BSM flexible clinical scale aseptic filling system do not restricts the choice of the container and has been considered a revolutionary solution by pharma manufacturers.
Berkshire Sterile Manufacturing in collaboration with Fedegari is now able to offer a cost-effective solution using a flexible isolator based sterile manufacturing system. BSM is already working closely with pharmaceutical industries to help advance their product candidate into the pre-clinical or clinical setting. With the necessary experience and capability to provide quality services that do not restrict the choice of the container, BSM is the unique CMO that incorporates 100% isolator technology to the filling lines utilizing state-of-the-art equipment. This technology allows to remove the risk of human contamination from the filling and formulation process as highly suggested by FDA, EMEA and other regulatory bodies.
Flexibility in primary containers
The result of the collaboration between Fedegari and Berkshire is an isolator based filling system that is able to fill different primary containers:
- bulk glass vials
- pre-sterilized nested vials (glass and plastic)
- pre-sterilized nested syringes (glass and plastic)
- pre-sterilized nested cartridges (glass and plastic)
- custom containers (glass and plastic)
The system works with both liquid and lyophilized products and the primary containers do not have to be exposed to hydrogen peroxide before entering the isolator.
“It is cost prohibitive to have multiple production lines, each of which is dedicated to one primary container type (vial, syringe, cartridge, or custom). 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 vapor hydrogen peroxide for all primary container packaging”, explains the CEO of BSM, Shawn Kinney.
“We have worked together with BSM to design and develop the highest performance customized solutions for the American market. This collaboration is a very promising beginning to a long and fruitful cooperation. Our partnership is making available the excellence in sterile manufacturing to improve drug industry productivity in many aspects”, said Giuseppe Fedegari, president of Fedegari Group.
BSM Aseptic Filling Services
The new Berkshire Corporate Center was inaugurated last year. It is equipped with the newest and most advanced technologies in the market – including Fedegari process equipment – to manufacture sterile drugs.
Learn more at: http://berkshiresterilemanufacturing.com