Steriline, a European company producing standard and robotic lines for the aseptic processing of injectable products, ends 2024 by consolidating its presence in the ophthalmic sector, a market in which Annex 1 has required a significant improvement in technologies.
Steriline
Because of its over thirty years of experience in the sterile-environment filling of injectable drugs, Steriline was chosen by Tubilux Pharma, which is part of the Content Group.
The advanced technologies in the group’s plants, combined with extensive professional skills and human qualities, make Content Group a solid pharmaceutical company specialised in the development, production, filling and packaging of pharmaceuticals for third parties. The group is one of the main European players in the ophthalmic sector, with clients worldwide and sales worth €97.8 million in 2023. It has significant growth prospects in Europe, the Middle East and North Africa and can now extend its activities to the US, following the FDA's approval of the Tubilux Pharma site in Pomezia (central Italy).
The update of Annex 1 has required all companies producing or processing medicinal products to adjust and comply with the new rules. The ophthalmic sector was no exception and had to consider new ways to process drugs, introducing a different approach that is very similar to the one for processing injectable drugs, a sector in which Steriline has been operating for 30 years. In accordance with Annex 1, the Steriline lines expose the product and everything in contact with it to a laminar air flow, allowing the loading of consumables and assembly of components in contact with the product to occur in aseptic conditions.
“The continuous innovation and experience the Company has gained with machines for sterile injectables means that we are now also identified and selected for the filling and management of ophthalmic drugs,” says Filippo Parini, Steriline sales area manager. “We are committed to developing equipment that not only meets the needs of today’s pharmaceutical industry but is also able to contribute to a more sustainable future for the pharmaceutical industry itself.”
Steriline’s considerable years of experience in the production and fine-tuning of standard and robotic machines for the processing of sterile injectables has enabled the company to produce adjusted lines that comply with the recent regulations and are also suitable for the ophthalmic sector. Underlying this new conquest are the concepts of quality by design, first air, assembly of components in direct contact with the product and loading of consumable components under aseptic conditions, in situ sterilisation systems, CIP (Clean-In-Place) and SIP (Sterilisation-In-Place), process controls.
Tubilux Pharma has chosen the Steriline ophthalmic line to fill glass and plastic vials with eye drops and freeze-dried products, with the aim of increasing production capacity while being fully compliant with Annex 1 and in line with industry best practices (GMP). The chosen line has great flexibility in processing different types of containers with a streamlined format change process: from classic plastic vials combined with different closure systems (stopper and screw cap, or sealing systems for multi-dose, preservative-free formulations), to glass vials with lyo cap.
“After an initial scouting phase with three possible partners, we chose Steriline, which showed us the advantages and business opportunities that their line could offer us, solving the problem of compliance with Annex 1, providing us with an innovative and compact line for sterile packaging suitable for the ophthalmic sector and increasing the capacity for preparing freeze-dried products,” says Andrea Piersigilli, site director of Tubilux Pharma.
Line testing will be completed by the end of 2024; the line will then be installed at Tubilux Pharma at the beginning of next year, so it will be definitively ready for production in the second half of 2025.