Steriline has revealed details of the product development that saw the aseptic processing expert deliver customised equipment for research and development (R&D) to Ferring, the Swiss pharmaceutical company with a global footprint.
Ferring Pharmaceuticals, a specialist in reproductive medicine, maternal health and in areas within gastroenterology, urology, endocrinology and orthopaedics, partnered with Steriline to satisfy the need for a small-scale customised vial capping and decontamination machine for high potent freeze-dried drugs processing. Ferring also required a small-scale external washing machine for vials and cartridges.
The Steriline and Ferring collaboration started in June 2017. Both companies joined forces at the Ferring International PharmaScience Center (IPC) in Copenhagen, with the technical assistance of Jacobs Engineering Milan.
"We experienced a good and open collaboration between three companies: Steriline, Jacobs Engineering and Ferring IPC," commented Anders Magnusson, Senior Scientist & Project Manager, Pharmaceutical Development, Ferring IPC. "Together we found the way to develop good engineering solutions focused on functionality, flexibility and personal safety," he added.
Flexible and small-scale solution
Steriline developed a flexible and small-scale solution, which is different from what's currently available on the market. The equipment features a customised monobloc made of a vial capping machine (VCM50) and external decontamination machine (EDM-C), with the new application of a transfer shuttle for moving vials from the freeze drier to the capping machine, and a robotic washing machine for vials and cartridges.
The equipment is now in use, and I am confident that it will improve and increase the efficiency of our development process for new drug products
"Developing novel equipment is known to be a challenging process," commented Helena Nicklasson, Vice President Global Product Development & Drug Delivery, Ferring IPC. "However, with the good collaboration of the three companies, the equipment is now in use, and I am confident that it will improve and increase the efficiency of our development process for new drug products," she added.
The project achieved yet another unique feature: the compact design of both machines allows for working under cRABS with common pressure control from the EDM-C.
Steriline's RL-1: Robotic washing machine for vials and cartridges customised for Ferring
Creativity, flexibility and reliability
Thanks to a continuous and open dialogue, the Steriline-Ferring-Jacobs team succeeded in finding solutions to all the different challenges they faced. For example, due to space constraint, the teams carried out a joint study for the application of a PUSH/PUSH filter and provided a safer filter change procedure from the inside of the EDM-C unit.
The bigger challenge, however, came up when the proposed standard washing machine (RA-V4) was still over-dimensioned for Ferring batch size. Steriline insisted and proposed the prototype of a machine studied explicitly as an alternative solution: a miniature robotic washing machine (RL-1) capable of handling vials and cartridges loaded from trays.
Again, through open dialogue and ongoing guidance to the client, Steriline met Ferring expectations about flexibility, price and delivery.
Every issue that came up during the project lifecycle was addressed promptly, and the RL-1 machine redesign was finally carried-out successfully. The full project implementation, from the kick-off meeting until the end of the site acceptance test (SAT) took only 18 months. A record time, considering all risks for designing, developing and evaluating prototypes for this kind of new customised machines.
"The area of R&D is very challenging with clients asking for support when there are new drugs to be developed," commented Federico Fumagalli, Chief Commercial Officer at Steriline. He continued: "We usually work on customising our standard solutions or on developing the new ones according to the specific requirements. And this was exactly the case with Ferring."
Steriline has proven to be the perfect partner to design and plan together new solutions to satisfy all client's requirements, as proven by Ferring.
The success of this project is leverage by Steriline's accurate and widespread assistance and training service, and the exceptionally striking cooperation attitude of the teams.
