+86 18186671616
Jason@cleanroomequips.com
MENU
What Does Class 10,000 Clean Room Mean?
A controlled environment for industries requiring stringent airborne particle control
A Class 10,000 clean room is a controlled environment designed to minimize the introduction, generation, and retention of airborne particles. According to the Federal Standard 209E, a Class 10,000 clean room allows no more than 10,000 particles per cubic foot of air that are 0.5 micrometers or larger. This classification signifies that the room has a maximum allowable particle count of approximately 352,000 particles per cubic meter, making it suitable for industries such as pharmaceuticals, biotechnology, and Electronics manufacturing.
Clean Room Specifications
Air Quality
- Max 10,000 particles/ft³ (0.5µm or larger)
- 352,000 particles/m³ equivalent
- HEPA filters capturing 99.97% of particles ≥0.3µm
Environmental Control
- Temperature: 20°C to 22°C (68°F to 72°F)
- Humidity: 30% to 60% RH
- 10-15 air changes per hour
Class 10,000 Clean Room ISO Equivalent
A Class 10,000 clean room is equivalent to ISO 7, as per ISO 14644-1 standards. ISO classification systems categorize clean rooms based on the maximum allowable particle concentration in the air.
| Clean Room Class | ISO Equivalent | Maximum Particles (0.5µm and larger) |
|---|---|---|
| Class 10,000 | ISO7 | 10,000 particles/ft³ (352,000/m³) |
Cost Breakdown for Class 10,000 Clean Room Setup
Initial Setup
$100-$400 per sq.ft.
Operational
$2-$5 per sq.ft./month
Compliance
$5,000-$20,000 annually
Requirements for Class 10,000 Clean Room
Design Specifications
Effective contamination control through suitable layout, non-porous materials, and ceiling height of 8 to 10 feet. 10 to 15 air changes per hour required.
Environmental Control
Temperature: 20°C to 22°C (68°F to 72°F), Humidity: 30% to 60% RH to prevent static electricity and moisture issues.
Personnel and Protocols
Strict gowning procedures (cleanroom suits, gloves, masks, shoe covers), limited access, and anteroom for decontamination.
How to Reduce Particle Count in A Clean Room?
Optimization of Airflow
Unidirectional airflow systems, properly designed air diffusers, and regular maintenance of air handling units.
Regular Cleaning
Rigorous cleaning schedules with appropriate agents, focusing on high-touch surfaces.
Contamination Control
Strict personnel flow control, material decontamination, and proper gowning protocols.
How Do You Measure Cleanroom Class?
Particle Count Measurement
Using calibrated particle counters to measure airborne particle concentration (max 10,000 particles/ft³ for 0.5µm and larger).
Sampling Protocols
Tests conducted during different operational conditions, at least monthly, following standardized sampling protocols.
Documentation and Compliance
Detailed records of all measurements, regular audits, and prompt corrective actions for any deviations.
Relevant Standards and Specifications
- iso 14644-1: Cleanrooms and Controlled Environments
- Federal Standard 209E: Cleanroom Standards
- iso 14644-2: monitoring to Provide Evidence of Cleanroom performance
