Class II isolator HC-IS

containmenttransferdispensing

GMP Class 2 containment enclosure designed for the most challenging containment levels during manipulations of High Potent Active Pharmaceutical Ingredients (HPAPI) for analysis/quality control activities. MAXIMUM SAFETY Maximizing operator protection is the primary characteristic of a containment isolator. Tema Sinergie assures very stringent containment levels 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). Turbulent air flow system, negative 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) filters. ISOLATOR CONFIGURATION The isolator configuration is composed of a 4-glove working chamber and an inlet/outlet transfer chamber. AUTOMATIC LEAK TEST The Dispensing isolator (QC Lab) 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 (E). GLOVE INTEGRITY TESTING The Dispensing isolator (QC Lab) can be equipped with an integrated Automatic Glove Leak Testing System (AGLTS) which performs an independent leak test cycle for each glove mounted on the isolator system according to the Positive Pressure Decay Method described in the international standard ISO 14644-7 Annex E.5.