Class 100 Clean Room:
Standards, Design Guide & Applications
A Class 100 clean room—also referred to as ISO 5 cleanroom—maintains an exceptionally low level of airborne particles. It allows no more than 100 particles (≥0.5 μm) per cubic foot of air, making it essential for industries that demand ultra-clean environments, such as semiconductor manufacturing, biotechnology, and aerospace.
This guide explains what Class 100 means, how it compares to other cleanroom classes, and what you need to know for construction, validation, and operation.
What is a Class 100 Clean Room?
A Class 100 clean room follows Federal Standard 209E, allowing a maximum of 100 particles (≥0.5µm) per cubic foot. This level corresponds to ISO 5 under ISO 14644-1 standards.
Class 100 (FED-STD-209E): 100 particles/ft³
ISO 5 (ISO 14644-1): 3,520 particles/m³
Key Features of Class 100 Cleanroom Design
– Air Changes per Hour (ACH): 240 – 480 times/hour
– HEPA/ULPA Filters: 99.999% efficiency at 0.3µm
– Laminar Flow Systems: Unidirectional airflow to sweep particles away
– Positive Pressure: Prevents ingress of external contaminants
– Materials: Seamless walls, epoxy flooring, stainless steel furnishings
Where Are Class 100 Clean Rooms Used?
– Biotech clean zones (e.g., PCR areas)
– Semiconductor wafer fabrication
– Precision optical assembly
– Sterile product filling zones in pharma
– Aerospace sensor assembly
Comparison with Other Cleanroom Classes
| Cleanroom Class | ISO Equivalent | Particle Count (≥0.5µm) | Typical Use Case |
|---|---|---|---|
| Class 10 | ISO 4 | 10/ft³ | Advanced chip labs |
| Class 100 | ISO 5 | 100/ft³ | Pharmaceutical fill lines |
| Class 1,000 | ISO 6 | 1,000/ft³ | Medical device assembly |
| Class 10,000 | ISO 7 | 10,000/ft³ | General clean assembly |
How We Build ISO 5/Class 100 Clean Rooms
At BAIHONGJINGHUA, we specialize in designing, manufacturing, and installing cleanroom systems that meet ISO 5 / Class 100 requirements. Our solutions feature:
– Turnkey design + engineering
– Fast installation using modular panels
– Comprehensive validation & test reports
– Post-sale maintenance and performance testing
Certification, Testing & Compliance
We ensure all Class 100 cleanrooms comply with international standards:
– ISO 14644-1 validation (particle count, airflow, pressurization)
– HEPA integrity test
– Cleanroom gowning procedures and SOPs
– Optional: cGMP, FDA, or EU Annex 1 compliance (for pharma)
FAQs About Class 100 Cleanrooms
Q: Is Class 100 the same as ISO 5?
Yes. ISO 5 is the international equivalent of Class 100 under the older US FED-STD-209E.
Q: How long does it take to build a Class 100 cleanroom?
Typically 20–40 days depending on size, layout, and industry standards required.
Q: What are the maintenance requirements?
Daily wipe-down, monthly filter check, annual full recertification.
Request a Quote or Consultation
Whether you need a single clean zone or a full-scale Class 100 facility, we can help.
