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An overview of our customized barrier isolator systems for aseptic and containment processes.
AP-IS 2 Compact
Aseptic Processing Isolator System
The AP-IS 2 Compact is a GMP Class A ISO 5 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 2 Compact isolator the perfect flexible equipment for different applications, such as Sterility Testing, Aseptic Dispensing & Sampling, and Aseptic Product Transfer.
The isolator is composed of one airlock to be also used as a rapid gas chamber and a three gloves process chamber.
The process chamber is equipped with a unidirectional air flow system which constantly guarantees a pressure gradient between the chamber 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 2 Compact 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.
- Main shell structure made of high-grade stainless steel AISI 316L
- Sheathings and support structure made of stainless steel AISI 304
- Mirror Brite internal finishing (<0,3 µm), and Scotch Brite external finishing (<0,8 µm)
- Weldings ground, smoothed and polished
- Exclusive automatic pressure & air flow control system developed by Tema Sinergie
- Integrated Vapour Phase Hydrogen Peroxide (VPHP) generator and distribution circuit
- VPHP resistant anemometer
- VPHP resistant relative humidity and temperature (rH%+T) sensor
- Handle with integrated safety switch
- LED lighting system
- External monolithic electrical & pneumatic cabinet made of stainless steel AISI 304
- Integrated thermal printer
- Vapour Phase Hydrogen Peroxide (VPHP) sensor for TLV environment
- VPHP sensors for chamber(s)
- Rapid transfer port, and transfer container
- Integrated sterility testing pump
- Integrated viable & non-viable monitoring system
- Integrated glove leak tester
- PC SCADA Advantech 10“ fitted with GE Proficy iFix, and database Historian
- Integrated 21 CFR part 11 compliant paperless graphic recorder
- Uninterruptable Power Supply (UPS)
- External sliding shield for Beta emitters
- Additional internal shieldings for Beta emitters on working surface
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The AP-IS 2 Compact is a fully PLC-controlled isolator system, 21 CFR part 11 compliant, fitted with a friendly operator interface available in different languages.
The isolator is also fitted with a Virtual Private Network connection, which allows a secure and private communication via Internet network, and provides remote access and assistance, updates and maintenance any time, everywhere.