Class II isolator

for powder handlingfor APIfor cytotoxics

The Analytical Testing Isolator System has been designed for pharmaceutical industries which require the highest containment levels during manipulations of potentially hazardous compounds (HAPIs). The Isolator System is a GMP Class 2 containment enclosure, and it’s composed of a 4 gloves working chamber, and an inlet/outlet airlock. A RTP (mod. DPTE 270-XS) and a continuous liner are integrated into the isolator. The isolator is also equipped with a Wash-In-Place (WIP) for manual washing operations.MAXIMUM SAFETY Maximizing operator protection is the primary characteristic of a containment isolator. Tema Sinergie Analytical Testing Isolator System 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 Analytical Testing Isolator System 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 the Analytical Testing Isolator System perfectly suitable to every need and process. A select number of available options may be added at a future date.