handling Systems
Clean air defines cleanroom performance. Our HVAC and filtration systems maintain consistent environmental conditions 24/7.
- HEPA/ULPA filtration for ISO 5–8 environments
- Temperature and humidity control for sensitive devices
- Differential pressure alarms and continuous monitoring
- Optional BMS integration for automated reporting
We make sure your cleanroom performs as expected — every shift, every product, every inspection.
Electrical, Lighting, and Controls
Lighting and electrical design directly affect worker accuracy and safety.
Our systems include:
- Bright, low-glare LED fixtures for cleanroom environments
- Power isolation for delicate instruments
- Motion-sensing and energy-efficient lighting options
- Access-control and emergency backup systems
Everything is installed with precision and verified for compliance before hand-over.
Cleanrooms for Every Medical Device Application
Our team has designed and built environments for a wide range of medical and life science applications:
- Catheter, tubing, and connector manufacturing
- Implant and surgical device production
- Diagnostic and imaging equipment assembly
- Sterile packaging and labeling areas
- Sensor, micro-device, and circuit integration
From startup facilities to large-scale manufacturing plants, we customize every project to your production needs.
Our Commitment to Compliance and Quality
Every project we complete follows the same principle: build once, validate easily, perform consistently.
We adhere to:
- ISO 14644-1 cleanliness classifications
- FDA 21 CFR Part 820 quality system regulations
- GMP and ISO 13485 quality management systems
- USP <797>/<800> for sterile handling where needed
Each cleanroom comes with full traceability of materials, finishes, and filters — ready for third-party validation or regulatory review.
Why Choose Ultrapure
Building a compliant cleanroom takes more than just construction — it takes understanding.
That’s what our clients appreciate most about Ultrapure Technology.
Deep industry knowledge
Over two decades working with medical device standards
Seamless project delivery
One partner from design to validation
Modular flexibility
Cleanrooms that grow with your operatio
Audit-ready quality
Every build documented for compliance
Global standards expertise
FDA, ISO, GMP, and EU Annex 1 alignment
Our mission is simple — create cleanrooms that protect both your products and your reputation.
Partner With Ultrapure Technology
Your cleanroom is more than a workspace — it’s where safety, precision, and innovation come together. With Ultrapure Technology, you get a partner who understands the importance of both performance and compliance.
Let’s start building your medical device cleanroom. 👉Contact Ultrapure Technology today to discuss your project and see why clients across the country choose Ultrapure Technology for precision-built, compliant cleanrooms.