Aseptic Isolators are fully compliant with the strictest cGMP and international regulations, and can service the pharmaceutical, biological and hospital industries worldwide. Typical applications are: Aseptic Filling, Aseptic Dispensing & Sampling, Aseptic Transfer. Aseptic Isolators are 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. A select number of available options may be added at a future date.
The AP-IS 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 (Rapid Gas Chamber complete cycle in 20 minutes, full aeration included)
- inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors.