What are the allowed total particle counts for ISO 5 classification?

In an ISO 5 classification, the allowed total particle count is essential for maintaining a controlled environment suitable for sterile compounding. ISO 5 means that the air in the environment where sterile preparations are made must have no more than 3,520 particles per cubic meter, specifically measuring particles that are 0.5 micrometers or larger.

This strict particle count is crucial because increased contamination can lead to a higher risk of infection and compromised drug efficacy in compounded sterile products. An ISO 5 environment typically includes the use of laminar airflow hoods or cleanrooms designed to ensure that the air quality meets or exceeds this standard.

In context, the other figures represent counts that are significantly higher than the permissible levels for ISO 5, indicating unacceptable air quality for sterile compounding practices.