Tema Sinergie

AP-IS

Aseptic Processing Isolator System

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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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

  • Modular configuration concept of the system
  • Exclusive automatic pressure & air flow control system developed by Tema Sinergie
  • Easily connectable to any gaseous H2O2 generator available on the worldwide market
  • Integrated gaseous H2O2 distribution circuit
  • Gaseous H2O2 resistant anemometer
  • Gaseous H2O2 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

AP-IS 1

  • Single Chamber
  • No Airlock
  • Compact dimensions

Dimensions (w x d x h, mm):
External: 2556 x 940 x 2500
Chamber: 1994 x 580 x 757

AP-IS 1

 

AP-IS 2

  • Single Chamber
  • Single Airlock on the left side
  • Integrated Gaseous H2O2 bio-decontamination system available

Dimensions (w x d x h, mm):
External: 3491 x 940 x 2500
Airlock: 794 x 500 x 757

AP-IS 2

 

AP-IS 3

  • Single Chamber
  • Double Airlock on both left and right side
  • Integrated Gaseous H2O2 bio-decontamination system available

Dimensions (w x d x h, mm):
External: 4406 x 940 x 2500

AP-IS 3

 

AP-IS 4

  • Single Chamber
  • Single Airlock on the right side
  • Integrated Gaseous H2O2 bio-decontamination system available

Dimensions (w x d x h, mm):
External: 3481 x 940 x 2500

AP-IS 4

 

AP-IS 5

  • Double Chamber
  • Single Airlock in the middle
  • Integrated Gaseous H2O2 bio-decontamination system available
  • Maximum operation

Dimensions (w x d x h, mm):
External: 5536 x 870 x 2500

AP-IS 5

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

The AP-IS 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.