How often should the PEC with ISO class 5 environment be cleaned?

The correct frequency for cleaning the Primary Engineering Control (PEC) that maintains an ISO Class 5 environment is at the beginning of each work shift. This practice ensures that the sterile environment within the PEC is properly maintained before any compounding activities commence. The rationale behind cleaning at the start of each shift is to remove any contaminants that may have settled during periods of inactivity, thereby reducing the risk of introducing pathogens during sterile compounding.

While maintaining a clean environment is crucial, it is particularly important to establish this routine before beginning work to ensure the integrity of any sterile products being prepared. This requirement aligns with guidelines from authoritative bodies like the United States Pharmacopeia (USP), which emphasizes maintaining cleanliness and sterility in environments where compounded sterile preparations are made.

In contrast, cleaning only when necessary may not effectively prevent contamination. Similarly, cleaning at the beginning of each week or every two hours does not adhere to the practical need for immediate cleanliness when beginning work in a sterile compounding area. Regular cleaning at the start of each shift strikes the right balance between thoroughness and practicality in maintaining the integrity of the sterile compounding environment.