Class II isolator HC-IS

containmenttransferdispensing

The High Containment Isolator System (HC-IS) is a GMP Class 2 modular HPAPI containment enclosure designed for the most challenging containment levels during manipulations of potentially hazardous compounds for Research & Development, Production and QC. High Containment Isolator System (HC-IS) can be equipped with an integrated AGLTS 2 Automatic Glove Leak Testing System MAXIMUM SAFETY Maximizing operator protection is the primary characteristic of a containment isolator. Tema Sinergie HC-IS assures very stringent containment levels (≤50ng /m3) thanks to a perfect combination of design and manufacturing strategies. The system is equipped with inflatable and/or static seals made of FDA approved EPDM (Ethylene Propylene Diene Monomer) to guarantee air tightness Class II (ISO 10648:2). The HC-IS is therefore the perfect adaptable solution for different applications, such as Product Transfer, Manual Sampling, Weighing and Dispensing operations of High Potent Active Pharmaceutical Ingredients (HPAPI). MODULAR BASED CONFIGURATION The system is based on a versatile modular concept: the base isolator configuration is composed of a single working chamber which can be easily expanded with additional chambers and/or airlocks. This makes HC-IS perfectly suitable to every need and process. A select number of available options may be added at a future date. AUTOMATIC LEAK TEST HC-IS is equipped with a routine automatic leak testing system which performs an independent leak test cycle for each chamber according to the pressure change method (5.2) ISO 10648-2:1994(E).