Tema Sinergie

Analytical Testing Isolator System

The Analytical Testing Isolator System has been designed for pharmaceutical industries which require the highest containment levels during manipulations of potentially hazardous compounds (HAPIs).

The Isolator System is a GMP Class 2 containment enclosure, and it’s composed of a 4 gloves working chamber, and an inlet/outlet airlock.

A RTP (mod. DPTE 270-XS) and a continuous liner are integrated into the isolator. The isolator is also equipped with a Wash-In-Place (WIP) for manual washing operations.

This isolator system is equipped with a turbulent air flow system, and constantly guarantees a pressure gradient between the chambers and the lab environment.

The high air quality of the isolated environment is assured by High Efficiency Particulate Air (HEPA H14) inlet and outlet filters.

The system is equipped with inflatable seals to guarantee air tightness Class II (ISO 10648:2). The inflatable seals are made of FDA approved EPDM (Ethylene Propylene Diene Monomer) manufactured by Garlock Technetics.

Operator safety is crucial because of the dangerous nature of the materials (OEL5: <0,1µg /m3).

 

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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

  • Integrated manual Wash-In-Place (WIP)
  • Handles with integrated safety switch
  • LED lighting system
  • Rapid transfer port, and transfer container
  • Continuous liner, and welder
  • Integrated automatic glove leak testing system (AGLTS)
  • Integrated thermal printer
  • 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 Analytical Testing Isolator System 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.