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 character to the pulsed light generator, produced by Claranor. The decontamination chamber is just part of an isolator system being built by Steriline, a company that specializes in producing complete lines for the aseptic processing of injectable products. Other critical equipment 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 into 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.
