Cleanroom Standards and Applications

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
2025-07-02 | Visits:

Cleanroom Standards and Applications

ISO Cleanroom Classes and Applications

ISO 5 Cleanroom

Nanofabrication cleanroom facility
Precision instrument production
Semiconductor manufacturing
Electronic component manufacturing

ISO 6 Cleanroom

Semiconductor industry
Electronics manufacturing services
Animal laboratory

ISO 7 Cleanroom

Semiconductor industry
Pharmaceutical industry
Food processing
Biologics and medical device manufacturing
Optical and precision instrument manufacturing

ISO 8 Cleanroom

Food processing
Pharmaceutical industry
Electronic product manufacturing
Cosmetic production
Medical device production

Cleanroom engineering Design

Pharmaceutical Clean Room

Advanced CAD plan for pharmaceutical production environments ensuring compliance with strict industry standards.

Food Clean Factory

Optimized layout for food processing facilities focusing on hygiene, efficiency, and product safety.

Electrical Panel Room

Specialized CAD drawing for electrical control rooms ensuring safety, accessibility, and optimal performance.

Cleanroom Standards and Guidelines

Standard	Requirement	Application Area
USA FDA aseptic guidance	20 ACH	Pharmaceutical manufacturing
EU GMP	Cleanup period 15–20 min	Medical device production
ISPE Good Practice Guide - HVAC	6–20 ACH for CNC (EU Grade D) 20–40 ACH for Grade 8 (EU Grade C) 40–60 ACH for Grade 7 (EU Grade B)	Semiconductor and electronics industries
WHO	6–20 ACH	Global healthcare facilities

Cleanroom design Elements

Area Division

Raw material area
Cleaning area
Processing area
Packing area
Finished product storage area

Personnel Flow

Unidirectional flow
Changing area

Safety and Hygiene

air shower room
Hand washing basin
Air curtain machine
Insect and rodent prevention facilities
Waste treatment area

Key Components

ISO Cleanliness Class
Air Filtration
Temperature and Humidity Control
Static Control
Unidirectional Flow
Cleaning Materials

Cleanroom Technology Overview

Cleanrooms are specialized environments designed to maintain extremely low levels of airborne particles, such as dust, microorganisms, and chemical vapors. They are critical for industries where even minor contamination can compromise product quality or research integrity.

The ISO classification system (ISO 14644-1) defines cleanroom standards based on the number of particles per cubic meter at a specified particle size. Each class represents a maximum allowable concentration of particles.

Proper cleanroom design involves careful consideration of airflow patterns, filtration systems, material selection, and personnel protocols to minimize contamination risks.