IMA Active and SAVIO Industrial: together for process optimisation.

The SAVIO pharmaceutical group is a group of businesses with entirely Italian capital dating back to 1925. With its headquarters in Pomezia (RM) and a second base in Pisa, SAVIO includes a parent company (F&S Holding s.r.l.) and four operational companies (I.B.N. Savio s.r.l., Savio Industrial s.r.l., Savio Pharma Italia s.r.l. and Farmaceutici Caber s.r.l.), which handle Research and Development, production and marketing of pharmaceutical specialties of its own and third-party production. One of the main players in the Italian pharmaceutical industry, the Group employs approximately 500 people, including over 200 in research and production and 230 medical and scientific informants for the entire country. It operates in a number of therapeutic areas, including: osteoarticular, diabetology, endocrinology, respiratory, cardiovascular, gastrointestinal, urological, anti-infective.
The Group also has two production facilities: one in Ronco Scrivia (GE), which specialises in the production of injectable drugs in a sterile environment and class III medical devices in prefilled syringes. The other facility, in Pavia, operates in the formulation, R&D, production and packaging of oral solids and liquids. The Pavia site recently expanded its granulation capacity by choosing IMA Active technology, following a period of process understanding supported by IMA Active process technologists. “Choosing a process plants supplier of the calibre of IMA Active, aside from being located a short distance from our Pavia site, enabled us to establish a partnership and have real confidence in the development of the project,” says Beppe Mazzocchi, QP and Quality Director. “We also set up a multidisciplinary in-house team to monitor the various phases of the project to make sure we kept to the initial schedule.”

What were the drivers behind the project to expand your granulation capacity?

The Pavia facility was sold by MSD to SAVIO in 2015; since then throughput at the site has grown continuously, which meant we were increasingly using the capacity of the two existing wet granulation modules. So the first driver was to proactively avoid the saturation of the existing capacity, as well as increase efficiency through a period of process understanding ahead of the expansion phase. A second driver was to add new capability in terms of granulation technologies, i.e. the possibility of having fluid bed granulation.

What role did the collaboration with IMA Active play from the point of view of engineering and process optimisation?

We worked closely with IMA Active from the very early phases of the project, sharing our requirements and goals. The type of plant we chose arose from SAVIO’s needs, which was confirmed after a series of visits to IMA during which we spoke with IMA Active process experts and saw both laboratory-scale and industrial-scale equipment at the test laboratory. This gave us an in-depth understanding of the potential of the technologies we could acquire and how they could be adapted to our production requirements. We collaborated with IMA Active on an ongoing basis both to optimise the processes to be transferred to the new granulation line and to integrate it in accordance with the existing handling operations at the department. Together we explored the possible engineering solutions for the installation of the granulation line, taking account of the available space and utilities, both in the production area and in the technical area. This teamwork, where everyone brought their own skills to the table to reach a shared goal, was fundamental for the success of the project.

IMA Active’s process consultancy and technological support service led to the acquisition of a 600-litre granulation line. What are the main advantages of this choice?

IMA Active’s laboratory process consultancy service did not stop at selecting and configuring the new plant for transferral of existing products; it also helped our R&D team in the industrialisation of a new product. First, we invited the IMA Active team of process experts to look at the production at our plant and we then worked together on a process understanding plan backed by a granulation test plan to be carried out on a pilot line available at the IMA Active laboratory. The goal was to find out how robust the process was, not least considering the manageability of possible variabilities in raw material. At the end of the tests, not only did we confirm that the product could be transferred to the new plant but we also made improvements to the process in terms of reducing times and manual operations.
At a later stage, we worked with the IMA Active laboratory again on a work order for a new product to be granulated with top spray fluid bed technology. Here too, we progressed from small-scale and pilot testing to an industrial-scale process on the Aria 600 fluid bed that we purchased. I have to say that the opportunity to work with an experimental design on small-scale plants had several advantages, from saving time to not interrupting the production cycle and minimising the quantity of material necessary for setting up the process. Another major advantage was being able to work with expert process technologists, who helped us in the scale-up activities and in starting the new granulation line.

The collaboration with IMA continued during the test and validation phase. Did it also lead to the development of other products?

Thanks to the excellent relationship we have established, the IMA Active experts continued supporting us until the industrial-scale process was fully validated. We have since continued working on the development of other products with IMA Active technologists. For example, we are currently working together on developing a product that involves not only granulation and drying phases but also tablet compression and coating. We believe it is very advantageous to work with a supplier such as IMA Active precisely because it enables us to make use of their process support services throughout the entire plant life cycle.