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.
AP-IS is equipped with inflatable seals to guarantee air tightness Class II (ISO 10648:2). The seals are made of FDA approved White Silicon Bio- Guardian® manufactured by Garlock. Bio-Guardian® is a silicone compound that contains anti bacteria inhibitors that prevent surface growth of micro organisms, and may achieve remarkable LOG reductions.
The AP-IS isolator system being based on a modular concept, any of the listed options might be added at a later date as further implementation of the module: Integrated gaseous hydrogen peroxide generators, Gaseous hydrogen peroxide sensor for TLV environment, Gaseous hydrogen peroxide sensors for chamber(s), Rapid transfer ports, and transfer container, Integrated sterility testing pumps, Integrated viable & non-viable monitoring systems, Integrated glove leak tester, Integrated 21 CFR part 11 compliant paperless graphic recorder, Integrated thermal printers, Uninterruptable power supply (UPS).
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