Transfer isolator AC-IS

class IIfor the pharmaceutical industryaseptic

The Aseptic Containment Isolator System is a modular cGMP Class A/ISO 5 isolator system specifically designed for the Sterile processing of High Potent Active Pharmaceutical Ingredients (HPAPIs). MODULAR BASED CONFIGURATION The system is based on a versatile modular concept: the base isolator configuration is composed of a single 4-gloves working chamber which can be easily expanded with additional chambers/airlocks. This makes AC-IS perfectly suitable to every need and process. A select number of available options may be added at a future date. GUARANTEED ASEPSIS The Aseptic Containment Isolator System assures the highest air quality of the isolated environment thanks to: – an engineered filtration system composed of Efficiency Particulate Air (EPA E11) inlet and exhaust filters and High Efficiency Particulate Air (HEPA H14) unidirectional down flow and safe charge return filters (bag in/bag out); – HYPER, Tema Sinergie’s integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle; – inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors. MAXIMUM SAFETY Maximizing operators’ protection is the primary characteristic of a HPAPI containment isolator. The Aseptic Containment Isolator System assures very stringent HPAPI containment levels thanks to a perfect combination of design and manufacturing strategies. The system is equipped with inflatable and static seals to guarantee air tightness Class II (ISO 10648:2). The isolator is therefore the perfect solution for sterile processing of High Potent Active Pharmaceutical Ingredients (HPAPIs).