Isolation Technology

Isolators for Aseptic Processes

Barrier Isolation Technology | PRODUCT MANUFACTURER: TEMA SINERGIE

Product Description

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.

Main Features and Benefits

  • GMP Class A ISO 5 contained enclosure
  • Recirculation unidirectional flow airflow system
  • Integrated Vapor Hydrogen Peroxide Bio-decontamination Systems
  • Controlled reliability of the process
  • High quality product with total efficiency
  • Increased safety by reducing contamination risks, and consequently increased patient safety
  • Full process equipment integration

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    Additional Product Model Imagery

    Isolator Chamber

    Validation Port

    Open Hatch

    Filling Station

    Filling Pump

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