What ISO classification is required for a Buffer or Clean Room?

A Buffer or Clean Room used in sterile compounding must adhere to specific cleanliness standards to ensure that the environment is suitable for preparing compounded sterile products. The ISO classification reflects the allowable level of particulate contamination in the air.

ISO 7 is the correct classification for a Buffer or Clean Room. This standard designates that the room must not exceed a maximum allowable particle count of 352,000 particles per cubic meter for particles of 0.5 micron size and larger. This level of cleanliness is critical in preventing contamination during the compounding process, which is essential for patient safety and the effectiveness of sterile medications.

Higher ISO classifications, such as ISO 6, are typically required for areas where the actual compounding takes place (like the Laminar Airflow Workbench or Biological Safety Cabinet), but for the Buffer or Clean Room, ISO 7 is adequate. ISO 8 and ISO 9 represent less stringent cleanliness levels and thus would not provide the necessary environment for sterile compounding activities.