Abstract
Abstract: For medical specialty that area unit administered by sure ways in which like pneumonic delivery, plastic ampoules offers several and points over glass ampoules, vials, or syringes. Plastic ampoules area unit manufacture victimisation blow–fill– seal (BFS) technology. within the BFS method plastic extrusion, molding, antiseptic filling in one line operation. not like tiny molecules, biological drug product, like proteins or being antibodies, area unit a lot of directed to degradation throughout process, which can end in degradation of activity or safety issues. The in operation conditions for a BFS method and therefore the nature of plastic ampoules provides several issues to the steadiness and integrity of biological drug product. during this article, the authors discuss issues within the development and producing of biological product victimisation the BFS method, as well as potential productexposure to elevated temperature, needs for leak detection, and packaging systems. They additionally highlight challenges and techniques for BFS method characterization and validation within the context of biopharmaceutical producing
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