An automation system in accordance to the GAMP5 pharmaceutical standard

By Fedegari, a Company specialized in the design of machines in the pharmaceutical field


Part of an international industrial group whose strategic objective is the supply of machines, systems, components and services in the field of contamination control sterilization for the pharmaceutical, biotech and food industries, Fedegari was created by the brothers Giampiero and Fortunato Fedegari in the early 50s in Pavia. Born as a small artisan company dedicated to the production of various carpentry products, it has progressively concentrated on the production of sterilizers, specializing in the design of these machines for application in the pharmaceutical field. In the early 90s, it diversified its production also in the field of supercritical fluid processes (mainly CO2), designing and building systems and machines for extraction and washing processes.

A unique feature of Fedegari is the extreme dedication of the company, which has always rejected the idea of ​​assembling sterilisers and sophisticated machines with commercial grade component. This dedication has allowed Fedegari’s technology to be developed through a deep knowledge of the machines and processes. The same statement is applicable in the automation area when, at the beginning of the 2000s, Fedegari started to develop the current platform starting from a sophisticated operating system (Wind River’s VxWorks).


Integrated cutting-edge system

Thanks to the collaboration with SEW-EURODRIVE, Fedegari has created a sterilization plant with an integrated and robotized handling system for parenteral solutions in bags (FEDEGARI AUTOMATIC HANDLING SYSTEM FOR FLEXIBLE BAGS) which will soon be delivered to an important US customer. The system integrates the palletization of the product coming from three filling lines, through several robot cells (delta and anthropomorphic) with automatic feeding to two autoclaves with superheated water of large dimensions (cylindrical chamber with a diameter of 2400 mm x 14500 mm in length). These sterilizers are able to load 24 pallets of 20 trays.

The plant is managed by an automation system made up of 3 PLCs (area handling, robot loading area and unloading robot area) that integrate the control and safety on an Ethernet fieldbus and talk with 16 robot controllers and a supervision SCADA . In the system there are 5 vision systems for the pick & place controls of the delta robots.. The system has a vertical integration with the MES for the production batch management and the customer HISTORIAN for the collection of production and sterilization data. The autoclaves are managed in an integrated way with the Fedegari Thema4 control system. SCADA server software is virtualized in the customer’s IT with all services (remote authentication, SNTP synchronization and HW and SW asset management) with the presence in the field of 3 fixed and 1 mobile client stations. The plant is connected to the Fedegari after-sales support.


The MOVIGEAR mechatronic drive on board the system

Fedegari was facing a new technological challenge as it was approaching issues like those of handling, but Sew is a partner that is capable to support the most appropriate architecture for top level performance required by the end customer. Detailed mechanical and electronic sizing, design support, commissioning and product training courses were carried out to better familiarize the clients with the equipment and procedures

By working with the engineers at SEW, the Fedegari group has centered its project objectives and appreciating SEW’s expertise, quality and organization. Fedegari intends to continue its partnership with SEW-EURODRIVE so that new projects for the future are already being developed


FEDEGARI: in the name of verticalization

“The company has always been oriented towards innovation – explains Paolo Fedegari, managing director of the group. Fedegari differs on the market by virtue of the numerous innovations introduced both in the field of machines and in processes, as well as for the extreme verticalization of production. We have always refused the idea of ​​assembling our machines with commercial components”, concludes Fedegari.

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