It’s time to upgrade your processes.

AP-IS
Aseptic Processing Isolator System
The shortest way to a sterile world.

The AP-IS is a GMP Class A ISO 5 isolator system specifically designed for QC labs, pilot scale pharmaceutical production and pharmacies. It’s a flexible equipment that guarantees the best working conditions in different applications such as Sterility Testing, Aseptic Filling, Aseptic Dispensing & Sampling and Aseptic Product Transfer.

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  • Ergonomic design

    Maximizing operators’ effectiveness is essential to minimize the risks of accidents, eliminate unscheduled downtime and boost production quality. Operators are assured the most comfortable working conditions by the outstanding ergonomics of the AP-IS.

  • Automatic leak test

    The AP-IS 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 10648-2:1994(E).

  • Guaranteed asepsis

    The AP-IS assures the highest air quality of the isolated environment thanks to:
    - An engineered filtration system composed by High-Efficiency Particulate Air (HEPA) pre-filters and Ultra Low Penetration Air (ULPA U15) unidirectional down flow and return filters
    - An 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

  • Modular based configuration

    The system is based on a handy modular configuration concept: the base isolator is composed of a single 3 to 4-gloves working chamber which can be easily expanded with additional modules, making AP-IS perfectly suitable to every need and process. Moreover, any of the available options might be added at a later date as further implementation of the equipment.

  • Ease of maintenance

    From few to numerous gloves to be tested, AGLTS has it all. Integrated configurations of AGLTS can be upgraded to any number of testing units for a faster parallel performance. Each glove is recognized by means of Radio Frequency Identification (RFID) Technology for a smart and easy glove management.

  • Data Management

    The AP-IS can also be upgraded with an Integrated Supervisory Control And Data Acquisition (SCADA) – iFIX with Historian Data Management Software (DMS) from GE Digital.

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    Glove Integrity Testing

    The AP-IS is equipped with an integrated Automatic Glove Leak Testing System (AGLTS) which performs an independent leak test cycle for each glove mounted on the isolator system according to the Positive Pressure Decay Method described in the international standard ISO 14644-7 Annex E.5.

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