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CDMO Adds Sterile Fill/Finish Line for Vials, Syringes, and More

Berkshire Sterile Mfg. chose Steriline to work with several suppliers to integrate an automated, isolator-based sterile filling line with lyophilization capability. The line processes multiple container types/sizes for pharma and biotech products.

The sterile filling line delivered to BSM. (Image: Steriline)
The sterile filling line delivered to BSM. (Image: Steriline)

Berkshire Sterile Manufacturing (BSM) is an American contract manufacturing and development organization (CDMO) that performs 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 possible, 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 machines from five different suppliers: 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, 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.

Steriline, an Italian manufacturer of fill/finish lines for aseptic processing of injectable drugs, recently delivered the integrated line to process glassware both in bulk and in ready to use (RTU) tubs to BSM. “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,” says 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.”

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