Which of the following is NOT a requirement for low-risk level CSPs?

Low-risk level Compounded Sterile Preparations (CSPs) are those that are prepared in a controlled environment with specific standards to ensure sterility and safety. Among the requirements for preparing these CSPs, proper environmental conditions and personnel practices play a crucial role.

Preparation in an ISO Class 5 environment is essential because it ensures that the preparations are made in an environment with an acceptable level of particulate contamination. ISO Class 5 indicates a specific limit on the number of particles in the air, thus minimizing the risk of contamination.

Personnel must follow proper cleansing and garbing procedures to maintain the sterile environment and prevent any introduction of contaminants during the compounding process. This means that staff need to wash their hands, wear appropriate sterile gloves, gowns, masks, and hats before compounding, further reinforcing the sterility of the CSP.

In regard to traffic in sterile compounding areas, it's important that the Compounding Aseptic Isolator (SCA) does not connect to high traffic areas. This requirement helps to minimize the risk of contamination by limiting the number of people entering and exiting the compounding area, preserving the sterile environment around CSP production.

The management of hazardous substances, while critical in the overall practice of sterile compounding,