Steriline, a company highly specialised in the production of complete lines for the aseptic processing of injectable and ophthalmic products intended for pharmaceutical companies worldwide, has recently delivered the OFCM84 solution, a filling and capping line, to Bausch+Lomb Italia which is aiming to expand its production capacity while simultaneously minimising the risks of microbial, particulate and endotoxin/pyrogen contamination in its eye care products.
With headquarters in Vimodrone (in the outskirts of Milan) and a production plant in Macherio (MB), 20 km further north, Bausch+Lomb currently operates in Italy with 3 specialised divisions: eye drops, eye care dietary supplements and foods for special medical purposes (for the treatment of eye diseases). The production site is dedicated to manufacturing lens care and eye care products packed in bottles ranging from 10 to 500 ml in size.
In response to the growing demand for smaller dose formats (from 10 to 60 ml), the company recently decided to expand its production capacity with a new, highly performing filling line. The main requirements for this line were a production speed of 200 pieces/min, cleaning in place (CIP), sterilisation in place (SIP) and a clean, easy-to-access design.
A further major factor when choosing the line was compliance with the guidelines contained in Annex 1 of the Good Manufacturing Practices (GMPs), deliberated by the European Commission in mid 2022.
The company eventually settled on Steriline’s proposal, as it satisfied all technical requirements with an excellent quality/price ratio.
“We really appreciated the design of the machine, and I believe that selecting a supplier specialised in solutions for aseptic processing was the winning choice, in terms of both technical and technological quality,” claimsAlessandro Barbaresi, Operation Supervisor of Bausch+Lomb Italia. “The operator panel is very intuitive, as are the CIP-SIP processes. Furthermore, the production start-up operations and format changes are very functional and easy, and no subsequent adjustments were necessary. The execution time is shorter compared to other lines not originally conceived for aseptic processing.”
Steriline’s Ophthalmic Filling and Capping Machine (OFCM84) is a linear solution, 5.7 m long and just 1 m wide, servo-actuated and equipped with 8 filling heads fed by ceramic volumetric pumps. The machine does not have any rotating parts, which are potential sources of contaminants.
The surfaces are smooth and impervious (for easier cleaning) and designed to minimise the shedding or accumulation of particles or micro-organisms. All moving parts have alternating motion aimed at preventing turbulence caused by laminar air flow (LAF) disturbance.
The total concentration of 0.5 µm particles is lower than 3,520 per cubic metre, both at rest and in operation, which means the line has grade A environmental cleanliness classification. Moreover, the machine is equipped with automatic CIP-SIP in the product piping, which reduces manual operations during machine set-up, minimising the contamination risk associated with operator interventions inside the grade A area.
“I am satisfied with the results achieved by this project and the partnership with a client of Bausch+Lomb Italia’s calibre,” declares Filippo Parini, Sales Area Manager of Steriline. “I am sure that this first success will lead Bausch+Lomb to return to Steriline for the supply of other systems. Indeed, Steriline can offer solutions compliant with the new regulations defined in Annex 1 and therefore can be a reliable partner even for players at the top of eye care market.”
After this first delivery, Bausch+Lomb confirmed its satisfaction with Steriline’s solution and has ordered 2 additional filling lines for its US production sites in Tampa (Florida) and Greenville (South Carolina).
“Steriline has always aimed for excellence,” concludes Federico Fumagalli, Chief Commercial Officer at Steriline. “If this is what our customers find in our products and services, it is because our people and collaborators are experts who share our values. The work of the project teams yet again led to excellent results. This line will help Bausch+Lomb Italia, a leading company in the eye care sector, to further increase its quality standards. I am sure that this reference will also help Steriline to make its way into the world of ophthalmic products, a rapidly growing sector.”
