In the pharmaceutical industry, Class ABCD refers to a grading system for cleanrooms based on their cleanliness levels. These grades, ranging from A (cleanest) to D (least clean), dictate the suitability of the environment for various manufacturing processes. This classification ensures the quality and sterility of pharmaceutical products.
Cleanroom Grade Classification:
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Grade A: This is the highest level of cleanliness, essential for high-risk activities like filling sterile products, aseptic connections, and other critical manufacturing steps. It's equivalent to ISO Class 5 (formerly Class 100). Examples include filling zones for sterile products and preparation of open ampoules and vials.
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Grade B: This grade is usually found surrounding Grade A areas, providing a buffer zone to maintain the cleanliness of the Grade A environment. It's typically equivalent to ISO Class 5.
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Grade C: Used for less critical operations within the manufacturing process, Grade C areas maintain a cleaner environment compared to Grade D. This might involve preparation activities before entering Grade B or A areas. It's equivalent to ISO Class 7 (formerly Class 10,000).
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Grade D: This is the least clean grade in the classification system, typically used for support operations such as packaging or activities less critical to sterility. This is equivalent to ISO Class 8 (formerly Class 100,000).
The specific requirements for each grade are defined by regulations like those of the European Union and other regulatory bodies. These standards are crucial for ensuring the quality and safety of pharmaceutical products.
The use of these classifications ensures that the pharmaceutical production environment minimizes contamination risks, thereby ensuring product sterility and quality. The level of cleanliness directly correlates with the risk of contamination and the specific manufacturing step.
