New advanced aseptic manufacturing technologies are available for filling liquid pharmaceuticals, including biologics.
In blow-fill-seal (BFS) technology, which is a form of advanced aseptic manufacturing, the container is formed, filled, and sealed in one continuous, automated system. A primary advantage of this technology is reducing human intervention, which reduces the risk of microbial contamination and foreign particulates. BFS has long been used in liquid pharmaceutical applications, including small containers, such as ophthalmic and respiratory drug ampoules, as well as larger volume containers, such as saline or dextrose solutions. More recently, BFS technology has been expanding into injectables and into biologics, including vaccines and monoclonal antibodies (mAbs).
(For ampoules with one set of molds for 10ml ampoule having 15 twin molds of 20 cavities.)
The System is having sequential combination of plastic extrusion followed by blowing, filling and sealing in a rotary mold mechanism. Plastic granules are fed in to the barrel through hopper and a capsule shape parison is extruded. Extruded parison is then taken out of the rotating blow molds and blown in to the shapes of pre shaped cavities of each mold. While the parison is blown in to cavities, filling is being done through stationary nozzles centered between the set of molds. Filled cavities of each mold are being sealed immediately by following set of molds.