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Latest company case about Guangzhou Cleanroom Construction Co., Ltd. Certifications

What is the FDA classification of clean rooms?

2025-07-30

Latest company case about What is the FDA classification of clean rooms?

Cleanrooms play a critical role in industries like pharmaceuticals, biotechnology, medical devices, and electronics manufacturing, where contamination control is essential. The U.S. Food and Drug Administration (FDA) provides guidelines for cleanroom classifications to ensure product safety and quality.

What Are FDA Cleanroom Classifications?

The FDA follows the International Organization for Standardization (ISO) 14644-1 standards for cleanroom classifications, which replaced the older Federal Standard 209E. These classifications are based on the allowable number of airborne particles per cubic meter at specified particle sizes.

ISO 14644-1 Cleanroom Classifications

The ISO standard categorizes cleanrooms from ISO 1 (cleanest) to ISO 9 (least clean).

ISO Class	Maximum Particles/m³ (≥0.1 µm)	Maximum Particles/m³ (≥0.5 µm)	Typical Applications
ISO 1	10	102, Building 4, No. 23 Yongfeng Road, Yongshan Village, Shiqi Town, Panyu District, Guangzhou City, Guangdong Province E-mail: sales01@gzkunling.com Tel: +8613316272505 Tel: +8613316272505 The Largest R&D and Production Prefab Cleanroom Supplier in China 8613316272505 13316272505 Privacy Policy \| sitemap \| China Good Quality Prefab Cleanroom supplier. 2021-2025 Guangzhou Cleanroom Construction Co., Ltd. . All Rights Reserved.