Tema Sinergie

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.

 

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General characteristics

  • 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

Key features

  • 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

Available Options:

  • 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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  • SIMATIC HMI TP700 Comfort Siemens, 7” Touch Panel with TFT colour widescreen display
  • PLC Siemens S7-1500
  • GAMP compliant software development
  • VPN connection for remote access and assistance, updates and maintenance

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.