Case Study Small Scale Solution for R&D

Editor: Ahlam Rais

Creativity, reliability and flexibility is vital to build business relationships — The case study elaborates on a promising partnership between different companies regarding the design of R&D machines for the pharmaceuticals industry which resulted in developing good engineering solutions that focused on functionality, flexibility and personal safety.

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The Capping machine (VCM50) for freeze-dried vials includes a transfer shuttle and an external decontamination (EDM-C).
The Capping machine (VCM50) for freeze-dried vials includes a transfer shuttle and an external decontamination (EDM-C).
(Source: Steriline)

Steriline, a highly specialised manufacturer of complete lines for the aseptic processing of injectable drugs, started a new promising collaboration with Ferring Pharmaceuticals, a leader in reproductive medicine, maternal health and in specialty areas within gastroenterology, urology, endocrinology and orthopedics.

Founded in 1950, Ferring Pharmaceuticals now employs more than 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. The company invests heavily in the process of creating new medicines through its research and development centers and research collaboration with scientific institutes as well as biotechnology and pharmaceutical companies throughout the world.

Successful Collaboration Since June 2017

Steriline and Ferring International Pharmascience Center (IPC) in Copenhagen started their partnership in June 2017, with the technical assistance of Jacobs Engineering Milan. The collaboration satisfied the pharmaceutical company’s R&D needs of a small-scale customised Vial Capping & Decontamination Machine for high potent freeze-dried drugs processing, and a small-scale External Washing Machine for vials and cartridges.

Steriline developed the project of a flexible and small-scale solution, different from its competitors, including a customised monobloc constituted by a Vial Capping ­Machine (VCM50) and an Exter- nal 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 & cartridges.

The compact design of both machines was perfectly suitable to work under “Crabs” with common pressure control from EDM-C. Thanks to a continuous and open dialogue, the team succeeded in finding solutions to all different challenges they faced. For example through a joint study for the application of a Push/Push filter, providing a safer filter change procedure from the inside of the EDM-C due to space constraint. Anders Magnusson, Senior Scientist & Project Manager, Pharmaceutical Development, Ferring IPC stated, “We experienced a good and open collaboration between the three companies. Together we found the way to develop good engineering solutions focused on functionality, flexibility and personal safety.”


Miniaturisation Solves Big Problems

Nevertheless, the bigger challenge came out when the proposed Standard Washing Machine (RA-V4) was still over dimensioned for Ferring’s batch sizes. Steriline insisted and proposed the prototype of a machine which was specifically studied as an alternative solution: a miniature Robotic Washing Machine (RL-1) capable of handling vials and cartridges loaded from trays. In fact, through open dialogue and ongoing guidance to the client, Steriline met Ferring’s expectations with regards to flexibility, price and delivery.

During the project lifecycle some problems occurred but even the RL-1 machine redesign was finally carried-out without any specific issue. The whole project implementation, from the kick-off meeting until the end of the Site Acceptance Test (Sat) took only 18 months: an exceptional timing considering all risks for designing, developing and evaluating prototypes for this kind of new customised machines. “Developing novel equipment is known to be a challenging process. However, with the good collaboration of all 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,” affirmed Helena Nicklasson, Vice President Global Product Development & Drug Delivery, Ferring IPC.

All this was made possible thanks to Steriline’s accurate and widespread assistance as well as training service. The project teams showed an exceptionally striking cooperation attitude. “The area of R&D is very challenging with clients asking for support when there are new drugs to be developed,” declared Federico Fumagalli, Chief Commercial Officer at Steriline. “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,” adds Fumagalli.

Steriline has proven to be the perfect partner to design and plan together new solutions to satisfy all client requirements, as in the case of the miniature washing machine. When it became clear that a part of the project was being questioned, the company carried out the design of a machine that could solve the problem and perfectly fit-in with production and space requirements.

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Additional Information
Interview with Federico Fumagalli, Chief Commercial Officer, Steriline
High Demand for Personalised Medicine Filling Machines

? What is the current trend in the global pharmaceutical industry?

Federico Fumagalli: Until some years ago, big pharmaceutical companies preferred multi-purpose production lines, capable of processing different formats at high-speed. Now the general trend is to install smaller dedicated lines working at a lower speed. This allows, in case the market requires any kind of change in production, to adapt the lines to the new requirements in a faster and easier way. Additionally, this approach also avoids complete production downtime.

? What are the ongoing trends in the aseptic processing market regarding injectable drugs?

Fumagalli: Robotic applications are progressively more and more available for aseptic processing of injectable drugs, mainly due to the flexibility, and reliability of robots. This also saves the operator’s time otherwise they would need to change several parts of the machine to fill different kinds of containers such as vials, syringes and cartridges, as well as different formats of the same container. With robotic machines, they just have to change a few parameters on the robot set-up.

? Please mention one of the latest solutions offered by Steriline for the Pharma industry. What are its benefits to industry players?

Fumagalli: Considering major companies manufacturing machines for the pharmaceutical industry, Steriline often had an “avant-garde” role. Steriline is among the few worldwide producers of aseptic filling machines for injectable drugs with robot transport systems, designed for both bulk and ready-to-use containers. Our robotic machines can also fill up to 6,000 vials per hour, much higher than what competitors can do.

? What are the challenges faced by pharmaceutical companies? How can it be overcome?

Fumagalli: Currently, the most common request coming from pharmaceutical companies is for “personalised” medicine filling machines, capable of a quick format change between the different vial sizes guaranteeing minimum operator interventions and production downtime. Our machines also follow a “zero-loss philosophy” (all missing stoppers/caps are collected and re-applied during the process) that today represents a huge advantage for pharma companies as compared to traditional applications.