Flexible Clinical Scale Filling System Installation For Aseptic Contract Manufacturing Organization

Berkshire Sterile Manufacturing is implementing a cost-effective strategy using a flexible isolator based sterile manufacturing system.

“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.