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Clean rooms are classified based on their cleanliness levels, which are determined by the number and size of particles permitted in the air. Various standards exist globally, including ISO classifications, the US Federal Standard 209E, and Good Manufacturing Practice (GMP) standards. Each classification system serves specific industries, ensuring that environments meet the necessary cleanliness requirements for production and research.
ISO Classifications
The ISO classification system, outlined in ISO 14644-1, is widely used to classify clean rooms based on the maximum allowable levels of airborne particulate contamination. The cleanroom classes range from ISO Class 1 to ISO Class 9, with Class 1 being the cleanest and Class 9 being the least clean. The classification is determined by the number of particles larger than 0.5 micrometers in a cubic meter of air.
| ISO Class | Particles per cubic meter (≥0.5 µm) | Description |
|---|---|---|
| ISO Class 1 | 10 | Extremely clean, used for semiconductor manufacturing and critical applications. |
| ISO Class 2 | 100 | Very clean, suitable for pharmaceutical production and biotechnology. |
| ISO Class 3 | 1,000 | Clean, used in aerospace and electronic assembly. |
| ISO Class 4 | 10,000 | Used in laboratories and certain medical applications. |
| ISO Class 5 | 100,000 | Common in many cleanroom environments, including pharmaceuticals. |
| ISO Class 6 | 1,000,000 | Used for less critical applications, like electronics assembly. |
| ISO Class 7 | 10,000,000 | Suitable for some manufacturing environments. |
| ISO Class 8 | 100,000,000 | General clean environments with limited requirements. |
| ISO Class 9 | No specific limit | Non-controlled environments, generally not suitable for cleanroom applications. |
ISO classifications emphasize the importance of controlling airborne contamination to ensure product quality and safety. Deiiang offers a range of cleanroom solutions that help organizations maintain compliance with ISO standards, ensuring optimal cleanliness in critical environments.
US Federal 209E Standard Classifications
The US Federal Standard 209E was a widely recognized CleanRoom Classification system used primarily in the United States. Although it has been officially discontinued and replaced by ISO classifications, it remains relevant for historical context and understanding. The classifications range from Class 1 to Class 100, with Class 1 being the cleanest.
| Federal Class | Particles per cubic foot (≥0.5 µm) | Description |
|---|---|---|
| Class 1 | 0.35 | Extremely clean, used for semiconductor and microelectronics manufacturing. |
| Class 10 | 3.5 | Very clean, suitable for pharmaceuticals and biotechnology processes. |
| Class 100 | 350 | Clean, used in laboratories and controlled production environments. |
| Class 1000 | 3,500 | Common in many manufacturing environments with less stringent requirements. |
| Class 10,000 | 35,000 | Suitable for less critical environments, such as storage areas. |
| Class 100,000 | 350,000 | General cleanroom environments with minimal control. |
While the US Federal Standard 209E has been largely superseded by ISO classifications, it serves as an important reference point for industries that were historically aligned with this standard. Organizations like Deiiang provide cleanroom solutions that facilitate compliance with both ISO and legacy US Federal Standards, ensuring a comprehensive approach to cleanliness.
GMP Standards
Good Manufacturing Practice (GMP) standards are regulations that ensure products are consistently produced and controlled according to quality standards. These standards apply to the pharmaceutical, biotechnology, and food industries, among others. GMP classifications do not use a specific numerical system like ISO or Federal standards but emphasize the need for clean environments based on the criticality of the processes involved.
| GMP Classification | Description |
|---|---|
| Class A | The cleanest environment, typically requiring ISO Class 5 or better. Used for sterile product manufacturing and critical filling processes. |
| Class B | A clean environment that may allow ISO Class 7 or better. Used in areas where Class A operations are performed. |
| Class C | Generally aligns with ISO Class 8 or better. Suitable for less critical processing and support areas. |
| Class D | May align with ISO Class 9, representing less stringent cleanliness requirements. Used for storage and non-critical operations. |
GMP standards focus on ensuring that cleanroom environments are properly monitored, maintained, and controlled, thereby safeguarding product quality and patient safety. Deiiang’s cleanroom solutions help organizations meet GMP requirements effectively, providing the necessary tools and materials for a compliant operation.
Reference to relevant international standards
For further details on cleanroom classifications and international standards, the following references can be consulted:
iso 14644-1: Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration.
iso 14644-2: Cleanrooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness.
U.S. Federal Standard 209E: Airborne Particulate Cleanliness Classes in Cleanrooms and Controlled Environments.
WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles.
