IBSA Farmaceutici Italia, a subsidiary of the Swiss Institute Biochimique S.A., aseptically fills and sterilizes syringes. At its site in Lodi, for instance, IBSA fills 16 million pre-filled syringes with sodium hyaluronate for intra-articular and intradermal use and 2.2 million syringes with solvents for freeze-dried powders. To meet increasing demand for prefilled syringes, IBSA added a new production building featuring Bosch Packaging Technology’s (www.boschpackaging.com ) FXS nested syringe filling. The new line will produce Diclofenac, an antiinflammatory active pharmaceutical ingredient used for muscular and rheumatic treatment; future plans are in place to fill hyaluronic acid for intraarticular and intradermal use.
Featuring an ABO 5000 bag opener, an ATO 5000 tub opener, and an open restricted access barrier system (RABS), the FXS line was designed to meet IBSA’s specific requirements. “Bosch designers and technicians showed the best attitude towards the project and were very fast in accepting our specifications,” said Roberto Maglio, Engineering & Maintenance Manager at IBSA, in a press release. “IBSA could draw on Bosch’s expertise and flexibility for the line configuration. Together, we managed to achieve a truly reliable aseptic process.”
IBSA can achieve an output of 12,000 syringes per hour with watery products and 6000 syringes per hour with viscous products. “Viscous products are filled and stoppered under vacuum, hence the lower output rate,” Maglio explained.
The line features a semi-automatic reject station outside of the aseptic filling zone and permits removal of out-of-specification syringes. Syringes without a stopper or with an incorrect filling weight are rejected via an automatic discharge function and are tracked on screen. Operators can then remove syringes manually to confirm their removal. Correctly closed and filled syringes continue down the line.
Controlling contamination was one of IBSA’s critical requirements. Empty sterile syringes contained in tubs are moved from a non-sterile area to the cleanroom area. Syringe sterility must be maintained during this critical transfer and throughout filling and handling. High-precision instruments can detect microbial contamination in real time. “The project was not only about the filling of our syringes; the complete process needed to be taken into account. We had to pay particularly high attention to microbiological contamination issues,” explains Paola Emaldi, responsible for quality assurance at IBSA’s Lodi site.
The first series of factory acceptance tests (FAT) were performed at Bosch’s location in Crailsheim, Germany. After only six weeks, the line was shipped to Lodi for testing at the actual place of production, including cleanrooms grade A, B and C. Once at IBSA’s plant in Italy, the line required some changes in configuration. Both the machine shape and the dimensions of critical machine parts were adapted, Bosch reports, to enable a smooth air pathway and material movement to and from the classified areas without contamination. Final tests were conducted and the line prepared for inspection by the Italian authorities. The results confirmed that all improvements had been successfully implemented. “The entire Bosch team was very committed. Clearly, their job not only consisted in the execution of a contract. Everyone involved was continuously seeking to improve processes and to find the best solutions for IBSA,” Roberto Maglio emphasized, adding that this attitude “really came out naturally.”
IBSA Farmaceutici Italia offers research and development, clinical development, production, and marketing of proprietary products. It also acts as an interface with the Italian authorities.