How many particles of 0.5 µm and larger are permitted in ISO Class 8?

In an ISO Class 8 clean room, the standard allows for a maximum of 3,520,000 particles per cubic meter of air that measure 0.5 micrometers (µm) and larger. This limit is established to ensure a cleaner environment that reduces contamination risks in settings such as pharmaceutical manufacturing and healthcare facilities.

The significance of this standard partly stems from the fact that smaller particles, including bacteria and dust, can adversely affect sterile processes and product integrity. ISO Class ratings classify the cleanliness of air in controlled environments, with Class 1 being the cleanest and with increasingly higher particle allowances for less stringent classes.

By adhering to the specified particle limit in ISO Class 8, facilities can maintain a suitable level of cleanliness while allowing for operations that require a moderate level of air quality. This helps ensure that operations like compounding IV medications or preparing sensitive materials can be conducted safely without excessive risk of contamination.