GMP Clean Room Classifications

Cleanroom classifications are used to categorize controlled environments based on their level of cleanliness. In the pharmaceutical industry, cleanroom classifications are defined by the European Union's Good Manufacturing Practice (GMP) guidelines for aseptic processing areas.

The GMP guidelines define four main cleanroom classifications, ranging from Class A (the cleanest) to Class D (the least clean). There are also two additional classifications, Class E and Class F, that may be used in ancillary areas or where lower levels of cleanliness are required.

Here are the definitions for each classification:

1. Class A: The highest classification, with a particle count of no more than 3,520 particles per cubic meter of air that are 0.5 microns or larger in size. This class is required for critical processing areas, such as filling machines or isolators.

2. Class B: Allows for a maximum particle count of 3,520 particles per cubic meter of air that are 0.5 microns or larger in size. This class may be used for adjacent spaces to Class A areas, such as buffer rooms.

3. Class C: Maximum particle count of 35,200 particles per cubic meter of air that are 0.5 microns or larger in size. This class may be used for less critical processing areas, such as gowning rooms.

4. Class D: Allows for a maximum particle count of 352,000 particles per cubic meter of air that are 0.5 microns or larger in size. This class may be used for non-processing areas, such as hallways or offices.

5. Class E: Allows for a maximum particle count of 3,520,000 particles per cubic meter of air that are 0.5 microns or larger in size. This class may be used for ancillary areas outside of the main manufacturing facility.

6. Class F: Allows for a maximum particle count of 35,200,000 particles per cubic meter of air that are 0.5 microns or larger in size. This class may be used for areas where lower levels of cleanliness are required, such as warehouses or storage areas.

It's important to note that achieving these classifications requires careful planning and design, as well as ongoing maintenance and monitoring to ensure that the environment remains clean and meets the necessary standards. Additionally, other factors such as temperature, humidity, and airflow must also be controlled to prevent microbial growth and maintain product quality.