EscoPharma - Aseptic Containment Isolator (ACTI)

• Unidirectional airflow – 0.45m/s ± 20% measured 150mm from the distribution screen face during normal operation provides ISO 5 / Grade A aseptic environment.
• Knife edge gel sealed U15 supply and optional U15 return filters
• Gasket sealed F8 room inlet and outlet filters
• System automatically compensates for containment breach in +ve or -ve mode via an egress or inward rush respectively
• Optional VHP Ports for automated aseptic processing allowing chamber or system decontamination.
• Biodecontamination loop for decontamination of viable or non viable monitoring systems
• Optional humidity/temperature sensors for environmental monitoring
• External sensors protected by instrument filters
• Optional distribution manifold allows more accurate sampling of upstream filter PAO concentration (since this manifold draws in PAO it is advice that this be cleaned before every filter change).
• Filter scanning ports for downstream filter integrity testing.
• Automated raise/lower carriage system via user ID input allows isolator to be raised to operator defined ergonomic height
• Safe change gloveport assembly allows for either single piece or split cuff gloves to be change without any breach in isolator condition
• Enhanced uniformity and entrainment of powders via our PLF screens
• Smooth flushed interior of isolator glazing means less crevices to improve cleanability / decontamination
• Single piece chamber fabricated of SS 316L hand polished to less than 0.4 microns with 19mm coved corners
• Glazing is made of toughened laminated safety glass
• PLF diffuser screens provides uniform airflow throughout the interior work zone
• Stainless steel is passivated post-fabrication with citric acid
• Clean sanitary finishing and perforated multi-piece work tray enhances unidirectional airflow for ultimate entrainment of contaminants and of potent powders
• International brand safe change filters means lower replacement costs and quicker turn-around time
• HMI/PLC control architecture with 4 defined levels of hierarchy
• Access for common replaceable items such as lights and ballasts are done all from the front of the unit

• Total unidirectional airflow provides superior aseptic work zones.
• Safety toughened laminated glass hinges upwards assisted with gas springs for batch loading.
• Airflow regime either runs in recirculatory or total exhaust airflow.
• Total exhaust airflow for fast purging of biodecontamination agent during aeration period.
• Recirculation option for reduced airflow taken from the room, thus, less air is exhausted during normal operation and during conditioning and decontamination phases.
• U15 supply and exhaust filters suitable for either toxic or non-toxic aseptic materials.
• Exhaust filter is directly below the isolator and can be removed with a bypass tube fitted (for non-potent material applications)

BUILT-IN OPTIONS

• Integrated automated pressure testing
• Filters can be upgraded to safe change with additional bags - Bag-In, Bag-Out (BIBO) rings
• Bypass option can be retrofitted with additional safe change housing
• System runs in any of the following airflow regimes in both positive and negative and can be configured in-situ by administrator access
• Volt free contacts provided for client connection to HVAC and optional 21 CFR Part 11 chart recorder for storing of process data