Sterility testing isolator ST-IS

transferISO class 5floor-standing

The ST-IS (Sterility Isolator System) is a cGMP Class A/ISO 5 custom isolator system specifically designed to meet every type of quality control requirement and guarantees the safest working conditions. Be it a question of developing an extremely specific process or the constraint being linked to a particular facility arrangement, ST-IS in its custom configuration is the solution to all your specific needs. OPERATION ST-IS is an aseptic isolation system designed to provide the best environmental and working conditions for conducting sterility tests according to Pharmacopeia. ST-IS consists of two chambers with different characteristics and functionalities. The first step of the workflow involves placing the material for sterility testing into the Transfer Chamber, followed by the execution of the decontamination process using the integrated VPHP system. Once the process is complete, the material can be transferred to the Processing Chamber without compromising the aseptic level of the Processing Chamber, which has been previously subjected to the decontamination process. The Working Chamber is equipped with a state-of-the-art integrated peristaltic pump, allowing for simple and reliable execution of the test. MAIN FEATURES GUARANTEED ASEPSIS The ST-IS assures the highest air quality in the isolated environment. AUTOMATIC LEAK TEST The ST-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(E).