Steriline Provides Fill-Finish Solution For Berkshire Sterile Manufacturing
With the mission to provide the safest sterile drug products for clinical use and achievable small-scale needs, BSM has grown steadily and in 2021 required a new, fully automated, 100% isolator-based, flexible sterile filling line with freeze dryer, capable of filling vials (bulk and RTU), syringes and cartridges.
First, BSM evaluated local partners and commissioned a Colanar filling machine, a Genesis capping machine and an IMA freeze dryer. Finally, Steriline was asked to provide the complementary machinery and isolators, as well as a Claranor-built Robotic Tub Decontamination System (RTDS2) for RTU tubs, to complete the line and integrate all equipment in a unique turnkey design.
“We selected Steriline to work with several other select equipment manufacturers to fully integrate and create a state-of-the-art isolator-based sterile filling line because they are a well-respected company with a solid track record of delivering a high-quality product,” said Shawn Kinney, CEO of BSM. “This filling line incorporates innovative technologies never before used in small volume aseptic fillers and sets a new standard for sterility assurance and technology in aseptic manufacturing.”
The five vendors joined forces and worked together for the first time to deliver the solution by 2022.
Eleonora Rizzi, Project Manager at Steriline, said: “Meetings every two weeks have become a fixed date for more than a year, which also requires constant commitment from a management perspective to keep all stakeholders informed. BSM shared a thematic agenda to prepare each meeting and, depending on the issue, we involved our technicians to ensure quality information sharing with the other teams.”
A number of additional one-on-one meetings between suppliers were conducted to resolve technical mismatches, from dimensions to speed and capacity, and to integrate the machines’ SCADA (Supervisory Control And Data Acquisition) systems.
The flexibility of the line is a core value. It processes up to 3,000 units/hour from 2R to 100R vials in RTU containers, from 0.5mL to 5mL syringes and 3mL cartridges. In addition, the solution can manage vials in bulk from 2R to 100mL-VI53 with a total production capacity of 3,000 units/hour to 900 units/hour.
Ron Trefzger, Associate Director of Engineering at BSM, recounts the complexity and efficiency of this project, led by Steriline as the supplier of most of the machines. “Integrating equipment from five companies into one line was a huge project,” he said. “We asked for a completely unique design and process flow to handle multiple container types and sizes to ensure the line met our needs. Steriline was instrumental in developing a solution that met our needs and integrating third party equipment to create a flexible, high quality and innovative line. Communication was constant and progress was steady.”
Federico Fumagalli, Chief Commercial Officer at Steriline, said: “The relationship between us and our customers is profound. Listening to them is crucial to understanding their needs, developing personalized solutions and teaching them how to maximize the value of our solution. Customer satisfaction is a lever for further ambitious cooperation and the development of new technologies and state-of-the-art products.”
After installing the solution, which increases BSM production capacity and allows the company to continue to serve customers in their clinical trials and attract new customers for flexibility and state-of-the-art equipment, Steriline has also planned a training course for BSM on the new isolator system.
