A high-performance integrated system designed and developed in-house for the most cost-effective pharma manufacturing
STATE-OF-THE-ART ROBOTIZED STERILIZATION PLANT
The latest turn-key solution delivered by Fedegari consists of an innovative sterilization plant with integrated robotic handling system for parenteral bags. The system has been recently installed in the pharmaceutical plant of an important US customer. It is evaluated in about US$ 10.000.000. The project integrates the palletization of the product from three filling lines using several robot cells (delta and anthropomorphic) with automatic dispensing on two large superheated water autoclaves (cylindrical chamber diameter 2.400 mm x 14.500 mm in length). These sterilizers are able to load until 24 pallets of 20 trays, with an estimated productivity of 13.440 bags in 2 hours (time required by the sterilization cycle). Then, the system is able to depalletize the product – by the same robot cells (delta and anthropomorphs). The product unloaded from Fedegari system reaches the external inspection stations.
The robotized sterilization plant is managed by an automated system consisting of 3 PLCs (area handling, loading robot area and unloading robot area). It integrates control and safety on an Ethernet field bus and interacts with 16 robot controllers and one SCADA supervisor. The robotized sterilization plant operates with five vision systems for delta robots pick & place as well as a viewing system for output trays control and a pallet traceability system with QRcode readers.
The system presents a vertical integration with MES for the batch management and with the customer’s HISTORIAN for collecting production and sterilization data. The autoclaves are managed in an integrated way by Thema4 control system. The SCADA server software is virtualized in the customer IT with all services (remote authentication, SNTP synchronization and asset management HW and SW) and works through 3 fixed station and 1 mobile stations. The plant is connected via teleservice to Fedegari after-sales support. The automation development has followed the GAMP5 pharmaceutical standard, addressing the customer engineering company requirements.
EXPERTISE IN AUTOMATION
“Our company has always been innovation-oriented”, explains Paolo Fedegari, CEO of the group. “Fedegari differs on the market thanks to the many innovations introduced both in the field of machines and manufacturing processes and due to our extreme verticalization. We have always rejected the idea of assembling our machines with commercial components (designed for different applications), rather than that we prefer to design and develop components and machines in-house in order to gain a deeper understanding of every detail that could affect performances of a machine”, concludes the CEO.
This statement has been confirmed by Fedegari employees. Automation has always been an important reference for technological development in pharmaceutical processing. The company’s mission is to provide turnkey integrated solutions and related services for the cost-effective manufacturing of sterile drugs. How? Capitalizing the experience of over 60 years as suppliers of the most sophisticated and innovative process equipment in the field of contamination control and managing any technology that impacts on the performance and reliability of the systems.
A unique feature of Fedegari is the extreme verticalization of the company, which has always refused the idea of assembling sterilizers and sophisticated machines with standard (COTS) components rather than designed for a variety of applications. Every component is designed and produced in-house with the goal to develop the most suitable solution for each specific customer need. Over the years, this has enabled to control technology through a deeper knowledge of machines and processes and, therefore, to constantly innovate products. The same happened to the automation area when Fedegari decided to develop the current platform, starting from a sophisticated operating system (Wind River VxWorks). This way, the automation area became autonomous in the development of the process controller installed on all the machines manufactured by Fedegari.
Developed to meet the strictest requirements of the pharmaceutical industry, Fedegari process controller Thema4 is pre-validated according to GAMP5 and FDA 21 CFR, Part 11 guidelines and can be natively integrated with the SCADA and MES systems most typically used.
Fedegari is an international industrial group with the strategic vision of delivering the highest performance machines, systems, components and services in the field of sterilization of contamination control for the pharmaceutical, biotech and food industry. The company was created in the early 1950s, in Pavia, by the will of the brothers, Giampiero and Fortunato. Born as a small handicraft company devoted to the production of various carpentry items, it has progressively improved its business in the production of sterilizers for pharmaceutical application. In the early 1990s, Fedegari diversified its production in the field of processes with supercritical fluids (mainly CO2), designing and building systems and machines for extraction and washing processes.