A New Technology Increases Sterility Assurance in Parental Manufacturing
Berkshire Sterile Manufacturing to be the first company in the U.S. to incorporate pulsed light into their sterile filling line
Lee, MA, March 02, 2021 (GLOBE NEWSWIRE) -- A new technology, called pulsed light decontamination, increases sterility assurance for the aseptic processing of injectables. On March 10, 2021 at 1PM EST, Berkshire Sterile Manufacturing, Claranor, and Steriline will present this technology and how it works in a webinar: How pulsed light technology provides added sterility assurance in sterile processing. This webinar is one in a series of presentations in their free webinar series, The Future of Small Scale Sterile Filling. The series was produced in collaboration with five leading equipment manufacturers: Claranor, Colanar, Genesis, IMA, and Steriline, with the goal of providing free information regarding the application of the latest technologies in small scale sterile filling.
Pulsed light decontamination sterilizes the outside of ready-to-use (RTU) tubs containing syringes, vials, or cartridges before they are introduced into an isolator-based sterile filling line. The innovative technology uses a high intensity broad spectrum pulsed light to sterilize the surface of the RTU tubs. The decontamination chamber, built by Steriline, involves an isolator-based, highly sophisticated robot arm that picks up tubs and presents each surface to the pulsed light generator, produced by Claranor. The decontamination chamber is just part of an isolator system being built by Steriline, a company specialized in producing complete lines for aseptic processing of injectable products. Other critical equipment in the system includes a filling system by Colanar, a lyophilizer from IMA, and a capping/closure system produced by Genesis.
Fill Finish CMO, Berkshire Sterile Manufacturing (BSM), will be the first company in the United States to incorporate this technology a sterile filling line. The line is currently under construction and will be in operation in Q1-2022. This technology will sanitize RTU tubs to a 6-log reduction in bioburden, significantly improving sterility assurance over the industry standard, no-touch-transfer systems.
“One of the greatest risks of contamination in sterile filling is the introduction of materials into the filling line,” said BSM CEO and Cofounder, Shawn Kinney. “This technology will provide active decontamination to RTU tubs and effectively eliminate that risk. This new filling line will redefine the requirements for sterile filling operations.”
This event is a perfect opportunity for viewers to get in depth information from experienced leaders in the industry.
Those interested can register for this free event here: https://berkshiresterilemanufacturing.com/how-pulsed-light-technology-provides-added-sterility-assurance-in-sterile-processing/
All other events as a part of this series are available to view here: https://berkshiresterilemanufacturing.com/the-future-of-small-scale-sterile-filling/
About Berkshire Sterile Manufacturing
Berkshire Sterile Manufacturing (BSM) is a fill finish CMO providing the safest and highest quality injectable drug products achievable for clinical trials and small commercial requirements. BSM uses advanced technologies, state-of-the-art flexible fillers based in isolators to fill syringes, cartridges, vials (RTU or bulk), lyophilized product, and unique containers.
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Andrea Wagner Berkshire Sterile Manufacturing 413-243-0330 info@berkshiresterile.com
