In the pharmaceutical industry, Class D refers to the least clean environment within a Good Manufacturing Practices (GMP) facility for sterile drug manufacturing. These areas are used for less critical steps in the production process.
Here are some key characteristics of Class D areas:
- Airborne particle classification: Equivalent to an ISO 8 cleanroom at rest, meaning it has a higher allowable concentration of airborne particles compared to Class A, B, and C areas.
- Purpose: Class D areas are commonly used for activities like cleaning, storage of non-sterile materials, and personnel gowning.
- Examples: Class D areas can be used as background zones within a larger cleanroom facility.
It's important to understand that while Class D is the least stringent cleanroom classification, it still plays a crucial role in maintaining a controlled environment to prevent contamination of sterile products.
