Aseptic Isolators
Principle: Our engineers develop aseptic isolators with guarantees of product protection and process integrity in a class A environment. Our aseptic isolators are systematically based on proven standard concepts (mechanical, electrical, safety, processes, etc.) in conjunction with a custom made design. These choices allow us to offer our customers solutions that are perfectly adapted to the new demands of the pharmaceutical industry with optimized costs and top of the range technical detail. Class A Environment: Our isolators are generally equipped with laminar flow and dynamic confinement technology so as to ensure the best guarantee of a class A working environment. A personalized QI-QO monitoring report includes the intervention of an independent organization in order to validate the operating mode and the classification of the insulator. Our aseptic isolators are designed on demand to operate in positive pressure, in air or in a pure atmosphere.
Depending on the processes carried out and the devices integrated into the isolator, the workspace can be set out in different sizes and designs. In two-glove, three-glove, four-glove or completely custom-made versions. In single-station or multi-station versions, in the form of a single isolator or interconnected isolators with process separation, and if necessary, with a customized geometry to ensure the best possible integration of a process machine (lyophilizer, presses and tableting machines, formulation and characterization devices, etc.) or other OEM equipment such as those allowing sterility control.
Particular emphasis is placed on ergonomics such as inclined or straight work faces, ovoid-shaped glove rings, location and inclination of glove rings made to measure according to the process, original storage solutions adapted to the application and a PLC/HMI touch screen control system which is programmed by our automation engineers with different access levels.
From a process safety point of view, the environment remains perfectly safe and controlled thanks to interlocking systems on the pull-down work panels and transfer locks.
Whatever the model, our isolators are systematically manufactured according to a one-piece boiler design with rounded corners allowing cleanability or irreproachable decontamination. Designed by experienced employees and manufactured in our own workshops with modern industrial technologies, our isolators fully comply with the highest standards of the pharmaceutical industry and GMP guidelines. Our creations are exclusively produced with best in quality materials such as AISI 316L stainless steel, tempered laminated mineral glass work faces, FDA approved seals and gloves.