Environment
- Sterile preparations are made in an ISO class 5 area (a laminar airflow workbench or biological safety cabinet), inside an ISO class 7 buffer room with an ISO class 8 ante-room.
- HEPA filters remove at least 99.97% of particles of 0.3 µm.
- Horizontal laminar-flow workbenches protect the product and are used for non-hazardous drugs.
- Cytotoxic and other hazardous drugs are prepared in a vertical-flow biological safety cabinet (class II) or isolator, which protects the operator too, ideally in a negative-pressure room.
- Work at least 15 cm (6 inches) inside the hood and never block the airflow between the filter and critical sites.