What is the FDA Classification of Clean Rooms?

The FDA classifies clean rooms based on their particle contamination control levels, which are essential for ensuring the quality and safety of products, particularly in pharmaceutical and biotechnology industries. The classification system, often used for the manufacturing and packaging of sterile drugs and medical devices, is closely aligned with the ISO clean room standards but has its own specific requirements. The FDA divides clean areas into Class A**, **Class B**, **Class C**, and **Class D based on the concentration of airborne particles, particularly those that are 0.5 microns and larger. Below, we will break down each of these Clean Room Classifications.

Class A Clean Area

Class A clean areas are the most stringent of the FDA classifications, requiring the Clean room environment to meet ISO 5** standards. This means that the maximum allowable number of particles of 0.5 microns or larger is **3,520 particles per cubic meter. The class is designed for environments where critical processes are carried out, such as aseptic filling or sterile product handling.

• - Airborne particle count:

• ≤3,520 particles per cubic meter (0.5 microns)

• - Suspended particles:** Must meet a limit of **≥5.0 microns

• in size.

• - Applications:

• Aseptic processing, sterile filling operations, handling of sterile products

• - Features:

• High-efficiency HEPA or ULPA filtration, laminar airflow, strict gowning protocols

Class B Clean Area

Class B clean areas are slightly less stringent but still highly controlled, meeting ISO 6** standards. These rooms are generally used in processes that require less strict particle control but still need a high level of air purity. Both **0.5 microns** and **5.0 micronsparticles are monitored and controlled in this class.

• - Airborne particle count:

• ≤35,200 particles per cubic meter (0.5 microns)

• - Suspended particles:** Must also control particles of **≥5.0 microns

• - Applications:

• Clean environments for aseptic preparation and handling, areas adjacent to Class A zones

• - Features:

• HEPA filters, controlled air exchanges, gowning procedures to reduce contamination

Class C Clean Area

Class c Clean Rooms follow ISO 7

standards under both static and dynamic conditions. These environments are suitable for processes where contamination control is important but less critical than in Classes A and B. For instance, Class C clean rooms are often used in the preparation and packaging of pharmaceutical products where sterility is not directly required but cleanliness is still a priority.

• - Airborne particle count:

• ≤352,000 particles per cubic meter (0.5 microns)

• - Airborne particle levels:

• Control for both static and dynamic conditions

• - Applications:

• Pharmaceutical manufacturing, packaging of non-sterile drugs

• - Features:

• HEPA filters, laminar airflow, regular monitoring of particle levels

Class D Clean Area

Class D clean areas are the least stringent of the FDA classifications, meeting ISO 8 standards under static conditions. These clean rooms are typically used for less sensitive operations where particle contamination is less of a concern. However, they still maintain control over airborne particles to ensure product safety and quality.

• - Airborne particle count:

• ≤3,520,000 particles per cubic meter (0.5 microns)

• - Applications:

• General pharmaceutical manufacturing, non-critical areas in sterile environments

• - Features:

• Basic filtration systems, lower airflow control requirements

of FDA Clean Room Classifications

• - Class A:ISO 5 – Aseptic processing, sterile handling (≥5.0 μm limit)

• - Class B:ISO 6 – Aseptic preparation, sterile manufacturing (≥5.0 μm limit)

• - Class C:ISO 7 – Pharmaceutical and non-sterile drug production (both static and dynamic)

• - Class D:ISO 8 – General manufacturing, non-sterile environments (static conditions)

Relevant Standards and Guidelines

• - FDA Guidelines for Aseptic Processing (CFR 21 Part 211):

• Provides detailed requirements for the classification of clean rooms and controlled environments in drug manufacturing.

• - ISO 14644-1:

• International standard for CleanRoom Classifications, including particle count limits and Monitoring procedures.

• - iso 14644-2:

• Specifies the requirements for monitoring the performance of cleanrooms and controlled environments.

• - EU GMP (Good Manufacturing Practice) Annex 1:

• Establishes European standards for cleanroom classifications, similar to FDA and ISO standards, particularly for sterile drug manufacturing.

By following these standards and classifications, manufacturers can ensure that their clean rooms meet the necessary cleanliness levels for safe and effective product production, ensuring compliance with regulatory requirements and safeguarding public health.