ISO class 5 isolator / for the pharmaceutical industry / aseptic / dispensing
AP-IS Tema Sinergie

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Characteristics

  • Class:

    ISO class 5

  • Applications:

    for the pharmaceutical industry, aseptic, dispensing, transfer, sampling, for radiopharmacy, for clean rooms, for liquid handling, for research

  • Configuration:

    floor-standing, modular

  • Other characteristics:

    glove box, negative pressure, stainless steel, with HEPA filter, positive pressure, custom, controlled atmosphere

Description

The Aseptic Processing Isolator System (AP-IS) is a GMP Class A ISO 5 modular isolator system, which has been designed for QC Labs, pharmaceutical production, and pharmacies.

The high level of aseptic conditions achievable within the isolated environment makes the AP-IS isolator the perfect flexible equipment for different applications, such as Sterility Testing, Aseptic Dispensing & Sampling, and Aseptic Product Transfer.

The base isolator is composed of a single four gloves working chamber, but additional chambers and/or airlocks can be also supplied upon customer request as option.
This isolator system is equipped with an unidirectional air flow system, and constantly guarantees a pressure gradient between the chamber(s) and the lab environment.

The advanced performances of the ventilation system are guaranteeed by the exclusive automatic pressure & air flow control system developed by Tema Sinergie over the years. This system also permits to operate the isolator system in either positive or negative pressure with a simple switch of the software set-up parameters.

The high air quality of the isolated environment is assured by High-Efficiency Particulate Air (HEPA) pre-filters, and Ultra Low Penetration Air (ULPA U15) unidirectional down flow, and return filters.

The AP-IS isolator system being based on a modular concept, several options might be added at a later date as further implementation of the module.