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CLEANROOM TECHNOLO November 2016 49 STERILE FILLING FLEXIBLE CLINICAL SCALE FILLING SYSTEM FOR ALL CONTAINERS Berkshire Sterile Manring is implementing a cost-ective production strate using a flexible isolator-based sterile mancturing stem engineered by Fedegari Many aseptic contract manufacturing organisations face the challenges of small batch sizes, varying primary container types and sizes, and customer expectations of the latest technologies in sterile manufacturing. lt is cost-prohibitive to have multiple production lines, each of which is dedicated to one primary container type (vial, syringe, cartridge or custom). Isolators represent the current trend in sterile filling technologies, but can add significant capita! expense to process manufacturing. 'Isolator-based "flex" lines capable of multiple containers have been used by some industries, but most are unable to accommodate bulk glass vials and some require previous treatment with vapour hydrogen peroxide far all primary container packaging,' explains Shawn Kinney, CEO of Berkshire Sterile Manufacturing (BSM). BSM is implementing a cost-effective strategy using a flexible isolator-based sterile manufacturing system to face all these challenges, and clean and sterile process equipment developer Fedegari is involved in this endeavour with experts in various aspects of fill, finish and contamination control technologies. The result of this collaboration is an isolator-based filling system that is able to fill the following primary containers: • bulk glass vials, • pre-sterilised nested vials (glass and plastic) and syringes (glass and plastic) • pre-sterilised nested cartridges (glass and plastic) • custom containers (glass and plastic) The system works with both liquid and lyophilised products and the primary containers do not have to be exposed to hydrogen peroxide before entering the isolator. Giuseppe Fedegari, president of Fedegari Group, explains: 'More than supplying state-of-the-art equipment to Berkshire's new facility, we are investing in this partnership to ce the challenges The view from outside Berkshire Sterile Manufacturing's new cleanroom Low volume sterile filling within a flexible isolator system of the post-blockbuster pharmaceutical industries.' He adds: 'We have worked together with BSM to design and develop the highest performance customised solutions far the American market. This collaboration is a very promising beginning to a long and fruitful co-operation. Our partnership is making available the excellence in sterile manufacturing to improve drug industry productivity in many aspects.' The biopharmaceutical start-up from Lee in Berkshire County, Massachusetts, focuses on contract manufacturing sterile drugs in the pre-clinical and clinica! phases far pharmaceutical, biotech, and medica! device companies at its new facility. lts services include the filling of syringes, vials, cartridges and dual chamber deces and it also provides formulation development, terminal sterilisation, freeze-drying, analytical chemistry and microbiologica! testing, quality assurance and stability studies. BSM's goal is to address the risks that are associated with drugs produced by small sterile drug manufacturing i I I: I I I , , 1 IJ I 111
