Filling isolator AP-IS

for the pharmaceutical industryasepticISO class 5

The Aseptic Filling Isolator is a custom-designed cGMP Class A/ISO 5 isolator system specifically designed for batch scale pharmaceutical production of injectable products for pre-clinical and clinical trial studies. This specific AP-IS Series isolator has been designed to meet mandatory user requirements and fully integrates AseptiFill, our automatic vials filling and capping machine. 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 H14) inlet, unidirectional down flow, return, and exhaust filters – HYPER, Tema Sinergie’s integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle (the Rapid Gas Chamber completes cycle in 20 minutes, full aeration included) – inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors. SAFETY Interlock system with integrated light barriers which interrupts the automatic process for operator safety. custom-designed An AP-IS Series isolator is a custom-designed aseptic processing isolator system, which can be composed of several modules. A base isolator configuration is composed of a 4-gloves working chamber, an inlet transfer chamber and outlet transfer chamber to allow a unidirectional workflow. This makes an AP-IS Series isolator perfectly suitable to every need and process.