High Containment Systems
FROM POWDER MIXING TO FINISHED GRANULATE IN THE ISOLATOR
Three-Tec develops high-quality volumetric and gravimetric feed units and extruders together with peripheral equipment such as spheronizers, granulators, hot die faces, conveyor belts and water baths. They impress due to their easy cleaning, simple handling and flexible adjustment to process requirements. Versatile options to integrate them into the production processes or test and laboratory applications of research and development make Three-Tec machines very popular products.
Three-Tec machines are produced as custom-made designs to meet customer requirements and are largely used in the testing and laboratory sectors of the pharmaceutical and food industries.
Three-Tec has now reacted to the growing demand for a production process for granulates in an isolated environ-ment and realised an isolator with integrated gravimetric feed unit, extruder, conveyor belt and granulator in accord-ance with ISO 14644-7 in collaboration with ART-Reinraumtechnik. As a result, the process – from powder mixing to finished granulate – takes place in a protected and controlled environment, which removes the need to set up a complete clean room.
The integrated machinery is designed especially for handling with gloves and can be dismantled and cleaned easily by a user. The drives of the integrated production line are either located outside the isolator or encased. The work-ing chambers and all the components coming into contact with the product within the machinery integrated into the isolator are made from stainless steel 1.4404 (316 L) with a surface finish of Ra ≤ 0.8 µm.
Through the controlled and filtered supply and exhaust air, a controlled low pressure is created in compliance with purity class C (OEB 4 / 5) in accordance with GMP guidelines and guarantees no product escaping (inflow) even if a glove tears. In addition, the failsafe components, automatic pressure holding test and static EPDM front pane seal ensure the safety of the user and the environment. All filters and gloves can be replaced without contamination.
The filling of the gravimetric feed unit in the isolator and the removal of the finished granulate occur via the interlock sluices, twin-door sluices or twin-valve sluices (RTP port).
The whole system can also be equipped with gas / compressed air extraction points, cleaning guns / WIP nozzles, vacuum cleaning system and inertisation and is also built as an explosion-protected and anti-static design.
