What facilities are designated for CAIs in terms of ISO classification?

Compounding Aseptic Isolators (CAIs) are specialized equipment used in sterile compounding environments to provide a controlled, clean environment for the preparation of sterile medications. The correct classification for facilities designated for CAIs in terms of ISO standards is ISO 7 or ISO 8.

ISO 7 and ISO 8 refer to cleanroom classifications that dictate the allowable number of particles of various sizes in the air. An ISO 7 cleanroom allows for a maximum of 352,000 particles per cubic meter for particles ≥0.5 micron, while ISO 8 has a higher allowable particle count, making it less stringent. These classifications are suitable for environments that support compounding processes involving non-hazardous drugs, which significantly reduces the risk of contamination while enabling effective aseptic techniques.

In a CAI setup, the isolator itself maintains an ISO 5 environment internally, which is critical for direct compounding activities since it minimizes exposure to airborne contaminants. However, the overall facility that houses the CAI can be classified as ISO 7 or ISO 8, especially in operational areas dealing with less critical processes or materials, creating a protective envelope around the CAI.

This understanding aligns with regulatory guidelines and best practices in sterile compounding,