Since it was established in 1948, Alfa Wassermann SpA has been deeply rooted in the Italian pharmaceutical market through the research, production and marketing of prescription and over-the-counter drugs.
Great versatility is what makes Alfa Wassermann a unique partner. Nearly all pharmaceutical forms are manufactured in its production plant from tablets to capsules, from creams to ointments. The plant is located in central Italy and since 1985 - when it was established - constant investment in new technologies has led Alfa Wassermann to reach high quality and reliability levels for pharmaceutical product processing. The plant's flagship, however, is the sterile department.
An important project to enlarge the department - called "Stelyo 1" - to a total of 1,800sqm, was completed in 2010. Here, sterile products are manufactured - from nose sprays to injectable liquids and lyophilised products. The department was designed to ensure the greatest versatility of organisational flows and of the whole manufacturing process, while always maintaining the highest safety standards where products are concerned.
The manufacturing activities of this department will triple during the first months of 2010, thanks to the start-up in 2009 of a cuttingedge, high-productivity line for filling ampoules and bottles. In addition, two new, cutting-edge twin lyophilisers from Ima Edwards started to operate in the department. Each of them has a capacity of 37sqm, and allows manufacturing batches up to 100,000 bottles and more than 200,000 ampoules. Flexibility was a major consideration during the upgrade of the plant. The department can also manufacture small and medium-sized batches, as well as different format products, such as bottles and ampoules with different types of sealing.
Lyophilisers were installed in dedicated premises, so that it is possible to lyophilise different products at the same time.
Lyophilisation is a critical process; various factors contribute to obtaining a product with the qualities required, and for this reason installations - which are completely automated - enable management and supervision of all critical parameters thanks to a control system that is able to manage the progress of the process in real time. It can also signal any abnormalities of the installation that may affect product quality. The working environment around the lyophiliser meets all regulatory requirements for manufacturing sterile products, thereby ensuring a suitable environment for processing lyophilised products.
There are no particular limits for the type of active principles contained in manufactured products; indeed, Alfa Wassermann's historic know-how is based on its experience working on many molecules, including hormones and long-chain peptides.
Another strength of the new sterile department is its innovative preparation room. Two independent solution preparation lines were installed in the new sterile products department. Each line is composed of a preparation tank and two tanks for storing solutions. The two lines are identical and can work batch sizes ranging from 30l to 1,000l of solution. The fillers installed in the sterile environment can be fed directly from the two storing tanks, thanks to a piping system. It is also possible to fill two fillers at the same time.
The installations are automated and controlled by a supervision system that controls all the manufacturing phases, as well as installation management. Both installations can be washed and sterilised on the spot, to ensure the best conditions before starting the preparation phase.
The choices made during the expansion phase have enabled Alfa Wasserman to present to the market contract manufacturing products that comply with the highest qualitative standards, while remaining competitive in terms of costs. The quality is also testified by the positive results of the audit carried out by the inspectors of Alfa Wassermann customers, important national and multinational pharmaceutical companies that commercialise the drugs manufactured in Alanno in the Italian market and in major European markets, such as Germany, France, the UK and Austria, as well as in South American markets.