Tema Sinergie

HC-IS

High Containment Isolator System

The High Containment Isolator System (HC-IS) has been designed for pharmaceutical industries which require the highest containment levels during manipulations of potentially hazardous compounds for Research & Development, Production and QC.

HC-IS is a GMP Class 2 modular containment enclosure. The base isolator is composed of a single 3 or 4 gloves working chamber, but additional chambers and/or airlocks can be supplied according to the process to be performed.

The high level of containment conditions achievable within the isolated environment makes HC-IS the perfect flexible equipment for different applications, such as Product Transfer, manual Sampling, Weighing and Dispensing operations of High Active Pharmaceutical Ingredients (HAPIs).

This isolator system will be equipped with a turbulent air flow system, and constantly guarantees a pressure gradient between the chamber(s) 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.

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

The isolator is also fitted with a VPN connection, that is a Virtual Private Network which allows a secure and private communication via Internet network. VPN provides remote access and assistance, updates and maintenance any time, everywhere.

The concepts the HC-IS is based upon are modular containment, cost-effectiveness and ease of use.

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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
  • Integrated manual & automatic Wash-In-Place (WIP)
  • Handle with integrated safety switch
  • LED lighting system

Optional Equipments

  • Rapid transfer ports, and transfer container
  • High containment valves, and stakable lidded drums
  • Fully automatic Clean-In-Place (CIP)
  • Continuous liner, and welder
  • Vacuum cleaners
  • Inert gas distribuition and monitoring system
  • Vacuum dryers
  • rH%+T sensors
  • Integrated glove leak tester
  • Integrated 21 CFR part 11 compliant  FDA 21 CFR Part 11 paperless graphic recorder
  • Integrated thermal printers
  • Uninterruptible power supply (UPS)

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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 HC-IS 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.