What is required for Low Risk CSPs that must be compounded in a cleanroom?

For Low Risk Compounded Sterile Preparations (CSPs) that are prepared in a cleanroom environment, the requirement of an ISO 7 ante area (non-hazardous drug) is essential to ensure that the environment is adequately controlled for the preparation of sterile products. The ante area serves as a transition space where personnel can prepare to enter the buffer area, allowing for proper gowning and equipment preparation.

An ISO 7 environment has specific standards for air quality, including allowable particles per cubic meter, which is stricter than general clean environments but less stringent than the specifications for areas where high-risk compounded sterile preparations are handled. This makes it suitable for low-risk CSPs, as it reduces the risk of contamination while not being as controlled as the conditions needed for more complex compounding.

The conditions of the ante area are complemented by the ISO 5 standard typically required for the compounding area itself, ensuring both locations provide a controlled environment that minimizes contamination risks. This standard combination achieves the necessary cleanliness to safely compound low-risk CSPs while managing preparation workflows in sterile compounding settings.