What is the designation of a cleanroom suite used for compounding Category 2 CSPs?

The designation of a cleanroom suite used for compounding Category 2 Compounded Sterile Preparations (CSPs) is ISO 5. This classification indicates an environment that maintains a maximum allowable particle count—specifically, 3,520 particles per cubic meter for particles greater than 0.5 micrometers in size.

In sterile compounding, maintaining a high level of cleanliness is crucial to minimize contamination risks to the preparation. ISO 5 provides a controlled environment ideal for compounding medications that will be introduced into sterile body cavities or that will be administered parenterally.

In contrast, ISO 6, ISO 7, and ISO 8 designations allow for higher particle counts, making them suitable for different aspects of compounding but not for the critical environments required for Category 2 CSPs. Thus, operations performed in these areas may not meet the stringent sterility standards necessary for the safe preparation of the more complex sterile compounds categorized as Category 2.