What is a Class 100000 Clean Room Environment?
Why It’s Essential for Clean and Reliable Plastic Injection Molding
In the fields of medical devices, healthcare consumables, and precision electronics, even the smallest particle can lead to defects, contamination, or regulatory failure. That’s why many manufacturers—including TXS—invest in clean room environments to maintain superior product quality.
But what exactly is a Class 100000 clean room?
Understanding Class 100000 Clean Rooms
A Class 100000 clean room, also known as ISO Class 8 under the ISO 14644-1 standard, is a controlled manufacturing environment where:
- The concentration of airborne particles ≥0.5μm must not exceed 100,000 particles per cubic foot of air.
- Air filtration is maintained using HEPA filters.
- Temperature, humidity, pressure, and airflow direction are carefully monitored and regulated.
- Workers wear protective clothing to prevent human-borne contamination.
At TXS, our 100,000-level clean room is purpose-built for medical and precision plastic injection molding, enabling us to produce plastic parts under clean, controlled, and certifiable conditions.
Key Benefits of a Class 100000 Clean Room for Injection Molding
Whether you’re manufacturing a diagnostic housing, IV tube connector, or microfluidic device, cleanroom conditions provide:
- ✅ Contamination control: Keeps dust, fibers, and microbes away from critical surfaces.
- ✅ Compliance with ISO 13485 and other standards: Essential for medical device production and regulatory clearance.
- ✅ Higher quality assurance: Reduces scrap rates and non-conformities.
- ✅ Trust for high-end markets: Healthcare and biotech buyers demand verified clean manufacturing processes.
TXS Clean Room Injection Molding Capabilities
TXS’s Class 100000 cleanroom workshop is part of our end-to-end mold and molding facility. Combined with Class 10000 bio-labs, our clean manufacturing setup allows us to:
- 🔍 Conduct particle and microbial contamination testing on products
- ⚙️ Operate over 20 injection molding machines within a clean production workflow
- 🧪 Perform quality control using 3D CMMs, particle detectors, and impact testers
- 🛠️ Support full mold development + injection + cleanroom assembly + packaging
From syringes, infusion pump components, to diagnostic casings, we ensure every medical part meets cleanliness standards—ready for global distribution.
Who Needs Class 100000 Clean Room Injection Molding?
If you’re developing:
- Medical devices and components
- IVD (in-vitro diagnostics) plastics
- Consumer health devices
- High-purity electronic housings
- Laboratory consumables (centrifuge tubes, pipette tips, etc.)
Then Class 100000 cleanroom molding is a non-negotiable requirement.
At TXS, we serve global customers,who trust us for cleanroom-grade manufacturing, ISO-certified processes, and fast time-to-market support.
Clean Environment, Clean Product, Clean Business
Selecting a molding supplier with certified cleanroom capacity gives you peace of mind—from R\&D validation to final production.
🔧 With TXS, you're not only getting a cleanroom; you’re getting a smart, integrated manufacturing partner with:
- ✅ ISO 13485 / ISO 9001 / IATF 16949 certifications
- ✅ Moldex3D simulation-driven tooling
- ✅ In-house mold building and clean assembly
- ✅ On-site lab testing and final inspection
📩 Want to ensure your products are made in a Class 100000 environment with Class A service?
Contact us today at [email protected] or visit www.molds-maker.com
