“We can perceive there’s a real need in the area for sterile manufacturing, not just locally but nationally”, said Andrea Wagner, BSM’s senior vice president for business development.

The biopharmaceutical firm focus on contract manufacturing sterile drugs in the pre-clinical and clinical phases for pharmaceutical, biotech, and medical device companies at its new facility. Berkshire Sterile’s services include the filling of syringes, vials, cartridges, and dual chamber devices and also provide formulation development, terminal sterilization, freeze-drying, analytical chemistry and microbiological testing, quality assurance, and stability studies.

BSM’s goal is to address the risks that are associated with drugs manufactured by small sterile drug manufacturing companies that lack adequate modern facilities and rigorous quality systems. The company plans to alleviate these concerns by using state-of-the art manufacturing equipment, isolators, flexible sterile filling equipment, and modern cleanroom and terminal steam sterilization capabilities.

“Many Aseptic Contract Manufacturing Organizations face the challenges of small batch sizes, varying primary container types and sizes, and customer expectations of the latest technologies in sterile manufacturing.  It 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 capital 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 vapor hydrogen peroxide for all primary container packaging”, explains the CEO of BSM, Shawn Kinney.

Berkshire Sterile Manufacturing implemented a cost effective strategy using a flexible isolator based sterile manufacturing system to face this challenges. Fedegari is proudly involved in this endeavor 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-sterilized nested vials (glass and plastic) and syringes (glass and plastic), pre-sterilized nested cartridges (glass and plastic), and 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.