what is iso class 7 cleanroom

what is iso class 7 cleanroom？

Author:Jason Peng
Cleanroom Engineering Technology Manager of Deiiang Company.

Product R&D Manager of GDC Inc. Cleanroom Equipment Manufacturing Company.

Executive Director of Guangdong Cleanroom Industry Association of China.

Engaged in R&D of related products for 15 years, with rich relevant technical experience
2024-09-27 | Visits:

A CleanRoom (simple clean room) is a specialized environment established for quick and convenient use, featuring various cleanliness levels and flexible space. It can be designed and produced according to specific needs, making it highly adaptable, easy to install, and quick to construct with the added benefit of being removable. Cleanrooms are often used to provide high cleanliness in local areas within a general-level cleanroom, helping to reduce costs through targeted upgrades.

A typical ISO Class 7 Cleanroom environment

Cleanliness Level Standard Grading

The ISO cleanliness level standard is an international benchmark for measuring cleanliness, widely applied in cleanrooms, laboratories, Electronics industry, pharmaceutical industry, and food industry. As per ISO 14644-1, cleanliness levels are categorized from 1 to 9, each corresponding to a specific count of suspended particles in the air.

ISO Level	Particle Limit (≥0.1μm per m³)
ISO 1	≤10
ISO 2	≤100
ISO 3	≤1,000
ISO 4	≤10,000
ISO 5	≤100,000
ISO 6	≤1,000,000
ISO 7	≤10,000,000
ISO 8	≤100,000,000
ISO 9	≤1,000,000,000

ISO 7 Cleanroom Standards

ISO 7 cleanroom standards are defined by both particle concentration and air change rates. Here's a detailed breakdown:

Air Change Requirements

25-30 air changes per hour
Complete air purification time after air exchange: ≤30 minutes
Maintains a controlled environment with consistent particle removal

Particle Concentration Limits

≤10,000,000 particles ≥0.1μm per m³
For 0.5μm particles: ≤3,500,000 per m³
For 5μm particles: ≤20,000 per m³

100,000 Clean Room Purification Standard

The 100,000 clean room (equivalent to ISO 7) has specific purification standards to ensure environmental control:

Standard Category	Requirement
dust particles	≥0.5μm: ≤3,500,000 per m³ ≥5μm: ≤20,000 per m³
Microorganisms	Planktonic bacteria: ≤500 per m³ Settling bacteria: ≤10 per petri dish
Differential Pressure	Same cleanliness level: maintained equally Adjacent different levels: ≥5Pa Cleanroom vs non-cleanroom: ≥10Pa

ISO 7 Cleanroom Application Areas

ISO 7 Cleanrooms find extensive use in various industries where controlled environments are essential to ensure product quality and process integrity:

Laboratory

Used for parts of experimental areas requiring clean environments to prevent impurity contamination during experiments.

Medical Industry

Applied in operating rooms, clean laboratories, and clean pharmacies to reduce the risk of intraoperative infections.

Electronic Industry

Widely used in the manufacturing process of electronic components to prevent dust and other impurities from contaminating products.

Pharmaceutical Industry

Used in drug packaging, preparation, and blending processes to ensure product cleanliness and quality requirements.

Principle of ISO 7 Cleanroom

The working principle of an ISO 7 cleanroom revolves around several key technologies and control mechanisms to maintain the required cleanliness level:

Air Filtration Technology

Air is filtered through multi-layer high-efficiency filters (HEPA and ULPA), effectively reducing the number of particles and microorganisms in the air.

Positive Pressure Maintenance

Maintaining positive pressure inside the cleanroom ensures air flows from inside to outside, preventing external contaminants from entering and ensuring air fully passes through filters.

Environmental Control

Precise control of internal parameters such as temperature, humidity, and static electricity to ensure stability within defined ranges, avoiding impacts on products and experiments.

Cleanroom Environmental Control.jpg