STERILINE S.r.l.

Steriline is a well-established European manufacturer highly specialized in the production of complete lines for the aseptic processing of injectable products, supplying pharmaceutical companies worldwide.

In 1989 Steriline was founded in Italy, in the Lake Como area where its headquarters and manufacturing facilities are still based. With operations in over 50 countries around the world Steriline has developed a vast network of over 180 people, including direct employees, external partners, and 40 sales representatives. Export represents more than 90% of Steriline’s turnover with over 1,300 machines installed throughout Asia, Europe, and the U.S.A.

With the focus on specialization, advanced engineering and collaborative partnerships, Steriline aims to become a preferred aseptic processing manufacturer for the pharmaceutical industry. Steriline is committed to providing customers with distinct, tailored and reliable solutions to help them meet a growing demand in the sector for improved efficiency, consistent quality and enhanced safety.

First established as a manufacturer of washing machines and depyrogenation tunnels, in 2007 Steriline launched its first complete line including isolators and filling and capping machines. Since then, Steriline has been able to significantly evolve into a single-source supplier of equipment solutions for the primary packaging of injectable drugs, ranging from complete lines to stand-alone machines.

As a testament to its commitment to Research & Development and technological innovation, in 2014 Steriline became a pioneer by introducing the first robotic application in the aseptic processing market. It was a groundbreaking solution that was built with a “zero-loss philosophy” and no format parts.

Currently, Steriline develops, manufactures and supplies a comprehensive range of solutions, including both mechanical and robotic applications for the aseptic processing. These applications are compatible with vials, ampoules, cartridges, and syringes and can handle toxic or non-toxic products in both liquid and powder form. Steriline’s complete lines include equipment spanning from washing machines, depyrogenation tunnels, filling and capping machines to external decontamination machines and barrier systems such as LAF, oRABS, cRABS and isolators.

Robotics will play a key role in the future of the pharmaceutical industry, as it continues to define new paradigms for manufacturing. In this scenario Steriline is currently strongly widening its portfolio of robotic solutions to further help injectable drug manufacturers face effectively the new global challenges. Steriline’s continuous drive for technological improvements and its strategic approach to innovation is realized by a close and well-established collaboration with Fondazione Politecnico di Milano.

Another crucial asset is Steriline’s relationship with customers which is shaped around a dialogue that is frequent, open and ongoing at all stages of product lifecycle. Whether a company is looking for a standard single machine or a customized robotic line, Steriline can leverage its inventive approach to engineering and advanced project management capabilities to deliver the most effective solutions for each customer specific needs.

In addition to offering complete planning and project management, Steriline the customer from the design and manufacturing phases through installation, qualification, validation and maintenance. Additionally, Steriline provides extensive customer support services including technical assistance through a staff of skilled engineers.

Established as a family-owned business more than 30 years ago, Steriline is still guided today by its founder, Gerardo Fumagalli, as President together with Ilaria Fumagalli, Chief Operating Officer, and Federico Fumagalli, Chief Commercial Officer.