What is the required ISO class for an Ante Room when it does not provide access to a negative pressure room?

The required ISO class for an Ante Room that does not provide access to a negative pressure room is ISO 8. This classification is specifically designed to ensure that the environment is adequately controlled for certain compounding activities, particularly when working with non-hazardous drugs.

An Ante Room serves as a transitional space where personnel can don and doff appropriate gowns and gear before entering a clean room environment. ISO 8 allows for a higher particle count when compared to stricter classifications like ISO 5, which is essential for areas directly adjacent to sterile compounding areas. Since the Ante Room does not involve the handling of sterile drugs that would require an ISO class of 5 (which would be used for sterile compounding), an ISO class of 8 ensures that air cleanliness is maintained without the stringent controls necessary for spaces where sterile products are compounded.

In summary, ISO 8 is the appropriate choice as it balances the need for cleanliness with the realities of operational workflow in environments that do not handle hazardous agents and do not require a higher standard of sterility control.