Design criteria and containment evaluation: For pharmaceutical containment systems in aseptic dosage form manufacturing facilities

This article describes the design criteria required to contain active pharmaceutical ingredients and the containment evaluations of barrier isolation systems used in aseptic dosage form manufacturing facilities. The isolation systems include closed and open systems, which are designed to allow manipulations at levels of containment < 1 μg/m³ and are categorized in the performance-based exposure control limit of 4. To evaluate the containment performances of not only the equipment itself but also of the facilities as a whole, this study focused on describing the relationship between an worker's operation and the containment of the potent compound during handling in nonaseptic and aseptically controlled areas. Results confirmed that the containment performances met the assumed design criteria.