Aseptic containment isolator

type Afor highly potent active pharmaceutical ingredientsfloor-standing

The Aseptic Containment Isolator System for Oncology Products is a cGMP Class A/ISO 5 isolator system specifically designed for the Sterile processing of High Potent Active Pharmaceutical Ingredients (HPAPIs). KEY FEATURES • Fully PLC controlled isolator system • Integrated manual & automatic Wash-In-Place (WIP) • Integrated VPHP generator and distribution circuit • VPHP sensor for TLV environment • VPHP sensors for chambers’ concentration monitoring (Hi/Low) • VPHP resistant anemometer • VPHP resistant relative humidity and temperature (rH%+T) sensor • Integrated Weighing Scales and Operator Terminals • Integrated High Containment Split Butterfly Valves (HCSBVs) • Rapid transfer port and transfer container • Aseptic rapid transfer system • Integrated Viable & non-viable monitoring system • External monolithic Control Cabinet made of AISI 304 stainless steel • View/Access panel latches with integrated safety switches • LED lighting system GUARANTEED ASEPSIS The Aseptic Containment Isolator System assures the highest air quality of the isolated environment thanks to: (1) an engineered filtration system composed by High-Efficiency Particulate Air (HEPA H14) inlet and exhaust filters and Ultra Low Penetration Air (ULPA U15) unidirectional down flow and return filters; (2) an integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle; (3) inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors.