weigh isolator / for active pharmaceutical ingredients / containment / dispensing
HC-IS Tema Sinergie

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Characteristics

  • Applications:

    weigh, for active pharmaceutical ingredients, containment, dispensing, transfer, sampling, for radiopharmacy, for clean rooms, for quality control, for research

  • Configuration:

    floor-standing, modular

  • Other characteristics:

    negative pressure, stainless steel, with HEPA filter, positive pressure, custom, controlled atmosphere

Description

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