What ISO Class must an ante area maintain if it is adjacent to a negative pressure room?

The ante area adjacent to a negative pressure room must maintain an ISO Class 7 environment. This classification is essential because it involves standards for cleanroom environments that help control the levels of airborne particles and microorganisms in the area where compounded sterile preparations or other pharmaceutical preparations are handled.

The negative pressure room serves to contain airborne contaminants and prevent them from escaping into adjacent spaces; thus, the ante area needs to be appropriately controlled to ensure that it does not compromise the integrity of the sterile compounding process.

ISO Class 7 allows for a moderate level of environmental control while still being able to achieve an appropriate degree of sterility when accessing the negative pressure room for compounding procedures. Establishing an ante area with a lower ISO classification, such as Class 8 or 9, would not provide the appropriate level of contamination control necessary for maintaining sterile conditions.