The Hardwall IsoSphere™AF-ST is an aseptic filling / sterility testing isolator that features positive pressure non-unidirectional airflow. This unit is complete with vaporized hydrogen peroxide decontamination integration.

• ISO 4 classification
• Eliminates the need for a cleanrom, and the risk of a false positive test
• Complete product/operator protection
• Small critical area: increased SAL
• Minimal energy requirements
• Integration of sterility testing pump; aseptic filling and process equipment
• Integration and decontamination with H2O2 generator
• Can be connected to a secondary HEPA filtration system (BIBO) for hazardous processing
• Can be connected to an IsoTransfer isolator via Alpha/Beta doors for materials transfer and decontamination
• IQ/OQ validation: documentation & execution