When is it acceptable to use a segregated compounding area?

Using a segregated compounding area is essential for ensuring a controlled environment when compounding sterile preparations, especially in a pharmacy setting. The establishment of such an area is specified in guidelines to enhance the quality and safety of compounded drugs.

When it comes to low-risk compounding, the use of a segregated area is acceptable as it allows pharmacists to prepare sterile products while reducing the risk of contamination. This area is equipped with appropriate tools and equipment to maintain sterility. This is especially relevant when a pharmacy lacks the resources or need for a full cleanroom setup but still requires a dedicated space to minimize risks associated with compounding.

High-risk compounding, on the other hand, typically necessitates stricter controls and an ISO Class 5 or better environment, usually found within a cleanroom. Immediate use preparations are more flexible and have different criteria, as they are intended for situations where sterility cannot be guaranteed but the preparation is needed urgently.

Overall, the categorization of low-risk compounding and its allowance for a segregated compounding area aligns with standards set by regulatory bodies to promote safety and efficacy in pharmacy practice.