300,000-level clean area air cleanliness level parameters

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
2024-10-20 | Visits:

Cleanroom Environmental standards Report

GMP Specifications and clean area Standards

cleanroom environment Overview

In the pharmaceutical and precision manufacturing industries, cleanroom Environmental standards are critical for product quality control. This report details the particulate and microbial control standards for Class 300,000 clean areas, as well as the facility requirements that comply with GMP (Good Manufacturing Practice). Cleanroom design follows strict environmental control standards to ensure that contaminants during the production process are controlled within acceptable limits.

Air Cleanliness

Strict control of particulate quantity and size distribution in the air to ensure compliance with ISO Standards.

Microbial Control

Rigorous monitoring of floating and settled bacteria to ensure biological contaminants remain within safe limits.

Pressure Control

Maintain cleanroom positive pressure >10Pa to prevent external contaminants from entering critical areas.

Class 300,000 Clean Area Standards

The following table details the maximum allowable levels of contaminants in Class 300,000 clean areas per cubic meter of air:

Parameter	≥0.5μm Particles	≥5μm Particles	Floating Bacteria/m³	Settled Bacteria/dish
Maximum Allowable Value	10,500,000	60,000	1000	15

GMP Compliance Requirements

Pressure Requirements

The external pressure of each room must meet GMP requirements for clean workshops, maintaining a minimum positive pressure differential of >10Pa. This pressure gradient ensures unidirectional airflow from cleaner to less clean areas, preventing cross-contamination.

Equipment & Installation

Confirmation: The equipment supplier and the construction/installation unit meet the construction and installation requirements of the GMP clean workshop. All materials, equipment, and installation procedures comply with GMP Standards for cleanroom environments.