What is the required ISO classification for the buffer room?

The required ISO classification for a buffer room is ISO 7. This classification is critical in maintaining appropriate environmental controls for the preparation of sterile products. ISO 7 specifies allowable particle counts in the air, ensuring that the buffer room is adequately controlled to minimize the risk of contamination during the compounding of sterile preparations.

In a pharmacy setting, the buffer room serves as the area where sterile products are prepared, which demands a clean environment to prevent contamination. The ISO 7 classification sets forth standards that help create an environment conducive to safeguarding patient health and ensuring the safety and efficacy of compounded sterile medications.

ISO classifications are hierarchical; as the ISO number decreases, the required air quality improves. Therefore, while regions such as the ante-room may have a classification of ISO 8 or higher, the buffer room itself requires the more stringent controls found in ISO 7 to protect against particulate contamination effectively. This distinction is crucial for pharmacy operations, especially when dealing with high-risk compounding activities.