Steriline, an Italian manufacturer of fill/finish lines for aseptic processing of injectable drugs, has recently delivered a line to process glassware both in bulk and in ready to use (RTU) tubs to Berkshire Sterile Manufacturing (BSM), n U.S.-based contract development and manufcturing organization (CDMO) performing filling and packaging of injectable drugs for the pharmaceutical and biotech industry.

With the mission of providing the safest sterile drug products for clinical use and small-scale requirements achievable, BSM has consistently grown and, in 2021, called for a new, fully automated, 100% isolator-based, flexible sterile filling line with a freeze dryer able to process vials (bulk and RTU), syringes, and cartridges.

Initially, BSM evaluated local partners and commissioned a filling machine from Colanar, a capping machine from Genesis, and a freeze dryer from IMA. Finally, Steriline was asked to provide the complementary machines and isolators and a Robotic Tub Decontamination System (RTDS2) for RTU tubs by UV built by Claranor to complete the line and incorporate all the equipment in a unique, turn-key design.

“We selected Steriline to work with several other selected equipment manufacturers to fully integrate and create a state-of-the-art, isolator-based sterile filling line because they were a reputable company with a solid track record for providing a high-quality product,” said Shawn Kinney, CEO at BSM. “This filling line incorporates innovative technologies never used before in small volume aseptic fillers setting a new standard of sterility assurance and technology in aseptic manufacturing.”

The five providers joined forces and worked together for the first time to deliver the solution by 2022.

Eleonora Rizzi, project manager at Steriline, said, “Bi-weekly meetings have become a fixed appointment for more than a year, requiring constant commitment also from the management point of view to update all players. BSM shared an agenda of topics in preparation for each meeting and, depending on the issues, we involved our technicians to ensure a quality sharing of information with the other teams.”

A series of additional one-to-one meetings among suppliers were made to solve technical incongruences, from dimensions to speed and capacity, and to integrate the Supervisory Control And Data Acquisition (SCADA) systems of the machines.

The line’s flexibility is a core value. It processes up to 3,000 units/hour from 2R to 100R vials in RTU tubs, from 0.5 mL to 5 mL syringes and 3 mL cartridges. In addition, the solution can manage vials in bulk from 2R to 100 mL-VI53 with an overall production capacity that ranges between 3,000 units/hour to 900 units/hour.

Ron Trefzger, associate director of engineering at BSM, recounts the complexity yet efficiency of this project led by Steriline as provider of the majority 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 be able to process multiple container types and sizes in order for the line to fit our needs. Steriline has been instrumental in designing a solution to meet our needs and incorporating equipment from other suppliers 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 visceral. Listening to them is crucial to understand their needs, develop personalized solutions and teach them how they can maximize the value of our solution. Customer satisfaction is a lever for further ambitious collaborations and the developing of new technologies and products at the state-of-the-art.” 

After the installation of the solution, that increases the BSM production capacity allowing the company to service clients further in their clinical studies and attract new ones for flexibility and state-of-the-art equipment, Steriline has also planned a training course to BSM on the new isolator system.