Tailor-made Machine Tools with Sterile Process Engineering
Working closely with leaders of pharmaceutical, medical, biotech and mechanical industries for over 35 years, MGA Technologies has developed special expertise in the design and production of custom-made machines for sterile pharmaceutical and biotechnological process applications.
Main Solutions of Machine Tools with Sterile Process Engineering
This automatic line collects the primary liquid that is intended for influenza vaccines production.
This machine is for then automatic impregnation of a process liquid on pharmaceutical granules.
Often with a mechanical and mechatronic basis, these automated and robotic machines have various applications that require its own design expertise, including the management of sterile product flows, the removal of hard-to-clean areas and the minimization of mechanical particle generation.
Good Manufacturing Practices, cGMP (current Good Manufacturing Practices) are taken into account and applied in the design right from the definition of the machine architecture. Embedded hardware is chosen to meet the requirements of the intended application. A quality follow-up in design and implementation is implemented to demonstrate the perfect match of the machine with the URS, User Requirements Specifications. The whole thing is recorded in a detailed technical documentation allowing the customers its integration in its documentary system. This equipment is often integrated in the clean rooms of our customers and the limits of services are agreed, but can integrate the problems of confinement, the aeraulic management of the flows and its own utilities.
The applications encountered are numerous and varied, from the dilution, impregnation, mixing or dosing of sterile, liquid or solid products, to the collection of primary process liquids and the clean assembly of sterile parts. We can provide solutions whenever a customer is confronted with a particular application for which there are no standard machines adapted to special constraints or requiring the integration of advanced technologies for sterile processes.