Fill Finish CMO, Berkshire Sterile Manufacturing (BSM), will reveal its new, fully automated, 100% isolator-based filling line in a webinar on November 16th at 1PM EST.
In 2020, BSM finalized plans and secured funding for a fully automated, 100% isolator-based, and highly flexible filling line for small scale sterile filling. BSM worked with five equipment manufacturers (Claranor, Colanar, Genesis, IMA, and Steriline) to develop a unique and customized product. Construction of the new line finished end of Q3 2022, and it is currently undergoing validation.
“We designed this line to have the ultimate flexibility of any automated and isolator-based filling line in the world,” said CTO and cofounder, Dr. Andrea Wagner.
The line can process bulk and RTU vials, syringes, and cartridges of varying sizes in batch sizes up to 60,000 units, and it has lyophilization capacity up to 35,000 10R vials in a single run with potential to add additional capacity down the road.
“The technology that we put into this line is incredible,” said BSM Associate Director of Engineering, Ron Trefzger, “This line features a Pulsed UV Light RTU tub decontamination chamber, an advanced flexible filling machine complete with robots, and an operator-less and fully isolated system to enhance flexibility, processing speed, and, of course, sterility assurance.”
BSM will introduce the new line in a documentary-style video with interviews of eight key contributors from Berkshire Sterile, including the company’s CEO, CTO, Associate Director of Engineering, Associate Director of Validation, Microbiology Manager, Director of Quality Assurance, Associate Director of Quality Assurance, and Vice President of Sales. The event will also include a physical walk-through of the filling line with the Associate Director of Validation.
The video will air in a webinar on November 16th at 1PM EST.
Those interested can register for this free event at https://berkshiresterilemanufacturing.com/events/webinars/introducing-the-future-of-sterile-filling/
About Berkshire Sterile Manufacturing
Berkshire Sterile is a state-of-the-art fill finish contract manufacturer that is specialized in small-scale sterile filling of vials, syringes, and cartridges for biotech and pharmaceutical industries. BSM also offers terminal steam sterilization of syringes, specialty filling, and lyophilization of vials all within an isolator. Analytical support, stability studies, lyophilization development, formulation development, and method development are also offered. For more information, please visit the company’s website (https://berkshiresterilemanufacturing.com/) or contact them at firstname.lastname@example.org.
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