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Contract Manufacturing

Alfasigma is a leading company in Contract Manufacturing, able to provide an integrated and exhaustive service covering all aspects of this activity.

 

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Alfasigma: presenting the new Sterile Department

Adding new facilities to meet your business needs

Alanno plant: The New Department

2020 will be a year of great news for Alfasigma Contract Manufacturing and its production sites in which two new sterile departments for sterile powder and pre-filled syringes will be improved. The first one will be activated by early months of the year, and will be completely dedicated to the production of vials filled with sterile powders and sterile liquids. Counting on a surface of over 450 sqm, the new department would meet all the European and US GMP standards and will rely to the new GMP Annex 1.

Technical features

The core of the department is a high speed filling line designed and manufactured by IMALife. The design concept of the line equipped with closed RABS, facilitate unidirectional flows so we can assure the highest level of safety. Integrated system allows the machine to carry out 100% automatic in Process Control without affecting the performance of the line that is able to reach an output of 18,000 pcs / h. Dosing accuracy is ensured by a "vacuum-pressure" system that guarantees excellent performance. This new facility could be able to manage low dosages less than 100 mg to higher dosages up to 10 g. To improve the versatility of the department, the filling line can also be used for liquid filling.

Robustness and safety of the aseptic area are ensured by sterilization systems (ovens, autoclaves, passboxes) designed and manufactured by Fedegari. All systems are integrated to provide data robustness and integrity.

Our experience

Alfasigma will offer an annual capacity of 250,000,000 vials that could supply all international markets thanks to its impressive know- how achieved during the past years into the field of the filling of sterile powders.

About Alfasigma

Alfasigma is a privately-owned, Italy-based integrated multinational pharmaceutical company with 2018 revenues in excess of €1 billion, 5 manufacturing plants, R&D facilities, and 3,000 employees globally. Outside of its core Italian market, Alfasigma has 16 subsidiaries in Europe, Asia, North and Central America and Africa, and is present in more than 90 countries.