Dispensing containment isolator HC-IS series

class IItransferfor highly potent active pharmaceutical ingredients

The Dispensing Isolator is a GMP Class 2 containment enclosure designed for the most challenging containment levels during manipulations of potentially hazardous compounds for production activities. The isolator system is equipped with a turbulent air flow system, and constantly guarantees a 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. 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). The Dispensing Isolator is the perfect solution for Manual Sampling, Weighing and Dispensing operations of High Potent Active Pharmaceutical Ingredients (HPAPI). ISOLATOR CONFIGURATION The isolator configuration is composed of a 4-glove working chamber and an inlet/outlet transfer chamber. An Elevated Platform is integrated into the isolator for a safe and efficient operation. AUTOMATIC LEAK TEST The Dispensing Isolator 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).