Pharmaceutical isolator AP-IS

aseptictransferISO class 5

The Aseptic Transfer Isolator is a custom-designed cGMP Class A/ISO 5 isolator system specifically designed for pharmaceautical companies which require a low rH% aseptic environment for semi-automatic transfer of liquid substances. This specific AP-IS Series isolator has been designed to meet mandatory user requirements. Compatible with AGLTS 2, the new glove integrity testing machine designed to support operators and pharmaceutical companies in the management of all glove testing-related operations. GUARANTEED ASEPSIS An AP-IS Series Isolator assures the highest air quality of the isolated environment thanks to: – An engineered filtration system composed of High-Efficiency Particulate Air (HEPA). – HYPER, Tema Sinergie’s integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle (the Rapid Gas Chamber completes its cycle in 20 minutes, full aeration included). – Inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors. CUSTOM DESIGNED An AP-IS Series isolator is a custom-designed aseptic processing isolator system, which can be composed of several modules. The specific isolator configuration is composed of a 4-gloves working chamber. A select number of available options may be added at a future date. AUTOMATIC LEAK TEST The AP-IS Series isolator is equipped with a routine automatic leak testing system which performs an independent leak test cycle for each chamber according to the pressure change method (5.2) ISO 10648-2(E).