What Does Class 10000 Clean Room Mean?

Why It Matters for High-Precision Injection Molding？

In industries like medical devices, electronics, and biotech, product quality starts with the environment in which it’s made. That’s where clean rooms come in. But what does “Class 10000 clean room” really mean—and why should it matter to you when selecting an injection molding partner?

Understanding Clean Room Classifications

Clean rooms are specialized environments where the concentration of airborne particles is strictly controlled to prevent contamination. The “Class 10000” label refers to the Federal Standard 209E classification system (also known as ISO 7 in ISO 14644-1).

• Class 10000 (ISO 7) allows no more than 10,000 particles (≥0.5μm) per cubic foot of air.
• In comparison, typical office air can contain over 1,000,000 particles per cubic foot.
• This environment requires HEPA filters, positive pressure airflow, and strict gowning protocols.

At TXS, we operate a certified Class 10000 clean room, ensuring exceptional cleanliness standards during the production of medical plastic components**, such as syringes, infusion pump casings, minimally invasive surgical parts, and diagnostic devices.

Why a Class 10000 Clean Room Matters

Here’s why working with a supplier like TXS—with cleanroom facilities—is critical for your product’s success:

• ✅ Minimized risk of contamination: Crucial for medical consumables and life sciences applications.
• ✅ Better product quality & consistency: Cleanroom molding helps avoid defects like particles, burrs, or surface blemishes.
• ✅ Regulatory compliance: For industries under ISO 13485requirements, cleanroom production supports smoother audits and market access.
• ✅ Improved brand trust: Clean production is a key selling point for high-end products, especially in healthcare and diagnostics.

Real Application: Medical Device Manufacturing at TXS

As a full-service mold & injection molding provider, TXS offers not only tooling and molding but also cleanroom assembly and packaging services for medical devices. Our one-stop service covers:

• 🔬 Product structure co-design & material validation
• 🔄 Mold development with Moldex3D simulation
• 🧼 Injection molding in 100000-class cleanroom
• 🧪 Testing in ISO-certified lab with microbial and particle detection equipment
• 🛠️ Assembly in 10000-class cleanroom controlled environments

We support customers by ensuring their high-precision products are made in a compliant, reliable, and clean environment.

Choosing a Partner with Cleanroom Capabilities

Not all injection molding suppliers offer cleanroom production—and even fewer have experience integrating it into a full product development cycle.

At TXS, we go beyond just molding—we help you bring your product from concept to market with cleanroom-grade quality and speed.

📩 Need cleanroom molding support for your medical or biotech project?

Contact us today at [email protected]
or visit www.molds-maker.com to learn how our cleanroom manufacturing solutions can support your innovation.