From the powder mixture to the finished granulate in the isolator

Three-Tec develops high-quality volumetric and gravimetric dosing systems and extruders, as well as peripheral equipment such as spheronizers, granulators, hot discharges, conveyor belts, and water beds. They impress with their easy cleaning, simple handling, and flexible adaptation to process requirements. Versatile integration options into manufacturing processes or test and laboratory applications in research and development make Three-Tec machines very popular products.

Three-Tec machines are custom-made according to customer specifications and are mostly used in the testing and laboratory sectors of the pharmaceutical or food industries.

In response to the increasing demand for a manufacturing process for granulates in an isolated environment, Three-Tec has collaborated with ART-Reinraumtechnik to realize an isolator with an integrated gravimetric dosing system, extruder, conveyor belt, and granulator according to ISO 14644-7. This allows the process from powder mixing to finished granulate to take place in a protected and controlled environment, eliminating the need to set up a complete cleanroom.

The installed machines are specifically designed for glove handling and can be easily disassembled and cleaned by an operator. The drives of the integrated production line are either located outside the isolator or are interconnected. The working chamber and all product-contacting parts of the machines integrated into the isolator are made of stainless steel 1.4404 (316 L) with a surface finish of Ra ≤ 0.8 μm.

Through controlled and filtered supply and exhaust air, a controlled negative pressure is created, maintaining cleanliness class C (OEB 4 / 5) according to GMP guidelines, and even when removing a glove, it guarantees that no product can escape to the outside (inflow). The fail-safe components, automatic pressure hold test, and static front glass seal made of EPDM ensure the safety of the operator and their environment. All filters and gloves can be replaced contamination-free.

The filling of the gravimetric dosing system within the isolator and the removal of the finished granulate are carried out via interlock chutes, double-door chutes, or double-flap chutes (RTP port).

The entire system can optionally be equipped with gas / compressed air outlets, cleaning guns / WIP nozzles, vacuum systems, and inerting, and is also built in explosion-proof and antistatic versions.