ISO 13485 / GMP / FDA-Compliant Cleanroom Systems
End-to-end cleanroom design, manufacturing,and installation for medical device production and assembly.
- 1.ISO 14644 / ISO 13485 Compliant
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2.Modular & Fast Deployment
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3.Global Certifications: CE / UL / ISO
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4.Designed for FDA & GMP Audits
Key Challenges in Medical Device Cleanroom Projects
Industry Expertise
We have deep experience in delivering ISO/GMP-compliant cleanrooms specifically for Class I–III medical devices.
→ We understand your regulatory challenges, and we build to match them.
Global Project Support
Whether in Asia, North America, or the Middle East, our team provides remote guidance or on-site support for cleanroom installation and training.
→ We’re ready wherever you are.
Turnkey Solutions
We provide end-to-end services: on-site measurement, custom design, engineering, production, trial assembly, shipping, and after-sales support.
→ One-stop service reduces coordination risks and accelerates project timelines.
In-House Manufacturing
Our cleanroom panels, doors, windows, and FFUs are all manufactured in our own ISO-certified facility, ensuring strict quality control, better lead time, and cost-efficiency.
→ You’re dealing directly with the source—no middlemen.
Precision Engineering & Modular Flexibility
Using our proprietary modular system, we deliver flexible and scalable cleanroom spaces that can be expanded, reconfigured, or relocated easily.
→ Future-proof your production environment.
Regulatory Compliance & Validation Support
We ensure compliance with ISO 14644, ISO 13485, FDA CFR 820, and GMP standards, and provide detailed documentation for audits and validation.
→ You get more than a room—you get peace of mind
One-Stop Medical Device Cleanroom Solution
From concept design to validated delivery — one partner, one responsibility.
Based on industry-specific products and customer-provided dimensions, layouts, and pedestrian and material flow patterns, we design customized solutions.
The factory adopts standardized production, precision manufacturing, and prefabrication of modules.
1. Provide installation instructions and online installation guidance;
2. Dispatch an external installation team;
3. Utilize locally partnered installation teams;
→ Cleanroom Design Built for Regulatory Approval
Applicable Processes
Medical Device Assembly & Aseptic/Non-aseptic Packaging &Injection Molding, Welding, Testing, Labeling
→ Modular Cleanroom System for Faster Deployment
→Stable Temperature, Humidity & Cleanliness Control
Related Cases
Biological Industry Cleanroom——ISO5 70m²
Our biotech cleanroom solutions break through the traditional pharmaceutical cleanliness standards and are designed for cutting-edge fields such as cell and gene therapy, synthetic biology, and microbiome. The use of dynamic pressure gradient control systems and molecular-level air purification technology not only meets the ISO 14644-1 standard, but also achieves precise control of 0.1μm ultrafine particles.Through modular negative pressure isolation units and flexible space layout, we provide biotechnology companies with full-chain environmental protection from GLP laboratories to GMP production.
Pharmaceutical Industry Cleanroom——ISO7 30m²
Cleanroom design includes key control measures such as intelligent personnel/logistics diversion, air lock buffer system, dynamic environmental monitoring, etc., which are suitable for the production and packaging of sterile preparations, biopharmaceuticals, vaccines, injections and highly active drugs. Through full-cycle verification (DQ/IQ/OQ/PQ) and digital environmental monitoring systems, we provide pharmaceutical companies with a safe, reliable and compliant clean production environment, helping to improve drug quality and international market access.
Medical Devices Cleanroom——ISO7 146m²
This project strictly follows ISO 14644 and GMP standards to create a modern clean room that meets the cleanliness level of A/B/C/D. It adopts a high-efficiency HEPA filtration system, precise temperature and humidity control, and laminar airflow organization to ensure that air cleanliness, microbial limits, and environmental parameters continue to meet standards. The clean room design includes key measures such as personnel/logistics separation, strict dressing procedures, and real-time environmental monitoring, and is suitable for the production and packaging of high-demand products such as sterile medical devices, implants, and in vitro diagnostic reagents.
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Looking to build or upgrade a Medical Device cleanroom?
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