Bosch
Bosch Packaging Technology has delivered its first FXS 3100 nested syringe filling line to Italy. IBSA Farmaceutici Italia purchased the line to improve its aseptic prefilled syringe operations in Lodi.
IBSA Farmaceutici Italia, a subsidiary of the Swiss Institute Biochimique S.A., specialises in small-volume production of aseptically filled and sterilised pharmaceuticals. This includes 16 million pre-filled syringes per year containing sodium hyaluronate for intra-articular and intradermal use and 2.2 million syringes for physiological solutions used as solvent for freeze-dried powders. IBSA recently added a new production building to its site in Lodi, close to Milan. To improve processes for its aseptically filled pre-filled syringes, the company decided to equip the plant with a Bosch FXS line. “Bosch designers and technicians showed the best attitude towards the project and were very fast in accepting our specifications,” commented Roberto Maglio, Engineering & Maintenance Manager at IBSA. On the new line, IBSA will mainly produce diclofenac, an anti-inflammatory API used for muscular and rheumatic treatment. In a further step, the company also plans to fill hyaluronic acid for intra articular and intradermal use.
Special emphasis on contamination issues
The new nested syringe filler for presterilised syringes produces at medium to high rates. IBSA achieves an output of 12,000 syringes per hour with watery products and 6,000 syringes per hour with viscous products. “Viscous products are filled and stoppered under vacuum, hence the lower output rate,” Maglio explained. The line is based on the FXS 3100 nested syringe filler from Bosch Packaging Technology. Combined with an ABO 5000 bag opener and an ATO 5000 tub opener, as well as open restricted access barrier system (RABS) technology, the line was configured to the special requirements of IBSA Farmaceutici Italia.
“Bosch was always open to new suggestions and quickly implemented our modifications,” said Maglio. Paola Emaldi, responsible for quality assurance at IBSA’s Lodi site, added: “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.” During the process, the empty sterile syringes contained in tubs are moved from the non-sterile area to the cleanroom area and sterility of those syringes must be ensured. Microbiological controls are executed by high-precision instruments being able to detect microbial contamination in real time, proving that no contamination occurred.
A truly reliable aspetic process
During the testing and implementation phase, both companies benefitted from each other’s knowledge and working conditions. “IBSA could draw on Bosch’s expertise and flexibility for the line configuration,” Maglio explained, “Together, we managed to achieve a truly reliable aseptic process.” The first series of factory acceptance tests (FATs) were performed at Bosch’s location in Crailsheim, Germany, before the line was shipped to Lodi, where more tests and adaptations were carried out. Both companies profited from testing at the actual place of production, including cleanrooms grade A, B and C.
The specific application at IBSA’s plant in Italy required some changes to the line configuration. Both the machine shape and the dimensions of critical machine parts were adapted and now ensure a smooth air pathway and material movement to and from the classified areas without contamination. The final tests had to wait until the line had been installed and the environmental conditions completed. The results confirmed that all improvements had been successfully implemented. “Everyone involved was continuously seeking to improve processes and to find the best solutions for IBSA,” Maglio emphasised, adding that this attitude “really came out naturally.”
Bosch Packaging Technology — Business Unit Pharma, +49 7951 402 517, klaus.ullherr@bosch.com, www.boschpackaging.com.